EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE by GYRUS MEDICAL, INC.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Everest Bipolar Needle Electrode and Gyrus Bipolar Needle Electrode. This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, most of the requested information regarding acceptance criteria and a study proving performance is not present in the provided document. The document focuses on demonstrating that the modified device is substantially equivalent to an already cleared predicate, meaning its design, materials, function, and intended use are similar enough that it raises no new issues of safety and effectiveness.

Here's a breakdown based on the information provided and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable / Not Provided: The document does not specify quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or specific performance thresholds) that the device must meet, nor does it present detailed performance results from a study against such criteria. The basis for clearance is substantial equivalence to a predicate, not meeting novel performance benchmarks.

2. Sample size used for the test set and the data provenance

Not Applicable / Not Provided: The submission is not based on a new clinical study with a test set of data. It relies on the assertion that the modified device is identical in construction (except for shaft length) and materials, and has the same intended use and energy source as the predicate (K904993). Therefore, no "test set" in the context of performance data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Provided: As no new clinical study with a test set is discussed, there is no mention of experts establishing a ground truth for performance evaluation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable / Not Provided: No test set or related adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable / Not Provided: This device is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related effectiveness metrics are irrelevant and not part of this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable / Not Provided: This device is a manual surgical instrument, not an algorithm. Standalone performance for an algorithm is not relevant here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable / Not Provided: No ground truth in the context of performance metrics is established or discussed, as the submission focuses on substantial equivalence of design and function. The "ground truth" for the submission is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not Applicable / Not Provided: This device is not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not Applicable / Not Provided: As above, this is not an AI/ML device, so a training set and its ground truth establishment are not relevant.

Summary Explanation:

The provided document is a 510(k) summary, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. The core argument for the Everest Bipolar Needle Electrode and Gyrus Bipolar Needle Electrode is that it is a modification to an existing predicate device (K904993).

The key statements supporting this are:

"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 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."

Based on these points, Gyrus Medical Inc. concludes that "no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent." This type of submission relies heavily on comparison to a predicate device and demonstration that the changes are minor and do not introduce new risks or alter fundamental performance characteristics, rather than presenting a performance study against specific, novel acceptance criteria.

Summary

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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.

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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 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.

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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 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

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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

Regulation Number and Section

§ 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.