Devon 52 Sequential Compression Device

K182150 · Devon Medical Products (Jiangsu), Ltd. · JOW · Dec 18, 2018 · Cardiovascular

Device Facts

• Record ID: K182150
• Device Name: Devon 52 Sequential Compression Device
• Applicant: Devon Medical Products (Jiangsu), Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: Dec 18, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Devon 52 Series Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions: - Lymphedema - Venous stasis ulcers - Venous insufficiency - Peripheral edema

Device Story

Devon 52 Sequential Compression Device is a pneumatic compression system; utilizes sequential compression technique to apply pressure to limbs. Device intended for treatment of lymphedema, venous stasis ulcers, venous insufficiency, and peripheral edema. Operates by inflating/deflating sleeves to promote blood/lymph flow; aids in reducing edema and managing venous conditions. Used in clinical or home settings under physician prescription. Healthcare providers use device to manage patient circulation; patient benefits from reduced swelling and improved venous return.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sequential pneumatic compression device; consists of controller and limb sleeves. Operates via pneumatic inflation/deflation cycles. Class II device (21 CFR 870.5800).

Indications for Use

Indicated for patients requiring treatment for lymphedema, venous stasis ulcers, venous insufficiency, or peripheral edema. Prescription use only.

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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December 18, 2018

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

Re: K182150

Trade/Device Name: Devon 52 Sequential Compression Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: November 19, 2018 Received: November 20, 2018

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 mediation-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) K182150

Device Name

Devon 52 Sequential Compression Device

Indications for Use (Describe)

The Devon 52 Series Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:

- Lymphedema
- Venous stasis ulcers
- Venous insufficiency
- Peripheral edema

| 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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