The Silverwear SilverPro Series Conductive Garments are cutaneous electrodes to be used with legally marketed TENS or NMES devices. The knitted garment electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include hand (glove), wrist (sleeve), elbow or arm (sleeve), knee high stockings, ankle (sleeve), back band, and shoulder band.

Device Description

The Silverwear SilverPro garment electrodes are conductive garments that are made from material which is knitted from primarily nylon yarn with minor amounts of lycra, spandex to achieve a stretch fabric for a snug garment fit polyester for tactile qualities and polyester sheathed carbon yarn and pure silver coated nylon fibers to provide conductivity. The knitting follows standard knitting procedures with the conductive knitted material being fabricated into wearable electrode garments which are provided in multiple sizes of various garment configurations including; gloves, bands, socks, and sleeves. The stretch characteristics of the material provide sufficient elasticity to ensure firm surface contact with the skin. The design of the devices is such that they can be used skin by reversing the surface contacting the skin. The entire surface of the garment electrode is very conductive having a resistance of less than 5 ohms per inch. This provides low current density with uniform current distribution to enable efficient use of these garment electrodes for use in TENS (transcutaneous electrical nerve stimulators) and NMES (powered muscle stimulator devices). The Silverwear SilverPro garment electrodes are non- sterile external devices which are designed for single patient, for multiple uses and are intended for OTC use with FDA Cleared TENS and NMES class II devices.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Silverwear Silver Pro Garment Device, structured according to your request.

Please note that the provided document is a 510(k) summary for a medical device seeking substantial equivalence to predicate devices, not typically a detailed report of a new clinical study. Therefore, some of your requested information, particularly regarding specific clinical study methodologies, may not be explicitly stated or might not be applicable in the same way it would be for a novel device requiring extensive clinical trials.

Acceptance Criteria and Device Performance

The document describes the device's characteristics and compares them to predicate devices to establish substantial equivalence. The "acceptance criteria" here are implicitly linked to demonstrating equivalence to the predicate devices across key technological characteristics and safety.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Criterion	Acceptance Criteria (Implicitly based on Predicate)	Reported Device Performance (Silverwear SilverPro)
Regulation Number	882.1320 (Cutaneous Electrodes)	882.1320 (Same as Predicates)
Product Code	GXY	GXY (Same as Predicates)
Intended Use / Indications	Cutaneous electrodes to be used with legally marketed TENS or NMES devices to deliver stimulation signals to the body surface.	Cutaneous electrodes to be used with legally marketed TENS or NMES devices to deliver uniformly to the skin low level stimulation current for pain relief. Intended for OTC use, external application to intact skin of low dose current density with uniform distribution. Locations cited: hand, wrist, elbow/arm, knee/leg, ankle, back, shoulder.
Material	Silver plated nylon (as seen in predicates)	Primarily nylon yarn with minor amounts of lycra, spandex, polyester sheathed carbon yarn, and pure silver coated nylon fibers.
Conductivity/Resistance	Predicate 1: "7 ohms resistance per inch". Predicate 2: "2 ohms resistance per inch". (The document implies the subject device should be comparable/perform acceptably within this range).	Less than 5 ohms per inch. (This is better than Predicate 1 and within the range of Predicate 2).
Washable	Washable (as seen in predicates)	Washable
Re-usable	For Single Patient (as seen in predicates)	For Single Patient
Biocompatibility	Complies with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization/Irritation)	Complied with ISO 10993-5, ISO 10993-10.
Sterility	Non-sterile (as seen in predicates)	Non-sterile
Mode of Use	OTC (desired, secondary predicate is OTC, primary is Rx)	OTC
Design/Configuration	Various garment forms (gloves, socks, sleeves, pads, bands)	Gloves, wrist sleeve, elbow/arm sleeve, knee/leg sleeve, knee high socks, ankle sleeve, back band, shoulder band. (Many similar to predicates, with some additional specific configurations).
Snug Fit	Implied-sufficient elasticity for firm surface contact	Stretch characteristics provide sufficient elasticity to ensure firm surface contact. Elastic properties provide a snug fit.
No Software	No software (as likely for predicate electrodes)	No software used.

