MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES

K992480 · Medifix, Inc. · HET · Sep 23, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K992480
• Device Name: MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES
• Applicant: Medifix, Inc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Sep 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Indications for Use

Laparoscopes, both the single and double puncture are for use when Gynecological Pelviscopy and Laparoscopic Cholecystectomy are medically indicated.

Device Story

Medifix Single and Double Puncture Laparoscopes are surgical instruments used by physicians in clinical settings to visualize the abdominal and pelvic cavities during minimally invasive procedures. The device functions as an optical tool, allowing the surgeon to inspect internal anatomy during Gynecological Pelviscopy or Laparoscopic Cholecystectomy. By providing direct visualization, the laparoscope assists the surgeon in performing diagnostic or therapeutic interventions, potentially reducing patient trauma compared to open surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rigid endoscopic instrument for visualization. Single and double puncture configurations. Class II medical device.

Indications for Use

Indicated for patients requiring Gynecological Pelviscopy or Laparoscopic Cholecystectomy.

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 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 1999

Mr. George Albulescu President Medifix, Inc. 8727 Narragansett Morton Grove, Illinois 60053

Re: K992480

> Trade Name: Medifix Single and Double Puncture Laparoscope Regulatory Class: II Product Code: HET, GCJ Dated: July 23, 1999 Received: July 26, 1999

Dear Mr. Albulescu:

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. George Albulescu

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,

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-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

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510(k) Number (if Known): Device Name: MEDIFIX Single and Double Puncture Laparoscopes

Indications for Use:

Laparoscopes, both the single and double puncture are for use when Gynecological Pelviscopy and Laparoscopic Cholecystectomy are medically indicated.

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Concurrance of CDRH, Office of Device Evaluation (ODE)

Prescription Use Over-The-Counter Use OR (Per 21 CFR 801.109) Optional Format 1-2-96) ral Restorativ 510(k) Numb