(47 days)
Mechanical cutting and electrosurgical coagulation of tissue during the performance of laparoscopic and general surgical procedures.
The device is a Class II medical device. The Everest LP Bipolar Scissors and Gyrus LP Scissors are a modification to the predicate device cleared under K904993. The Bipolar Bipolar LP Scissors are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The scissors blades are electrically isolated from each other enabling one blade to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical coagulation and mechanical cutting during surgical procedures is similar to the predicate device cleared under K904993. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices.
The provided text is a 510(k) summary for the Everest LP Bipolar Scissors and Gyrus LP Bipolar Scissors. It discusses the device's substantial equivalence to a predicate device and its intended use. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects like sample sizes, expert ground truth, or AI performance that your request asks for.
The document states:
"The Bipolar Bipolar LP Scissors are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The scissors blades are electrically isolated from each other enabling one blade to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical coagulation and mechanical cutting during surgical procedures is similar to the predicate device cleared under K904993. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices."
"In conclusion, as the design, materials of construction, function and intended use of the Modified LP Bipolar Scissors is similar to that of the predicate devices currently cleared, Gyrus Medical Inc. believes that no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent."
This indicates that the device was cleared based on substantial equivalence to an existing predicate device (K904993), rather than requiring a new clinical performance study with specific acceptance criteria as you've outlined. The FDA's 510(k) process often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, without necessarily requiring new, extensive clinical trials for every submission, especially for modifications that don't alter fundamental technology.
Therefore, I cannot populate the table or answer the specific questions you've posed because the provided text does not contain that type of detailed study information. The clearance was based on the premise that the device is "substantially equivalent" to one already on the market, implying that its performance would be similar, and thus, specific performance metrics and studies to prove them are not detailed in this summary.
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F: 510(k) Summary (K031081)
March 31, 2003
| Company: | Gyrus Medical, Inc.6655Wedgwood RoadMaple Grove, MNTel. No. (763) 416-3000FAX. No. (763) 416-3070 |
|---|---|
| Contact: | Mercedes BayaniDirector, Regulatory& Clinical Affairs |
| Common/Usual Name: | Electrosurgical Instruments |
| Classification Name: | Electrosurgical Cutting and Coagulation DeviceAnd Accessories (21 CFR 878.4400) |
| Proprietary Name: | Everest LP Bipolar Scissors and Gyrus LPBipolar Scissors |
The device is a Class II medical device. The Everest LP Bipolar Scissors and Gyrus LP Scissors are a modification to the predicate device cleared under K904993. The Bipolar Bipolar LP Scissors are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The scissors blades are electrically isolated from each other enabling one blade to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical coagulation and mechanical cutting during surgical procedures is similar to the predicate device cleared under K904993. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices .
In conclusion, as the design, materials of construction, function and intended use of the Modified LP Bipolar Scissors is similar to that of the predicate devices currently cleared, Gyrus Medical Inc. believes that no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent.
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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures or profiles facing to the right, with flowing lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 2003
Ms. Mercedes Bayani Director, Regulatory Affairs Gyrus Medical, Inc. 6655 Wedgwood Road Maple Grove, Minnesota 55311
Re: K031081
Trade/Device Name: Everest LP Bipolar Scissors and Gyrus LP Bipolar Scissors Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 31, 2003 Received: April 24, 2003
Dear Ms. Bayani:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Mercedes Bayani
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark A. Millener
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ≤△3108 l
Device Name: __ Everest LP Bipolar Scissors and Gyrus LP Bipolar Scissors
Indications for Use:
Mechanical cutting and electrosurgical coagulation of tissue during the performance of laparoscopic and general surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurence of CDRH, Office of Device Evaulation (ODE) | |
|---|---|
| (Optional Format 3-10-98) | |
| (Posted July 1, 1998) | |
| (Division Sign-Off) | |
| Division of General, Restorative | |
| and Neurological Devices | |
| 510(k) Number | K031081 |
§ 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.