The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-towhite (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation.

This device is intended for use by physicians and eye-care- professionals and may only be use dunder the supervision of a physician.

Device Description

The IOLMaster 500 is a non-contact biometry instrument for measurements of the eve required for preoperative computation of intraocular lens (IOL) type and power. As with the IOLMaster 500 predicate device, the IOLMaster 500 provides measurements of axial length, corneal radius (keratometry), anterior chamber depth and the "white" distance (WTW).

AI/ML Overview

Here's an analysis of the acceptance criteria and the studies performed for the IOLMaster 500, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the IOLMaster 500 are implicitly defined by its performance in comparison to established manual keratometers (Marco and Javal). The device is deemed acceptable if its measurements demonstrate a high level of agreement and improved or comparable repeatability/reproducibility compared to these predicate devices.

The text does not explicitly state numerical thresholds as "acceptance criteria" but presents comparative results to demonstrate substantial equivalence. The device's performance is reported in terms of agreement (95% Limits of Agreement), and repeatability/reproducibility (Standard Deviation, Limit, and %COV).

Table 1: Agreement with Marco Keratometer (61 eyes)

Measurement	Acceptance Criteria (Implicit: High agreement with predicate)	Reported IOLMaster Performance (Difference ± SD, 95% LoA)
Power in Flat Meridian	(Within clinically acceptable limits for IOL calculations)	+0.24 ± 0.13 D, -0.07 to +0.55 D
Power in Steep Meridian	(Within clinically acceptable limits for IOL calculations)	+0.43 ± 0.21 D, +0.02 to +0.84 D
Mean Power (P1+P2)/2	(Within clinically acceptable limits for IOL calculations)	+0.33 ± 0.13 D, +0.05 to +0.63 D
Astigmatic Power	(Within clinically acceptable limits for IOL calculations)	-0.18 ± 0.23 D, -0.64 to +0.26 D
Axis [°]	(Within clinically acceptable limits for IOL calculations)	4.00 ± 3.30 °, +10.47 ° (upper limit)

Table 2: Repeatability and Reproducibility (IOLMaster vs. Marco)

Measurement	Acceptance Criteria (Implicit: Comparable or better than predicate)	Reported IOLMaster Repeatability	Reported IOLMaster Reproducibility
R1, Radius in Flattest Meridian [mm]	(Better than Marco: SD 0.0381, Limit 0.1068, %COV 0.48%)	SD 0.0154, Limit 0.0431, %COV 0.20%	SD 0.0165, Limit 0.0462, %COV 0.21%
R2, Radius in Steepest Meridian [mm]	(Better than Marco: SD 0.0654, Limit 0.1832, %COV 0.86%)	SD 0.0179, Limit 0.0501, %COV 0.24%	SD 0.0192, Limit 0.0539, %COV 0.25%
P1, Power in Flattest Meridian [D]	(Better than Marco: SD 0.2201, Limit 0.6162, %COV 0.52%)	SD 0.0686, Limit 0.1921, %COV 0.16%	SD 0.0748, Limit 0.2094, %COV 0.18%
P2, Power in Steepest Meridian [D]	(Better than Marco: SD 0.3953, Limit 1.1067, %COV 0.90%)	SD 0.0875, Limit 0.2449, %COV 0.20%	SD 0.1010, Limit 0.2827, %COV 0.23%
Mean Power, (P1 + P2)/2 [D]	(Better than Marco: SD 0.2388, Limit 0.6686, %COV 0.56%)	SD 0.0563, Limit 0.1577, %COV 0.13%	SD 0.0663, Limit 0.1855, %COV 0.15%
Astigmatic Power [D]	(Better than Marco: SD 0.4249, Limit 1.1896, %COV 30.76%)	SD 0.1369, Limit 0.3833, %COV 8.75%	SD 0.1403, Limit 0.3927, %COV 8.96%
Axis [°]	(Similar to Marco: SD 3.1692, Limit 8.8738, %COV 2.86%)	SD 3.9249, Limit 10.9897, %COV 3.44%	SD 4.1737, Limit 11.6863, %COV 3.66%

Table 3: Agreement with Javal Keratometer (116 eyes)

