May 16, 2019

Santec Corporation
℅ Dave Yungvirt
CEO
Third Party Review Group, LLC
25 Independence Blvd
Warren, NJ 07059

Re: K191051
Trade/Device Name: Argos
Regulation Number: 21 CFR 886.1850
Regulation Name: AC-powered slitlamp biomicroscope
Regulatory Class: Class II
Product Code: MXK
Dated: April 17, 2019
Received: April 19, 2019

Dear Dave Yungvirt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.
K191051 - Dave Yungvirt Page 2

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling
(21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events)
(21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products
(see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820)
for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act);
21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification"
(21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation
(21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and
Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website
(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or
phone (1-800-638-2041 or 301-796-7100).

Sincerely,
Alexander Beylin - 2019.05.16
S 17:08:14 -04'00'
for Malvina B. Eydelman, M.D.
Director
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: January 31, 2017
Indications for Use See PRA Statement below.

510(k) Number (if known)

K191051

Device Name
ARGOS (ARGOS ver1.5)

Indications for Use (Describe)

ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The
device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate
intraocular lens (IOL) power and type for implantation during intraocular lens placement. ARGOS measures the
following 9 parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, K-values (Radii of
flattest and steepest meridians), Astigmatism, White-to-white (corneal diameter) and Pupil Size. The Reference Image
functionality is intended for use as a preoperative and postoperative image capture tool.
It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the
supervision of a physician.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
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Office of Chief Information Officer
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“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (1/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
 K191051
510(k) SUMMARY

The information contained in this premarket notification 510(k) summary is submitted as required by
21 CFR 807.92:

1. Type of Submission
510k Traditional submission for New Devices

2. Applicant Company:
SANTEC CORPORATION
5823 Ohkusa-Nenjozaka,
Komaki, Aichi 485-0802, JAPAN
Phone: 81 (0568) 79 3535
www.santec.com

3. Applicant (Contact Person) Name:

Changho Chong

4. Date Summary Prepared:

May 15, 2019

5. Device Trade / Proprietary Name (Model name):

ARGOS (ARGOS ver1.5)

6. Common Name:
Optical Biometer

7. Regulation

Regulation Number: 21 CFR 886.1850

Regulation Name: AC-Powered Slitlamp Bio-Microscope
Regulatory Class: Class II
Product Code: MXK

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8. Indications for Use:

ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence

tomography (SS-OCT). The device is intended to acquire ocular measurements as well as
perform calculations to determine the appropriate intraocular lens (IOL) power and type
for implantation during intraocular lens placement. ARGOS measures the following 9
parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness,
K- values (Radii of flattest and steepest meridians), Astigmatism, White-to-white
(corneal diameter) and Pupil Size. The Reference Image functionality is intended for use
as a preoperative and postoperative image capture tool.
It is intended for use by ophthalmologists, physicians, and other eye-care professionals
and may only be used under the supervision of a physician.

The indications for use are similar between the proposed and predicate ARGOS devices.
The proposed ARGOS device has additional reference image functionality as minor
difference.

9. Device Descriptive
The ARGOS is substantially equivalent to the predicate device identified previously:

• the ARGOS (Santec Corporation) that was cleared by the FDA on October 2nd,
2015(K150754) as the primary predicate as it has the most similar intended use and
characteristics
• the IOLMaster 700 (Carl Zeiss Meditec) that was cleared by the FDA on June 29,
2015 (K143275, K170171) as an additional (secondary) predicate to support a new
feature of reference image capture on the version of ARGOS in this submission.
The predicate devices are Class 2 devices to premarket notification, as defined per
regulation number 21 CFR 886.1850. In addition, the predicate devices have product codes
of MXK(ARGOS), and HJO(IOLMaster700).
The version of ARGOS in this submission is a modified version of the Argos cleared under
K150754 which is substantially equivalent with regard to intended use, operating principle,
function, materials, and energy source. The differences from the predicate ARGOS
(K150754) that are subject of this 510(k) submission are:
• An additional feature of reference image capture function
• Labeling change including change in the intended use adding the feature of reference
image capture.
• This image can be transferred to image guided devices in order to support the
execution of preoperative plan.

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The changes described in this submission do not affect how the hardware is used to acquire
measurements as a biometer, nor do these changes affect the principle of operation of the
device.

