KOWA SL-17 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

Device Description

The KOWA SL-17 is a non-invasive ophthalmic device that is able to illumination, magnification and observation of the human eye. It consists of a hand-held, battery powered slit-lamp biomicroscope with viewing and illumination optical systems and a stand.

AI/ML Overview

The document provided (K133755) describes the KOWA SL-17, a non-invasive ophthalmic device intended for eye examination of the anterior eye segment. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device (KOWA SL-15, K063640), rather than proving the device meets specific performance criteria for novel claims.

Therefore, the study described is a substantial equivalence comparison to a predicate device, not a performance study against acceptance criteria in the typical sense for a new clinical claim. The "acceptance criteria" here refer to conformance with various standards and safety requirements to demonstrate that the new device is as safe and effective as the predicate.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for substantial equivalence, the "acceptance criteria" are compliance with relevant safety and performance standards, and the "reported device performance" is the confirmation that the device met these standards. There are no specific clinical performance metrics (e.g., sensitivity, specificity) listed for the KOWA SL-17 itself, as its function is observation and illumination, and its equivalency is largely based on technical specifications and safety.

Acceptance Criteria (Standard / Evaluation)	Reported Device Performance
Performance: ISO10939	The KOWA SL-17 met all requirements of the standard.
Electrical Safety: IEC60601-1	The KOWA SL-17 met all requirements of the standard.
Electromagnetic Compatibility: IEC60601-1-2	The KOWA SL-17 met all requirements of the standard.
Optical Safety: ISO15004-2	The KOWA SL-17 met all requirements of Group 2 instrument in the standard.
Software Evaluation: FDA Guidance (2005, 2002)	Software was evaluated and confirmed to be appropriate.
Biocompatibility: Assessment	Biocompatibility assessment performed. Materials used are the same as other legally marketed devices (K063640).
Risk Management: ISO14971	Risk management evaluation deemed satisfactory; no remnant risk.
Substantial Equivalence: CDRH Guidance 6/30/86	KOWA SL-17 and the predicate device (KOWA SL-15) are substantially equivalent.

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

This submission focuses on engineering and safety testing. There is no clinical "test set" or patient data mentioned for validating clinical performance in the provided document. The testing involved compliance with various international standards for medical devices (ISO, IEC, FDA guidance), which typically involve laboratory or bench testing rather than patient data.

Sample Size for Test Set: Not applicable as no clinical test set is described.
Data Provenance: Not applicable as no patient data (country of origin, retrospective/prospective) is described.

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

Not applicable. This type of submission relies on engineering standards and comparisons, not on expert-established ground truth for clinical performance.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. The document does not describe an MRMC comparative effectiveness study. The submission is for substantial equivalence to a predicate device, focusing on technical and safety aspects, not on improving human reader performance with AI assistance.

Effect size of human readers improve with AI vs without AI assistance: Not applicable.

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

No. The KOWA SL-17 is a physical medical device (a slit lamp biomicroscope) used directly by a human operator, not an algorithm that performs standalone analysis.

7. The Type of Ground Truth Used

Not applicable as there is no mention of a ground truth for clinical performance. The "ground truth", in this context, would be the requirements of the standards (e.g., ISO, IEC) which were met by the device.

8. The Sample Size for the Training Set

Not applicable. The KOWA SL-17 is a physical optical device, not an AI/ML algorithm that requires a training set of data.

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

Not applicable.

Summary

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K133755 MAR 1 1 2014 Kowa, Kowa Company. Ltd.

LIFE SCIENCE DIVISION 4-14, NIHONBASHI-HONCHO 3-CHOME, CHUO-KU, TOKYO 103-8433 JAPAN TEL: +81-(0)42-444-5079 FAX: +81-(0)42-440-7618

510(k) Summary

Submitter information:
Applicant:	Kowa Company, Ltd.4-14, Nihonbashi-honcho 3-ChomeChuo-ku, Tokyo, 103-8433 JapanPhone: +81-42-444-5079Fax: +81-42-440-7618
Contact:	Hiroyuki Koide
Date summary prepared:	December 6, 2013
Device identification:
Device trade name:	KOWA SL-17
Classification name:	Biomicroscope, Slit-Lamp, Ac-Powered
Product code:	HJO

Identification of predicate device:

Kowa Company believes that this device is substantially equivalent to: KOWA SL-15 manufactured by Kowa, 510(k) # K063640

Device description:

Intended use:

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510tk) Notification

Technical characteristics:

Performance

To guarantee Performance, ISO10939 test was performed. The KOWA SL-17 met all requirements of the standard.