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

The document describes bench testing, not a clinical test set with human subjects.

Sample Size for Test Set: Not explicitly stated as a number of devices. The testing was conducted on "the fabric used to fabricate the various forms" of the devices.
Data Provenance: The testing was "bench testing" and "resistivity testing was conducted using standard industry testing." These are laboratory tests on the device materials and finished product. There is no indication of country of origin for data (as it's not a patient study), but the applicant and distributor are listed with US addresses (Englewood Cliffs, NJ). The testing appears to be conducted specifically for this device submission.

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

This question is not applicable in the context of the provided document. The "ground truth" for this type of submission is the measured technical performance (e.g., resistance, biocompatibility) of the device against established industry standards and comparison to predicate devices' known characteristics. It does not involve expert consensus on clinical findings or diagnoses.

4. Adjudication Method for the Test Set

This question is not applicable. "Adjudication methods" like 2+1 or 3+1 are used in clinical studies when multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved to establish a definitive ground truth. As noted above, this document describes bench testing, not human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human reader performance (e.g., radiologists interpreting images). The Silverwear Silver Pro Garment Device is a conductive electrode, not an AI-powered diagnostic tool, and its submission relies on demonstrably equivalent physical and electrical properties to predicate devices through bench testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study in the sense of an algorithm operating without human interaction was not done. The device itself is a passive conductive garment; it does not contain an algorithm. Its function is to deliver stimulation signals from another (TENS or NMES) device. Performance is assessed through physical and electrical bench tests.

7. The Type of Ground Truth Used

The "ground truth" for the acceptance criteria in this submission is established through:

Direct Measurement: Bench testing provides quantitative measurements for characteristics like resistance.
Industry Standards: Compliance with recognized international standards for biocompatibility (ISO 10993-5, ISO 10993-10).
Predicate Device Characteristics: The known and accepted characteristics of the legally marketed predicate devices serve as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

This question is not applicable. The device is not an AI/machine learning algorithm, so there is no "training set" in the computational sense. The manufacturing process of the garment itself is based on conventional knitting procedures and material selection.

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

This question is not applicable for the same reason as point 8; there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

June 1, 2018

Media Plus, LLC % Sharon Blinkoff Counsel Locke Lord LLP 200 Vesey Street New York, New York 10281

Re: K171798

Trade/Device Name: Silverwear Silver Pro Garment Device Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: March 1, 2018 Received: March 5, 2018

Dear Sharon Blinkoff:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Vivek J. Pinto -S

for 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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Indications for Use

510(k) Number (if known) K171798

Device Name Silverwear Silver Pro Garment Device

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510 (k) Summary

Media Plus LLC Applicant: 560 Sylvan Avenue, 3rd floor Englewood Cliffs, NJ 07632

Contact: Rita Vaccaro

Phone number: 201-541-1222 ext. 300

Distributor: SilverWear USA, LLC 560 Sylvan Avenue, 3rd floor Englewood Cliffs, NJ 07632 (844-884-4499)

Contact: Rita Vaccaro 201-541-1222 ext. 300
Contact

For 510k

Submission : Sharon Blinkoff Locke Lord LLP 200 Vesey Street New York NY 10281 Sharon.blinkoff@lockelord.com (232-912-2983)
Date of Submission:

Proprietary Name: Silverwear SilverPro Garment Electrodes Common Name: Cutaneous Electrodes 21 CFR 882.1320 Product Code: GXY Cutaneous Electrodes Panel: Neurological Devices

Trade Name: Silverwear SilverPro model numbers: SP 1001, SP 1002, SP 1002, SP 1003, SP 1004, SP 1005, SP 1006, SP 1007, SP 1008, SP 1009

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A. Legally Marketed Predicate devices