10. Guidance on the Recognition and Use of Consensus Standards:

ARGOS complies with the requirements of listed FDA Recognized Consensus Standards.
Compliant standard Description Classification
ANSI/AAMI ES 60601-1 Electrical safety Class 1 Type B
IEC 60601-1-2 Electrical safety Refer to Appendix 4
IEC 60529 Housing protection IP20
ANSI.Z80-36 Ophthalmics - Light Hazard Group 2
Protection For Ophthalmic
Instruments
IEC 62471 LED light hazard Exempt group
IEC 60825-1 Laser product safety Laser Class 1
ISO 10343 Ophthalmometer

Page 3
 11. Substantial equivalence to the predicate device
11.1 Comparisons of technological characteristics with Predicate ARGOS devices
Table of Comparison between the ARGOS and the Predicate Device
New Device (Subjective device) Primary Predicate Device Secondary Predicate device Comparison
Manufacturer santec corporation santec corporation Zeiss Meditech -
Model ARGOS ver1.5 ARGOS IOLMaster 700 -
510(k) number K150754 K143275, K170171 -
Class II II II Same
Classification Ophthalmic device panel Same
Ophthalmic device panel Ophthalmic device panel
panel
Product code MXK MXK HJO Same
Classification AC-Powered Slitlamp Bio- Device, Analysis, Anterior AC-Powered Slitlamp Bio- Same
number Microscope Segment Microscope
Type Optical biometer Optical biometer Biometer Same
ARGOS is a non-invasive, non-contact ARGOS is a non-invasive, non- The indications for use are identical Similar to Primary,
biometer based on swept-source contact biometer based on swept- between the subject and predicate additional feature
optical coherence tomography (SS- source optical coherence IOLMaster 700 devices. identical to
OCT). The device is intended to tomography (SS-OCT). The device The IOLMaster 700 is intended for
acquire ocular measurements as well is intended to acquire ocular biometric measurements and
secondary
as perform calculations to determine measurements as well as perform visualization of ocular structures. The predicate
the appropriate intraocular lens (IOL) calculations to determine the measurements and visualization assist
power and type for implantation during appropriate intraocular lens (IOL) in the determination of the appropriate
intraocular lens placement. ARGOS power and type for implantation power and type of intraocular lens.
measures the following 9 parameters: during intraocular lens placement. The IOLMaster 700 measures:
Axial Length, Corneal Thickness, ARGOS measures the following 9 • Lens thickness
Anterior Chamber Depth, Lens parameters: Axial Length, Corneal • Corneal curvature and thickness
Intended Use Thickness, K-values (Radii of flattest Thickness, Anterior Chamber • Axial length
and steepest meridians), Astigmatism, Depth, Lens Thickness, K-values • Anterior chamber depth
White-to-white (corneal diameter) and (Radii of flattest and steepest • Pupil diameter
Pupil Size. The Reference Image meridians), Astigmatism, White-to- • White-to-white distance (WTW)
functionality is intended for use as a white (corneal diameter) and Pupil For visualization, the IOLMaster 700
preoperative and postoperative image Size. employs optical coherence
capture tool. It is intended for use by tomography (OCT) to obtain two-
It is intended for use by ophthalmologists, physicians, and dimensional images of ocular
ophthalmologists, physicians, and other eye-care professionals and structures of the anterior and posterior
other eye-care professionals and may may only be used under the segments of the eye.
only be used under the supervision of supervision of a physician. The Reference Image functionality is
a physician. intended for use as a preoperative and
postoperative image capture tool.
Axial Length, Corneal Thickness, Axial Length, Corneal Lens thickness, Corneal Same parameters
Anterior Chamber Depth, Lens Thickness, Anterior Chamber curvature and thickness, Axial
Thickness, K-values (Radii of Depth, Lens Thickness, K- length, Anterior chamber
Measured flattest and steepest meridians), values (Radii of flattest and depth,Pupil diameter, White-to-
parameters Astigmatism (Toric Angle), White- steepest meridians), white distance (WTW)
to-white (corneal diameter), and Astigmatism (Toric Angle),
Pupil Size. White-to-white (corneal
diameter), and Pupil Size.
In-vivo Axial length: range 14-38mm, SD Axial length: range 14-38mm, Axial length: range 14-38mm, Same between
repeatability 0.01mm SD 0.01mm SD 0.005mm subjective and
Corneal thickness: range 200- Corneal thickness: range 200- Corneal thickness: range 200- primary, Similar
between subjective
120um, SD 10um 120um, SD 10um 120um, SD 2.5um
and secondary
Anterior Chamber Depth: range Anterior Chamber Depth: Anterior Chamber Depth: range predicate
0.7-8.0mm SD 0.01mm range 0.7-8.0mm SD 0.01mm 0.7-8mm SD 0.007mm
Lens Thickness: range 0.5- Lens Thickness: range 0.5- Lens Thickness: range 1-10.0mm
10.0mm SD 0.02mm 10.0mm SD 0.02mm SD 0.006mm
Keratometry: range 5.5-10.0mm Keratometry: range 5.5- Keratometry: range 5-11.0mm SD
SD 0.02mm 10.0mm SD 0.02mm 0.09D(~0.02mm)
Astigmatism: range 0-180deg, SD Astigmatism: range 0-180deg, Astigmatism: range 0-180deg, SD
5deg (Cylinder>1D) SD 5deg (Cylinder>1D) 3.8deg (Cylinder>0.75D)
Pupil size: range 2-13mm SD Pupil size: range 2-13mm SD Pupil size: (no specification
0.09mm 0.09mm available)
White-to-White: range 7-15mm White-to-White: range 7-15mm White-to-White: range 8-16mm
SD 0.06mm SD 0.06mm SD 0.111mm

