(173 days)
Our device has the same indications for use as both the Tandem Scanning Instrument and as the Tomey Confocal microscope. These indications are to view ocular images, and evaluate ocular disease and infections in patients.
CON-S LTD. CONFOCAL MICROSCOPE
This document is a 510(k) clearance letter from the FDA for a Confocal Microscope, and as such, it does not contain the detailed information about acceptance criteria, study design, or performance metrics that would typically be found in a study report. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and the reported device performance: This document does not specify any performance attributes or acceptance criteria for the device, nor does it report any specific performance data.
- Sample size used for the test set and the data provenance: Not available in this clearance letter.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this clearance letter.
- Adjudication method for the test set: Not available in this clearance letter.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not available in this clearance letter.
- If a standalone performance (algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (confocal microscope), not an AI algorithm.
- The type of ground truth used: Not available in this clearance letter.
- The sample size for the training set: Not applicable, as this is a physical medical device (confocal microscope), not an AI algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
The document states that the device has "the same indications for use as both the Tandem Scanning Instrument and as the Tomey Confocal microscope," which are "to view ocular images, and evaluate ocular disease and infections in patients." The substantial equivalence determination means that the FDA believes the new device performs as safely and effectively as a legally marketed predicate device, but it does not detail the specific studies or performance data that led to this conclusion.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 15 1997
Herbert E. Kaufman, M.D. Con-S Ltd. The Galleria One Galleria Boulevard Suite 912 Metairie, LA 70002
Re: K970414 Trade Name: Confocal Microscope Regulatory Class: II Product Code: 86 HJO Dated: May 8, 1997 Received: May 19, 1997
Dear Dr. Kaufman:
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 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 - Herbert E. Kaufman, M.D.
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) 594-4613. 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,
A Roerl lorenttal
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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CON-S LTD. 10K Application nfocal Microscop ary 1997
510(k) Number (If Known):
K970414
CON-S LTD. CONFOCAL MICROSCOPE Device Name:
Indications for Use: Our device has the same indications for use as both the Tandem Scanning Instrument and as the Tomey Confocal microscope. These indications are to view ocular images, and evaluate ocular disease and infections in patients.
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Bruce Drum
Division Sign-Off
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K970414*
Prescription Use Over-The-Counter Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
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.(b)
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.