DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration

10903 New Hampshire Avenue
Document Control Center - WO66-G609
Silver Spring, MD 20993-0002

January 20, 2016

Oculus Optikgerate Gmbh

Mr. Randy Prebula
Partner
Hogan Lovells US LLP
555 Thirteenth Street NW
Washington, DC 20016

Re: K152311
Trade/Device Name: Pentacam AXL
Regulation Number: 21 CFR 886.1850
Regulation Name: AC-Powered Slitlamp Biomicroscope
Regulatory Class: Class II
Product Code: MXK, HJO
Dated: December 21, 2015
Received: December 21, 2015

Dear Mr. Prebula:

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. 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.

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-
Page 2 - Mr. Randy Prebula

related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product
radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please
contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041
or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the
Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)
796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -A
for Malvina B. Eydelman, M.D.
Director
Division of Ophthalmic, and Ear,
Nose and Throat Devices
Office of Device Evaluation
Center for Devices and Radiological

Enclosure
 Pentacam AXL 510(k) Summary

510(k) SUMMARY

OCULUS Pentacam AXL

General Information

Applicant:

OCULUS Optikgerte GmbH

Mncholzhuserstr. 29
35582 Wetzlar
Germany
Phone: +49(0)641 2005-0
Fax +49(0)641 2005-255
Contact Person:

Mr. Eckhard Loh

Head of Quality and Regulatory Affairs
OCULUS Optikgerte GmbH
Mncholzhuserstr. 29
35582 Wetzlar
Germany
Phone: +49(0)641 2005-0
Fax +49(0)641 2005-255
Summary Prepared: December 18, 2015
Device Information

Classification Name: Device, analysis, anterior segment

(AC-powered slitlamp biomicroscope)
Trade/Propriety Name: Pentacam AXL
Regulation Number: 886.1850
Device class: II
Product Code: MXK, HJO

Predicate Devices

Carl Zeiss Meditec AG, IOLMASTER 500 (K122418)

OCULUS Optikgerte GmbH, Pentacam Scheimpflug Camera (K030719)
 Pentacam AXL 510(k) Summary

Intended Use / Indications for Use

The intended use of the Pentacam AXL is defined as:

The Pentacam is designed to take photos of the anterior segment of the eye
which includes the cornea, pupil, anterior chamber and lens of the eye. To
evaluate:

corneal shape,
analyze condition of the lens (opaque crystalline lens),
analyze the anterior chamber angle,
analyze anterior chamber depth,
analyze the volume of the anterior chamber,
analyze anterior or posterior cortical opacity,
analyze the location of cataracts (nuclear, sub capsular
and or cortical), using cross slit imaging with densitometry,
corneal thickness,
axial length,
white-to-white distance.

The Pentacam AXL also performs calculations to assist

physicians in determining the power of the intraocular lens for
implantation.

Product Description/Technological Characteristics

The Pentacam AXL is designed to take photos of the anterior segment of the eye to
measures eye components such as Axial length, Corneal thickness, Anterior
chamber depth, Corneal curvature, Corneal cylinder, Corneal cylinder axis and
White-to-white-distance. The measured parameters can be used by physicians to
calculate the power of the intraocular lens (IOL) implanted during a cataract surgery.

While rotating around the eye, the Pentacam AXL captures Scheimpflug images of
the anterior eye segment through varying axes. The Scheimpflug images created
during an examination are transmitted to the connected PC.
The axial length of the eye is measured by interferometry.

Scheimpflug images can be captured within maximum two seconds. Up to 138,000

genuine height values are measured and analyzed from the Scheimpflug images.

The Scheimpflug images are the basis for the height data which are used to calculate
a mathematical 3D model of the anterior eye segment.

