(90 days)
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.
The Meditec Link is an adapter which attaches to slit lamps, 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 lamps. The laser light (532 nm) can then be directed to selected sites within the eye by an ophthalmologist.
Here's an analysis of the provided text regarding the Meditec Link device, addressing your specific questions.
Based on the provided documentation, the Meditec Link is an adapter for ophthalmic slit lamps, designed to deliver green laser light (532 nm) via fiber optic for use by an ophthalmologist.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Substantial Equivalence:
The documentation states that the Meditec Link is considered substantially equivalent to its predicate device, the Infinitech Multi-Spot Slit Lamp laser Adapter. This means the acceptance criteria are primarily based on demonstrating:
- Same Intended Use: The device must have the same fundamental purpose as the predicate.
- Same Technological Characteristics: The device's design and operating principles must be similar to the predicate.
- No new questions of safety and effectiveness: The device should not introduce new risks or effectiveness concerns compared to the predicate.
Given these overarching criteria, the specific performance aspects are implicitly tied to the predicate device's established performance. The submission explicitly states: "The specifications and intended uses of the Meditec Link are the same or 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."
Reported Device Performance:
| Acceptance Criteria Category | Specific Criterion | Reported Meditec Link Performance |
|---|---|---|
| Intended Use Equivalence | Intended to be attached to slit lamps (e.g., Zeiss, Haag Streit 900 BQ/BM) to allow green laser energy light (532 nm) to be delivered to the slit lamp via fiber optic for directing to selected sites within the eye by an ophthalmologist. | The Meditec Link's intended use is stated to be the same or very similar to the predicate: "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... to be directed to selected sites within the eye by an ophthalmologist." |
| Technological Characteristics Equivalence | Design and fundamental operating principles of the adapter for integrating a green laser with slit lamps. | The Meditec Link's specifications and design are stated to be the same or very similar to the predicate. No significant differences in design were identified. |
| Safety and Effectiveness Equivalence (Risk) | No new questions of safety or effectiveness are raised. This implies that the device does not introduce new failure modes, optical hazards, or mechanical instability that would make it less safe or effective than the predicate. | The submission concludes: "Aesculap-Meditec believes that the Meditec Link is substantially equivalent to legally marketed predicate devices." This implies that no new questions of safety and effectiveness were raised. |
| Clinical Performance (if applicable) | The predicate device has demonstrated clinical utility in ophthalmic laser procedures. | The document explicitly states: "Because of this, performance data were not required." The substantial equivalence claim is based on similarity to the predicate, not new clinical trials. |
Study that Proves the Device Meets Acceptance Criteria:
The documentation does not describe a detailed study with specific acceptance criteria beyond the substantial equivalence comparison. The conclusion is based on a comparative analysis of the device's design, specifications, and intended use against a legally marketed predicate device (Infinitech Multi-Spot Slit Lamp laser Adapter).
The key statement is from the "Performance Data" section: "The specifications and intended uses of the Meditec Link are the same or 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."
This indicates that a formal efficacy or safety study with acceptance criteria, as one might expect for a novel device, was not conducted or submitted because the device was deemed sufficiently similar to an already approved device. The "study" here is essentially the 510(k) substantial equivalence determination process itself, where the manufacturer provides evidence (in the form of descriptions and comparisons) to establish similarity to a predicate.
Additional Requested Information:
Given that the submission asserts "performance data were not required" due to substantial equivalence, most of the following questions cannot be answered as no specific performance study was conducted.
- Sample size used for the test set and the data provenance: Not applicable. No test set or performance study was conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set was performed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a physical adapter for a laser system, not an AI or imaging diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical accessory, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for the submission is the regulatory acceptance and established performance of the legally marketed predicate device.
- The sample size for the training set: Not applicable. The device is not a machine learning model, so there is no "training set."
- How the ground truth for the training set was established: Not applicable.
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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 GmbHPrussingstrasse 41D-07739 JenaGERMANY |
| Contact Person: | Mr. William T. KelleyGeneral ManagerAesculap-Meditec, North America23832 Via MonteCoto De Caza, CA 92679-4001 |
| Telephone: | 714-589-8536714-589-6259 (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)Product Code: HJO |
| As an accessory to an ophthalmic laser the device couldreference the classification regulation for ophthalmic lasers (21CFR 886.4390) and the ophthalmic laser product code (HQF). | |
| Class: | An accessory to a medical device is normally placed in thesame 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.
all Mandharacter and and the same and comments of
1/1 13
- 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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use(Per 21 CFR 801.109) | ✓ |
|---|---|
| ------------------------------------------ | --- |
OR
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K981196 |
|---|---|
| --------------- | --------- |
| Over-The-Counter-Use | |
|---|---|
| ---------------------- | -- |
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 886.4390 Ophthalmic laser.
(a)
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.(b)
Classification. Class II.