MEDITEC LINK

K981196 · Aesculap-Meditec North America · HQF · Jun 17, 1998 · Ophthalmic

Device Facts

• Record ID: K981196
• Device Name: MEDITEC LINK
• Applicant: Aesculap-Meditec North America
• Product Code: HQF · Ophthalmic
• Decision Date: Jun 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Meditec Link is intended to be attached to slit lamps to allow green laser energy light to be delivered to the slit lamp via fiber optic. Once the Meditec Link is attached to a slit lamp the user should refer to the User's Manual or Operator's Manual provided with the laser for clinical use information regarding the laser and for additional use instructions or information. The Meditec Link is presently designed for attachment to Zeiss Slit Lamps or to Haag Streit 900 BQ and 900 BM Slit Lamps.

Device Story

Meditec Link is a mechanical adapter for slit lamps; enables delivery of 532 nm green laser energy via fiber optic cable to the slit lamp. Used by ophthalmologists in clinical settings to direct laser light to selected ocular sites. Device attaches to Zeiss or Haag Streit 900 BQ/BM slit lamps. Does not perform laser emission itself; relies on the connected ophthalmic laser system for clinical function and operational instructions. Benefits patient by allowing precise laser delivery to eye structures during ophthalmic procedures.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Mechanical adapter for slit lamp attachment; fiber optic delivery system for 532 nm laser light. Compatible with Zeiss and Haag Streit 900 BQ/BM slit lamps. No software or electronic components.

Indications for Use

Indicated for use as an adapter to attach to specific slit lamps (Zeiss, Haag Streit 900 BQ/BM) to facilitate delivery of green laser energy (532 nm) for ophthalmic procedures performed by ophthalmologists.

Regulatory Classification

Identification

An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

Predicate Devices

• Infinitech Multi-Spot Slit Lamp laser Adapter

Submission Summary (Full Text)

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## APPENDIX D

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## 510(k) SUMMARY

## MEDITEC LINK

This 510(k) summary of safety and effectiveness for the Meditec Link 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<br>Prussingstrasse 41<br>D-07739 Jena<br>GERMANY |
| Contact Person: | Mr. William T. Kelley<br>General Manager<br>Aesculap-Meditec, North America<br>23832 Via Monte<br>Coto De Caza, CA 92679-4001 |
| Telephone: | 714-589-8536<br>714-589-6259 (Fax) |
| Preparation Date: | March 1998 |
| Device Trade Name: | Meditec Link |
| Common Name: | Adapter for attachment to slit lamps |
| Classification Name: | Accessory to an ophthalmic laser (21 CFR 886.4390)<br>Product Code: HJO |
| | As an accessory to an ophthalmic laser the device could<br>reference the classification regulation for ophthalmic lasers (21<br>CFR 886.4390) and the ophthalmic laser product code (HQF). |
| Class: | An accessory to a medical device is normally placed in the<br>same class as the device to which it is an accessory. |
| Legally marketed predicate devices: | Infinitech Multi-Spot Slit Lamp laser Adapter |

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- The Meditec Link is an adapter which attaches to slit lamps, Description of Devices: e.g., Zeiss Slit Lamps and Haag Streit 900 BQ and 900 BM Slit Lamps, to allow green laser light, to be delivered to the slit The laser light (532 nm) can then be directed to lamps. selected sites within the eye by an ophthalmologist.
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- The Meditec Link is intended to be attached to slit lamps to Intended Use: allow green laser energy light to be delivered to the slit lamp via fiber optic.
Once the Meditec Link is attached to a slit lamp the user should refer to the User's Manual or Operator's Manual provided with the laser for clinical use information regarding the laser and for additional use instructions or information.

The Meditec Link is presently designed for attachment to Zeiss Slit Lamps or to Haag Streit 900 BQ and 900 BM Slit Lamps.

- The specifications and intended uses of the Meditec Link are the same or Performance Data: very similar to those of the claimed predicate devices. There are no significant differences between the Meditec Link in design or intended use and the claimed predicates under conditions of intended use of these accessories to ophthalmic lasers..
Because of this, performance data were not required.

- CONCLUSION: Based on the foregoing. Aesculap-Meditec believes that the Meditec Link is substantially equivalent to legally marketed predicate devices (adapters for slit lamps to allow the introduction of laser light to the slit lamp).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 17 1998

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

Re: K981196 Trade Name: Meditec Link Regulatory Class: II Product Code: HQF Dated: March 17, 1998 Received: March 19, 1998

#### 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 requirement, 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 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,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### APPENDIX B

981196 - x 9 8118

510(K) Number (if known): _New Submission

Device Name Meditec Link

Indications For Use:

The Meditec Link is intended to be attached to slit lamps to allow green laser energy light to be delivered to the slit lamp via fiber optic.

Once the Meditec Link is attached to a slit lamp the user should refer to the User's Manual or Operator's Manual provided with the laser for clinical use information regarding the laser and for additional use instructions or information.

The Meditec Link is presently designed for attachment to Zeiss Slit Lamps or to Haag Streit 900 BQ and 900 BM Slit Lamps.

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| Prescription Use<br>(Per 21 CFR 801.109) | ✓ |
|------------------------------------------|---|
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OR

(Division Sign-Off)

Division of General Restorative Devices

| 510(k) Number | K981196 |
|---------------|---------|
|---------------|---------|

| Over-The-Counter-Use | |
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Concurrence of CDRH, Office of Device Evaluation (ODE)