1. Theraknit Garment Electrodes K053214
1. Cutaneous Electrodes K141076 secondary predicate

B. Device Description

C. Intended Use
The Silverwear SilverPro garment cutaneous electrodes are provided in various sizes of several forms of garments such as gloves, socks, sleeves knee pads, pads and bands are intended for use with legally marketed electrostimulation TENS and NMES devices, to deliver uniformly to the skin low level stimulation current for pain relief. The garment electrodes can be used on external body parts of the body with external application to hands, feet, arms legs, low back, knee and shoulder for pain relief using electrostimulation. The devices are intended for OTC use, for external application to intact skin of low dose current density with uniform distribution which follows the conductive materials knitted into the fabric.

Elements ofcomparison	Subject Device	Primary Predicate	Secondary Predicate
Company	Silverwear SilverPro Garment	Neurotron Medical, Inc.	Shenzhen KonmedTechnology Co., Ltd	--

D. Comparison to Predicate Device

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Device Name	Silverwear SilverPro wearable therapy garments	TheralKnit garment	Electrodes with silver conductive Model:KM-406: Glove StyleKM-407: Socks StyleKM-408: Wristbands StyleKM-409: Elbow pads StyleKM-410 : Knee Pads Style
Regulation Number	882.1320	882.1320	882.1320	same
Product k number	Applying	K053214	K171721	--
code	GXY	GXY	GXY	same
OTC / Rx	OTC	Rx	OTC	similar
Intended Use /Indications for Use	The Silverwear SilverPro SeriesConductive Garments arecutaneous electrodes to be usedwith legally marketed TENS orNMES devices. The knittedgarment electrodes are non-sterile reusable OTC conductivegarments that are intended todeliver the stimulation signalsgenerated by the stimulator tothe body surface with whichthey are in contact. These bodyparts can include hand (glove),wrist (sleeve), elbow or arm(sleeve), knee or leg (sleeve),knee high stockings, ankle(sleeve), back band, andshoulder band.	The TheralKnit Garmentelectrodes are cutaneousto be used with legallymarketed TENSstimulating device. Theknitted garment electrodeswill deliver thestimulation signalsgenerated by thestimulator to the bodysurface with which theyare in contact. These bodyparts can include hand(glove), feet (socks),elbow or knee (sleeve),arm, leg, shoulder, back(pads).	Electrodes with silverconductive as Glove style,Socks style, WristbandsStyle, Wrist sleeve, ElbowPads Style and Knee PadsStyle, Elbow Sleeve, areintended for use withlegally marketed TENSstimulating device. Theelectrodes with silverconductive will deliverstimulation signalsgenerated by the stimulatorto the body surface withwhich they are in contact.These body parts caninclude such as hands(gloves), feet (socks),wrist, elbow and knee.	same
Design (Shape)	Electrode A: Glove StyleElectrode B: Wrist SleeveElectrode C: Elbow/Arm SleeveElectrode D: Knee/Leg SleeveElectrode E: Knee High SocksElectrode F: Ankle SleeveElectrode G: Back BandElectrode H: Shoulder Band	Electrode A: Glove StyleElectrode B: Socks StyleElectrode C: Sleeve StyleElectrode D: Pads Style	KM-406: Glove StyleKM-407: Socks StyleKM-408: Wristbands StyleKM-409: Elbow pads StyleKM-410: knee Pads Style	similar
Size	All Sizes	All Sizes	One sizeBelow is size for whenwithout stretched:KM-406: 200 (cm2)KM-407: 285 (cm2)KM-408: 95 (cm2)KM-409: 160 (cm2)KM-410: 236 (cm2)	similar
Impedance	7 ohms resistance per inch	7 ohms resistance per inch	2 ohms resistance per inch	similar

