A patient contacting layer of hydrogel material which has been tested and . found to be bio-compatible with humans and provides both the electrically conductive medium necessary to aid in the transmission of electrical current to the patient plus the adhesive properties necessary to maintain sufficient contact with the patient's skin.
A carbon dispersion pad middle layer that evenly distributes the electrical . current across the surface of the electrode,
A non-conductive top layer of various materials such as spun lace (fabric), . polyethylene or polypropylene foam or other similar materials that form a protective and flexible top layer to the electrode.
A wire or conductive carbon fiber lead wire which is glued to the assembly . of the middle and top layer and terminates in a .080" (2mm) female connector common to the electrotherapy industry and which mates with the plurality of commercially available nerve stimulation devices on the market today. The female connector complies with IEC60601-1 Sub clause 56 3(c).

Theratrode electrodes are non-sterile and are intended for multiple use by a single patient to apply electrical stimulation. Theratrode's construction is equivalent to the predicate device's construction.

AI/ML Overview

The provided document, K112312, is a 510(k) summary for Phoenix Medical Devices' Theratrode Family of Cutaneous Electrodes. This document does not describe an AI/ML medical device, and therefore the requested information regarding AI model performance, multi-reader multi-case studies, expert adjudication, training/test sets, and ground truth establishment for AI applications is not applicable to this submission.

Instead, this document details the substantial equivalence of the Theratrode electrodes to a legally marketed predicate device (Lifecare Electrodes, K083302) based on traditional medical device assessment methods.

Here's a breakdown of the relevant information provided:

Acceptance Criteria and Device Performance (for a non-AI/ML device)

The basis for substantial equivalence for this type of device (cutaneous electrodes) primarily relies on:

Construction: The Theratrode electrodes are constructed in the same manner as the predicate device (layered assembly of hydrogel, carbon dispersion pad, non-conductive top layer, lead wire).
Materials: Constructed of the same or similar bio-compatible materials to the predicate device.
Indications for Use: Identical indications for use as the predicate device: "To conduct electrical stimulation from commercially available nerve stimulation devices to the patient's skin. Single patient use - re-usable. Self adhering and re-positionable. Over the counter use."
Performance Characteristics: Very similar performance characteristics, specifically electrical conductivity (inverse of impedance).

Acceptance Criteria and Reported Device Performance Table (based on the provided document)

Since there are no established performance standards for cutaneous electrodes, the acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device. The key performance metric assessed was electrical conductivity.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (Theratrode)
Construction	Constructed in the same manner as the predicate device.	Confirmed: Layered assembly (hydrogel, carbon dispersion pad, non-conductive top layer, lead wire).
Materials	Constructed of same or similar materials as the predicate device; bio-compatible.	Confirmed: Hydrogel passed three biocompatibility tests (skin irritation, cytotoxicity, delayed contact sensitization). Materials are described as same or similar to predicate.
Indications for Use	Identical indications for use as the predicate device.	Confirmed: "To conduct electrical stimulation from common varieties of electrical stimulators to the patient's skin. Single patient use - re-usable. Self adhering and re-positionable. Over the counter use." - Identical to predicate device's use.
Performance Characteristics (Electrical Conductivity)	Equivalent or superior electrical conductivity (inverse of impedance) compared to the predicate device.	"The comparison tests conclusively prove that Theratrode is at a minimum as efficient at conducting electricity as the Predicate device."

Non-Applicable Information for this Traditional Device Submission

As this is a 510(k) for cutaneous electrodes, and not an AI/ML medical device, the following points from your request are not relevant or discussed in the document:

Sample size used for the test set and the data provenance: Not an AI test set; bench testing was performed. The document doesn't specify a "sample size" in the context of a dataset for an algorithm. It implies multiple electrodes were tested.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not generated for this type of device.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating observer performance, typically with imaging or diagnostic devices where human interpretation is central.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable in the AI sense. The "ground truth" for this device lies in its physical and electrical properties being demonstrably equivalent to a safe and effective predicate.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

In summary, the K112312 submission demonstrates substantial equivalence for a traditional medical device (cutaneous electrodes) through a comparison of design, materials, intended use, and bench test performance to a predicate device, rather than through AI/ML model validation methods.

Summary

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K112312

Attachment H

Image /page/0/Picture/2 description: The image shows the logo for Phoenix Medical Devices. The logo features a stylized phoenix bird with its wings spread above the company name. The text "PHOENIX MEDICAL DEVICES" is written in a bold, sans-serif font, with "PHOENIX" on the top line and "MEDICAL DEVICES" on the bottom line.

