The SLIT LAMP SL-2000 is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. This device is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

Device Description

The SLIT LAMP SL-2000 is used to magnify the eyeball, eyelid, and eyelash of patients for observation, using slit illumination light.

The SL-2000 comprises the main unit that incorporates the microscope unit, illumination unit, base plate unit, and power supply box.

AI/ML Overview

This document is a 510(k) premarket notification for the Nidek Co., Ltd. Slit Lamp SL-2000. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria. Therefore, much of the requested information regarding specific performance metrics, clinical study design, and ground truth establishment is not present in this document because it is not typically required for a 510(k) submission for a device like a slit lamp.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) for the slit lamp, as it is a diagnostic tool observed by a human, not an automated diagnostic system. Instead, it focuses on demonstrating that the device meets safety and performance standards equivalent to predicate devices. The "performance" mentioned primarily refers to compliance with international standards for ophthalmic instruments and electrical safety.

Feature/Test	Acceptance Criteria (Implicit)	Reported Device Performance
Ophthalmic Performance	Compliance with ISO 15004-1 (Ophthalmic instruments - Slit-lamp microscopes - Part 1: Requirements for slit-lamp microscopes)	Performed, results demonstrate no new questions of safety/effectiveness.
	Compliance with ISO 15004-2 (Ophthalmic instruments - Slit-lamp microscopes - Part 2: Requirements for illumination safety)	Performed, results demonstrate no new questions of safety/effectiveness.
Ergonomics/Optical	Compliance with ISO 10939 (Ophthalmic instruments - Slit-lamp microscopes - Requirements and test methods)	Performed, results demonstrate no new questions of safety/effectiveness.
Eyepieces	Range of total magnification equivalent to predicate devices with 12.5x eyepieces. No new safety/effectiveness questions with optional 16x eyepieces.	12.5x standard, 16x optional. Total magnification range with 16x eyepieces is equivalent to predicate device range.
Field of View Diameter	Range of field of view diameter almost equivalent to predicate device (Zeiss SL 130). Compliance with specifications.	Range nearly equivalent to Zeiss SL 130. Verified and found to comply.
Ametropia Compensation	Compensates ±8 D, equivalent to predicate devices.	Compensates ±8 D.
Interpupillary Adjustment	Meets range for interpupillary adjustment of 55 mm to 72 mm as required by ISO 10939:2007.	Range of 50 mm to 78 mm. Meets ISO 10939:2007 requirements.
Illumination	Width of slit image, slit rotation, angle of incidence, brightness control method same as Zeiss SL 130. Length of slit image range within predicate devices. LED light source. Compliance with ISO 15004-2. Filters (blue, red free, neutral density, barrier for fluorescent observation - yellow). IR cut filter (no heat absorption needed with LED).	Same as Zeiss SL 130 for width, rotation, incidence, brightness control. Length of slit image within predicate range. Uses LED light source, complies with ISO 15004-2. Provided with specified filters. IR cut filter works with LED.
Software	Verification and Validation	Performed, results demonstrate no new questions of safety/effectiveness.
Usability	Compliance with IEC 60601-1-6 (Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability) and IEC 62366 (Medical devices - Application of usability engineering to medical devices)	Performed, results demonstrate no new questions of safety/effectiveness.
Electrical Safety	Compliance with AAMI/ANSI ES60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)	Performed, results demonstrate no new questions of safety/effectiveness.
EMC	Compliance with IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests)	Performed, results demonstrate no new questions of safety/effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail specific "test set" sample sizes in the context of clinical performance data for diagnosis of diseases. The testing described is primarily limited to bench testing and compliance with engineering and safety standards. There is no mention of clinical data or patient samples being used in the validation tests outlined.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as a clinical test set with ground truth established by experts is not described in this document for a device like a slit lamp in a 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as a clinical test set with expert adjudication is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

Not applicable. The Slit Lamp SL-2000 is a manual observation device, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI improvement metrics are relevant or discussed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is a manually operated medical device without an AI algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of clinical diagnostic accuracy. The "ground truth" for the tests performed would be the specifications and requirements outlined in the referenced ISO, IEC, and AAMI/ANSI standards (e.g., a specific light intensity, magnification, or electrical characteristic).

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/machine learning device.

Summary

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

May 19, 2017

Nidek Co., Ltd. Toshio Murata Senior RA/QA Manager Nidek Inc. 47651 Westinghouse Drive Fremont, CA94539

Re: K163564

Trade/Device Name: Slit Lamp SL-2000 Regulation Number: 21 CFR 886.1850 Regulation Name: AC-Powered Slitlamp Biomicroscope Regulatory Class: Class II Product Code: HJO Dated: April 7, 2017 Received: April 10, 2017

Dear Toshio Murata:

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.

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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 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 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,

Denise L. Hampton -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

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Indications for Use

510(k) Number (if known) K163564

Device Name SLIT LAMP SL-2000

Indications for Use (Describe)

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

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

| X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for NIDEK CO., LTD. The logo includes the company name and address, which is "34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan". The logo also states that NIDEK is a manufacturer, exporter, and importer of ophthalmic instruments and opto-electronics instruments. The logo also includes a blue eye symbol.