Measurement	Acceptance Criteria (Implicit: High agreement with predicate)	Reported IOLMaster Performance (Difference ± SD, 95% LoA)
Power in Flat Meridian	(Within clinically acceptable limits for IOL calculations)	+0.24 ± 0.16 D, -0.00 to +0.48 D
Power in Steep Meridian	(Within clinically acceptable limits for IOL calculations)	+0.25 ± 0.17 D, -0.08 to +0.58 D
Mean Power (P1+P2)/2	(Within clinically acceptable limits for IOL calculations)	+0.24 ± 0.11 D, +0.02 to +0.46 D
Astigmatic Power	(Within clinically acceptable limits for IOL calculations)	-0.01 ± 0.19 D, -0.38 to +0.36 D
Axis [°]	(Within clinically acceptable limits for IOL calculations)	3.82 ± 3.51 °, +10.70 ° (upper limit)

Table 4: Repeatability (IOLMaster vs. Javal)

Measurement	Acceptance Criteria (Implicit: Comparable or better than predicate)	Reported IOLMaster Repeatability
R1, Radius in Flattest Meridian [mm]	(Better than Javal: SD 0.0207, Limit 0.0581, %COV 0.26%)	SD 0.0109, Limit 0.0304, %COV 0.14%
R2, Radius in Steepest Meridian [mm]	(Better than Javal: SD 0.0252, Limit 0.0706, %COV 0.33%)	SD 0.0180, Limit 0.0503, %COV 0.24%
P1, Power in Flattest Meridian [D]	(Better than Javal: SD 0.1104, Limit 0.3091, %COV 0.26%)	SD 0.0587, Limit 0.1644, %COV 0.14%
P2, Power in Steepest Meridian [D]	(Better than Javal: SD 0.1387, Limit 0.3885, %COV 0.32%)	SD 0.1023, Limit 0.2864, %COV 0.23%
Mean Power, (P1 + P2)/2 [D]	(Better than Javal: SD 0.0919, Limit 0.2574, %COV 0.22%)	SD 0.0583, Limit 0.1632, %COV 0.14%
Astigmatic Power [D]	(Better than Javal: SD 0.1709, Limit 0.4787, %COV 13.27%)	SD 0.1192, Limit 0.3337, %COV 9.22%
Axis [°]	(Better than Javal: SD 2.8377, Limit 7.9456, %COV 2.74%)	SD 2.4242, Limit 6.7877, %COV 2.37%

Studies Proving Device Meets Acceptance Criteria:

The IOLMaster 500 underwent two clinical studies to demonstrate its performance and substantial equivalence:

1. Prospective, Single Site Clinical Study - Comparison with Marco Manual Keratometer:

Sample size used for the test set: 61 astigmatic eyes (with at least 0.75 D of astigmatism).
Data provenance: Prospective, single site clinical study. The country of origin is not explicitly stated but is implied to be within the scope of Carl Zeiss Meditec AG's operations (Germany/USA).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The "ground truth" is effectively the measurements from the Marco manual keratometer, which is a widely accepted clinical device. The study design implies skilled operators were used for both devices.
Adjudication method for the test set: Not explicitly mentioned, but the Bland-Altman method was used to assess agreement, which is a statistical tool for comparing two measurement methods.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not in the traditional sense of human readers interpreting images. This study compared device measurements. However, the study included evaluation of "inter-operator variability" in Phase 2, which involves multiple operators.
If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a measurement instrument, not an AI for image interpretation. The study evaluates the accuracy and precision of the device itself compared to manual methods.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device IOLMaster 500 is a standalone measurement device with integrated algorithms. Its performance was tested as a system. The "manual keratometer" serves as the human-in-the-loop comparison.
The type of ground truth used: The measurements obtained from the Marco manual keratometer, a widely accepted clinical device, served as the comparative standard.
The sample size for the training set: Not applicable. This device is not an AI algorithm that requires a separate "training set" in the context of machine learning. Its operation is based on established optical biometry principles and integrated algorithms for IOL calculations.
How the ground truth for the training set was established: Not applicable for this type of device.

2. Retrospective Analysis of a Previously Conducted Prospective, Single Site Clinical Study - Comparison with Javal Manual Keratometer:

Sample size used for the test set: 116 astigmatic eyes (with at least 0.75 D of astigmatism).
Data provenance: Retrospective analysis of a previously conducted prospective, single site clinical study. Country of origin not explicitly stated.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The study states "a single operator" performed five measurements on each eye using both the IOLMaster 500 and the Javal keratometer.
Adjudication method for the test set: Not explicitly mentioned, but the Bland-Altman method was mentioned for assessing agreement.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The IOLMaster 500 was tested as a standalone measurement device.
The type of ground truth used: The measurements obtained from the Javal manual keratometer, a widely accepted clinical device, served as the comparative standard.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Overall Conclusion from the Studies:

The studies concluded that the IOLMaster 500 demonstrated excellent agreement with both the Marco and Javal manual keratometers for corneal power, astigmatic power, and axis measurements. Furthermore, the IOLMaster 500 generally showed superior repeatability and reproducibility compared to the manual keratometers, with the exception of axis measurements, where both instruments had similar performance. These results support the claim of substantial equivalence to the predicate device and suitability for toric IOL calculations.

