AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08

K974467 · Aesculap-Meditec North America · HJO · Feb 19, 1998 · Ophthalmic

Device Facts

• Record ID: K974467
• Device Name: AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08
• Applicant: Aesculap-Meditec North America
• Product Code: HJO · Ophthalmic
• Decision Date: Feb 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SL07 and SL08 laser slit lamps are intended for use in ophthalmology to deliver a thin, intense beam of light into the eye. Both include an adapter to deliver green laser light (532 nm) to the slit lamp by fiber optic. The user should refer to the User Manual provided with the laser for clinical use information for the laser or for additional information.

Device Story

SL07 and SL08 are modified slit lamps (Zeiss SL 20 and Haag-Streit HS 900 BQ) equipped with fiber optic adapters; designed to deliver 532 nm green laser light from an external source (e.g., EyeLite Laser) into the eye. Operated by ophthalmologists in clinical settings; device directs laser energy to selected ocular sites for photocoagulation. Physician selects laser intensity; device provides visualization via biomicroscopy. Benefits include precise delivery of therapeutic laser energy for ophthalmic treatment.

Clinical Evidence

Bench testing only. No clinical data required as the device is a modification of legally marketed slit lamps with equivalent specifications and intended use.

Technological Characteristics

Modified Zeiss SL 20 (SL08) and Haag-Streit HS 900 BQ (SL07) slit lamps. Features fiber optic delivery (50 um fiber, SMA connector) for 532 nm frequency-doubled Nd:YAG laser. Includes L5 (DIN EN 207) eye protection. Spot size range 50-1000 um. Standalone biomicroscope functionality with integrated laser delivery adapter.

Indications for Use

Indicated for use in ophthalmology to deliver a thin, intense beam of light into the eye for photocoagulation procedures. Intended for prescription use by ophthalmologists.

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

• Zeiss Slit Lamps
• Haag Streit Slit Lamps
• Infinitech Multi-Spot Slit Lamp laser Adapter for Haag Streit Slit Lamp
• Oculight SLx

Reference Devices

• Aclon Frequency Double YAG (Fx-2)
• IRIS Oculite Slx

Submission Summary (Full Text)

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APPENDIX E

# 510(k) SUMMARY

FEB 19 1998

# SL07 and SL08 LASER SLIT LAMPS

This 510(k) summary of safety and effectiveness for the SL07 and SL08 laser slit lamps is submitted in accordance with the requirements of SMDA 1990 and follows guidance from the Office of Device Evaluation concerning the organization and content of a 510(k) summary.

Applicant: Aesculap-Meditec, North America

Address (Manufacturer): Aesculap-Meditec GmbH
Prussingstrasse 41
D-07739 Jena
GERMANY

Contact Person: Mr. William T. Kelley
General Manager
Aesculap-Meditec, North America
23832 Via Monte
Coto De Caza, CA 92679-4001

Telephone: [phone]
714-589-6259 (Fax)

Preparation Date: November 1997

Device Trade Name: SL07 and SL08 Laser Slit Lamps

Common Name: Slit Lamp

Classification Name: Biomicroscope, Slit Lamp, AC powered
(see: 21 CFR 886.1850)
Product Code: HJO

As an accessory to an ophthalmic laser the device could reference the classification regulation for ophthalmic lasers (21 CFR 886.4390) and the ophthalmic laser product code (HQF).

Class: Class II medical device (as slit lamps or as accessories to ophthalmic lasers)

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Legally marketed predicate devices:

Zeiss and Haag Streit Slit Lamps; Infinitech Multi-Spot Slit Lamp laser Adapter for Haag Streit Slit Lamp; Oculight SLx

Description of Devices:

The SL07 and SL08 slit lamps are commercially available slit lamps which have been modified by Aesculap-Meditec to accommodate an adapter through which green laser light, e.g., from the EyeLite™ Laser, is delivered to the slit lamps. The laser light (532 nm) can then be directed to selected sites within the eye by an ophthalmologist.

