BioWave BioWraps

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July 8, 2021 BioWave Corporation % Dave McGurl Director, Spine Regulatory Affairs MCRA, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20005 Re: K203158 Trade/Device Name: BioWave BioWraps Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: October 22, 2020 Received: October 22, 2020 Dear Dave McGurl: We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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 con tract 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 {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Heather Dean, PhD Assistant Director. Acute Injurv Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203158 Device Name BioWave BioWraps #### Indications for Use (Describe) The BioWave BioWraps are cutaneous electrodes to be used with legally marketed BioWave branded neurostimulators. The knitted garment electrodes are non-sterile reusable prescription-use and 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 include hand/wrist, elbow, foot/ankle, knee, and lower back. Type of Use (Select one or both, as applicable) | <div> <input checked="true" type="checkbox"/> <span>For Routine Handling of PCB Waste Streams</span> </div> | <div> <input checked="true" type="checkbox"/> <span>For Use Specifically Handling PCB Materials</span> </div> | |-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| X 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. 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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 | Device Trade Name: | BioWave BioWraps | |--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer: | BioWave Corporation<br>8 Knight Street, Suite 201<br>Norwalk, CT 06851 | | Contact: | Bradford Siff<br>Founder & President<br>BioWave Corporation<br>8 Knight Street, Suite 201<br>Norwalk, CT 06851<br>Phone: 203-247-9020 or 203-635-7175<br>Fax: 203-286-2518<br>brad.siff@biowave.com | | Prepared by: | Dave McGurl<br>Director, Spine Regulatory Affairs<br>MCRA, LLC<br>1050 K Street NW, Suite 1000<br>Washington, DC 20001<br>Office: 202.552.5797<br>Fax: 202.552.5798<br>dmcgurl@mcra.com | | Date Prepared: | December 14, 2020 | | Classifications: | 21 CFR §882.1320, Cutaneous Electrode | | Class: | II | | Product Codes: | GXY | ## Indications for Use: The BioWave BioWraps are cutaneous electrodes to be used with legally marketed BioWave branded neurostimulators. The knitted garment electrodes are non-sterile reusable prescription-use and 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 include hand/wrist, elbow, foot/ankle, knee, and lower back. ### Device Description: The BioWave BioWraps are washable, wrappable bands made from a stretchable neoprene-like outer and silver fiber conductive inner fabric. The electrodes are secured to the skin through the wrapping of the bands. The BioWraps are intended for use on the hand/wrist, elbow, foot/ankle, {4}------------------------------------------------ knee, and lower back. When used alongside a conductive cream, the electrodes provide a low current density with uniform current distribution. The BioWraps are to be used alongside cleared BioWave neurostimulator devices (the BioWavePRO® RX (K052289), BioWaveHOME® RX (K152437), and BioWaveGO® OTC (K180943)). ## Predicate Devices: The BioWave Corporation's BioWave BioWraps are substantially equivalent to the primary predicate previously cleared with respect to indications, design, function, and materials, as outlined below. | Manufacturer | Device Name | K-Number | |-----------------------------------------|---------------------------------------------------|----------| | Primary Predicate | | | | SilverWear USA, LLC. | SilverPro Garment Electrodes | K171798 | | Reference Predicate | | | | Shenzhen Konmed<br>Technology, Co. LTD. | Electrodes with Silver Conductive | K171721 | | Prizm Medical, Inc. | Electro-Mesh Sock, Wrap, and<br>Sleeve Electrodes | K944487 | # Performance Testing Summary: Bench testing conducted on the BioWave BioWraps has demonstrated that the garments meet design controls with regard to conductivity, resistivity, impedance, and uniform delivery of low doses of current consistent with that of the cited predicate. Reusability has been duly demonstrated. Biocompatibility testing, inclusive of cytotoxicity, sensitization and cutaneous reactivity, conducted on the BioWraps met the established acceptance criteria per ISO 10993-5 and 10993-10. # Substantial Equivalence: | Element of<br>Comparison | Subject Device | Primary Predicate | Reference Predicate | Reference<br>Predicate | Differences | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------| | Company | BioWave Corporation | SilverWear USA,<br>LLC. | Shenzhen Konmed<br>Technology, Co. LTD. | Prizm<br>Medical, Inc. | -- | | Device Name | BioWave BioWraps | SilverPro | Electrodes with Silver<br>Conductive | Electro-<br>Mesh Sock,<br>Wrap, and<br>Sleeve<br>Electrodes | -- | | Regulation<br>Number | 882.1320 | 882.1320 | 882.1320 | 882.1320 | Same | | Clearance<br>Number | -- | K171798 | K171721 | K944487 | Same | | Product Code | GXY | GXY | GXY | GXY | Same | | OTC / Rx | OTC and Rx | OTC | OTC | OTC | Similar | | Intended Use /<br>Indications for<br>Use | The BioWave BioWraps<br>are cutaneous electrodes to<br>be used with legally<br>marketed BioWave<br>branded neurostimulators.