Summary

{0}------------------------------------------------

K122418

510(K) SUMMARY

APR 1 2 2013

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a).

SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE SUMMARY PREPARED

a.	Applicant:	Carl Zeiss Meditec AGGoeschwitzer Strasse 51-5207745 JenaGermany
b.	Contact Person:	Judith A. Brimacombe, MADirector, Clinical/Regulatory AffairsCarl Zeiss Meditec, Inc.5160 Hacienda DriveDublin, CA 94568USAj.brimacombe@meditec.zeiss.comTel: (925) 557-4616Fax: (925) 557-4259

August 6, 2012 c. Summary Prepared:

NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME

a.	Trade/Proprietary Name:	IOLMaster® 500
b.	Common/Usual Name:	Biometer
c.	Classification Name:	AC-powered slit lamp biomicroscope
d.	Product Code and Class:	HJO - Class II
e.	Classification Number:	886.1850.

{1}------------------------------------------------

PREDICATE DEVICE

The IOLMaster 500, the subject of this 510(k), is substantially equivalent to the predicate IOL.Master 500 (Carl Zeiss Meditec, AG) cleared for marketing under 510(k) number K101182 in October 2010.

DEVICE DESCRIPTION

STATEMENT OF INTENDED USE

The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation.

This device is intended for use by physicians and eye-care professionals and may only be used under the supervision of a physician.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The IOLMaster 500 has the same indications for use and operating characteristics as the predicate IOLMaster 500.

The IOLMaster 500 utilizes partial coherence interferometry and traditional ophthalmic biometry techniques to obtain measurements for axial length, corneal radius, anterior chamber depth and white-to white distance. Integrated algorithms in the software allow for the use of clinically recognized formulas for the calculation of IOL type and power prior to cataract surgery. These functions are identical for the IOLMaster 500 and the predicate device.

New software features have been added to the updated IOLMaster 500. These include implementation of the Holladay 2 IOL calculation formula, improvements in displayed parameters, and the use of Netviewer one2meet for remote connection to Carl Zeiss Meditec Service.

As the measurements are achieved in the same manner using the identical optical technology; the IOLMaster 500 is therefore substantially equivalent to the predicate IOLMaster 500 (K101182).

{2}------------------------------------------------

BRIEF SUMMARY OF PERFORMANCE TESTS AND RESULTS

A prospective, single site clinical study comparing the performance of the IOLMaster 500 with the Marco (Bausch & Lomb, Inc.) manual keratometer was conducted in 61 astigmatic eyes with at least 0.75 D of astigmatism. This study evaluated the agreement in the keratometry function for corneal power, cylindrical power (i.e., astigmatic power) and axis. The agreement between the instruments is summarized in Table 1.

TABLE 1 AGREEMENT BETWEEN THE MARCO KERATOMETER AND THE IOLMASTER IN 61 EYES (ALL VALUES ARE IN D AND ARE MEAN ± SD UNLESS INDICATED)

	MarcoKeratometer	IOLMaster	Difference	95% LoA
Power in Flat Meridian	42.30 ± 1.42	42.54 ± 1.40	+0.24 ± 0.13	-0.07 to +0.55
Power in Steep Meridian	43.68 ± 1.46	44.11 ± 1.47	+0.43 ± 0.21	+0.02 to +0.84
Mean Power (P1+P2)/2	42.99 ± 1.39	43.33 ± 1.37	+0.33 ±0.13	+0.05 to +0.63
Astigmatic Power	-1.38 ± 0.80	-1.56 ± 0.86	-0.18 ± 0.23	-0.64 to +0.26
Axis [°]*	110.89 ± 71.59	113.97 ± 72.33	4.00 ± 3.30	+10.47

The upper limit was derived based on the method of Brand and Altman, DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet i:307-310, 1986). The lower limit was not provided since the difference in axis is always a positive number.

