LIGHTSOURCE OR ILLUMINATOR

K980166 · Cuda Products Co. · HET · Apr 1, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K980166
• Device Name: LIGHTSOURCE OR ILLUMINATOR
• Applicant: Cuda Products Co.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Apr 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Intended Use

To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource actaches to fiberoptic cable which is then attached to an instrument or headlight.

Device Story

Device functions as light source/illuminator for surgical applications; connects to fiberoptic cables which interface with surgical instruments or headlights. Provides illumination to surgical fields. Operated by clinicians in surgical environments. Benefits patient by enabling visualization of surgical sites during procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Illumination device; fiberoptic cable interface; electrical power source; standard surgical light source configuration.

Indications for Use

Indicated for providing illumination to surgical fields via fiberoptic cables and connected instrumentation or headlights in clinical settings.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Submission Summary (Full Text)

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Food and Drug Administration 9.200 Corporate Boulevard Rockville MD 20850

APR - 1 1998

Ms. Kimberly Reed Director, Advertising and Marketing Cuda Products Corporation 6000 Powers Avenue Jacksonville, FL 32217-2279

Re: K980166 I-250 and M2-250TR Lightsources Dated: September 18, 1997 Received: January 16, 1998 Regulatory Class: II 21 CFR 884.1720 Procodes: 85 HET, 78 FCW, 78 FFS, 84 HBI, 78 FCR

Dear Ms. Reed:

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 (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 (OS) 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.

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 (2) CFR Part 801 and additionally 809.10 for in vitro clagnostic 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/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K980166

Device Name: Lightsource or Illuminator M2-250TR or 1-250

Indications for use:

To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource actaches to fiberoptic cable which is then attached to an instrument or headlight.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

*Roler asthly*
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number *K980166*

Prescription USE
or
Over-The-Counter Use-........

(Optional Format 1-2-96)