CONFOCAL MICROSCOPE

K970414 · Con-S , Ltd. · HJO · Jul 15, 1997 · Ophthalmic

Device Facts

• Record ID: K970414
• Device Name: CONFOCAL MICROSCOPE
• Applicant: Con-S , Ltd.
• Product Code: HJO · Ophthalmic
• Decision Date: Jul 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended 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.

Device Story

Confocal microscope used for viewing ocular images and evaluating ocular disease and infections. Device captures high-resolution images of ocular structures; enables clinicians to visualize and assess pathology. Operated by eye care professionals in clinical settings. Output consists of visual images for diagnostic review by physicians. Facilitates clinical decision-making regarding ocular health and infection management.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological and intended use similarities to predicate devices.

Technological Characteristics

Confocal microscopy imaging system. Designed for ocular visualization. Operates as a diagnostic imaging device.

Indications for Use

Indicated for patients requiring ocular imaging for the evaluation of ocular disease and infections.

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

• Tandem Scanning Instrument
• Tomey Confocal microscope

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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 [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,


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.
510K Application
Confocal Microscope
January 1997

510(k) Number (If Known): K970414

Device Name: CON-S LTD. CONFOCAL MICROSCOPE

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 of Ophthalmic Devices
510(k) Number K970414

Prescription Use ☑
Over-The-Counter Use
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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