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Washable or not	Washable	Washable	Washable	same
Re-usable	For Single Patient	For Single Patient	For Single Patient	same
Biocompatibility	Complied with ISO 10993-5, ISO 10993-10	Complied with ISO10993-5, ISO 10993-10	Complied with ISO 10993-5, ISO 10993-10	same
Patient ContactingMaterial	Silver plated nylon	Silver plated nylon	Silver plated nylon	same

E. Substantial Equivalence Summary

The Silverwear SilverPro device garment cutaneous electrodes are medical devices that have the same design features, construction, intended use, conductivity, electrical connection and target population as the legally marketed predicate devices. The Silverwear SilverPro devices have the same technological characteristics as the predicate devices. Both the Silverwear SilverPro and the predicate devices receive electrostimulation signals from legally marketed TENS or NMES devices through a standard electrical connection of an adhesive electrode which adhesively connects to the Silverwear SilverPro device and is wired to the TENS or NMES device. Both the Silverwear SilverPro and the predicate devices are washable and intended for multiple uses by a single patient with intact skin.

F. Technological Characteristics
The Silverwear SilverPro garment electrodes are made from silver plated nylon yarn and a polyester sheath yarn with carbon filling, using a conventional knitting process. The fabric is highly conductive and provides less than 5 ohms resistance per inch. The actual devices which are fabricated into multiple different garment forms with each form being designed to accept an adhesively applied electrode component from the NMES or TENS device which is the source of the current that is delivered by the garment electrodes to the target skin tissue. The Silverwear SilverPro devices are non- sterile multiple use devices which are washable using conventional detergents. Bench tests of the fabric show that the garment electrodes do not change their inherent conductivity with multiple washings so that there is no significant adverse effect on the conductivity of the device or its inherent ability to deliver low dose current density uniformly to the skin of the wearer even after multiple washings. The Silverwear SilverPro garment electrode provide a snug elastic fit against the skin based upon the low mild elastic properties of the yarn used to fabricate the devices, these elastic proper a snug fit for delivery of the current generated by the TENS or NMES devices.
G. Software
There is no software used in the Silverwear SilverPro devices

H. Testing

Bench testing has been conducted on the fabric used to fabricate the various forms of the Silverwear SilverPro devices to demonstrate that the fabric and the devices meet design controls in terms of conductivity and resistivity, and uniform delivery of low doses of current all

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consistent with that of the predicate devices. Resistivity testing was conducted using standard industry testing to confirm that the resistivity met the standards of less than 7 ohms per inch through multiple washings to confirm the multiple use aspects of the device.

Biocompatibility tests were conducted on the SilverWear SilverPro devices, which are intended for external use only, on intact skin of limited body areas for less than 24 hour. Biocompatibility was conducted using tests methods to determine Cytotoxicity, Sensitization and Irritation of Cutaneous Reactivity.

l. The subject device:

a. is OTC only
b. Intended for limited external exposure only not for internal use
ls for application to intact skin and not for application on mucosal areas ﻥ
d. Is for application to limited areas of skin and for limited duration of use under 24 hours and as prescribed in the TENS and NMES devices for which use of these wearable electrodes are intended. These devices are not intended for use in mucosal areas

J. Conclusions

The subject Silverwear SilverPro devices are comparable in design specifications to the predicate garment devices and like the predicate garment devices come in multiple versions all of which have the same intended use, are intended to be used on the same patient population, with the same technical electrical performance to deliver low doses of current to provide electrical stimulation to the skin, which like the predicate devices are intended to be used with the same FDA cleared OTC TENS or NMES predicate devices as the predicate devices. Testing has demonstrated that this SilverPro device is in terms of conductivity and resistivity relies on the same principles of Technology as the comparable predicate devices and in terms of design, material of fabrication, method of application, and intended use and performance is comparable to its predicate devices in delivering the uniform delivery of low dose current generated by FDA cleared OTC TENS or NMES devices. The proposed device presents no new technological, safety or effectiveness differences from those of the predicate class II garment electrode devices. Thus, the Silverwear SilverPro garment electrodes are substantially equivalent to the predicate devices.

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).