Electrical safety

To guarantee Electrical safety, IEC60601-1 test was performed. The KOWA SL-17 met all requirements of the standard.

Electromagnetic compatibility

To guarantee Electromagnetic compatibility, IEC60601-1-2 test was performed. The KOWA SL-17 met all requirements of the standard.

Optical safety

To guarantee Optical safety, ISO15004-2 evaluation was performed. The KOWA SL-17 met all requirements of Group 2 instrument in the standard.

Software evaluation

The Software of KOWA SL-17 was evaluated by FDA guidance, "Guidance for the content of premarket submissions for software contained in medical devices, 2005" and

"General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002". It was confirmed that the software was appropriate.

Biocompatibility

To guarantee biocompatibility, biocompatibility assessment was performed. The materials were used the same of the other legally marked devices in US. (#K063640)

Risk Management

The KOWA SL-17 was evaluated in accordance with ISO14971. The risk management of the device was deemed satisfactory. There was no remnant risk.

Substantial Equivalence

According to Guidance on the CDRH Premarket Notification Review Program 6/30/86, we determined the predicate device. From the above assessment, KOWA SL-17 and the predicate device is substantially equivalent.

Conclusion

The KOWA SL-17 is equipped with the fundamental technology features equivalent to the predicate device, and also delivers the equivalent level of safety. Therefore, it is concluded that there is no significant difference in the basic functions, safety and effectiveness between KOWA SL-17 and the predicate device.

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510(k) Notification

	Proposed device	Predicate device
Device Name	KOWA SL-17	KOWA SL-15
510(k) number	-	K063640
Indications for use orScope	KOWA SL-17 is intended for use ineye examination of the anterior eyesegment, from the cornea epitheliumto the posterior capsule. It is used toaid in the diagnosis of diseases ortrauma which affect the structuralproperties of the anterior eyesegment.	KOWA SL-15 is an ophthalmicdevice indicated for non-invasiveillumination, magnification andobservation of the human eye. Itconsists of a hand-held, batterypowered slit-lamp biomicroscopewith viewing and illuminationoptical systems and anAC-powered stand.
Slit lamp function and principal parts
Illumination light source	White LED	Halogen lamp
Aperture diameter	Three selection(φ1, φ5, φ12mm)	φ12mm Fixed
Slit length	12mm
Slit width	Three selection(0.1, 0.2, 0.8mm)
Spot	φ1, φ5, φ12mmand shapes of ellipse
Light intensity	Adjustable continuously	Three selection(1/16, 1/4, Full)
Power supply	4pcs of AAA batteries (Alkaline orNi-MH)	Lithium-ion rechargeable battery

Table 5-1: Comparison with Predicate Device

. .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

March 11, 2014

Public Health Service

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

Kowa Company, Ltd. % Mr. Hiroyuki Koide 4-14, Nihonbashi-honcho 3-chome Chuo-ku, Tokyo, 103-8433 Japan

Re: K133755

Trade/Device Name: KOWA SL-17 slit lamp Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: HJO Dated: January 14, 2014 Received: January 16, 2014

Dear Mr. Koide:

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 cither 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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Page 2 - Mr. Ryan O'Leary

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 53)-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.lda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/deTault.hun 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.htm1.

Sincerely yours,

Kesia Y. Alexander -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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3 (41) Socilianion:

4.0 Indications for Use Statement

_ K133755 510(k) Number (if know):

Device Name:

Indications for Use:

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

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

(PLEASE DO WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device

Clu

(Division Sign-Off)
Division of Ophthalmic and Ear, Nose
and Throat Devices
510(k) Number K133755

Andrew Yang -S
2014.02.24
17:01:35 -05'00'

Kowa Company, Tra KOREA SI F

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.