UFR FIBEROPTIC CABLE

K972225 · Universal Fiberoptic Repair, Inc. · FST · Mar 18, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K972225
• Device Name: UFR FIBEROPTIC CABLE
• Applicant: Universal Fiberoptic Repair, Inc.
• Product Code: FST · General, Plastic Surgery
• Decision Date: Mar 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

The UFR fiberoptic cable is Intended to transmit light for illumination purposes from light source to various instruments such as headlights, microscopes, endoscopes, etc. It is manufactured to the buyers' specifications and is intended for use with the buyers' existing equipment.

Device Story

UFR Fiberoptic Cable transmits light from external light sources to medical instruments (headlights, microscopes, endoscopes). Device acts as a conduit for illumination. Used in clinical settings where existing light sources and instruments are present. Operated by healthcare professionals. Benefits include providing necessary illumination for surgical or diagnostic procedures. Device is manufactured to buyer specifications to ensure compatibility with existing equipment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fiberoptic light transmission cable. Designed for compatibility with existing medical light sources and instruments. Form factor and specifications are customized to buyer requirements.

Indications for Use

Indicated for transmission of light for illumination purposes from a light source to various medical instruments, including headlights, microscopes, and endoscopes, for use with existing equipment.

Regulatory Classification

Identification

A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Derek N. May General Manager Universal Fiberoptic Repair 9 Wrights Crossing Pomfret Center, Connecticut 06259

MAR 1 8 1998

K972225 Re: UFR Fiberoptic Light Cable Trade Name: Regulatory Class: II Product Code: FST Dated: February 26, 1998 March 2, 1998 Received:

Dear Mr. May:

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 In addition, FDA may publish further announcements action. 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. May

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 requlation (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,

Stephen Rhodes

Celia M. Witten, Ph.D.

a 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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Section #3

Indications for Use

510(k) Number: K972225

Device Name: UFR Fiberoptic Cable

indication For Use

The UFR fiberoptic cable is Intended to transmit light for illumination purposes from light source to various instruments such as headlights, microscopes, endoscopes, etc. It is manufactured to the buyers' specifications and is intended for use with the buyers' existing equipment.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stephen Elwell

General Restorative Device

Over-The-Counter Use __X

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