PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B

K121962 · Mego Afek AC , Ltd. · JOW · Oct 19, 2012 · Cardiovascular

Device Facts

• Record ID: K121962
• Device Name: PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B
• Applicant: Mego Afek AC , Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: Oct 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Primary lymphedema . Secondary lymphedema . . Venous insufficiency Venous stasis ulcers . Dysfunction of the muscle pump . The device is intended to be used by patient at home, as well as by physicians at clinic.

Device Story

PCD 901A and 901B are compression devices designed to treat lymphedema, venous insufficiency, venous stasis ulcers, and muscle pump dysfunction. Device operates by applying pneumatic compression to limbs to assist fluid circulation. Used by patients in home settings or by physicians in clinics. Output consists of controlled mechanical compression; assists in reducing edema and improving venous return. Benefits include management of chronic venous and lymphatic conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Pneumatic compression device (Class II, Product Code JOW). Operates as a compressible limb sleeve system. Technical specifications and materials not detailed in the provided documentation.

Indications for Use

Indicated for patients with primary or secondary lymphedema, venous insufficiency, venous stasis ulcers, or dysfunction of the muscle pump. Intended for use by patients at home or by physicians in 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT
19
2012

Mego Afek AC Ltd. c/o Mr. Alex Rapel QA & RA Manager Kibbutz Afek Afek Israel 30042

Re: K121962

Trade/Device Name: Practical Compression Device (PCD) 901A and 901B Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: September 13, 2012 Received: September 17, 2012

## Dear Mr. Rapel

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. 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.

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Page 2 - Mr. Alex Rapel

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

M.A. Killehen

>Bram D. Zuckerman. MD 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): K121962

Device Name: PCD 901A&B

Indications for Use:

- Primary lymphedema .
- Secondary lymphedema .
- . Venous insufficiency
- Venous stasis ulcers .
- Dysfunction of the muscle pump .

The device is intended to be used by patient at home, as well as by physicians at clinic.

Prescription Use__X__

AND/OR

Over-The Counter Use_

(Part 21 CFR 801 subpart D)

(21 CFR 801 subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mestillehen

(Division Sign-Off) Division of Čardiovascular Devices

510(k) Number 1-121962