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, 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)).

AI/ML Overview

The BioWave BioWraps are cutaneous electrodes designed for use with BioWave neurostimulators. The provided document is a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed clinical study proving the device meets specific acceptance criteria in a comparative effectiveness study with human readers.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the format of a clinical trial endpoint. Instead, it describes performance characteristics for substantial equivalence to predicate devices.

Performance Characteristic	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (BioWave BioWraps)
Conductivity	Similar to predicate devices	Highly conductive, less than 1.27 ohms resistance per inch (similar or less than predicates)
Resistivity	Similar to predicate devices	Meets design controls
Impedance	Similar to predicate devices	Meets design controls; 1.27 ohms resistance per inch (compared to predicate's 7 ohms/inch and 2 ohms/inch)
Uniform Current Delivery	Consistent with predicate devices	Uniform delivery of low doses of current
Reusability	Demonstrated by predicate devices	Duly demonstrated, no significant adverse effect on conductivity after multiple washings
Biocompatibility	Compliant with ISO 10993-5 and 10993-10	Compliant with ISO 10993-5 and 10993-10 (cytotoxicity, sensitization, cutaneous reactivity met established acceptance criteria)

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

Test Set Sample Size: Not applicable. The "study" described is bench testing, not a clinical trial with a test set of patients or medical images.
Data Provenance: Not applicable for clinical data. The testing described is laboratory-based bench testing.

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

Not applicable. Ground truth as typically understood in medical device AI (e.g., expert consensus on diagnosis) is not relevant for this type of bench testing. The "ground truth" here is the adherence to engineering specifications and international standards.

4. Adjudication Method for the Test Set:

Not applicable. There was no clinical test set requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for cutaneous electrodes, which does not typically involve such studies. The device is not an AI-powered diagnostic tool, but rather an accessory to a neurostimulator. It does not involve human readers for interpretation in the way AI in radiology would.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is not an algorithm. The performance described is the physical and electrical characteristics of the garment electrodes themselves.

7. The Type of Ground Truth Used:

The "ground truth" for the bench testing was based on engineering specifications, material science principles, and compliance with international standards (e.g., ISO 10993 for biocompatibility) and comparisons to the performance characteristics of legally marketed predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. No training set was used.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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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

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Indications for Use

510(k) Number (if known) K203158

Device Name BioWave BioWraps

Indications for Use (Describe)

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

For Routine Handling of PCB Waste Streams	For Use Specifically Handling PCB Materials
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X 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

Device Trade Name:	BioWave BioWraps
Manufacturer:	BioWave Corporation8 Knight Street, Suite 201Norwalk, CT 06851
Contact:	Bradford SiffFounder & PresidentBioWave Corporation8 Knight Street, Suite 201Norwalk, CT 06851Phone: 203-247-9020 or 203-635-7175Fax: 203-286-2518brad.siff@biowave.com
Prepared by:	Dave McGurlDirector, Spine Regulatory AffairsMCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001Office: 202.552.5797Fax: 202.552.5798dmcgurl@mcra.com
Date Prepared:	December 14, 2020
Classifications:	21 CFR §882.1320, Cutaneous Electrode
Class:	II
Product Codes:	GXY

Indications for Use:

Device Description:

