KOWA SL-15 is an ophthalmic device indicated for non-invasive 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 an AC-powered stand.

Device Description

AI/ML Overview

The provided document is a 510(k) premarket notification for the Kowa SL-15 Slit Lamp. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with acceptance criteria, sample sizes, and ground truth establishment in the way typically seen for novel AI/medical device performance claims.

Therefore, many of the requested elements for describing "the acceptance criteria and the study that proves the device meets the acceptance criteria" are not found in this document. This submission primarily relies on engineering and design comparisons to an existing, legally marketed device (the Kowa Portable Slit Lamp SL-14).

Here's an analysis based on the provided text, addressing the points where information is available or noting where it is not applicable for this type of submission:

Summary of Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria for the KOWA SL-15 are implicitly set by its substantial equivalence to the predicate device, the KOWA Portable Slit Lamp SL-14. This means the device must perform similarly and be as safe and effective as the predicate. The "study" is a comparative analysis of specifications and design changes.

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission for a traditional medical device (not an AI algorithm), the "acceptance criteria" are the specifications and performance characteristics of the predicate device. The "reported device performance" is the KOWA SL-15's specifications, which are deemed "substantially equivalent" for the majority of features.

Feature / Acceptance Criteria (from Predicate SL-14)	Reported Device Performance (KOWA SL-15)	Met/Not Applicable (NA)	Notes
Indications For Use: Non-invasive illumination, magnification, and observation of the human eye.	Same	Met	Explicitly stated as "Same".
Microscope Angle of convergence: 13 degree	Same	Met	Explicitly stated as "Same".
Magnification: 10X/16X	Same	Met	Explicitly stated as "Same".
Reticles: Built-in both oculars	Same	Met	Explicitly stated as "Same".
Magnification change: 16X and 10X changed through movement of objectives.	Same	Met	Explicitly stated as "Same".
Range of interpupillary distance adjustment: 50mm to 70mm	Same	Met	Explicitly stated as "Same".
Range of examiner's dioptric protection adjustment: -8D to +4D	Same	Met	Explicitly stated as "Same".
Slit projection unit Slit selection: Turret	Same	Met	Explicitly stated as "Same".
Slit length: 12mm Fixed	Same	Met	Explicitly stated as "Same".
Slit width: 0.1, 0.2, 0.8mm and φ12 spot	Same	Met	Explicitly stated as "Same".
Light Intensity selection: Three selection: Full, 1/2 and 1/4	Three selection: Full, 1/4 and 1/16	Partially Met	Modification: Light intensity options differ, but still offers three selections. Likely considered equivalent in function.
Slit projection angle: 60 degree for Horizontal	Same	Met	Explicitly stated as "Same".
Filter: Built-in blue filter	Same	Met	Explicitly stated as "Same".
Light source: 7.2V, 15W Halogen lamp	7.5V, 15W Halogen lamp	Partially Met	Modification: Small voltage change for the halogen lamp.
Duration of illumination: Approximately 20 minutes	Approximately 40 minutes	Met (Improved)	Modification: Improved battery life. This is a positive change.
Electric rating: DC 9V, 15W	DC 8.4V, 15W (Lithium-ion rechargeable battery)	Partially Met	Modification: Change due to new battery type.
Power unit Type and electric rating: Charger / Slit lamp stand	Same	Met	Explicitly stated as "Same".
Input voltage: AC 100/117/220/240V, 50/60Hz	AC 100-240V, 50/60Hz	Partially Met	Modification: Wider input voltage range, indicating improved compatibility.
Power consumption: 70VA	90VA	Partially Met	Modification: Increased power consumption. This likely relates to the new charging circuitry for the Li-ion battery or the new power unit.
EMC compliance with safety standards: -	IEC60601-1-2: 2001	NA	New: The predicate did not list this, indicating an update to safety standards for the new device.
Safety compliance with safety standards: -	IEC60601-1: 1988	NA	New: The predicate did not list this, indicating an update to safety standards for the new device.
Microscope Size: 95mm(W)x214mm(D)x213mm(H)	221mm(W)x106mm(D)x214mm(H)	Partially Met	Modification: Significant change in dimensions. While different, it is for a hand-held device and likely does not affect fundamental safety/effectiveness for its intended use.
Microscope Weight: 900g	790g	Met (Improved)	Modification: Lighter weight. This is a positive change.
Power unit Size: Type A: 190mm(W)x250mm(D)x125mm(H), Type B: 150mm(W)x250mm(D)x97mm(H)	124mm(W)x253mm(D)x68mm(H)	Partially Met	Modification: Different dimensions for the power unit.
Power unit Weight: Type A: 3.5kg, Type B: 2.5kg	1.25kg	Met (Improved)	Modification: Lighter power unit. This is a positive change.

Key modifications identified:

Change to Lithium-ion rechargeable battery.
Modification of charging circuit for Lithium-ion battery.
Modification of power unit to switching regulator.
Change of lamp bulb from 7.2V/15W to 7.5V/15W Halogen lamp.
Improved illumination duration (40 min vs 20 min).
Lighter microscope and power unit.
Updated compliance with EMC and Safety standards.

2. Sample sized used for the test set and the data provenance

Sample Size for Test Set: Not applicable. This submission relies on engineering comparison and compliance with standards rather than a clinical test set of patient data with a specific sample size.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There was no clinical "test set" and thus no ground truth established by experts in this context. The substantial equivalence argument rests on the predicate device's established safety and effectiveness.

