Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System

K190423 · Devon Medical Products (Jiangsu), Ltd. · JOW · Mar 19, 2019 · Cardiovascular

Device Facts

• Record ID: K190423
• Device Name: Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System
• Applicant: Devon Medical Products (Jiangsu), Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: Mar 19, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Devon24D deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used in the home or clinical settings to: - Aid in the prevention of DVT - Enhance blood circulation - Diminish post-operative pain and swelling - Reduce wound healing time - Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs - As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

Device Story

Portable DVT prevention system; stimulates blood flow in extremities via simulated muscle contractions. Used in home or clinical settings; operated by patients or healthcare providers. Device applies pneumatic compression to limbs to enhance circulation, reduce edema, and aid wound healing. Output is mechanical compression; assists clinical decision-making by providing prophylactic or therapeutic circulatory support. Benefits include DVT prevention, pain/swelling reduction, and improved healing times.

Clinical Evidence

Bench testing only.

Technological Characteristics

Compressible limb sleeve system (21 CFR 870.5800). Portable design. Operates via pneumatic compression to simulate muscle contractions. Class II device.

Indications for Use

Indicated for patients requiring DVT prophylaxis or treatment of venous/arterial/diabetic ulcers, stasis dermatitis, chronic venous insufficiency, and lower limb edema. Suitable for patients expecting long periods of stationarity. Prescribed by physicians for use in home or clinical settings.

Regulatory Classification

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.

Submission Summary (Full Text)

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March 19, 2019

Devon Medical Products (Jiangsu) Ltd % Ruth Wu Consultant Devon MD LLC 700 American Ave. Ste 100 King of Prussia, Pennsylvania 19406

Re: K190423

Trade/Device Name: Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: January 23, 2019 Received: February 22, 2019

Dear Ruth Wu:

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. 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 Actinclude 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

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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Fernande Aguel Fernando Aguel -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K190423

Device Name

Devon 24D Deep Vein Thrombosis Prevention Therapy System

Indications for Use (Describe)

The Devon24D deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

This device can be used in the home or clinical settings to:

- Aid in the prevention of DVT
- Enhance blood circulation
- Diminish post-operative pain and swelling
- Reduce wound healing time

- Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs

- As a prophylaxis for DVT by persons expecting to be stationary for long periods of time
Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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