MIS ELECTROSURGICAL ELECTRODE

• K Number: K971829
• Device Name: MIS ELECTROSURGICAL ELECTRODE
• Manufacturer: E-TEK, INC.
• Date Cleared: 1998-01-28 ( 257 days)
• Product Code: GEI
• Regulation Number: 878.4400
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

General surgery.

The MIS Electrosurgical Electrodes when used with an electrosurgical generator are intended to cut and coagulate tissue during minimally invasive surgical procedures.

Device Description

MIS Electrosurgical Electrode

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for an electrosurgical electrode. It states that the device is substantially equivalent to legally marketed predicate devices. This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Details about experts used for ground truth establishment.
4. Adjudication methods.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results from a standalone algorithm performance study.
7. The type of ground truth used in any study.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document indicates that the device's indications for use are "General surgery" and that it is "intended to cut and coagulate tissue during minimally invasive surgical procedures" when used with an electrosurgical generator. The FDA's determination of substantial equivalence is based on a comparison to predicate devices, which implies that the device is expected to perform similarly to those already on the market, but the specific performance metrics and acceptance criteria for that comparison are not detailed in this letter.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three wavy lines extending from its head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 1998

Mr. Daniel S. Brown President E-TEK. Incorporated 16 Pennsylvania Street Denver, Colorado 80203-4115

Re: K971829

Trade Name: MIS Electrosurgical Electrode Regulatory Class: II Product Code: GEI Dated: October 29, 1997 Received: October 31, 1997

Dear Mr. Brown:

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 requirements , 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

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Page 2 - Mr. Brown

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 your 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. ळ20/2

ia 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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11971829 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: MIS Electrosurgical Electrode

Indications For Use:

General surgery.

The MIS Electrosurgical Electrodes when used with an electrosurgical generator are intended to cut and coagulate tissue during minimally invasive surgical procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

tiosell

(Division Sign-Off)
Division of General Restorative Devices, K971829..
510(k) Number

Prescription Use .... (Per 21 CFR 801.109)

OR

Over-The-Counter-Use .........................................................................................................................................................

(Optional Format 1-2-96)

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.