(47 days)
No
The summary describes a modification to a predicate electrosurgical device, focusing on mechanical and electrical aspects. There is no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is used for electrosurgical cutting and mechanical dissection of tissue, which are surgical procedures, not therapeutic treatments.
No
The device is described for "electrosurgical cutting and mechanical dissection of tissue," which indicates therapeutic or surgical function, not diagnostic.
No
The device description clearly states it is a "Bipolar Needle Electrode" and describes its physical construction and function in electrosurgical cutting and mechanical dissection, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Electrosurgical cutting and mechanical dissection of tissue, during the performance of laparoscopic and general surgical procedures." This describes a surgical tool used on the patient's body, not a device used to examine specimens outside the body to diagnose conditions.
- Device Description: The description details a surgical electrode used for cutting and dissection. This aligns with a surgical instrument, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
Therefore, this device is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Electrosurgical cutting and mechanical dissection of tissue, during the performance of laparoscopic and general surgical procedures.
Product codes
GEI
Device Description
The Bipolar Needle Electrode is a modification to the predicate device cleared under K904993. The bipolar Needle Electrodes are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The cutting electrode is electrically isolated from the return electrode, enabling one electrode 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.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
March 31, 2003
Gvrus Medical, Inc. Company: 6655Wedgwood Road Maple Grove, MN 55311-3602 Tel. No. (763) 416-3000 FAX. No. (763) 416-3070
- Contact: Mercedes Bayani Director, Requlatory Affairs
- Electrosurgical Instruments Common/Usual Name:
- Electrosuraical Cutting and Coagulation Device Classification Name: and Accessories (21 CFR 878.4400)
- Proprietary Name: Everest Bipolar Needle Electrode and Gvrus Bipolar Needle Electrode
The device is a Class II medical device. The Bipolar Needle Electrode is a modification to the predicate device cleared under K904993. The bipolar Needle Electrodes are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The cutting electrode is electrically isolated from the return electrode, enabling one electrode 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 cutting, and mechanical dissection are identical to the predicate devices 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 bipolar needle electrode 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.
1
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 stylized eagle with three stripes forming its wing. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 21 2003
Ms. Mercedes Bayani Director, Regulatory Affairs Gyrus Medical, Inc. 6655 Wedgwood Road Maple Grove, Minnesota 55311
Re: K031079
Trade/Device Name: Everest Bipolar Needle Electrode and Gyrus Bipolar Needle Electrode 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 vours.
Sincererly, yours,
Mark N Milliman
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
3
510(k) Number (if known): __ K031079 Device Name: Everest Bipolar Needle Electrode & Gyrus Bipolar Needle Electrode
Indications for Use:
Electrosurgical cutting and mechanical dissection of tissue, during the performance of laparoscopic and general surgical procedures.
Mark N. Millerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Number KOS1077