(90 days)
Infinitech Multi-Spot Slit Lamp laser Adapter
Not Found
No
The device description and intended use clearly define the device as a mechanical adapter for delivering laser light, with no mention of AI/ML capabilities or image processing.
No
The device is described as an "adapter" that attaches to slit lamps to deliver green laser energy light. It facilitates the delivery of laser light but does not, in itself, perform a therapeutic function. The therapeutic action would be performed by the laser, which the adapter merely helps to deliver.
No
The device delivers laser energy light to the eye via a slit lamp for treatment, not for diagnosis. It explicitly states "for clinical use information regarding the laser" and "performance data were not required," indicating it's a therapeutic or accessory device.
No
The device is described as an "adapter which attaches to slit lamps" and facilitates the delivery of laser light via fiber optic. This description clearly indicates a physical hardware component, not a software-only device.
Based on the provided information, the Meditec Link is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Meditec Link's Function: The Meditec Link is an adapter that facilitates the delivery of laser light to the eye for treatment purposes. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for delivering laser energy to the eye via a slit lamp for clinical use by an ophthalmologist. This is an in-vivo (within the living body) application, not in-vitro.
Therefore, the Meditec Link falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HJO, HQF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Infinitech Multi-Spot Slit Lamp laser Adapter
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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JUN 17 1998
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1 . . .
APPENDIX D
. .
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 |
| 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: | 714-589-8536 |
| 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) |
| 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: | An accessory to a medical device is normally placed in the |
| same class as the device to which it is an accessory. | |
| Legally marketed predicate devices: | Infinitech Multi-Spot Slit Lamp laser Adapter |
1
- 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).
2
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
4
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)