BC 900 SLIT LAMP

K982057 · Haag-Streit AG · HJO · Aug 14, 1998 · Ophthalmic

Device Facts

• Record ID: K982057
• Device Name: BC 900 SLIT LAMP
• Applicant: Haag-Streit AG
• Product Code: HJO · Ophthalmic
• Decision Date: Aug 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used in the fitting of contact lenses and to aid in the diagnosis of diseases or trauma which affect the structural properties or topographic features of the anterior eye segment.

Device Story

BC 900 Slit Lamp is an AC-powered biomicroscope used for eye examination and contact lens fitting. Device combines a microscope with a light source capable of narrowing into a slit for illumination of the eye. Operated by eye care professionals in a clinical setting. Accessories allow for tonometry, vitreous/fundus examination, and documentation of eye shapes. Output is a magnified visual view of the eye provided to the clinician for diagnostic assessment and contact lens fitting. Benefits include non-invasive visualization of anterior eye structures to aid in diagnosis of trauma or disease.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

AC-powered (7-12V, 50-60 Hz) slit lamp biomicroscope. Consists of a microscope and adjustable slit light source. Compatible with standard accessories for tonometry and fundus/vitreous examination. Mechanical/optical design.

Indications for Use

Indicated for eye examination of the anterior eye segment (corneal epithelium to posterior capsule), contact lens fitting, and diagnosis of diseases or trauma affecting anterior eye segment structural properties or topography.

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

• Haag-Streit brand slit lamp 900 BM

Submission Summary (Full Text)

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AUG 1 4 1998

Haaq-Streit AG Gartenstadtstrasse 10 CH-3098 Köniz / Bern

Telefon [phone] / 56 l-ax 031 971 97 73

510 (k)#: K982057

FDA, Center for Devices and Radiological Health Document Mail Centre (HFZ-401) 9200 Corporate Blvd. Rockville, Maryland 20850 / USA

UUma

Köniz, May 13, 1998

Owner/Operator ID No. 8010098 -

#### 510 (k) Summary

This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

The submitter of this pre-market notification is: 1.

> Dr. Gerd Ulbers, Director R & D Haag-Streit AG Gartenstadtstrasse 10 CH-3098 Köniz-Berne Telephone: [phone] [phone] Fax:

This summary was prepared on May 13, 1998.

The name of the device is the Haad-Streit BC 900 Sift Lamp. Its common name is the sit lamp 2. and the classification name is the AC-powered slit lamp biornicroscope.

3. The BC 900 device is substantially equivalent to the Haad-Streit brand slit lamp 9000 BM.

The Haag-Streit brand BC 900 slit lamp is an instrument used for eye examination and the 4. fitting of contact lenses. The device consists of a microscope combined with a light source that can be narrowed into a slit for illumination of the eye. Each is available with accessories to measure characteristics of the eye and to document actual shapes. The device is powered by 7 to 12V AC and 50-60 Hz.

The device and accessories are indicated as a nonlivasive aid in the examination and 5. diagnosis of eye conditions and in the fitting of contact lenses. The indications are the same as those claimed for the predicate devices.

The technological characteristics are the same or similar to those found with the predicate 6. devices where the eye is examined by projecting light onto it. Aditionally, standard accessories are used for tonometry, examining the vitreous and tundus of the eye and contact lens filting as those claimed for the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 4 1998

Dr. Gerd Ulbers Director, Rearch and Development Haag - Streit AG Gartenstadtstrasse 10 CH- 3098 Köniz - Berne Switzerland

Re: K982057 Trade Name: BC 900 Slit Lamp Regulatory Class: II Product Code: 86 HJO Dated: May 13, 1998 Received: June 11, 1998

Dear Dr. Ulbers:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Dr. Gerd Ulbers

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### APPENDIX 3

Haaq-Streit AG Gartenstadtstrasse 10 CH-3098 Köniz / Bern

Telefon [phone] / 56 Fax [phone]

FDA, Center for Devices and Radiological Health Document Mail Centre (HFZ-401) 9200 Corporate Blvd. Rockville, Maryland 20850 / USA

Owner/Operator ID No. 8010098

Ul/mg

Köniz, July 24, 1998

| 510(K) Number (if known) | : Not yet allocated |
|--------------------------|---------------------|
| Device Name | : BC 900 Slit Lamp |

4982057

### Indications for Use

(Per 21 CFR 801.109)

An AC-powered slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used in the fitting of contact lenses and to aid in the diagnosis of diseases or trauma which affect the structural properties or topographic features of the anterior eye segment.

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Callaway
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number. K982057

Prescription Use ✓ OR Over-the-Counter Use