The results of the study demonstrate a high level of agreement between the instruments for measurements of power in the flat and steep meridians, mean power, astigmatic power and axis. Typically, the manual keratometer measured significantly flatter radii and hence lower corneal power in both meridians. The mean power (±SD) as measured by the IOLMaster was 43.33 ± 1.37 D compared to 42.99 ± 1.39 D for the manual keratometer. Overall, the manual keratometer measured less astigmatic power (-1.38 ± 0.80 D) compared to the IOLMaster (-1.56 ± 0.86 D). The differences between the measurements would be inconsequential in toric IOL calculations.

To evaluate the repeatability and reproducibility of the IOLMaster compared to the manual keratometer, the study was conducted in two phases designed to evaluate repeatability and reproducibility of the measurements.

. In Phase 1, inter-instrument variability for both the IOLMaster and the Marco keratometer was evaluated, as was the agreement between the two instruments. Three IOLMaster units and three manual keratometer units were used, and 5 measurements were taken with each unit (30 total measurements per subject).
. In Phase 2, inter-operator variability for both the IOLMaster and the Marco keratometer was evaluated, as was the agreement between the IQLMaster and the Marco keratometer. One IOLMaster unit and one Marco manual keratometer unit were used by three operators, and 5 measurements were taken by each operator (30 total measurements per subject).

The results of the analysis for repeatability and reproducibility for the Marco manual Keratometer and the IOLMaster 500 are summarized in Table 2.

{3}------------------------------------------------

	OverallMean	Repeatability			Reproducibility
		SD	Limit	%COV	SD	Limit	%COV
MARCO
R1, Radius in FlattestMeridian [mm]	7.88	0.0381	0.1068	0.48%	0.0492	0.1376	0.62%
R2, Radius in SteepestMeridian [mm]	7.63	0.0654	0.1832	0.86%	0.0799	0.2237	1.05%
P1, Power in FlattestMeridian [D]	42.30	0.2201	0.6162	0.52%	0.2800	0.7840	0.66%
P2, Power in SteepestMeridian [D]	43.68	0.3953	1.1067	0.90%	0.4774	1.3367	1.09%
Mean Power,(P1 + P2)/2 [D]	42.99	0.2388	0.6686	0.56%	0.3162	0.8854	0.74%
Astigmatic Power [D]	-1.38	0.4249	1.1896	30.76%	0.4604	1.2890	33.34%
Axis [°]	110.89	3.1692	8.8738	2.86%	4.6560	13.0369	4.20%
IOLMaster
R1, Radius in FlattestMeridian [mm]	7.84	0.0154	0.0431	0.20%	0.0165	0.0462	0.21%
R2, Radius in SteepestMeridian [mm]	7.56	0.0179	0.0501	0.24%	0.0192	0.0539	0.25%
P1, Power in FlattestMeridian [D]	42.54	0.0686	0.1921	0.16%	0.0748	0.2094	0.18%
P2, Power in SteepestMeridian [D]	44.11	0.0875	0.2449	0.20%	0.1010	0.2827	0.23%
Mean Power,(P1 + P2)/2 [D]	43.32	0.0563	0.1577	0.13%	0.0663	0.1855	0.15%
Astigmatic Power [D]	-1.56	0.1369	0.3833	8.75%	0.1403	0.3927	8.96%
Axis [°]	113.97	3.9249	10.9897	3.44%	4.1737	11.6863	3.66%

TABLE 2 REPEATABILITY AND REPRODUCIBILITY MARCO MANUAL KERATOMETER AND IOLMASTER 500

Repeatability includes variation due to measurement error.

Reproducibility includes variations due to device, operator, interaction between device and subject, interaction between operator and subject, and measurement error.

Repeatability %COV = (Repeatability SD)/|Overall Mean|*100%

Reproducibility %COV = (Reproducibility SD)/|Overall Mean|* 100%

The prospective clinical study demonstrated excellent agreement between the IOLMaster and Marco manual keratometer for corneal power, astigmatic power and axis. As demonstrated by these results, for all measurements, with the exception of axis, the repeatability and reproducibility limits, and the standard deviations were smaller for the IOLMaster than for the manual keratometer. For axis, the instruments have similar repeatability and reproducibility.

{4}------------------------------------------------

Additionally, a retrospective analysis of a previously conducted prospective, single site clinical study comparing the performance of the IOLMaster 500 with the Javal (Haag-Streit) manual keratometer was conducted in 116 astigmatic eyes with at least 0.75 D of astigmatism. This study evaluated the agreement in the keratometry function for corneal power, cylindrical power (i.e., astigmatic power) and axis.

