Silverwear Silver Pro Garment Device

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K171798 Device Name Silverwear Silver Pro Garment Device #### Indications for Use (Describe) 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. | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 {4}------------------------------------------------ #### A. Legally Marketed Predicate devices - 1. Theraknit Garment Electrodes k053214 - 2. Cutaneous Electrodes k141076 secondary predicate ### B. 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. - 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 of<br>comparison | Subject Device | Primary Predicate | Secondary Predicate | | |---------------------------|------------------------------|-------------------------|----------------------------------------|----| | Company | Silverwear SilverPro Garment | Neurotron Medical, Inc. | Shenzhen Konmed<br>Technology Co., Ltd | -- | ### D. Comparison to Predicate Device {5}------------------------------------------------ | Device Name | Silverwear SilverPro wearable therapy garments | TheralKnit garment | Electrodes with silver conductive Model:<br>KM-406: Glove Style<br>KM-407: Socks Style<br>KM-408: Wristbands Style<br>KM-409: Elbow pads Style<br>KM-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 /<br>Indications for Use | The Silverwear SilverPro Series<br>Conductive Garments are<br>cutaneous electrodes to be used<br>with legally marketed TENS or<br>NMES devices. The knitted<br>garment electrodes are non-<br>sterile reusable OTC conductive<br>garments that are intended to<br>deliver the stimulation signals<br>generated by the stimulator to<br>the body surface with which<br>they are in contact. These body<br>parts can include hand (glove),<br>wrist (sleeve), elbow or arm<br>(sleeve), knee or leg (sleeve),<br>knee high stockings, ankle<br>(sleeve), back band, and<br>shoulder band. | The TheralKnit Garment<br>electrodes are cutaneous<br>to be used with legally<br>marketed TENS<br>stimulating device. The<br>knitted garment electrodes<br>will deliver the<br>stimulation signals<br>generated by the<br>stimulator to the body<br>surface with which they<br>are in contact. These body<br>parts can include hand<br>(glove), feet (socks),<br>elbow or knee (sleeve),<br>arm, leg, shoulder, back<br>(pads). | Electrodes with silver<br>conductive as Glove style,<br>Socks style, Wristbands<br>Style, Wrist sleeve, Elbow<br>Pads Style and Knee Pads<br>Style, Elbow Sleeve, are<br>intended for use with<br>legally marketed TENS<br>stimulating device. The<br>electrodes with silver<br>conductive will deliver<br>stimulation signals<br>generated by the stimulator<br>to the body surface with<br>which they are in contact.<br>These body parts can<br>include such as hands<br>(gloves), feet (socks),<br>wrist, elbow and knee. | same | | Design (Shape) | Electrode A: Glove Style<br>Electrode B: Wrist Sleeve<br>Electrode C: Elbow/Arm Sleeve<br>Electrode D: Knee/Leg Sleeve<br>Electrode E: Knee High Socks<br>Electrode F: Ankle Sleeve<br>Electrode G: Back Band<br>Electrode H: Shoulder Band | Electrode A: Glove Style<br>Electrode B: Socks Style<br>Electrode C: Sleeve Style<br>Electrode D: Pads Style | KM-406: Glove Style<br>KM-407: Socks Style<br>KM-408: Wristbands Style<br>KM-409: Elbow pads Style<br>KM-410: knee Pads Style | similar | | Size | All Sizes | All Sizes | One size<br>Below is size for when<br>without stretched:<br>KM-406: 200 (cm2)<br>KM-407: 285 (cm2)<br>KM-408: 95 (cm2)<br>KM-409: 160 (cm2)<br>KM-410: 236 (cm2) | similar | | Impedance | 7 ohms resistance per inch | 7 ohms resistance per inch | 2 ohms resistance per inch | similar | {6}------------------------------------------------ | 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 ISO<br>10993-5, ISO 10993-10 | Complied with ISO 10993-<br>5, ISO 10993-10 | same | | Patient Contacting<br>Material | 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 {7}------------------------------------------------ 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.