KOWA SL-15

K063640 · Kowa Co. , Ltd. · HJO · Dec 18, 2006 · Ophthalmic

Device Facts

• Record ID: K063640
• Device Name: KOWA SL-15
• Applicant: Kowa Co. , Ltd.
• Product Code: HJO · Ophthalmic
• Decision Date: Dec 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended 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 powered slit-lamp biomicroscope with viewing and illumination optical systems and an AC-powered stand.

Device Story

KOWA SL-15 is a hand-held, battery-powered slit-lamp biomicroscope used by eye care professionals for non-invasive examination of the human eye. The device utilizes an optical system for magnification and a halogen light source for illumination. It features a turret-based slit selection, adjustable slit width, and built-in blue filter. The device is powered by a rechargeable Lithium-ion battery and includes an AC-powered stand for charging. The clinician observes the eye through the microscope to assess ocular health. The device provides illumination and magnification to facilitate clinical diagnosis and decision-making. It is a modification of the predicate SL-14, featuring updated battery technology, a modified charging circuit, a switching regulator power unit, and a 7.5V/15W halogen lamp.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on design, technological characteristics, and safety standard compliance (IEC60601-1 and IEC60601-1-2).

Technological Characteristics

Hand-held slit-lamp biomicroscope; 7.5V/15W halogen light source; Lithium-ion rechargeable battery (DC 8.4V); switching regulator power unit; 10X/16X magnification; turret slit selection; built-in blue filter; AC 100-240V charging stand. Complies with IEC60601-1 (safety) and IEC60601-1-2 (EMC).

Indications for Use

Indicated for non-invasive illumination, magnification, and observation of the human eye in clinical settings.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• KOWA Portable Slit Lamp SL-14 (K954782)

Submission Summary (Full Text)

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510(k) Notification

063640

# 9. Certification 9.1 Summary for public disclosure

#### Submitter information:

| Applicant: | Kowa Company, Ltd.<br>4-14, Nihonbashi-honcho 3-Chome<br>Chuo-ku, Tokyo, 103-8433 Japan<br>Phone: [phone]<br>Fax: [phone]<br>DEC 1 8 2006 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact:<br>E-mail address: | Satohiko Takanashi, PE<br>[e-mail] |
| 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:

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.

## 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 Lamp<br>SL-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 |
|-----------------------------------------------------------|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>For Use | Same | KOWA Portable Slit Lamp SL-14<br>is an ophthalmic device indicated<br>for non-invasive illumination,<br>magnification and observation of<br>the human eye. It consists of a<br>hand-held, battery powered slit-<br>lamp biomicroscope with viewing<br>and illumination optical systems<br>and an AC-powered stand. |
| Microscope | | |
| Angle of<br>convergence | Same | 13 degree |
| Magnification | Same | 10X/16X |
| Retiles | Same | Built-in both oculars |
| Magnification<br>change | Same | 16X and 10X Magnification is<br>changed through movement of<br>objectives to two positions. |
| Range of<br>interpupillary<br>distance adjustment | Same | 50mm to 70mm |
| Range of examiner's<br>dioptric protection<br>adjustment. | 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 Intensity<br>selection | Three selection:<br>Full, 1/4 and 1/16 | Three selection:<br>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 of<br>illumination | Approximately 40 minutes | Approximately 20 minutes |
| Electric rating | DC 8.4V, 15W<br>(Lithium-ion rechargeable battery) | DC 9V, 15W |
| Dimensions | | |
| Power unit | | |
| Type and electric<br>rating | Same | Charger / Slit lamp stand |
| Input voltage | AC 100-240V, 50/60Hz | AC 100/117/220/240V<br>Selected 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:<br>190mm(W)x250mm(D)x125mm(H)<br>Type B:<br>150mm(W)x250mm(D)x97mm(H) |
| Weight | 1.25kg | Type A: 3.5kg<br>Type B: 2.5kg |

# Table B Predicate device comparison

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Table C Predicate Device Comparison

: :

24

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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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 [phone]. 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 [phone] or [phone] 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