(47 days)
Not Found
No
The description focuses on mechanical cutting and electrosurgical coagulation, and explicitly states the modification has not altered the fundamental technology of the predicate device. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device performs mechanical cutting and electrosurgical coagulation during surgical procedures, which are interventional actions rather than therapeutic in the sense of treating a condition. Its function is to facilitate surgery, not to directly treat a disease or condition itself.
No
Explanation: The device is described as performing "mechanical cutting and electrosurgical coagulation of tissue during the performance of laparoscopic and general surgical procedures." This indicates a therapeutic function, not a diagnostic one. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description explicitly states it is a modification to a predicate device and describes physical components like "scissors blades" and "shaft length," indicating it is a hardware device with a mechanical cutting and electrosurgical function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Mechanical cutting and electrosurgical coagulation of tissue during the performance of laparoscopic and general surgical procedures." This describes a surgical tool used directly on a patient's tissue in vivo (within the living body).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are performed in vitro (outside the living body).
- Device Description: The description details a surgical instrument with scissors blades and electrosurgical capabilities, designed for use during surgery. This aligns with a surgical device, not an IVD.
The information clearly indicates this is a surgical device used for cutting and coagulation of tissue during procedures, which is distinct from the purpose of an IVD.
N/A
Intended Use / Indications for Use
Mechanical cutting and electrosurgical coagulation of tissue during the performance of laparoscopic and general surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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 .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
F: 510(k) Summary (K031081)
March 31, 2003
| Company: | Gyrus Medical, Inc.
6655Wedgwood Road
Maple Grove, MN
Tel. No. (763) 416-3000
FAX. No. (763) 416-3070 |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| Contact: | Mercedes Bayani
Director, Regulatory& Clinical Affairs |
| Common/Usual Name: | Electrosurgical Instruments |
| Classification Name: | Electrosurgical Cutting and Coagulation Device
And Accessories (21 CFR 878.4400) |
| Proprietary Name: | Everest LP Bipolar Scissors and Gyrus LP
Bipolar 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.
Page 10 of 10
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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.
2
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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Page 1 of 1
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 |