MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY

K990372 · Dr. Fritz GmbH · HET · Oct 14, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K990372
• Device Name: MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY
• Applicant: Dr. Fritz GmbH
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Oct 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Viewing of and access to, the surgical site during endoscopic gynecological surgical procedures

Device Story

Modular Instrument System for Minimal Invasive Surgery consists of endoscope accessories used to facilitate visualization and access to surgical sites during endoscopic gynecological procedures. Operated by surgeons in clinical/OR settings. Device provides mechanical access and viewing capabilities to assist in minimally invasive surgical interventions. Benefits include improved surgical site visibility and access, potentially reducing invasiveness of gynecological procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Modular instrument system for endoscopic gynecological surgery. Mechanical endoscope accessories. No software or electronic components described.

Indications for Use

Indicated for viewing and accessing the surgical site during endoscopic gynecological surgical procedures. For prescription use only.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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OCT 1 4 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Fritz GmbH c/o Mr. James Chitty Official Correspondent Altomec Service Center 13311 Brooks Drive, Suite E Baldwin Park, California 91706

Re: K990372 Trade Name: Modular Instrument System for Minimal Invasive Surgery Regulatory Class: II Product Code: HET Dated: August 30, 1999 Received: September 21, 1999

Dear Mr. Chitty:

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 enclosures) 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. James Chitty

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,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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Indications for use

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Center for Devices and Radiological Health

510(k) Number (if known): K990372

:

Modular Instrument System for Minimal Invasive Device Name: Surgery. [Endoscope Accessories]

Indications for Use:

Viewing of and access to, the surgical site during endoscopic gynecological surgical procedures

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س بہ جہ دیتھا ، وقت ،

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|----------|
| <img alt="Signature" src="signature.png"/> | |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K 990372 |

OR

| Prescription Use<br>(Per 21 CFR 801.109) <img alt="Check Mark" src="check_mark.png"/> | Over-The-Counter-Use<br>(Optional Format 1-2-9) |
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