KOWA SL-17

K133755 · Kowa Co. , Ltd. · HJO · Mar 11, 2014 · Ophthalmic

Device Facts

• Record ID: K133755
• Device Name: KOWA SL-17
• Applicant: Kowa Co. , Ltd.
• Product Code: HJO · Ophthalmic
• Decision Date: Mar 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

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 Story

KOWA SL-17 is a hand-held, battery-powered slit-lamp biomicroscope used for non-invasive illumination, magnification, and observation of the human eye. It enables clinicians to examine the anterior eye segment, including the cornea epithelium through to the posterior capsule, to assist in diagnosing ocular diseases or trauma. The device features a white LED light source, adjustable aperture diameters (1mm, 5mm, 12mm), and adjustable slit widths. It is operated by eye care professionals in clinical settings. The device provides direct visual output to the clinician, who uses the magnified view to assess structural properties of the eye, facilitating clinical decision-making regarding patient diagnosis and treatment.

Clinical Evidence

Bench testing only. The device underwent performance testing per ISO 10939, electrical safety testing per IEC 60601-1, electromagnetic compatibility testing per IEC 60601-1-2, and optical safety evaluation per ISO 15004-2. Biocompatibility was assessed by comparing materials to the predicate device (K063640). No clinical data was required or provided.

Technological Characteristics

Hand-held slit-lamp biomicroscope. Features white LED illumination, adjustable aperture (1, 5, 12mm), and slit width (0.1, 0.2, 0.8mm). Powered by 4x AAA batteries (Alkaline or Ni-MH). Complies with ISO 10939 (performance), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and ISO 15004-2 (optical safety).

Indications for Use

Indicated for eye examination of the anterior eye segment (cornea epithelium to posterior capsule) to aid in the diagnosis of diseases or trauma affecting structural properties. For prescription use.

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 SL-15 (K063640)

Submission Summary (Full Text)

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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: [phone] FAX: [phone]

### 510(k) Summary

| 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] |
| 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:

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.

#### Intended use:

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.

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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 or<br>Scope | KOWA SL-17 is intended for use in<br>eye examination of the anterior eye<br>segment, from the cornea epithelium<br>to the posterior capsule. It is used to<br>aid in the diagnosis of diseases or<br>trauma which affect the structural<br>properties of the anterior eye<br>segment. | KOWA SL-15 is an ophthalmic<br>device indicated for non-invasive<br>illumination, magnification andobservation of the human eye. It<br>consists of a hand-held, battery<br>powered slit-lamp biomicroscope<br>with viewing and illumination<br>optical systems and an<br>AC-powered stand. |
| Slit lamp function and principal parts | | |
| Illumination light source | White LED | Halogen lamp |
| Aperture diameter | Three selection<br>(φ1, φ5, φ12mm) | φ12mm Fixed |
| Slit length | 12mm | |
| Slit width | Three selection<br>(0.1, 0.2, 0.8mm) | |
| Spot | φ1, φ5, φ12mm<br>and shapes of ellipse | |
| Light intensity | Adjustable continuously | Three selection<br>(1/16, 1/4, Full) |
| Power supply | 4pcs of AAA batteries (Alkaline or<br>Ni-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

D

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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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