The EPRT Bodihealth TENS System (Transcutaneous Electrical Nerve Stimulator for Pain Relief) with Silver Wrap is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

Device Description

The Bodihealth TENS system was previously described in K052836. The Silver Wrap is the component of the Bodihealth System that is used to transfer the energy from the Bodihealth device to the patient. It consists of a MediSponge foam 100 to which silver fabric is laminated, and then covered by urethane. The silver wrap is one-piece and consists of (a) a Urethane outer layer, (b) an adhesive layer, (c) a silver plated nylon conductive layer and (d) a foam layer that acts as the material that contacts the patient. The silver wrap functions as the means to conduct a maximum current of 3 milliamperes at 0.000732 Hz for 23 minutes. The electric currents produced are compatible with the natural electric currents of the human body.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a Class II medical device, the EPRT Bodihealth TENS System with Silver Wrap. This submission aims to demonstrate substantial equivalence to a predicate device (EPRT Bodihealth System with Foam and Rubber Wrap, K052836) due to a modification in the wrap component.

Here's an analysis of the acceptance criteria and study information, addressing your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical performance metrics (e.g., sensitivity, specificity). Instead, they are framed as design inputs that the new "Silver Wrap" component must meet to demonstrate equivalence to the predicate device's "Foam and Rubber Wrap." The reported device performance is described qualitatively and through engineering testing, indicating that these requirements were met.

Acceptance Criteria (Design Input)	Reported Device Performance
Obtain foam component equivalent to that used in predicate wrap	Medi-Sponge 100 selected as a suitable replacement. "Engineering Testing meets the requirements as shown in this section."
Simplify the device from a two-piece system to a single-piece wrap	Successful development of a one-piece wrap. "Improved and simplified as described in User Preference Testing shown in this section." (Note: "User Preference Testing" is mentioned but details are not provided in the excerpt).
Reduce the resistance encountered in the previous rubber Strap/Conco foam.	One-piece silver wrap reduced the resistance as required in design input. "Engineering testing demonstrated that the silver wrap has over 1/24th the resistance as the predicate (see User Preference Testing shown in this section)." (Again, "User Preference Testing" details are missing).
Improve uniform energy transfer from the Bodihealth device to the patient.	Silver fabric is silver-plated over nylon, laminated to foam with a hot melt grid adhesive. The grid pattern allows a conductive path from the silver fabric through the wet foam. "See Engineering Testing meets the requirements as shown in this section."
Ensure that waveform and energy output of the improved device matches that of the predicate.	Equivalent to predicate. "See Engineering Testing shown in this section demonstrates equivalent waveforms to the predicate."

2. Sample Size Used for the Test Set and the Data Provenance

The document does not detail a study involving test subjects or a test set of data in the traditional sense of clinical performance for a diagnostic device. The evaluation focuses on bench testing and engineering comparisons of the new wrap component to the predicate. Therefore, there is no mention of sample size for a test set, country of origin, or whether the data was retrospective or prospective in the context of clinical performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. The study described is primarily engineering/bench testing comparing device components, not a clinical study requiring expert-established ground truth on patient data.

4. Adjudication Method for the Test Set

Not applicable. As described above, there is no clinical test set that would require adjudication.

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 submission is for a TENS device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or reporting of improvement with AI assistance is not relevant or included.

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

Not applicable. This device is not an algorithm, but rather a physical component (wrap) for an existing TENS system. Its performance is evaluated through engineering testing of its conductive properties and energy transfer, not as a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the performance and characteristics of the predicate device's wrap (K052836 with Foam and Rubber Wrap). The study's aim is to demonstrate that the new Silver Wrap achieves "equivalence" to this established performance. The methods used to establish this equivalence are primarily:

Bench Testing/Engineering Testing: This involved direct measurement and comparison of physical and electrical properties (e.g., resistance, waveform, energy output) between the new Silver Wrap and the predicate wrap.
User Preference Testing: Although details are sparse in the excerpt, this type of testing (if conducted, as stated in the table) would assess user perception or interaction with the simplified design, likely against the predicate's two-piece system.
Biocompatibility Testing: To ensure the materials of the new wrap are safe for patient contact.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an algorithm-based device.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.

