K Number

Device Name

IOLMASTER 500

Manufacturer

CARL ZEISS MEDITEC AG

Date Cleared

2010-11-03

(190 days)

Product Code

HJO

Regulation Number

886.1850

Intended Use

The IOLMaster is intended for the biometric determination of ocular measurements for axial length, anterior chamber depth, corneal radius, white-to-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.

Device Description

The IOLMaster 500 is a non-contact biometry instrument for measurements of the eye required for preoperative computation of intraocular lens (IOL) type and power. As with the IOLMaster predicate device, the IOLMaster 500 provides measurements of axial length, corneal radius (keratometry), and anterior chamber depth. In the new model of the IOLMaster, the optical measurement technology has remained the same and the measurements of axial length, corneal radius and anterior chamber depth are achieved in the same fashion. In addition to these three parameters, using the same optical techniques with advances in software, the modified IOLMaster also has the capability to measure a fourth parameter, i.e., the "white-to-white" distance (WTW). Incorporation of this additional information extends the physician's choice of computational formulas.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K993357, K082891

Reference Devices

Grieshaber Biometric System (GBS), Renaissance, Lenstar LS 900

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device that uses established optical measurement techniques and software advancements for calculating ocular parameters and IOL power. There is no mention of AI, ML, or related concepts like training sets or complex algorithms typically associated with AI/ML in medical devices. The performance studies focus on agreement with predicate/reference devices and repeatability/reproducibility, not on AI/ML performance metrics.

Therapeutic

No
The device is a diagnostic tool used to measure ocular parameters, which then assists physicians in determining an appropriate intraocular lens (IOL) for implantation. It does not directly treat or restore health.

Diagnostic

Yes
The device is described as being used for "biometric determination of ocular measurements" and "performs calculations to assist physicians in determining the appropriate IOL power and type for implantation," which indicates its role in diagnosing and planning treatment for patients.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "non-contact biometry instrument" and uses "optical measurement technology" and "optical techniques," indicating it includes hardware components for measurement.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
IOLMaster Function: The IOLMaster is described as a "non-contact biometry instrument for measurements of the eye." It measures physical characteristics of the eye (axial length, anterior chamber depth, corneal radius, white-to-white, pupil size, visual axis deviation) using optical techniques.
Lack of Sample Analysis: The device does not analyze biological samples taken from the patient's body. It directly measures the physical structure of the eye.
Intended Use: The intended use is for "biometric determination of ocular measurements" and "calculations to assist physicians in determining the appropriate IOL power and type for implantation." This is a measurement and calculation tool for surgical planning, not a diagnostic test performed on a biological sample.

Therefore, the IOLMaster falls under the category of a medical device used for measurement and planning, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

HJO

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

optical measurement technology, partial coherence interferometry

Anatomical Site

ocular / eye

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical Evaluation:
Type: Comparison with other instruments (literature review).
Axial length, anterior chamber depth, and corneal radius:

Axial length (AL) and anterior chamber depth (ACD) measurements of IOLMaster were compared to a high precision immersion ultrasound system (Grieshaber Biometric System (GBS)).
Sample size: 189 consecutive eyes presented for cataract evaluation were measured with IOLMaster. 146 phakic eyes for axial length comparison (excluded 10 pseudophakic and 1 aphakic eye). 151 eyes for ACD comparison (excluded 6 pseudophakic eyes where ACD could not be measured).
Corneal radius: Compared to a handheld keratometer (Renaissance, Alcon).
Sample size: 154 eyes (excluded 2 eyes with no available keratometry results and 1 eye with unreliable readings).
White-to-white measurement:
Compared to Lenstar LS 900 (Haag-Streit).
Sample size: 112 cataract surgery eyes.

Repeatability and Reproducibility Study:
Type: Prospective study.
Parameters measured: axial length (AL), corneal radius (corneal curvature), anterior chamber depth (ACD) and white-to-white (WTW).
Sample size: 30 subjects.
Phase I (Inter-device variability): Each subject imaged 3 times on each of three IOLMaster 500 instruments by one operator.
Phase II (Inter-operator variability): Each subject imaged 3 times by each of three operators.
Inclusion criteria: Subjects were 18 years or older with healthy eyes and no ocular opacities.