The mathematical 3D model, corrected for eye movements, provides the basis for all
subsequent analysis.
 Pentacam AXL 510(k) Summary

Summary of clinical results

Comparison Pentacam AXL with IOL Master

A clinical study was performed to compare the parameters axial length (AL), corneal
curvature flat meridian (Rf), corneal curvature steep meridian (Rs), corneal cylinder
(Astig), corneal cylinder axis (Axis flat), anterior chamber depth (ACD), White-to-
White-distance (WTW) measured by the Pentacam AXL with those obtained by the
IOL Master 500 (K122418; Carl Zeiss Meditec AG, Jena, Germany) as predicate
device

Eighty (80) subject eyes were assessed in the first Agreement study, 20 eyes in each
of the four eye populations.

The four eye populations consisted of:

1. Normal eyes (phakic eyes without cataracts or corneal disease);

2. Eyes with cataracts;
3. Eyes with abnormal corneal shape (including eyes post-
keratorefractive surgery), and
4. Eyes without a natural lens (including aphakic and pseudophakic eyes);
 Pentacam AXL 510(k) Summary

Eye Population total

Eighty eyes were assessed in the agreement portion of the study with IOL Master
500 as predicated device. Mean age was 49.2 16.6 years (minimum age
was 17, maximum 79 years).

Table 1 shows the descriptive statistics for all parameters, the mean
differences SD, the confidence intervals for the mean differences and the
Limit of Agreement for the differences.
Measure Pentacam IOL Master Difference 95% CI for 95% LoA for
AXL (Mean (Mean SD) (Mean SD) Mean Difference
SD) Difference
Axial Length N=80 N=80 -0.003 0.058 [-0.016; 0.010] (-0.116; 0.110)
[mm] 24.23 1.73 24.23 1.71
Radius Flat N=76 N=79 0.024 0.044 [0.014; 0.034] (-0.063; 0.111)
Meridian 7.86 0.35 7.82 0.38
[mm]
Radius Steep N=76 N=79 0.037 0.058 [0.024; 0.051] (-0.077; 0.152)
Meridian 7.58 0.37 7.51 0.44
[mm]
Mean Radius N=76 N=79 0.030 0.038 [0.022; 0.040] (-0.045; 0.106)
(Rm) 7.72 0.34 7.67 0.39
[mm]
Corneal N=76 N=79 -0.10 0.45 [-0.20; 0.01] (-0.99; 0.79)
Cylinder [D] 1.6 1.4 1.8 1.7
Corneal N=76 N=79 3,6 13.6 [0.4; 6.7] (-23.0; 30.2)
Cylinder Axis 102.0 71.8 97.6 69.6
[]
Anterior N=60 N=60 0.05 0.10 [-0.03; 0.08] (-0.14; 0.24)
Chamber 3.53 0.36 3.48 0.36
Depth [mm]
White-to N=68 N=73 -0.26 0.16 [-0.30; -0,22] (-0.57; 0.04)
White 11.69 0.38 11.95 0.43
Distance
[mm]
 Pentacam AXL 510(k) Summary

Eye Population Normal

Among the 80 eyes were 20 eyes of healthy patients without any known corneal
pathology and without cataract. Mean age was 42.6 14 years.

Table 2 shows the descriptive statistics for all parameters, the mean differences
SD, the confidence interval for the mean differences and the Limit of Agreement for
all parameters of the 20 normal eyes.
Measure Pentacam IOL Master Difference 95% CI for 95% LoA for
AXL (Mean (Mean SD) (Mean SD) Mean Difference
SD) Difference
Axial Lenght N=20 N=20 -0.014 0.057 [-0.041; 0.012] -0.126; 0.098
[mm] 24.22 1.06 24.24 1.06
Radius Flat N=19 N=20 0.03 0.03 [0.02; 0.05] -0.03; 0.09
Meridian 7.85 0.24 7.86 0.29
[mm]
Radius Steep N=19 N=20 0.04 0.04 [0.02; 0.05] -0.03; 0.11
Meridian 7.66 0.18 7.67 0.26
[mm]
Mean Radius N=19 N=20 0.03 0.02 [0.02; 0.04] -0.01; 0.08
[mm] 7.75 0.20 7.76 0.27
Corneal N=19 N=20 -0.04 0.28 [-0.18; 0.09] -0.60; 0.51
Cylinder [D] 1.03 0.55 1.05 0.54
Corneal N=19 N=20 5.0 21.0 [-5.1; 15.2] -36.2; 46.2
Cylinder Axis 81.7 80.7 81.7 79.9
[]
Anterior N=20 N=20 0.06 0.09 [0.02; 0.10] -0.12; 0.24
Chamber 3.57 0.28 3.51 0.26
Depth [mm]
White-to N=20 N=14 -0.24 0.23 [-0.38; -0.11] -0.70; 0.21
White 11.7 0.3 12.0 0.3
Distance
[mm]
 Pentacam AXL 510(k) Summary