Summary

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MAR 1 2 2014 KI31675

Section 8: Special 510(k) Summary

The following information is provided as required by 21 CFR § 807.92 for EPRT Technologies' 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

Sponsor: EPRT Technologies 1925 Angus Avenue, Unit D Simi Valley, CA 93063 USA
Contact: Katherine Blake President EPRT Technologies. 1925 Angus Avenue, Unit D Simi Valley, CA 93063 USA (805) 526-2184

Date of Submission:	June 4, 2013
Proprietary Name:	EPRT Bodihealth TENS System with Silver Wrap
Common Name:	Transcutaneous Electrical Nerve Stimulator for Pain Relief
Regulatory Class:	Class II
Product Codes:	GZJ
Regulation Number:	21CFR 882.5890
Predicate Device(s):	EPRT Bodihealth System (K052836) with Foam andRubber Wrap

Device Description:

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The silver wrap is one-piece and consists of (a) a Urethane outer layer, (b) an adhesive layer, (c) a silver plated nylon conductive layer and (d) a foam layer that acts as the material that contacts the patient.

The silver wrap functions as the means to conduct a maximum current of 3 milliamperes at 0.000732 Hz for 23 minutes. The electric currents produced are compatible with the natural electric currents of the human body.

Technological Characteristics:

The BodiHealth device is used to generate pulses which may be varied in frequency and pulse duration by potentiometer type controls. The pulses are amplified and coupled to output jacks to which the wrap is attached by wires.

Intended Use:

Comparison to Predicate Devices:

The EPRT Bodihealth TENS System with Silver Wrap has the same intended use and similar technological characteristics as the Bodihealth TENS System with previous with the Foam and Rubber Wrap described in K052836. Bench testing has proven the Silver Wrap to be equivalent to the Foam and Rubber Wrap previously used.

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Design Control Summary

Design Input	Design Output	Verification/Validation
Obtain foam componentequivalent to that used inpredicate wrap	Medi-Sponge 100 selected as asuitable replacement	Engineering Testing meets therequirements as shown in thissection.
Simplify the device from a two-piece system to a single-piecewrap	Successful development of aone-piece wrap	Improved and simplified asdescribed in User PreferenceTesting shown in this section.
Reduce the resistanceencountered in the previousrubber Strap/Conco foam.	One-piece silver wrap reducedthe resistance as required indesign input	Engineering testingdemonstrated that the silverwrap has over 1/24th theresistance as the predicate (seeUser Preference Testing shownin this section)
Improve uniform energy transferfrom the Bodihealth device to thepatient.	Silver fabric is silver plated overnylon that is then laminated tofoam with a hot melt gridadhesive. The grid pattern allowsa conductive path from the silverfabric through the wet foam.	See Engineering Testing meetsthe requirements as shown inthis section
Ensure that wave form andenergy output of the improveddevice matches that of thepredicate	Equivalent to predicate	See Engineering Testing shownin this section demonstratesequivalent waveforms to thepredicate

Conclusion:

The EPRT Bodihealth TENS System with Silver Wrap has a similar design and the same intended use as the predicate wrap used in EPRT Bodihealth System (K052836). Biocompatibility testing and the current knowledge of the material provided by scientific literature demonstrated the appropriateness of the device materials for the proposed intended use. Engineering testing confirms that there is no change in the energy delivered to the patient due to the modification of the wrap component.

The test data demonstrate that the EPRT Bodihealth TENS System with Silver Wrap is substantially equivalent to the predicate (previous) wrap used in the device and that there is no change in the safety and effectiveness due to the modification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 12, 2013

EPRT Technologies, Inc. c/o Jeff Morgan JWM Associates LLC 15-2807 Puna Parkway Pahoa, HI 96778

Re: K131675

Trade/Device Name: EPRT Bodihealth TENS System with Silver Wrap Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: February 6, 2014 Received: February 11, 2014

Dear Mr. Morgan:

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

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Page 2 - Mr. Jeff Morgan

CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L.. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K131675

Device Name

EPRT Bodihealth TENS System with Silver Wrap

Indications for Use (Describe)

The EPRT Bodihealth TENS System (Transcutaneous Electrical Nerve Stimulator for Pain Relief) with Silver Wrap is intended for temporary symptomatic relief and management of chractable pain and as an adjunctive treatment in the management of postsurgical and post-traumatic pain.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Carlos L. Pena -S

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Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).