TEL +81-533-67-6611
FAX +81-533-67-6610
URL http://www.nidek.co.jp
http://www.nidek.com

K163564

510(K) SUMMARY

GENERAL INFORMATION

Applicant:

NIDEK CO., LTD. 34-14 Maehama, Hiroishi-cho, Gamagori, Aichi, 443-0038 Japan Phone: +81-533-67-8901 Fax: +81-533-67-6628

Contact Person:

Toshio Murata Senior RA/QA Manager NIDEK INC. 47651 Westinghouse Drive Fremont, CA 94539 U.S.A. Phone: 510-353-7789 FAX: 510-226-5750

Date Prepared: May 16, 2017

DEVICE INFORMATION

Trade Name: SLIT LAMP SL-2000

Generic/Common Name:

AC-powered Slitlamp Biomicroscope

Classification:

21 CFR §886.1850, Class II

NIDEK CO., LTD

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K163564

Classification panel:

Ophthalmic

Product Code:

HJO

PREDICATE DEVICE(S)

· SL 130 Slit Lamp, Carl Zeiss Meditec AG. (K133476)
Slit Lamp H-Series Digital, Keeler Limited (K140451)

INDICATIONS FOR USE

PRODUCT DESCRIPTION

The SLIT LAMP SL-2000 is used to magnify the eyeball, eyelid, and eyelash of patients for observation, using slit illumination light.

The SL-2000 comprises the main unit that incorporates the microscope unit, illumination unit, base plate unit, and power supply box.

Comparison of technological characteristics with predicate devices

The SL-2000 and the predicate devices are all slit lamps that are intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. All these devices are Galilean type slit lamps with converging binoculars.

The SL-2000 is provided with evepieces 12.5× as the predicate devices are and optional eyepieces 16× with which the predicate devices are not provided. Because the range of the total magnification of the SL-2000 with eyepieces 16× is equivalent to that of the predicate devices, use of optional eyepieces 16× does not raise new safety or effectiveness questions.

NIDEK CO., LTD

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K163564

The range of the field of view diameter of the SL-2000 is almost equivalent to that of the Zeiss SL 130 Slit Lamp. In addition, the real field of view diameters were verified and found to comply with the specifications.

The SL-2000 compensates ametropia of ±8 D as the predicate devices do.

The SL-2000 allows interpupillary adjustment in the range of 50 mm to 78 mm. Although there is a difference in the range of adjustment between the SL-2000 and predicate devices, this does not affect the safety and effectiveness because the SL-2000 and the predicate devices meet the range for interpupillary adjustment of 55 mm to 72 mm required in ISO10939:2007.

With regard to illumination, the width of slit image, slit rotation, angle of incidence, and brightness control method are the same between the SL-2000 and Zeiss SL 130 Slit Lamp. The range of length of slit image of the SL-2000 falls within that of the predicate devices. The SL-2000 as well as Keeler Slit Lamp H-Series Digital uses an LED as a light source and all the devices comply with ISO 15004-2. The SL-2000 is provided with the blue, red free, neutral density filters, and barrier filter for fluorescent observation (yellow filter) as the predicate devices are. Although the IR cut filter of the SL-2000 does not absorb heat, the filter does not need to have such a characteristic because the LED of the SL-2000 does not emit infrared rays (heat rays).

As mentioned, the minor differences in specifications between the SL-2000 and the predicate devices do not raise new questions of safety and effectiveness and do not adversely affect the safety and effectiveness of the device.

SUBSTANTIAL EQUIVALENCE

The SLIT LAMP SL-2000 is substantially equivalent to the predicate devices, Carl Zeiss Meditec AG., SL 130 Slit Lamp, Keeler Limited Slit Lamp H-Series Digital.

The SL-2000 is similar in technological characteristics, performance, and principles of operation and has similar indications for use as the predicate devices. Any differences in technological characteristics between the proposed device and the predicate devices do not

NIDEK CO., LTD

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raise any new issues of safety or effectiveness. Thus, the SL-2000 is substantially equivalent to the predicate devices.

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary bench testing was conducted on the SLIT LAMP SL-2000 to support a determination of substantial equivalence to the predicate devices. The tests performed include:

Ophthalmic Testing per ISO 15004-1 and ISO 15004-2
· Testing per ISO 10939
Software Verification and Validation
Usability Testing per IEC 60601-1-6 and IEC 62366
· Electrical Safety Testing per AAMI/ANSI ES60601-1 and Electromagnetic Compatibility Testing per IEC 60601-1-2.

The collective performance testing demonstrates that the SL-2000 does not raise any new questions of safety or effectiveness when compared to the predicate devices. The results of the performance testing demonstrate that the SL-2000 performs as intended and does not raise any new questions of safety or effectiveness.

CONCLUSION

In summary, NIDEK CO., LTD. is of the opinion that the SLIT LAMP SL-2000 does not introduce any new potential safety risks, is as effective and performs as well as the predicate devices, and concludes that the SL-2000 is substantially equivalent to the predicate devices.

SUMMARY

The SLIT LAMP SL-2000 is substantially equivalent to the predicate devices.

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.