3M™ Universal Electrosurgical Pads are designed to work with most electrosurgical units (ESUs) for virtually every surgical application where electrosurgery is utilized to provide a safe return path for electrosurgical current. Solid Universal Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split style Universal Electrosurgical Pad is for use with ESUs that have a CQMS (i.e. REM, ARM, NESSY etc.). 3M™ Universal Electrosurgical Pads are designed to be used on any patient where full skin contact and a suitable placement site can be obtained. There are no patient weight restrictions for use of this product. Use of this product for unintended applications could lead to an unsafe condition.

Device Description

3M™ Universal Electrosurgical Pads, 9130 & 9160 have green shaded coating technology that more uniformly distributes electrosurgical RF current over the whole conductive surface of the more uniform distribution technology and square shape permits universal orientation of the pad at a suitable placement site. The pad has a maximum temperature rise that is similar to pads up to 25% larger in conductor surface area. The entire surface of the conductive area is covered with a soft, conformable hydro-gel conductive adhesive. The pad also has a non-conductive border adhesive surrounding the entire conductive sufface area to isolate the conductive area from surgical fluids.

AI/ML Overview

The provided text describes the 3M™ Universal Electrosurgical Pad (9130 & 9160) and its 510(k) summary, but it does not contain information about a study proving the device meets acceptance criteria.

The document states that "The 3M Universal Electrosurgical Pads meets the dispersive electrode performance standards of the voluntary ANSI/AAMI HF18-1993 for Electrosurgical Devices." This is a statement of compliance with a standard, not a description of a specific study or its results, nor does it provide detailed acceptance criteria that would include quantitative performance metrics.

Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance or describe a study proving its conformance.

To answer your specific points based on the lack of information:

A table of acceptance criteria and the reported device performance: Not provided in the document. The document only states compliance with ANSI/AAMI HF18-1993.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no such study is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. This device is an electrosurgical pad, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrosurgical pad, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no specific performance criteria or ground truth are described beyond meeting an industry standard.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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K971446

510(k) Summary 3M™ Universal Electrosurgical Pad 9130 & 9160

JUL 1 8 1997

Name and address of Device Manufacturer submitting 510(k) Notification:

3M Medical Products Group 3M Health Care 3M Center St. Paul. MN 55144-1000

Requlatory Correspondent of Device Manufacturer:

Linda Johnsen Senior Regulatory Affairs Associate 3M Health Care Building 275-3E-08 St. Paul, MN 55144-1000 612 737-4376

Date Summary was prepared: April 18, 1997

Name of Devices:

3M™ Universal Electrosurgical Pad, Split (Catalog 9160) 3M™ Universal Electrosurgical Pad, Solid (Catalog 9130)

Classification: Electrosurgical Cutting and Coagulation Device and Accessories, Class II per 21 CFR 878.4400

Indications for Use:

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510(K) Premarket Notification Submission 3M™ Universal Electrosurgical Pad 9130 & 9160

Description of the Devices: 3M™ Universal Electrosurgical Pads, 9130 & 9160 have green shaded coating technology that more uniformly distributes electrosurgical RF current over the whole conductive surface of the more uniform distribution technology and square shape permits universal orientation of the pad at a suitable placement site. The pad has a maximum temperature rise that is similar to pads up to 25% larger in conductor surface area. The entire surface of the conductive area is covered with a soft, conformable hydro-gel conductive adhesive. The pad also has a non-conductive border adhesive surrounding the entire conductive sufface area to isolate the conductive area from surgical fluids.

Safety and Efficacy:

Biocompatibility:

The biological safety of selected components of the 3M™ Universal Electrosurgical Pads has been assured through the selection of materials which demonstrate appropriate ievels of biocompatiability. Tests were selected on the bases of Part-1 of ISO 10993-1, "Biological Evaluation of Medical Devices".

Performance Testing:

The 3M Universal Electrosurgical Pads meets the dispersive electrode performance standards of the voluntary ANSI/AAMI HF18-1993 for Electrosurgical Devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Linda Johnsen Senior Regulatory Affairs Associate 3M Health Care 3M Center, Building 275-3E-08 St. Paul, Minnesota 55144-1000

JUL 1 8 1997

Re: K971446

Trade Name: 3M™ Universal Electrosurgical Pad, Split (Catalog 9160) and 3M™ Universal Electrosurgical Pad, Solid (Catalog 9130) Regulatory Class: II Product Code: GEI Dated: April 18, 1997 Received: April 21, 1997

Dear Ms. Johnson:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification .

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Page 2 - Ms. Linda Johnsen

submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If vou desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

[signature]

Celia 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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K971446 510(k) Number (lf Known):

Device Name: 3M™ Universal Electrosurgical Pad, Split (Catalog Number 9160) and 3M™ Universal Electrosurgical Pad. Solid (Catalog Number 9130)

Indications For Use:

These electrodes will include the precaution statement: Federal (U.S.A.) Law restricts this device to sale by or on the order of a physician.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K971446

Prescription Use(Per 21 CFR 801.109)	OR	Over-the Counter Use
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(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.