Key results:
Agreement with Other Instruments:

Axial length: Mean Difference -0.01 mm, SD +/- 0.19 mm (N=146 vs GBS)
Corneal curvature: Mean Difference -0.01 mm, SD +/- 0.05 mm (N=154 vs Renaissance)
Anterior chamber depth: Mean Difference +0.03 mm, SD +/- 0.18 mm (N=151 vs GBS)
White-to-white: Mean Difference +0.06 mm, SD +/- 0.33 mm (N=112 vs Lenstar LS900)

Repeatability and Reproducibility of the IOLMaster 500 Measurements:

Axial length: Repeatability SD 0.0206 mm, Repeatability Limit 0.0577 mm; Reproducibility SD 0.0222 mm, Reproducibility Limit 0.0623 mm.
Corneal curvature: Repeatability SD 0.0162 mm, Repeatability Limit 0.0455 mm; Reproducibility SD 0.0167 mm, Reproducibility Limit 0.0468 mm.
Anterior chamber depth: Repeatability SD 0.0347 mm, Repeatability Limit 0.0972 mm; Reproducibility SD 0.0494 mm, Reproducibility Limit 0.1383 mm.
White-to-white: Repeatability SD 0.0558 mm, Repeatability Limit 0.1562 mm; Reproducibility SD 0.0647 mm, Reproducibility Limit 0.1811 mm.

Conclusion:

the axial length, corneal radius, anterior chamber depth measurements of the modified IOLMaster are substantially equivalent to those of the predicate device;
white-to-white measurements using the IOLMaster 500 are substantially equivalent to those of the predicate device;
the IOLMaster meets the requirements for electrical and laser safety;
usability of the IOLMaster has been verified in accordance with appropriate standards.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K993357, K082891

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

K101182

4.0 510(K) SUMMARY

NOV - 3 2010 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 4.1 PREPARED

| a. | Applicant: | Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
07745 Jena
Germany |
|----|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| b. | Contact Person: | Judith A. Brimacombe, MA
Director, Clinical/Regulatory Affairs
Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, CA 94568
USA
j.brimacombe@meditec.zeiss.com
Tel: (925) 557-4616
Fax: (925) 557-4259 |

October 7, 2010 Summary Prepared: C.

Name of device, including trade name and classification name 4.2

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

PREDICATE DEVICE 4.3

The IOLMaster 500, the subject of this 510(k), is substantially equivalent to the predicate IOLMaster (Carl Zeiss Meditec, AG) cleared for marketing under 510(k) number K993357 and the Lenstar Model LS 900 (Haag-Streit AG) cleared for marketing under 510(k) number K082891.

DEVICE DESCRIPTION 4.4

4.5 STATEMENT OF INTENDED USE

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 4.6

The IOLMaster 500 has the same indications for use and operating characteristics as the predicate IOLMaster with the exception that the white-to-white measurement has been added to the indications for use statement.

The IOLMaster 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 the same for the IOLMaster 500 and the predicate device.

Software enhancements using the Windows XP platform have improved the Graphic User Interface (GUI) and the usability of the IOLMaster. Additionally, modifications have been made to the IOLMaster computer hardware to incorporate USB ports for importing and exporting data to and from the IOLMaster 500.

Since the measurements are achieved in the same fashion using the identical optical technology, the IOLMaster 500 is therefore substantially equivalent to the predicate IOLMaster (K993357).

4.7 CLINICAL EVALUATION

Clinical data reported in the literature was reviewed to determine agreement between the IOL Master, Grieshaber Biometric System, and Lenstar Model LS900. The results are provided in Table 1 on the following page.

Axial length, anterior chamber depth and corneal radius

IOLMaster axial length (AL) and anterior chamber depth (ACD) measurements were compared to measurements obtained with a high precision immersion ultrasound system (Grieshaber Biometric System (GBS)). A total of 189 consecutive eyes presented for cataract evaluation were measured with the IOLMaster. Excluded from the study were 32 eyes not measured with GBS. Mean difference for axial length was calculated based on 146 phakic eyes comparative axial length measurements between IOLMaster and GBS (10 pseudophakic eyes and 1 aphakic eye were excluded). Mean difference for ACD was calculated based on measurements on 151 eyes comparing IOLMaster and GBS (in 6 pseudophakic eves. ACD could not be measured). Mean difference for the average corneal radius was calculated based on keratometry measurements on 154 eyes comparing IOLMaster and a handheld keratometer ((Renaissance, Alcon). Two eyes with no available keratometry results and one eye with unreliable readings due to dry eye were excluded).2

White-to-white measurement

IOLMaster white-to-white measurements were compared to measurements obtained with a Lenstar LS 900 (Haag-Streit) in 112 cataract surgery eyes.2

1 Haigis W, Lege B: Akustische und optische Biometrie im klinischen Einsatz; in Wenzel M, Kohnen B. (eds): 14. Kongress der Deutschsprachigen Gesellschaft für Intraokulariinsen-Implantation und refractive Chirurgie, Jahresband der DGII, Luzern, February 2000. Koln, Biermann, 2000, pp 73-78. [ Haigis W, Lege B: Acoustical and Optical Biometry in Clinical Application; in Wenzel M, Kohnen T, Blumer B. (eds): 14. Congress of the german-speaking society for implantation of intraocular lenses and refractive surgery (DGII), Annual book of the DGII, Luzern, February 2000. Koln, Biermann, 2000, pp 73-78.] 4 Buckhurst PJ, Wolffson JS, Shah S, Naroo SA, Davies LN, Berrow EJ. A new optical low coherence reflectometry device for ocular biometry in cataract patients. Br J Ophthalmol 2009; 93 (7): 949-953.

