(248 days)
Viewing of and access to, the surgical site during endoscopic gynecological surgical procedures
Modular Instrument System for Minimal Invasive Surgery. [Endoscope Accessories]
This is a 510(k) clearance letter for a medical device, not a study report. Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, study details, or ground truth establishment.
A 510(k) clearance signifies that the FDA has determined the device is substantially equivalent to a legally marketed predicate device. This process typically relies on comparisons to existing devices for safety and effectiveness rather than requiring new clinical trials or detailed performance studies like those described in the prompt for AI/diagnostic devices.
Therefore, I cannot provide the requested table and study details.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its body and wings.
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.
{1}------------------------------------------------
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{2}------------------------------------------------
Indications for use
ﺎﺭ ﺍﻟﻤﺮﺍﺟﻊ
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
(do not write below this line - continue on another page if needed)
س بہ جہ دیتھا ، وقت ،
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K 990372 |
OR
| Prescription Use(Per 21 CFR 801.109) | Over-The-Counter-Use(Optional Format 1-2-9) |
|---|---|
| --------------------------------------------------------------------------------------- | ------------------------------------------------- |
page 1 of 1
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.