DermaSense PLUS Dispersive Electrode is a disposable, single use device commonly referred to in the industry as a neutral electrode, patient plate, or return electrode. A split, dual conductive plate design allows this device to be used with Return Electrode Monitor (REM) systems found on most electorsurgical generators being marketed today.

AI/ML Overview

This submission (K980171) for the DermaSense PLUS Dispersive Electrode primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics. The document states that the device design, materials, nominal specifications, and performance standards are "either identical or substantially equivalent" to predicate devices and that both the Horizon device and predicates "meet the ANSI/AAMI HF-18 and IEC 601-2-2 industry performance standards." However, specific acceptance criteria and the results of a study demonstrating these are not explicitly presented.

Based on the provided text, the following information can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Inferred from Predicate Equivalence and Standards)	Reported Device Performance (Inferred from Substantial Equivalence Claim)
Intended Use: Provides a return path for high-frequency electrical current to the electrosurgical generator; no electrosurgical effect intended at the electrode.	Met: Same intended use as predicate devices.
Technological Characteristics: Single-use, non-sterile, for monopolar electrosurgical applications, split dual-plate design, Return Monitor compatible, comprised of electrode body and cable assembly. Materials: acrylic adhesive coated thermoplastic film or closed cell polyethylene foam border with hydrogel conductive adhesive layer covering an aluminum metallized/laminated plastic film on a closed cell polyethylene foam backing.	Met: Technological characteristics, device design, materials, nominal specifications are either identical or substantially equivalent to predicate devices.
Performance Standards: Meets ANSI/AAMI HF-18 and IEC 601-2-2 industry performance standards.	Met: "The Horizon and predicate devices meet the ANSI/AAMI HF-18 and IEC 601-2-2 industry performance standards." (This implies the new device also meets these, assuming equivalence.)

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

Sample Size: Not specified.
Data Provenance: Not specified. The submission likely refers to internal testing or comparisons against established predicate device performance and industry standards, rather than a clinical trial with a specific test set.

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

Not applicable as no specific test set requiring expert ground truth is described. The evaluation is based on technical specifications and adherence to industry standards, and comparison to legally marketed predicate devices.

4. Adjudication method for the test set:

Not applicable as no specific test set requiring expert adjudication is described.

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. This device is a medical electrode, not an AI-assisted diagnostic or therapeutic tool for human readers.

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

Not applicable. This device is a passive electrical component, not an algorithm.

7. The type of ground truth used:

The "ground truth" here is implied to be adherence to established industry performance standards (ANSI/AAMI HF-18 and IEC 601-2-2) and equivalence to the technological characteristics and performance of legally marketed predicate devices (Valleylab REM PolyHesive II Patient Return Electrode and ConMed ThermoGard PLUS ABC Dual Dispersive Electrode). This would involve engineering testing and comparative analysis against the specifications and known performance of the predicate devices.

8. The sample size for the training set:

Not applicable as this is not an AI/ML device requiring a training set.

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

Not applicable.

Summary

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K980171

FEB 2 7 1998

APPENDIX V

Summary of Safety and Effectiveness

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The DermaSense PLUS Dispersive Electrode has the same intended use as the currently marketed predicate devices. The Dispersive Electrode has technological characteristics that are substantially equivalent to the predicate devices. The device design, device materials, nominal specifications and performance standards are either identical or substantially equivalent. The Dispersive Electrode has the same mode of operation as the predicate devices.

COMPANY AND CONTACT PERSON

Horizon Medical, Inc. 1719 South Grand Avenue Santa Ana, CA 92705

Philip L. Ritger Technical Director (714) 259-5200

DEVICE NAME

DermaSense™ PLUS Dispersive Electrode

NAME OF PREDICATE OR LEGALLY MARKETED DEVICE

1. Vallevlab. Inc. REM® PolvHesive® II Patient Return Electrode
1. ConMed Corporation ThermoGard™ PLUS ABC® Dual Dispersive Electrode

DESCRIPTION OF DEVICE

STATEMENT OF INTENDED USE

DermaSense PLUS Dispersive Electrode is a disposable, single use, neutral electrode which provides a return path for high frequency electrical current to the electrosurgical generator. No electrosurgical effect, e.g., cutting and removal of tissue or coagulation, is intended at this electrode.

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STATEMENT OF INTENDED USE OF PREDICATE/MARKETEDDEVICES

1. The Valleylab REM PolyHesive II Patient Return Electrode is a disposable, single use, neutral electrode which provides a return path for high frequency electrical current to the electrosurgical generator..
1. The ConMed ThermoGard PLUS ABC Dual Dispersive Electrode is a disposable, single use, neutral electrode which provides a return path for high frequency electrical current to the electrosurgical generator ..

STATEMENT OF COMPARISON OF TECHNOLOGICAL CHARACTERISTICS BETWEEN DEVICE AND PREDICATE DEVICE

For the Horizon and predicate devices, the dispersive electrodes are single use, non-sterile devices for use in monopolar electrosurgical applications. The electrodes are split, dual plate designs which are Return Monitor compatible. All of the devices are comprised of an electrode body and cable assembly.

All of the electrodes are comprised of an acrylic adhesive coated thermoplastic film or closed cell polvethylene foam border with a hydrogel conductive adhesive layer covering an aluminum metallized or laminated plastic film on a closed cell polyethylene foam backing.

The Horizon and predicate devices meet the ANSI/AAMI HF-18 and IEC 601-2-2 industry performance standards.

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Image /page/2/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 image of an eagle with its wings spread, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 1998

Mr. Philip L. Ritger Technical Director Horizon Medical, Inc. 1719 South Grand Avenue Santa Ana, California 92705-4808

Re: K980171 DermaSense Plus Dispersive Electrode Trade Name: Requlatory Class: II Product Code: GEI Dated: January 15, 1998 Received: January 20, 1998

Dear Mr. Ritger:

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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 requirement, 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Ritger

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 requlation (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 device, 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,

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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510(k) Number (if known): K980171

Oevice Name: DERMASENSE PLUS DISPERSIVE ELECTRODE

Indications For Use:

A NEUIRAL ELECTRODE AT WHICH NO SURGICAL EFFECT IS INTENDED WHICH PROVIDE A RETURN PATH FOR ELECTRICAL CURRENT TO GENERATOR.

(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	K980171

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