Page 4
 Same
Method for
Interferometry (SS-OCT) Interferometry (SS-OCT) Interferometry (SS-OCT)
biometry

Method for Same

Video keratometry (16 LED) Video keratometry (16 LED) Video keratometry (IR LED)
keratometry
Optical
radiation
Same
Wavelength swept laser (3kHz Wavelength swept laser (3kHz Wavelength swept laser (2kHz
Type of light swept rate) swept rate) swept rate)
source
Wavelength 1060nm Wavelength 1060nm Wavelength 1055nm Same
Power <0.72mW (<0.1mW Power <0.72mW (<0.1mW Same
average at 1mm aperture during average at 1mm aperture unavailable
B-scan) during B-scan)

Same
Class 1 (IEC 60825) Class 1 (IEC 60825) Class 1 (IEC 60825)
(ANSI.Z80-36 is
Laser class ANSI-Z80.36-2016 Group2 ISO15004-2 Group2 ISO15004-2 Group2
equivalent to
ISO15004-2)
Light source: IR-LED Light source: IR-LED Light source: IR-LED Same between
Keratometry Wavelength: 850nm Wavelength: 850nm Wavelength: 950nm Primary and
delivered power <0.02mW delivered power <0.02mW subjective
The above (IR-LED) Different
The above (IR-LED)
Illumination The above (IR-LED) Green LED(590nm) for reference
White LED for reference image
image
Different
Fixation light Red(630nm) delivered power Green LED (530nm) delivered
Red(660nm) delivered power
<10nW power <10nW

ANSI/AAMI ES 60601-1, ANSI/AAMI ES 60601-1, Same

Compliant ANSI/AAMI ES 60601-1,
ANSI.Z80-36, ISO62471, ISO15004-2, ISO62471,
standards ISO15004-2, ISO60825
ISO60825, ISO 10343, IP20 ISO60825, ISO 10343, IP20
Input: 100-240V, 50/60Hz I Input: 100-240V, 50/60Hz Input: 100-240V, 50/60Hz Same
Power supply ANSI/AAMI ES 60601 compliant ANSI/AAMI ES 60601 ANSI/AAMI ES 60601 compliant
Secondary side: 24V compliant Secondary side: 24V Secondary side: 24V
Same
Accessories Calibration tool/ Dust cover Calibration tool/ Dust cover ----

11.2 Summary of Differences

Model Proposed ARGOS Predicate ARGOS Secondary(IOLMaster700)
Intended use The Reference Image Camera image was The Reference Image functionality
functionality is intended for use present for alignment is intended for use as a
as a preoperative and purpose but not for preoperative and postoperative
postoperative image capture tool. capture. image capture tool.
Light source for LED 16 @ 850nm LED 16 @ 850nm IR LEDs@ 950nm
illumination LED 8 @ white light Green LEDs @590nm
Fixation LED LED @ 630nm LED @ 530nm LED @ 660nm