JAN 2 5 2012

510(k) Summary for the Theratrode Family of Cutaneous Electrodes

1. Sponsor

Phoenix Medical Devices, LLC 2458 Alton Parkway Irvine, Ca 92606

Registration Number: 3004620982

Contact Person: Jim Klett Telephone: (800) 689-9892 (949) 266-8126 Fax:

Date Prepared: February 26, 2011

2. Device Name

Theratrode Brand Cutaneous Electrodes comprised of the following model numbers and descriptions:

T1 = 2" (5 0.5mm) Square Electrode ("Squircle")

T2 = 2" (5cm) Round Electrode

T3 = 2″ x 4″ (5cm x 10cm) Rectanqu lar Electrode

T4 = 2" x 4" (5cm x 10cm) Oval Electrode

T5 = 1.25" (3cm) Round Electrode

T6 = 2.75" (7cm) Round Electrode

T7 = 1.5" (4cm) Square Electrode

T8 = 1.5" x 2.5" (4cm x 6cm) Rectanqular Electrode

T9 = 1.5" x 2.5" (4cm x 6cm) Oval Electrode

T 10= 1.5" x 3.5" (4cm x 9cm) Rectangular Electrode

T 1 = 3" x 5" (7.5cm x 13cm) Rectangular Electrode

T12= 2″ (5 0mm) Square Electrode

Common/Usual Name: Cutaneous Electrode Classification Names: Electrode, Cutaneous Classification Panel: Neurology Panel/Product Code: 882.1320 / GXY

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K112312

3. Legally Marketed Device to Which Equivalence is Claimed Marketed Device #1

Proprietary Name: Lifecare Electrodes, K083302 Common/Usual Name: Lifecare Neurostimulation Electrodes Classification Names: Electrode, Cutaneous Classification Panel: Neurology Panel/Product Code: Neurology / GXY

4. Intended Use / Indications For Use

To conduct electrical stimulation from commercially available nerve stimulation devices to the patient's skin.

Single patient use - re-usable.

Self adhering and re-positionable.

Over the counter use.

5. Device Description

Theratrode electrodes are constructed as a layered assembly comprised of four components:

A patient contacting layer of hydrogel material which has been tested and . found to be bio-compatible with humans and provides both the electrically conductive medium necessary to aid in the transmission of electrical current to the patient plus the adhesive properties necessary to maintain sufficient contact with the patient's skin.
A carbon dispersion pad middle layer that evenly distributes the electrical . current across the surface of the electrode,
A non-conductive top layer of various materials such as spun lace (fabric), . polyethylene or polypropylene foam or other similar materials that form a protective and flexible top layer to the electrode.
A wire or conductive carbon fiber lead wire which is glued to the assembly . of the middle and top layer and terminates in a .080" (2mm) female connector common to the electrotherapy industry and which mates with the plurality of commercially available nerve stimulation devices on the market today. The female connector complies with IEC60601-1 Sub clause 56 3(c).

6. Basis for Substantial Equivalence

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K112312

We have examined the Theratrode electrodes in comparison to the Predicate Device and determined the Theratrode electrodes to be Substantially Equivalent to the Predicate Device because they both:

. Are constructed in the same manner,
are constructed of same or similar materials, .
have identical indications for use, and .
have very similar performance characteristics (see bench test data . included in this submission).

Any minor visual, dimensional or labeling differences between the Predicate device and the Theratrode electrodes do not pose any risk to their safe and effective use.

1. Differences between the Marketed Device and the Theratrode family of cutaneous electrodes.
  There are no significant differences between the Theratrode Electrodes and the Marketed device.

8. Bench Testing (non-clinical)

Comparison testing was performed between the Predicate Device and the Theratrode Electrode. There are no established performance standards for cutaneous electrodes so we chose to measure the electrical conductivity (inverse of impedance) as an appropriate measure of the electrode's performance. The comparison tests conclusively prove that Theratrode is at a minimum as efficient at conducting electricity as the Predicate device.

Theratrode's hydrogel has passed three biocompatibility tests; skin irritation, cytotoxicity and delaved contact sensitization

9. Conclusion

Through careful examination of the construction, materials, indications for use and performance we conclude the Theratrode electrodes are Substantially Equivalent to the Predicate Device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002

Phoenix Medical Devices, LLC c/o Mr. Jim Klett President 2458 Alton Parkway Irvine, CA 92606

Re: K112312

Trade/Device Name: Theratrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated: November 23, 2011 Received: November 29, 2011

Dear Mr. Klett:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

JAN 2 5 2012

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Page 2 - Mr. Jim Klett

device-related adverse events) (21 CFR 803); 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. .

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Deboral Fills

Malvina B. Eydelman, M.D. Director

Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 《//23/2

Device Name: Theratrode

Model Numbers:

T1 = 2" (50.5mm) Square Electrode (Squircle Shape) T2 = 2" (5cm) Round Electrode T3 = 2" x 4" (5cm x 10cm) Rectangular Electrode T4 = 2" x 4" (5cm x 10cm) Oval Electrode T5 = 1.25" (3cm) Round Electrode T6 = 2.75" (7cm) Round Electrode T7 = 1.5" (4cm) Square Electrode T8 = 1.5" x 2.5" (4cm x 6cm) Rectangular Electrode T9 = 1.5" x 2.5" (4cm x 6cm) Oval Electrode T10= 1.5" x 3.5" (4cm x 9cm) Rectangular Electrode T11= 3" x 5" (7.5cm x 13cm) Rectangular Electrode T12 = 2" (50mm) Square Electrode

Indications for Use:

To conduct electrical stimulation from common varieties of electrical stimulators to the patients skin.

Single patient use - re-usable.

Self adhering and re-positionable.

Over the counter use.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Eyaluation (ODE)

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear. Nose and Throat Devices

510(k) Number K112312

Page of

Phoenix Medical Devices 510(k) Submission for Theratrode 1-800-689-9892

Page 18 of 100

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).