The Venowave VW5 series of devices are prescriptive and induce improved vascular and lymphatic flow of the lower limbs. Venowave device are intended to treat the following:
Indications for Use:

Management of the symptoms of post thrombolytic syndrome (PTS)
Prevention of deep vein thrombosis (DVT)
Prevention of primary thrombosis
Treatment of lymphedema
Diminishing post-operative pain and swelling
Treatment of leg swelling due to vascular insufficiency
Treatment of varicose veins
Treatment of chronic venous insufficiency
Enhancing blood circulation
Treatment of intermittent claudication

Device Description

The Venowave VW5 is a series of compact, battery-operated peristaltic pumps that generate a wave-form motion, and when worn below the knee strapped firmly to the calf, result in compression of the calf and consequently, an increased upward volumetric displacement of venous and lymph fluid. Each of the models within the family (VW5-6;VW5-10; VW5-20; and VW5-30) is distinguished by the maximum number of times the wave plate cycles each minute (6, 10, 20 and 30 cycles/minute respectively). Clinical preference to choose a specific frequency of motion for each specific patient based upon that patient's clinical symptoms, severity of disease, and perceived compliance with treatment has been the motivation for creating each model within the series.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) premarket notification decision letter from the FDA for the Venowave VW5 device.

It primarily focuses on:

Substantial Equivalence: The FDA's determination that the Venowave VW5 is substantially equivalent to a legally marketed predicate device (K073028).
Device Description and Intended Use: Details about the device's function as a peristaltic pump to improve vascular and lymphatic flow in lower limbs, and its intended uses (e.g., prevention of DVT, treatment of lymphedema).
Comparison to Predicate: A table outlining updates and changes made to the device compared to the predicate, such as specified contraindications, design changes, and battery type.
Summary of Testing: A brief list of performance testing conducted (Software Verification, EMC, Electrical Safety Drop Test, Battery Testing) with "Pass" results.

The document does not provide:

A table of specific acceptance criteria (e.g., "Device must achieve 90% accuracy in detecting X") and reported performance metrics against those criteria.
Details on sample size, data provenance, expert ground truth establishment, or adjudication methods for any clinical study.
Information on multi-reader multi-case studies or standalone algorithm performance.
Details on the type of ground truth used or the sample size/establishment of ground truth for a training set.

The "Summary of Testing" section lists general performance tests (Software, EMC, Safety, Battery) which are typically engineering or non-clinical tests, not clinical performance studies with acceptance criteria relevant to medical diagnosis or treatment effectiveness.

Summary

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June 25, 2024

Thermabright Liane Parker Official Correspondent 4035 Cinwood Street NW Massillon, Ohio 44646

Re: K232640

Trade/Device Name: Venowave VW5 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: June 3, 2024 Received: June 3, 2024

Dear Liane Parker:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Nicole M. Gillette -S

Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K232640

Device Name VENOWAVE VW5

Indications for Use (Describe)

The Venowave VW5 series of devices are prescriptive and induce improved vascular and lymphatic flow of the lower limbs. Venowave device are intended to treat the following:

Indications for Use:

Management of the symptoms of post thrombolytic syndrome (PTS)
· Prevention of deep vein thrombosis (DVT)
· Prevention of primary thrombosis
· Treatment of lymphedema
· Diminishing post-operative pain and swelling
· Treatment of leg swelling due to vascular insufficiency
· Treatment of varicose veins
Treatment of chronic venous insufficiency
· Enhancing blood circulation
· Treatment of intermittent claudication

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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1. 510(K) SUMMARY

I. Submitter: Therma Bright, Inc. 345 Danforth Ave. Toronto, Ontario, Canada M4K 1N7
- Contact: Liane Parker RN CPHM 4035 Cinwood street NW Massillon, Ohio 44646 Email: liane@quantifyrc.com Phone: 740-792-1264 FAX: 740-888-0306

Date Prepared: 06/03/2024

II. DEVICE:

Trade Name: Venowave VW5 Common Name: Wave Generating Device Classification Name: Sleeve, Limb Product Code: JOW Regulation No. 870.5800

III. PREDICATE DEVICE: K073028 Trade Name: Venowave VW5

IV. Device Description:

V. Intended Use:

The Venowave VW5 series of devices are prescriptive and induce improved vascular and lymphatic flow of the lower limbs. Venowave is intended for use on patients who are 18 years of age or older. Venowave devices are intended to treat the following:

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· Management of the symptoms of post thrombolytic syndrome (POTS)
· Prevention of deep vein thrombosis, (DVT)
· Prevention of primary thrombosis
Treatment of lymphedema
· Diminishing post-operative pain and swelling
· Treatment of leg swelling due to vascular insufficiency
· Treatment of varicose veins
Treatment of chronic venous insufficiency
Enhancing blood circulation
Treatment of intermittent claudication

VI. COMPARISON TO THE PREDICATE:

The purpose of this Special 510(k) is to remove the contraindication from the Indications for Use statement. Additionally, the contraindication was updated and specified to be "Venowave device should not be used to treat patients who have open or freshly healed ulcers or other wounds or otherwise fragile skin between the knee and the ankle of the leg to be treated" and the labeling was updated to reflect the new contraindication.

Update	Predicate Device	Subject Device	Conclusion
Contraindication	Venowave, due to itsmechanical pressureapplied on the muscle,may exacerbate healingof open wounds andhence is contra-indicated for theseconditions	Venowave deviceshould not be used totreat patients who haveopen or freshly healedulcers or other woundsor otherwise fragile skinbetween the knee andthe ankle of the leg to betreated	Specifiedcontraindication toadequately capture therisk
Design Changes	1. No Cover2. Two metal barsconnecting the motor tothe waveplatemechanism.	1. Cover added to topand sides of device2. Replaced with 2plastic piecesconnecting the motor tothe waveplatemechanism.	Same operatingprinciples
Leg Wrap	Velcro	Neoprene leg wrap	Both materials areknown to be biocompatible
Speed	Multiple speed options	Fixed to 1 speed	Both devices capable of6 cycles per minute
Battery	Two NiMh 1.5V DC AArechargeable batteries	One rechargeable CR-V3 battery	Performance testingdemonstratesequivalence
TreatmentTiming	Does not have thiscapability	Microprocessor basedcircuit which candisplay usage data forlast patient (hrs.), totaluse time of the device(hrs.) and remaininguseable hours	Device is functionallysubstantially equivalentto cleared device

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VII. Summary of Testing

Performance Testing	Result
Software Verification Testing andValidation	Pass
EMC:IEC 60601-1-2: 2014IEC 60601-1-2:2014/AMD1:2020	Pass
Electrical Safety Drop Test	Pass
Battery Testing	Pass

VIII. Conclusion

Thermabright has demonstrated that the Venowave VW5 series is substantially equivalent to the predicate device based on the fundamental technologies, principles of operation and performance being unchanged from the predicate device.

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).