Table 1. Agreement with Other Instruments

	N	Mean Difference	Standard Deviation
Axial length*	146	-0.01 mm	±0.19 mm
Corneal curvature**	154	-0.01 mm	±0.05 mm
Anterior chamber depth*	151	+ 0.03 mm	±0.18 mm
White-to-white***	112	+ 0.06 mm	±0.33 mm

All referenced studies compared measurements from eyes evaluated for cataract surgery.

In comparison to high precision immersion ultrasound instrument (Grieshaber Biometric Systems, GBS) *
** In comparison to manual keratometer (Renaissance, Alcon)*
*** In comparison to optical low coherence reflectometry (Lenstar LS900, Haig-Streit)*

Repeatability and Reproducibility

A study was conducted to determine repeatability and reproducibility of the IOLMaster 500 measurements of axial length (AL), corneal radius (corneal curvature), anterior chamber depth (ACD) and white-to-white (WTW). Phase I of the study enrolled 30 subjects and was designed to determine inter-device variability, wherein each subject was imaged 3 times during a single visit on each of three IOLMaster 500 instruments by one operator. Phase II enrolled the same 30 subjects and was designed to determine inter-operator variability, wherein each subject was imaged three times during a single visit by each of three operators. Subjects in the study were 18 years or older with healthy eyes and no ocular opacities. The precision of axial length measurements and anterior chamber depth measurements may be different in eyes with cataract or corneal abnormalities.

The repeatability and reproducibility results are shown in Table 2 on the following page.

3 Carl Zeiss Meditec, Inc., Clinical Study: Repeatability of IOLMaster 500; 2010.

	Repeatability		Reproducibility
	Repeatability
SD
(mm)	Repeatability
Limit
(mm)	Reproducibility
SD
(mm)	Reproducibility
Limit
(mm)
Axial length	0.0206	0.0577	0.0222	0.0623
Corneal curvature	0.0162	0.0455	0.0167	0.0468
Anterior chamber depth	0.0347	0.0972	0.0494	0.1383
White-to-white	0.0558	0.1562	0.0647	0.1811

Table 2. Repeatability and Reproducibility of the IOLMaster 500 Measurements

Repeatability is defined as the standard deviation of measurements taken by a single operator/single instrument. The repeatability standard deviation was estimated by the squared error. Reproducibility is the standard deviation of measurements that include between operator and between instrument variability. The reproducibility standard deviation was estimated by the square root of the sum of random measurement variability, inter-device variability, inter-operator variability, subject and device interaction variability, and subject and operator interaction variability.

The repeatability limit is the upper 95% limit for the differences between repeated results. Per ISO 5725-6, the repeatability limit = 2.8 x repeatability SD.

The reproducibility limit is the upper 95% limit calculated for the difference between individual measurements using different operators and different instruments. Per ISO 5725-6, the reproducibility limit = 2.8 x the reproducibility SD.

BRIEF SUMMARY OF PERFORMANCE TESTS AND RESULTS 4.8

The IOLMaster has been designed and tested to the applicable safety standards. The performance data supporting safety and substantial equivalence of the IOLMaster 500 to the predicate device demonstrates that:

the axial length, corneal radius, anterior chamber depth measurements of the . modified IOLMaster are substantially equivalent to those of the predicate device;
white-to-white measurements using the IOLMaster 500 are substantially equivalent . to those of the predicate device;
the IOLMaster meets the requirements for electrical and laser safety; .
usability of the IOLMaster has been verified in accordance with appropriate . standards.

4.9 CONCLUSION

The IOLMaster 500 is substantially equivalent to the predicate devices.

Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and three parallel lines extending from the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

Carl Zeiss Meditec Incorporated c/o Judith A. Brimacombe, M.A. Director, Clinical and Regulatory Affairs 5160 Hacienda Drive Dublin, CA 94568

Re: K101182

Trade Name: IOLMaster 500 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slit lamp biomicroscope Regulatory Class: Class II Product Code: HJO Dated: September 13, 2010 Received: September 14, 2010

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, 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

NOV - 3 2010

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

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Debra Falls

Malvina B. Eydelman, M. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

510(k) Number (if known): K101182

Device Name(s): IOLMaster 500 NOV - 3 2010

Indications for Use:

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

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

DemR

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Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices

510(k) Number K101182