4. Adjudication method for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI device and no MRMC study was conducted.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" here is the long-established safety and effectiveness of the predicate device (KOWA Portable Slit Lamp SL-14) based on its market history and regulatory clearance. The KOWA SL-15 is demonstrated to be substantially equivalent through design and specification comparison.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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510(k) Notification

063640

9. Certification 9.1 Summary for public disclosure

Submitter information:

Applicant:	Kowa Company, Ltd.4-14, Nihonbashi-honcho 3-ChomeChuo-ku, Tokyo, 103-8433 JapanPhone: +81-3-3279-7329Fax: +81-3-3245-1109DEC 1 8 2006
Contact:E-mail address:	Satohiko Takanashi, PEs-takana@kowa.co.jp
Date summary prepared:	December 6, 2006

Device identification:

Device trade name:	KOWA SL-15
Classification name:	Biomicroscope, Slit lamp, AC-powered
Product code:	HJO

Intended use:

Comparison:

The KOWA Portable Slit Lamp SL-14 was chosen as a substantially equivalent device. The predicate device is a hand-held slit lamp and is equipped with rechargeable battery. Similar to the predicate device the KOWA SL-15 is equipped with a rechargeable battery.

The KOWA SL-15 has the following similarities to those of the predicate device:

has the same indicated use,
uses the same operating principle,
incorporates the same basic optical design,
incorporates the similar materials,
incorporates the similar light source.

The only modifications that were made are:

Change the battery to Lithium-ion rechargeable battery from.
Kowa Company, Ltd., Modification of KOWA Portable Slit Lamp SL-14

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Modify the charging circuit for Lithium-ion battery,
Modify the power unit to switching regulator.
Modify lamp bulb to 7.5V/15W Halogen lamp from 7.2V/15W Halogen lamp.

The comparison tables of KOWA SL-15 and KOWA Portable Slit Lamp SL-14 are shown in Table 4-1 and 4-2.

In summary, the KOWA SL-15 described in this submission is, in our opinion, substantially equivalent to the predicate device.

Conclusion:

KOWA SL-15 is equipped with the same fundamental technology features equivalent to the predicate devices, and also delivers the equivalent level safety and effectiveness. Thus it is concluded that there is no significant difference in the basic functions, safety and effectiveness between KOWA SL-15 and the predicate device.

Predicate Device	Manufacturer	510(k) No.	Date Cleared
KOWA Portable Slit LampSL-14	Kowa Company, Ltd.	K954782	Nov.24, 1995

Table A: Predicate device

Kowa Company, Ltd., Modification of KOWA Portable Slit Lamp SL-14

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	KOWA SL-15	KOWA Portable Slit Lamp SL-14
IndicationsFor Use	Same	KOWA Portable Slit Lamp SL-14is an ophthalmic device indicatedfor non-invasive illumination,magnification and observation ofthe human eye. It consists of ahand-held, battery powered slit-lamp biomicroscope with viewingand illumination optical systemsand an AC-powered stand.
Microscope
Angle ofconvergence	Same	13 degree
Magnification	Same	10X/16X
Retiles	Same	Built-in both oculars
Magnificationchange	Same	16X and 10X Magnification ischanged through movement ofobjectives to two positions.
Range ofinterpupillarydistance adjustment	Same	50mm to 70mm
Range of examiner'sdioptric protectionadjustment.	Same	-8D to +4D
	KOWA SL-15	KOWA Portable Slit Lamp SL-14
Slit projection unit
Slit selection	Same	Turret
Slit length	Same	12mm Fixed
Slit width	Same	0.1, 0.2, 0.8mm and φ12 spot
Light Intensityselection	Three selection:Full, 1/4 and 1/16	Three selection:Full, 1/2 and 1/4
Slit projection angle	Same	60 degree for Horizontal
Filter	Same	Built-in blue filter
Light source	7.5V, 15W Halogen lamp	7.2V, 15W Halogen lamp
Duration ofillumination	Approximately 40 minutes	Approximately 20 minutes
Electric rating	DC 8.4V, 15W(Lithium-ion rechargeable battery)	DC 9V, 15W
Dimensions
Power unit
Type and electricrating	Same	Charger / Slit lamp stand
Input voltage	AC 100-240V, 50/60Hz	AC 100/117/220/240VSelected 50/60Hz
Power consumption	90VA	70VA
Compliance with safety standards
EMC	IEC60601-1-2: 2001	-
Safety	IEC60601-1: 1988	-
Dimension
Microscope
Size	221mm(W)x106mm(D)x214mm(H)	95mm(W)x214mm(D)x213mm(H)
Weight	790g	900g
Power unit
Size	124mm(W)x253mm(D)x68mm(H)	Type A:190mm(W)x250mm(D)x125mm(H)Type B:150mm(W)x250mm(D)x97mm(H)
Weight	1.25kg	Type A: 3.5kgType B: 2.5kg

Table B Predicate device comparison

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Table C Predicate Device Comparison

: :

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KOWA Company, Ltd. c/o Satohiko Takanashi, PE, Chief Analyst 4-14. Nihonbashi-Honcho 3-chome Chuo-ku, Tokyo, 103-8433 Japan

Re: K063640

DEC 1 8 2006

Trade/Device Name: Kowa SL-15 Slit Lamp Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slit lamp biomicroscope Regulatory Class: Class II Product Code: HJO Dated: December 6, 2006 Received: December 7, 2006

Dear Mr. Takanashi:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Eychlemu SimMD

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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510(k) Notification

Indications for Use

510(k) Number (if know):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

KOWA SL-15 is an ophthalmic device indicated for non-invasive illumination, magnification and observation of the human eye. It consists of a hand-held, battery maginneation and 00001 croscope with viewing and illumination optical systems and an AC-powered stand.

Over-The-Counter Use Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) AND/OR

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

Concurrence of CDRH, Office of Device

Office of Device

Dexyhuhr 12/15/06

vision Sian-Off vision of Ophthalmic Ear, Throat Devis

510(k) Number _

Kowa Company, Ltd., Modification of KOWA Portable Slit Lamp SL-14

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.