Page 5
 Software difference between Proposed Argos 1.5 and Predicate Argos
Model Proposed ARGOS Predicate ARGOS Note
Software Vision Planner software Argos UI software Different
components package
Argos UI software
Interface UI Patient planning(patient Patient information entry Similar
information entry, summary, Summary
IOL power calculation/setting) IOL power calculation/setting
Constant optimization Constant optimization

Measurement with reference Measurement Different

image capture

Analysis Analysis Same

Connection to Connectivity to Verion n.a. Different
external device devices, ORA system

Analysis of Why These Differences Do Not Affect Safety or Effectiveness or Raise Different Questions
of Safety or Effectiveness
Differences Analysis
The Reference Image functionality is intended for use as a
preoperative and postoperative image capture tool. This image is
used for optional guidance for planning subsequent surgical
Intended use adding Reference image planning, but no association to biometer measurement itself.
capture Subjective quality check is done by the user and the user can repeat
the capture.
Secondary predicate (IOLMaster700, K143275) has the same
description of functionality in the intended use.
For power level, duration of white flash illumination for the above
mentioned reference image capture is very short (<0.25sec) and
exposure is well below permissible exposure limits set by the
standards and all compliant with IEC60825, ANSI.Z80.36.
Testing based on ANSI Z80.36 demonstrated that the ARGOS
near-infrared radiation from a swept source is below all of the
LED 8 @ white LED for the above reference
applicable exposure limits-including the guidelines for the Group
image capture
1 ophthalmic instrument for normal use and Group 2 only for
single fault case.
This capture is done successively after biometry/keratometry
measurement and has no effect on the measurement itself.

Very low power, parts identified as exempt from ISO 62471. It is

Fixation LED @630nm
assured that the power level is within ANSI.Z80-36 criteria.

Vision Planner software package acts as interface for the proposed

Argos ver1.5 but contains common functionalities (Patient
information entry, IOL power calculation/setting, constant
optimization) found in Predicated Argos. Software integration with
Vision Planner software package and Argos software was validated
Software module and its usability including reference image capture was evaluated. It
was found to achieve comparable usability to predicate Argos.
(Section 22 Performance Testing-Bench, Appendix 13 Usability
evaluation report), Additional connectivity to external device is
validated in system level test. (Appendix 12. Software Documents for
Vision Planner)

11.3 Substantial Equivalence Conclusion

Comparisons and analysis of technological characteristics of the proposed ARGOS with
Predicate ARGOS devices were performed and found to be substantially equivalent.

Page 6
12. Performance Testing

12.1 Bench Test

Performance of the ARGOS was evaluated by bench tests based on the relevant standards
(ISO15004-1, ANSI.Z80-36, IEC 60825, ISO 10343).
Both ISO 15004-1 and ANSI.Z80-36, and IEC60825 tests prove the fundamental
requirements for ophthalmic instruments and optical radiation safety of ARGOS are
equivalent to predicate device. ISO 10343 tests results provided the required accuracy
performance for ophthalmometer which measures corneal radii of curvature and angle of
meridian with a certain cylinder (toroidal surface).
Hardware specifications were validated for axial/lateral distance measurement accuracy and
range, signal-to-noise ratio, and depth attenuation, to prove that ARGOS meets the hardware
performance requirements.

In addition, usability of the system including user interface software was evaluated and
validated. Usability engineering conforms to IEC 62366, a collateral standard of ANSI/AAMI
ES 60601-1.

12.2 Software Verification and Validation

Software verification and validation were performed according to ISO14971 and FDA
guidance “Guidance for the Content of Premarket Submissions for Software Contained in
Medical Devices” (May 11, 2005). The verification and validation results confirm the
fulfillment of software requirement specifications.

12.3 Cybersecurity review

Cybersecurity hazard analysis and risk management were conducted according to FDA
guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical
Devices” (Oct 2, 2014).

12.4 Conclusion drawn from Performance Testing and Software verification and validation
The summary of bench tests and software verification and validation showed that the
ARGOS was substantially equivalent to the predicate ARGOS devices -Information was
submitted to demonstrate that there are no significant differences in technological
characteristics between the proposed ARGOS and the predicate ARGOS devices.

13. Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based
on the information provided in this Premarket Notification, Santec Corporation concludes
that the ARGOS is safe and effective, and substantially equivalent to predicate devices as
described herein.

END OF SUMMARY

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