(22 days)
The Dexide Bipolar Forceps II** device is indicated for use in laparoscopic and open bipolar procedures, to grasp, coagulate and transect tissues.
The Dexide Bipolar Forceps II** device is a grasping, coagulating, and transecting bipolar forceps, which is intended for use in laparoscopic and open procedures. The device is intended for use with bipolar outputs of compatible electrosurgical generators.
The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Dexide Bipolar Forceps II** device) and primarily discusses its intended use, classification, and substantial equivalence to previously marketed devices based on compliance with manufacturing and safety standards. It does not include specific performance data or a study report with quantitative acceptance criteria.
Therefore, the requested tables and information cannot be extracted from the provided text.
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IX. 510(k)_Summary of Safety and Effectiveness
| SUBMITTER: | United States Surgical150 Glover AvenueNorwalk, CT 06856 |
|---|---|
| CONTACT PERSON: | Christopher A. Graham |
| DATE PREPARED: | September 8, 1999 |
| CLASSIFICATION NAME: | Electrosurgical cutting and coagulation device and accessories |
| COMMON NAME: | Bipolar Forceps |
| PROPRIETARY NAME: | Dexide Bipolar Forceps II** device |
| DEVICE DESCRIPTION: | The Dexide Bipolar Forceps II** device is a grasping,coagulating, and transecting bipolar forceps, which is intendedfor use in laparoscopic and open procedures. The device isintended for use with bipolar outputs of compatibleelectrosurgical generators. |
| INTENDED USE: | The Dexide Bipolar Forceps II** device is indicated for use inlaparoscopic and open bipolar procedures, to grasp, coagulateand transect tissues. |
| MATERIALS: | All component materials of the Dexide Bipolar Forceps II **device are comprised of materials which are in accordance withISO Standard # 10993-1. |
| PERFORMANCE DATA: | The Dexide Bipolar Forceps II** device is in compliance withANSI/AAMI American National Standard for ElectrosurgicalDevices HF-18/1993 |
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with outstretched wings, depicted in a minimalist, flowing design.
OCT 5 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Christopher A. Graham Senior Associate, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
Re: K993055
Trade Name: Dexide Bipolar Forceps II** Device Regulatory Class: II Product Code: GEI Dated: September 8, 1999 Received: September 13, 1999
Dear Mr. Graham:
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. Christopher A. Graham
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 vour 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. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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IV. Indications For Use:
510(k) Number (if known): _ K 993055
Name: Dexide Bipolar Forceps II** device
Indications For Use:
The Dexide Bipolar Forceps II** device is indicated for use in laparoscopic and open bipolar procedures, to grasp, coagulate and transect tissues.
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Concurrence of CDRH, Office of Evaluation (ODE)
Prescription Use: \checkmark OR Over-The-Counter Use: __
(Per 21 CFR §801.109)
(Division Sign-Off)
Division of General Restorative Devices K993055
510(k) Number_
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.