<br>The knitted garment<br>electrodes are non-sterile<br>reusable prescription-use<br>and OTC conductive<br>garments that are intended | The Silverwear<br>SilverPro Series<br>Conductive Garments<br>are cutaneous<br>electrodes to be used<br>with legally marketed<br>TENS or NMES<br>devices. The knitted<br>garment electrodes are<br>non-sterile reusable | Electrodes with silver<br>conductive as Glove<br>style, Socks style,<br>Wristbands Style, Wrist<br>sleeve, Elbow Pads<br>Style and Knee Pads<br>Style, Elbow Sleeve, are<br>intended for use with<br>legally marketed TENS<br>stimulating device. The | Not<br>Available | Similar,<br>except<br>K944487 | | Element of<br>Comparison | Subject Device | Primary Predicate | Reference Predicate | Reference<br>Predicate | Differences | | | to deliver the stimulation<br>signals generated by the<br>stimulator to the body<br>surface with which they<br>are in contact. These body<br>parts include hands/wrist,<br>elbow, foot/ankle, knee,<br>and lower back. | OTC conductive<br>garments that are<br>intended to deliver the<br>stimulation signals<br>generated by the<br>stimulator to the body<br>surface with which<br>they are in contact.<br>These body<br>parts can include hand<br>(glove), wrist (sleeve),<br>elbow or arm (sleeve),<br>knee or leg (sleeve),<br>knee high stockings,<br>ankle (sleeve), back<br>band, and shoulder<br>band. | electrodes with silver<br>conductive will deliver<br>stimulation signals<br>generated by the<br>stimulator to the body<br>surface with which they<br>are in contact. These<br>body parts can include<br>such as hands (gloves),<br>feet (socks), wrist,<br>elbow and knee. | | | | Design (Shape) | Wrappable bands for the<br>hand/wrist, elbow,<br>foot/ankle, knee, and<br>lower back | Electrode A: Glove<br>Style<br>Electrode B: Wrist<br>Sleeve<br>Electrode C:<br>Elbow/Arm Sleeve<br>Electrode D:<br>Knee/Leg Sleeve<br>Electrode E: Knee<br>High Socks<br>Electrode F: Ankle<br>Sleeve<br>Electrode G: Back<br>Band<br>Electrode H: Shoulder<br>Band | KM-406: Glove Style<br>KM-407: Socks Style<br>KM-408: Wristbands<br>Style KM-409: Elbow<br>pads Style<br>KM-410: knee Pads<br>Style | Knitted<br>series of<br>garments<br>inclusive of<br>socks,<br>gloves,<br>sleeves, and<br>back braces. | Similar | | Size | All BioWraps are<br>available in small/medium<br>(S/M) and large/extra-<br>large (L/XL) sizes:<br><br>Low Back:<br>- S/M: 28-38" Waist<br>- L/XL: 38-50" Waist<br><br>Knee:<br>- S/M: 12-15.5"<br>circumference around the<br>kneecap<br>- L/XL: 15.5 - 19"<br>circumference around the<br>kneecap<br><br>Foot/Ankle:<br>- S/M: Women's shoe size<br>6-9, Men's shoe size 7-8.5<br>- L/XL: Women's shoe<br>size 9.5-11, Men's shoe<br>size 9-13<br><br>Elbow:<br>- S/M: 8-12"<br>circumference around the<br>elbow joint with arm<br>extended<br>- L/XL: 12-16"<br>circumference around the<br>elbow joint with arm<br>extended | Information not<br>publicly available | Gloves KM-406: 200<br>cm²<br>Socks KM-407: 285 cm²<br>Wristbands KM-408: 95<br>cm²<br>Elbow pads KM-409:<br>160 cm²<br>Knee Pads KM-410: 236<br>cm² | Information<br>not publicly<br>available | Similar | | Element of<br>Comparison | Subject Device | Primary Predicate | Reference Predicate | Reference<br>Predicate | Differences | | | - S/M: 6-9" circumference<br>around the dominant hand<br>- L/XL: 9-12"<br>circumference around the<br>dominant hand | | | | | | Impedance<br>Parameters | 1.27 ohms resistance per<br>inch | 7 ohms resistance/inch | 2 ohms resistance/inch | Information<br>not publicly<br>available | Similar | | Washable / Not<br>Washable | Washable | Washable | Washable | Not<br>Available | Same<br>except<br>K944487 | | Reusable | Single Patient, Reusable | Single Patient,<br>Reusable | Single Patient, Reusable | Single<br>Patient,<br>Reusable | Same | | Biocompatibility | Compliant with ISO<br>10993-5 and -10 | Compliant with ISO<br>10993-5 and -10 | Compliant with ISO<br>10993-5 and -10 | Not<br>Available | Same,<br>except<br>K944487 | | Patient<br>Contacting<br>Materials | Silver Fiber | Silver-coated Nylon | Silver-coated Nylon | Information<br>not publicly<br>available | Similar | {5}------------------------------------------------ {6}------------------------------------------------ The subject devices are a garment cutaneous electrodes medical devices that have the same or similar design features, construction, intended use, conductivity, electrical connection and target population as the legally marketed predicate devices. The subject devices have similar technological characteristics as the predicate devices. Both the subject and the predicate devices receive electrostimulation signals from legally marketed TENS devices through a standard electrical connection of an electrode which is wired to the TENS device. Both the subject and the predicate devices are washable and intended for multiple uses by a single patient with intact skin. The subject electrodes are made from silver fiber and is highly conductive and provides less than 1.27 ohms resistance per inch which is similar or less than the predicate devices. The actual devices which are fabricated into multiple different garment forms and is connected to a TENS device which is the source of the current that is delivered by the garment electrodes to the target skin tissue. The subject 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 treatment uniformly to the skin of the wearer even after multiple washings. The biocompatibility testing demonstrates the material is acceptable in comparison to the predicates for the intended use. The subject devices, the BioWave BioWraps, were demonstrated to be substantially equivalent to the predicate and reference devices cited in the table above with respect to indications, design, materials, function, availability (i.e., over-the-counter use), and/or performance. ### Conclusion: The BioWave BioWraps have been found to be substantially equivalent to the previously cleared predicate device, SilverPro Garment Electrodes (K171798), and the included reference predicates, Electrodes with Silver Conductive (K171721) and Electro-Mesh (K944487), with respect to indications, design, materials, function, availability, and performance.