(259 days)
No
The summary describes a passive electrode garment and does not mention any AI or ML capabilities.
No.
The BioWave BioWraps are conductive garment electrodes that are intended to deliver stimulation signals generated by neurostimulators to the body surface. They are accessories to therapeutic devices (neurostimulators), rather than therapeutic devices themselves.
No
The device is described as cutaneous electrodes intended to deliver stimulation signals from neurostimulators to the body surface. Its function is to facilitate the delivery of therapy, not to diagnose conditions.
No
The device description clearly states the BioWave BioWraps are "washable, wrappable bands made from a stretchable neoprene-like outer and silver fiber conductive inner fabric," indicating a physical hardware component.
Based on the provided information, the BioWave BioWraps are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- BioWave BioWraps Function: The BioWave BioWraps are described as cutaneous electrodes that deliver electrical stimulation to the body surface. They are used in conjunction with neurostimulators for therapeutic purposes (pain relief, likely, given the anatomical sites).
- No Specimen Analysis: There is no mention of the BioWave BioWraps analyzing any biological specimens. Their function is to conduct electrical signals to the skin.
Therefore, the BioWave BioWraps fall under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GXY
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)).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand/wrist, elbow, foot/ankle, knee, and lower back
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
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
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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)
| For Routine Handling of PCB Waste Streams | For Use Specifically Handling PCB Materials |
|---|---|
| ------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Device Trade Name: | BioWave BioWraps |
|---|---|
| Manufacturer: | BioWave Corporation |
| 8 Knight Street, Suite 201 | |
| Norwalk, CT 06851 | |
| Contact: | Bradford Siff |
| Founder & President | |
| BioWave Corporation | |
| 8 Knight Street, Suite 201 | |
| Norwalk, CT 06851 | |
| Phone: 203-247-9020 or 203-635-7175 | |
| Fax: 203-286-2518 | |
| brad.siff@biowave.com | |
| Prepared by: | Dave McGurl |
| Director, Spine Regulatory Affairs | |
| MCRA, LLC | |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20001 | |
| Office: 202.552.5797 | |
| Fax: 202.552.5798 | |
| 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 | ||
| Technology, Co. LTD. | Electrodes with Silver Conductive | K171721 |
| Prizm Medical, Inc. | Electro-Mesh Sock, Wrap, and | |
| 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
Comparison | Subject Device | Primary Predicate | Reference Predicate | Reference
Predicate | Differences |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------|
| Company | BioWave Corporation | SilverWear USA,
LLC. | Shenzhen Konmed
Technology, Co. LTD. | Prizm
Medical, Inc. | -- |
| Device Name | BioWave BioWraps | SilverPro | Electrodes with Silver
Conductive | Electro-
Mesh Sock,
Wrap, and
Sleeve
Electrodes | -- |
| Regulation
Number | 882.1320 | 882.1320 | 882.1320 | 882.1320 | Same |
| Clearance
Number | -- | K171798 | K171721 | K944487 | Same |
| Product Code | GXY | GXY | GXY | GXY | Same |
| OTC / Rx | OTC and Rx | OTC | OTC | OTC | Similar |
| Intended Use /
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 | 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 | Electrodes with silver
conductive as Glove
style, Socks style,
Wristbands Style, Wrist
sleeve, Elbow Pads
Style and Knee Pads
Style, Elbow Sleeve, are
intended for use with
legally marketed TENS
stimulating device. The | Not
Available | Similar,
except
K944487 |
| Element of
Comparison | Subject Device | Primary Predicate | Reference Predicate | Reference
Predicate | Differences |
| | to deliver the stimulation
signals generated by the
stimulator to the body
surface with which they
are in contact. These body
parts include hands/wrist,
elbow, foot/ankle, knee,
and lower back. | 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 or leg (sleeve),
knee high stockings,
ankle (sleeve), back
band, and shoulder
band. | electrodes with silver
conductive will deliver
stimulation signals
generated by the
stimulator to the body
surface with which they
are in contact. These
body parts can include
such as hands (gloves),
feet (socks), wrist,
elbow and knee. | | |
| Design (Shape) | Wrappable bands for the
hand/wrist, elbow,
foot/ankle, knee, and
lower back | Electrode A: Glove
Style
Electrode B: Wrist
Sleeve
Electrode C:
Elbow/Arm Sleeve
Electrode D:
Knee/Leg Sleeve
Electrode E: Knee
High Socks
Electrode F: Ankle
Sleeve
Electrode G: Back
Band
Electrode H: Shoulder
Band | KM-406: Glove Style
KM-407: Socks Style
KM-408: Wristbands
Style KM-409: Elbow
pads Style
KM-410: knee Pads
Style | Knitted
series of
garments
inclusive of
socks,
gloves,
sleeves, and
back braces. | Similar |
| Size | All BioWraps are
available in small/medium
(S/M) and large/extra-
large (L/XL) sizes:
Low Back:
- S/M: 28-38" Waist
- L/XL: 38-50" Waist
Knee:
- S/M: 12-15.5"
circumference around the
kneecap - L/XL: 15.5 - 19"
circumference around the
kneecap
Foot/Ankle:
- S/M: Women's shoe size
6-9, Men's shoe size 7-8.5 - L/XL: Women's shoe
size 9.5-11, Men's shoe
size 9-13
Elbow:
- S/M: 8-12"
circumference around the
elbow joint with arm
extended - L/XL: 12-16"
circumference around the
elbow joint with arm
extended | Information not
publicly available | Gloves KM-406: 200
cm²
Socks KM-407: 285 cm²
Wristbands KM-408: 95
cm²
Elbow pads KM-409:
160 cm²
Knee Pads KM-410: 236
cm² | Information
not publicly
available | Similar |
| Element of
Comparison | Subject Device | Primary Predicate | Reference Predicate | Reference
Predicate | Differences |
| | - S/M: 6-9" circumference
around the dominant hand - L/XL: 9-12"
circumference around the
dominant hand | | | | |
| Impedance
Parameters | 1.27 ohms resistance per
inch | 7 ohms resistance/inch | 2 ohms resistance/inch | Information
not publicly
available | Similar |
| Washable / Not
Washable | Washable | Washable | Washable | Not
Available | Same
except
K944487 |
| Reusable | Single Patient, Reusable | Single Patient,
Reusable | Single Patient, Reusable | Single
Patient,
Reusable | Same |
| Biocompatibility | Compliant with ISO
10993-5 and -10 | Compliant with ISO
10993-5 and -10 | Compliant with ISO
10993-5 and -10 | Not
Available | Same,
except
K944487 |
| Patient
Contacting
Materials | Silver Fiber | Silver-coated Nylon | Silver-coated Nylon | Information
not publicly
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.