Intended Use:

The SL07 and SL08 slit lamps are intended for use in ophthalmology to deliver a thin, intense beam of light into the eye. Both include an adapter to deliver green laser light (532 nm) to the slit lamp by fiber optic. The user should refer to the User Manual provided with the laser for clinical use information for the laser or for additional information.

This intended use is the same or similar to that for the claimed predicate devices (see below) and for slit lamps as described in 21 CFR 886.1850, i.e., to direct a thin, intense light into the eye.

Performance Data:

The specifications and intended uses of the SL07 and SL08 laser slit lamps are the same or very similar to those of the claimed predicate devices and other legally marketed slit lamps (as devices or as accessories to ophthalmic lasers). There are no significant differences between the SL07 and SL08 devices and claimed predicates under conditions of intended use.

Because of this, performance data were not required.

CONCLUSION:

Based on the foregoing, Aesculap-Meditec believes that the SL07 and SL08 laser slit lamps are substantially equivalent to legally marketed predicate devices.

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COMPARISON TABLE/PREDICATE DEVICES

| DEVICE CHARACTERISTIC | SL08 SLIT LAMP | SL07 SLIT LAMP | INFINITECH MULTI-SPOT ADAPTER | ACLON FREQUENCY DOUBLE YAG (Fx-2) |
| --- | --- | --- | --- | --- |
| Device | Zeiss SL 20 slit lamp modified to accommodate the adapter | Haag-Streit HS 900 BQ slit lamp modified to accommodate the adapter | | Cites Zeiss, Haag-Streit and similar slit lamps |
| Indications (biomicroscope, slit lamp) | See 21 CFR 886.1850 and medical practice | See 21 CFR 886.1850 and medical practice | No information | Labeled for ophthalmic use; refers to several slit lamps |
| Spot Size | Range: 50 um - 1000 um
Imaging: 50 um - 400 um focusing
>400 um - 1000 um defocusing | Range: 50 um - 1000 um
Imaging: 50 um - 400 um focusing
>400 um - 1000 um defocusing | relies on slit lamp, multi-spot is capable of creating 4 spots centered on guide beam | relies on slit lamps |
| Laser Connection | 50 um fiber with SMA connector | 50 um fiber with SMA connector | -- | Has connector |
| Wavelength | Frequency doubled Nd:YAG | Frequency doubled Nd:YAG | Argon/Krpton and frequency doubled Nd:YAG | Frequency doubled Nd:YAG |
| Eye Protection | For wavelength; protection type L5 (DIN EN 207) at 532 um | For wavelength; protection type L5 (DIN EN 207) at 532 um | not specified; presumably for wavelength | not specified; presumably for wavelength |
| Tissue Effect of Laser | Photocoagulation | Photocoagulation | Photocoagulation | Photocoagulation |
| Laser Intensity | selected by physician | selected by physician | selected by physician | selected by physician |

Note: The IRIS Oculite Slx brochure (referenced above but not included in the tabular comparisons) cites adapters for the Zeiss 20 SL and Haag-Streit 900 BQ slit lamp.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
FEB 19 1998

Mr. William T. Kelley
General Manager
Aesculap- Meditec North America
23832 Via Monte
Coto De Caza, CA 92679-4001

Re: K974467
Trade Name: AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08
Regulatory Class: II
Product Code: 86 HJO
Dated: November 21, 1997
Received: November 26, 1997

Dear Mr. Kelley:

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 (QS) 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 - Mr. William T. Kelley

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

If you desire specific advice for your devices 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 devices, 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 C

510(K) Number (if known): K974467

Device Name: SL07 and SL08 Laser Slit Lamps

Indications For Use:

The SL07 and SL08 laser slit lamps are intended for use in ophthalmology to deliver a thin, intense beam of light into the eye. Both include an adapter to deliver green laser light (532 nm) to the slit lamp by fiber optic. The user should refer to the User Manual provided with the laser for clinical use information for the laser or for additional information.

Daryl L. Kauffer
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K974467

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter-Use

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