Eye Population Cataract

In this group patients were included with cataract but without any other known ocular
pathology. Mean age of the 20 eyes was 57 14 years.

Table 3 shows the descriptive statistics for all parameters, the mean difference SD,
the confidence interval for the mean differences and the limits of agreement (LoA) for
the differences of the 20 eyes with cataract.
Measure Pentacam IOL Master Difference 95% CI for 95% LoA for
AXL (Mean SD) (Mean SD) Mean Difference
(Mean SD) Difference
Axial Lenght N=20 N=20 0.014 0.039 [-0.004; 0.032] -0.062; 0.091
[mm] 24.28 1.24 24.27 1.25
Radius Flat N=20 N=20 0.018 0.048 [-0.005; 0.040] -0.076; 0.112
Meridian 7.83 0.29 7.81 0.31
[mm]
Radius Steep N=20 N=20 0.031 0.037 [0.013; 0.048] -0.043; 0.104
Meridian 7.68 0.28 7.65 0.28
[mm]
Mean Radius N=20 N=20 0.024 0.033 [0.009; 0.040] -0.041; 0.090
(Rm) [mm] 7.76 0.28 7.73 0.29
Corneal N=20 N=20 -0.07 0.28 [-0.20; 0.06] -0.62; 0.48
Cylinder [D] 0.83 0.42 0.90 0.60
Corneal N=20 N=20 2.6 11.0 [-2.6; 7.8] --19.1; 24.2
Cylinder Axis 102.9 68.6 100.4 67.3
[]
Anterior N=20 N=20 0.08 0.13 [0.02; 0.14] -0.02; 0.33
Chamber 3.37 0.39 3.29 0.37
Depth [mm]
White-to N=15 N=19 -0.26 0.08 [-0.30; -0.21] -0.41; -0.11
White 11.6 0.4 11.9 0.5
Distance
[mm]
 Pentacam AXL 510(k) Summary

Eye Population abnormal corneal shape

In this group patients were included that had either a corneal pathology or previous
refractive surgery (LASIK or PRK). Mean patient age in this subgroup was 39 11
years.

Table 4 shows the descriptive statistics for all parameters, the mean differences
SD. the confidence interval for the mean differences and the Limit of Agreement
(LoA) for the differences of the 20 eyes with cataract.
Measure Pentacam IOL Master Difference 95% CI for 95% LoA for
AXL (Mean (Mean SD) (Mean SD) Mean Difference
SD) Difference
Axial Lenght N=20 N=20 0.016 0.030 [0.003; 0.030] -0.042; 0.075
[mm] 24.00 1.15 23.99 1.13
Radius Flat N=17 N=20 0.020 0.044 [-0.002; 0.042] -0.007; 0.106
Merdian [mm] 8.02 0.42 7.89 0.47
Radius Steep N=17 N=20 0.051 0.086 [0.006; 0.095] -0.118; 0.219
Meridian 7.56 0.52 7.37 0.64
[mm]
Mean Radius N=17 N=20 0.035 0.047 [0.011; 0.060] -0.129; 0.059
[mm] 7.79 0.44 7.63 0.53
Corneal N=17 N=20 -0.26 0.69 [-0.62; 0.10] -1.62; 1.10
Cylinder [D] 2.6 1.9 3.2 2.3
Corneal N=18 N=18 5.0 12.4 [-1.4; 11.3] -19.4; 29.3
Cylinder Axis 107.7 71.2 98.7 67.7
[]
Anterior N=18 N=18 0.01 0.05 [-0.01; 0.04] -0.09; 0.12
Chamber 3.64 0.37 3.63 0.38
Depth [mm]
White-to N=18 N =20 -0.26 0.18 [-0.35; -0.17] -0.62; 0.10
White 11.9 0.3 12.1 0.3
Distance
[mm]
 Pentacam AXL 510(k) Summary