In this study, five measurements were taken on each eye with one IOLMaster 500 instrument and one Javal keratometer by a single operator. The agreement between the instruments is summarized in Table 3 with the repeatability of measures shown in Table 4.

TABLE 3

AGREEMENT BETWEEN THE JAVAL KERATOMETER AND THE IOLMASTER IN 116 EYES (ALL VALUES ARE IN D AND ARE MEAN ± SD UNLESS INDICATED)

	JavalKeratometer	IOLMaster	Difference	95% LoA
Power in Flat Meridian	42.02 ± 1.30	42.27 ± 1.28	+0.24 ± 0.16	-0.00 to +0.48
Power in Steep Meridian	43.31 ± 1.47	43.56 ± 1.45	+0.25 ± 0.17	-0.08 to +0.58
Mean Power (P1+P2)/2	42.67 ± 1.36	42.91 ± 1.34	+0.24 ± 0.11	+0.02 to +0.46
Astigmatic Power	-1.29 ± 0.54	-1.29 ± 0.54	-0.01 ± 0.19	-0.38 to +0.36
Axis [°]*	102.12 ± 82.19	100.63 ± 82.31	3.82 ± 3.51	+10.70

*The upper limit was derived based on the method of Brand and Altman (Bland, JM and Altman, DG. Statistical methods for assessing agreement between two methods of clinical measurement, Lancet, i:307-310, 1986). The lower limit was not provided since the difference in axis is always a positive number.

	OverallMean	SD	RepeatabilityLimit	%COV
Javal
R1, Radius in FlattestMeridian [mm]	7.91	0.0207	0.0581	0.26%
R2, Radius in SteepestMeridian [mm]	7.67	0.0252	0.0706	0.33%
P1, Power in FlattestMeridian [D]	42.02	0.1104	0.3091	0.26%
P2, Power in SteepestMeridian [D]	43.31	0.1387	0.3885	0.32%
Mean Power,(P1 + P2)/2 [D]	42.67	0.0919	0.2574	0.22%
Astigmatic Power [D]	-1.29	0.1709	0.4787	13.27%
Axis [°]	103.67	2.8377	7.9456	2.74%
IOLMaster
R1, Radius in FlattestMeridian [mm]	7.86	0.0109	0.0304	0.14%
R2, Radius in SteepestMeridian [mm]	7.63	0.0180	0.0503	0.24%
P1, Power in FlattestMeridian [D]	42.27	0.0587	0.1644	0.14%
P2, Power in SteepestMeridian [D]	43.56	0.1023	0.2864	0.23%
Mean Power,(P1 + P2)/2 [D]	42.91	0.0583	0.1632	0.14%
Astigmatic Power [D]	-1.29	0.1192	0.3337	9.22%
Axis [°]	103.18	2.4242	6.7877	2.37%

TABLE 4 REPEATABILITY OF JAVAL MANUAL KERATOMETER AND IOLMASTER 500

Repeatability includes variation due to measurement error.

Repeatability %COV = (Repeatability SD)/|Overall Mean|* 100%

{5}------------------------------------------------

CONCLUSION

The IOLMaster 500 is substantially equivalent to the predicate device. Additionally, the keratometry function of the IOLMaster 500 provides cylindrical power and axis measurements comparable to manual keratometry, suitable for use in toric lens power calculations.

{6}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

April 12, 2013

Public Health Service

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

Carl Zeiss Meditec AG % Judith A. Brimacombe, M.A. Director, Clinical/ Regulatory Affairs 5160 Hacienda Drive Dublin, CA 94568

Re: K122418

Trade/Device Name: IOLMaster 500 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slit lamp biomicroscope Regulatory Class: Class II Product Code: HJO Dated: March 12, 2013 Received: March 13, 2013

Dear Ms. Brimacombe:

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. Iisting 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

{7}------------------------------------------------

Page 2 - Ms. Judith A. Brimacombe, M.A.

device-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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Deborah Likalls -S

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 Health

Enclosure

{8}------------------------------------------------

Indications for Use

510(k) Number (if known): K122418

Device Name: IOLMaster 500

Indications For Use:

This device is intended for use by physicians and eye-care- professionals and may only be use dunder the supervision of a physician.

Prescription Use X (part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ka N. To
2013.04.09 18:57:39 +04'00'

(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number:_ K122418

Regulation Number and Section

§ 886.1850 AC-powered slitlamp biomicroscope.

(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.