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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 KonmedTechnology, Co. LTD.	Electrodes with Silver Conductive	K171721
Prizm Medical, Inc.	Electro-Mesh Sock, Wrap, andSleeve 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 ofComparison	Subject Device	Primary Predicate	Reference Predicate	ReferencePredicate	Differences
Company	BioWave Corporation	SilverWear USA,LLC.	Shenzhen KonmedTechnology, Co. LTD.	PrizmMedical, Inc.	--
Device Name	BioWave BioWraps	SilverPro	Electrodes with SilverConductive	Electro-Mesh Sock,Wrap, andSleeveElectrodes	--
RegulationNumber	882.1320	882.1320	882.1320	882.1320	Same
ClearanceNumber	--	K171798	K171721	K944487	Same
Product Code	GXY	GXY	GXY	GXY	Same
OTC / Rx	OTC and Rx	OTC	OTC	OTC	Similar
Intended Use /Indications forUse	The BioWave BioWrapsare cutaneous electrodes tobe used with legallymarketed BioWavebranded neurostimulators.The knitted garmentelectrodes are non-sterilereusable prescription-useand OTC conductivegarments that are intended	The SilverwearSilverPro SeriesConductive Garmentsare cutaneouselectrodes to be usedwith legally marketedTENS or NMESdevices. The knittedgarment electrodes arenon-sterile reusable	Electrodes with silverconductive as Glovestyle, Socks style,Wristbands Style, Wristsleeve, Elbow PadsStyle and Knee PadsStyle, Elbow Sleeve, areintended for use withlegally marketed TENSstimulating device. The	NotAvailable	Similar,exceptK944487
Element ofComparison	Subject Device	Primary Predicate	Reference Predicate	ReferencePredicate	Differences
	to deliver the stimulationsignals generated by thestimulator to the bodysurface with which theyare in contact. These bodyparts include hands/wrist,elbow, foot/ankle, knee,and lower back.	OTC conductivegarments that areintended to deliver thestimulation signalsgenerated by thestimulator to the bodysurface 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), backband, and shoulderband.	electrodes with silverconductive will deliverstimulation signalsgenerated by thestimulator to the bodysurface with which theyare in contact. Thesebody parts can includesuch as hands (gloves),feet (socks), wrist,elbow and knee.
Design (Shape)	Wrappable bands for thehand/wrist, elbow,foot/ankle, knee, andlower back	Electrode A: GloveStyleElectrode B: WristSleeveElectrode C:Elbow/Arm SleeveElectrode D:Knee/Leg SleeveElectrode E: KneeHigh SocksElectrode F: AnkleSleeveElectrode G: BackBandElectrode H: ShoulderBand	KM-406: Glove StyleKM-407: Socks StyleKM-408: WristbandsStyle KM-409: Elbowpads StyleKM-410: knee PadsStyle	Knittedseries ofgarmentsinclusive ofsocks,gloves,sleeves, andback braces.	Similar
Size	All BioWraps areavailable in small/medium(S/M) and large/extra-large (L/XL) sizes:Low Back:- S/M: 28-38" Waist- L/XL: 38-50" WaistKnee:- S/M: 12-15.5"circumference around thekneecap- L/XL: 15.5 - 19"circumference around thekneecapFoot/Ankle:- S/M: Women's shoe size6-9, Men's shoe size 7-8.5- L/XL: Women's shoesize 9.5-11, Men's shoesize 9-13Elbow:- S/M: 8-12"circumference around theelbow joint with armextended- L/XL: 12-16"circumference around theelbow joint with armextended	Information notpublicly available	Gloves KM-406: 200cm²Socks KM-407: 285 cm²Wristbands KM-408: 95cm²Elbow pads KM-409:160 cm²Knee Pads KM-410: 236cm²	Informationnot publiclyavailable	Similar
Element ofComparison	Subject Device	Primary Predicate	Reference Predicate	ReferencePredicate	Differences
	- S/M: 6-9" circumferencearound the dominant hand- L/XL: 9-12"circumference around thedominant hand
ImpedanceParameters	1.27 ohms resistance perinch	7 ohms resistance/inch	2 ohms resistance/inch	Informationnot publiclyavailable	Similar
Washable / NotWashable	Washable	Washable	Washable	NotAvailable	SameexceptK944487
Reusable	Single Patient, Reusable	Single Patient,Reusable	Single Patient, Reusable	SinglePatient,Reusable	Same
Biocompatibility	Compliant with ISO10993-5 and -10	Compliant with ISO10993-5 and -10	Compliant with ISO10993-5 and -10	NotAvailable	Same,exceptK944487
PatientContactingMaterials	Silver Fiber	Silver-coated Nylon	Silver-coated Nylon	Informationnot publiclyavailable	Similar

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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.

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).