Eyes without natural lens

In this group eyes without a natural crystalline lens were analyzed. All 20 eyes had
cataract surgery before and the crystalline lens was replaced by an intraocular lens
(IOL). Mean patient age was 60 15 years.

Table 5 shows the descriptive statistics for all parameters. the mean difference SD.
the confidence interval for the mean differences and the Limit of Agreement (LoA) for
the differences of the 20 eyes with cataract.
Measure Pentacam IOL Master Difference 95% CI for 95% LoA for
AXL (Mean SD) (Mean SD) Mean Difference
(Mean SD) Difference
Axial Length N=20 N=20 -0.027 0.081 [-0.066; 0.011] -0.187; 0.132
[mm] 24.40 2.88 24.43 2.84
Radius Flat N=20 N=19 0.027 0.054 [0.001; 0.053] -0.079; 0.133
Meridian 7.76 0.42 7.72 0.44
[mm]
Radius Steep N=20 N=19 0.033 0.067 [0.005; 0.065] -0.098; 0.163
Meridian 7.40 0.38 7.35 0.37
[mm]
Mean Radius N=20 N=19 0.030 0.049 [0.006; 0.054] -0.066; 0.126
[mm] 7.58 0.37 7.54 0.39

Corneal N=20 N=19 -0.04 0.47 [-0.26; 0.19] -0.95; 0.88

Cylinder [D] 2.1 1.6 2.2 1.5
Corneal N=14 N=14 1.9 6.6 [-1.3; 5.1] -11.1; 14.9
Cylinder Axis 115.5 67.8 110.4 64.6
[]
Anterior - N=19 - - -
Chamber 4.3 0.61
Depth [mm]
White-to N=15 N=20 -0.29 0.08 [-0.33; -0.24] -0.45; -0.12
White 11.5 0.5 11.8 0.5
Distance
[mm]

The Pentacam AXL demonstrated agreement to the IOL Master 500 (K122418;
Carl Zeiss Meditec AG, Jena, Germany) for the assessment of axial length (AL),
corneal curvature flat meridian (Rf), corneal curvature steep meridian (Rs), corneal
cylinder (Astig), corneal cylinder axis (Axis flat), anterior chamber depth (ACD) and
White-to-White-distance (WTW) parameters in normal eyes, eyes with cataracts,
eyes with Abnormal corneal shape and eyes without natural lens.
 Pentacam AXL 510(k) Summary

Agreement between Pentacam AXL and Pentacam

In a second agreement study between the Pentacam AXL and Pentacam

(K030719, OCULUS Optikgerte GmbH, Wetzlar, Germany) as predicated device
was tested. Both devices are using an automatic rotating Scheimpflug camera in
order to derive a three dimensional model of the anterior segment. Based on this
model all parameters that describe corneal shape such as mean radius of curvature
or corneal thickness are calculated. The anterior chamber depth is also calculated
based on the rotating Scheimpflug camera. As both devices are using the same
measuring technique a high agreement between the two devices can be expected.

For this study 138 eyes of 138 patients were measured with both devices. Mean age
was 69 11 years (youngest 26 years. oldest 90 years), 78 males (57%) and 60 (43
%) females were measured.

