Electromed Reusable Neurostimulation Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Electromed Reusable Electrodes are designed and intended to be used with marketed, Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) of PGF (Pulsed Galvanic Stimulation).

Device Description

Electrodes, cutaneous

AI/ML Overview

The provided text describes Electromed Reusable Neurostimulation Electrodes and states that no clinical testing was applicable or performed to demonstrate performance against acceptance criteria. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from the provided document.

The document focuses on demonstrating substantial equivalence to predicate devices through technological and labeling comparisons, and bench testing, rather than presenting a performance study with detailed acceptance criteria.

Here's a breakdown of why each requested point cannot be answered:

A table of acceptance criteria and the reported device performance: Not available. The document states "Bench testing demonstrated that the characteristics of Electromed are substantially equivalent to that of the predicate device," but no specific performance metrics or acceptance criteria are listed.
Sample size used for the test set and the data provenance: Not applicable, as no clinical performance study was conducted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method 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 electrode and does not involve AI or human reader interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an electrode and does not involve an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The conclusion from testing explicitly states: "The Electromed is substantially equivalent in electrical output to the predicate device and any differences between the devices do not pose new questions of safety." This indicates the review was based on equivalence rather than meeting specific performance criteria demonstrated by a clinical study.

Summary

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'JUN 1 1 2003

KO 30800

11_Appendix_D_510(K)Summary

510(k) Summary

Submitter's Information:	Lydia BaynesElectromed4938 Hampden Lane#750Bethesda, MD 20814	Phone: 1-703-448-9644FAX: 1-703-356-2182
Date of preparation:	March 11, 2003
Proprietary Name:	Electromed Reusable Neurostimulation Electrodes
Common Name:	Neurostimulation Electrodes
Classification Name:	Electrodes, cutaneous
Predicate Device:	K963125 (M & R Manufacturing, Inc.)K932849 (Pepin Mfg., Inc.)
Description of Device:	Electrodes, cutaneous
Intended Use:	Electromed Reusable Neurostimulation Electrodes are intended for use as thedisposable, conductive adhesive interface between the patient's skin and theElectrical Stimulator. Electromed Reusable Electrodes are designed andintended to be used with marketed, Electrical Stimulators i.e. TENS(Transcutaneous Electrical Nerve Stimulation), EMS (Electrical MuscularStimulation, IF (Interferential) of PGF (Pulsed Galvanic Stimulation).
Technological Comparison:	The Electromed has technological characteristics that are substantiallyequivalent to those of the predicate device, as determined criteria specified in theTripartite Biocompatibility Guidance for Medical Devices.
Labeling Comparison:	The labeling of the Electromed is substantially equivalent to that of the predicatedevice.
Nonclinical Testing:	Bench testing demonstrated that the characteristics or Electromed aresubstantially equivalent to that of the predicate device.
Clinical Testing:	Not applicable.
Conclusions from Testing:	The Electromed is substantially equivalent in electrical output to the predicatedevice and any differences between the devices do not pose new questions of safety.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, arranged in a cascading manner. These profiles are depicted in black and are positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the profiles.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1 2003

Ms. Lydia Baynes ElectroMed, Inc. 4938 Hampden Lane #750 Bethesda, MD 20814

Re: K030800

Trade/Device Name: ElectroMed Reusable Neurostimulation Electrodes ™ sizes - 32mm round, 54x34mm, 50x90mm, 40x60mm oval, and 50x100mm oval Regulation Numbers: 21 CFR 882.1320 Regulation Names: Cutaneous electrodes Regulatory Class: Class II Product Codes: GXY Dated: March 11, 2003 Received: March 13, 2003

Dear Ms. Baynes

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

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Page 2 - Ms. Lydia Baynes:

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. 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 . 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 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Millman

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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Indications for Use 4

510(k) Number:

Device Name: Electromed Reusable Neurostimulation Electrodes™

030800

Indications for Use:

These electrodes will include the precaution statement: Federal 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 AS NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark A. Milburn

Division Sign-Off of Ceneral. Restorative nd Neurological Devices

510(k) Number K030820

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).