Table 6 shows the agreement results for the analyzed parameters Central Corneal
Thickness (CCT). Radius Flat Meridian (Rf), Radius Steep Meridian (Rs), mean
Radius of Curvature (Rm), Corneal Cylinder (Astigmatism) and Anterior Chamber
Depth (ACD).
Measure Pentacam Pentacam Difference 95% CI for 95% LoA for
AXL (Mean (Mean SD) (Mean SD) Mean Difference
SD) Difference
CCT[m] N=113 N=120 29 [0; 4] -15; 19
559 34 555 35
Radius Flat N=113 N=120 0.011 0.032 [0.005; 0.017] -0.051; 0.074
Meridian [mm] 7.91 0.31 7.89 0.31
Radius Steep N=113 N=120 0.009 0.040 [0.001; 0.016] -0.071; 0.088
Meridian [mm] 7.76 0.30 7.74 0.30
Mean Radius N=113 N=120 0.009 0.031 [0.004; 0.015] -0.051; 0.069
[mm] 7.83 0.30 7.82 0.30
Corneal N=113 N=120 0.0008 0.23 [-0.04; 0.04] -0.46; 0.46
Cylinder [D] 0.8 0.6 0.8 0.6
Anterior N=113 N=120 0.05 0.06 [0.03; 0.06] -0.07; 0.16
Chamber 3.26 0.41 3.20 0.40
Depth [mm]

The Pentacam AXL demonstrated agreement to the Pentacam (K030719,

OCULUS Optikgerte GmbH, Wetzlar, Germany) for the assessment of Central
Corneal Thickness (CCT), Radius Flat Meridian (Rf), Radius Steep Meridian (Rs),
mean Radius of Curvature (Rm), Corneal Cylinder (Astigmatism) and Anterior
Chamber Depth (ACD).
 Pentacam AXL 510(k) Summary

In-house Precision Testing: Results

40 eyes of 40 subjects were assessed in the Precision part of the study. To obtain
repeatability values three measurements were performed on the same eye and on
the same instrument under the same conditions. Mean age of the subjects involved in
this study was 35 9 years. 20 right and 20 left eyes were analyzed. 12 females and
28 males were involved in the study.

Table 7 shows the results of the Precision study for the analyzed parameters axial
length (AL), mean radius of curvature, corneal cylinder (astigmatism), cylinder axis
(axis flat meridian), central corneal thickness (CCT) and anterior chamber depth
(ACD).

Measure Number of mean Repeatability Reproducibility

subjects
SD CV [%] SD CV [%]

Axial length [mm] 40 23.779 0.025 0.10 0.030 0.13

CCT[m] 40 550 4 0.67 5 0.90

7.85
Radius flat (Rf) [mm] 40 0.012 0.15 0.017 0.21

Radius steep (Rs) [mm] 40 7.69 0.012 0.15 0.018 0.23

Mean Radius (Rm)

40 7.77 0.010 0.13 0.015 0.19
[mm]

Corneal Cylinder [D] 40 0.92 0.07 7.68 0.10 10.84

Axis flat Meridian [] 40 102.0 4.9 4.76 6.35 6.22

ACD [mm] 40 3.53 0.022 0.61 0.026 0.75

WTW [mm] 40 11.8 0.04 0.37 0.08 0.70

All parameters showed reproducibility and repeatability with coefficients of variation in

most cases of less than one percent. Axial length measurement showed repeatability
and reproducibility with a coefficient of variation of close to zero percent and
intraclass correlation coefficients close to 1. Two parameters that had CV values
above 1 percent were corneal cylinder measurements and the determination of axis
of flat meridian. In both cases the coefficient of variation was still below 10 percent
which is still reflecting repeatability.
 Pentacam AXL 510(k) Summary

Substantial Equivalence

The Pentacam AXL is as safe and effective as the IOLMASTER 500 and the
Pentacam. The Pentacam AXL has the same intended use and similar
indications, technological characteristics, and principles of operation as its predicate
devices. The minor technological differences between the Pentacam AXL and its
predicate devices raise no new issues of safety or effectiveness. Performance data
demonstrates that the Pentacam AXL is as safe and effective as IOLMASTER 500
and Pentacam. Thus, the Pentacam AXL is substantially equivalent.