LYMPHA PRESS PLUS DEVICE

K013331 · Mego Afek · JOW · Nov 30, 2001 · Cardiovascular

Device Facts

• Record ID: K013331
• Device Name: LYMPHA PRESS PLUS DEVICE
• Applicant: Mego Afek
• Product Code: JOW · Cardiovascular
• Decision Date: Nov 30, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lympha Press Plus device is intended for treatment of lymphatic disorders, venous disorders, post- mastectomy lymph-edema and dysfunction of the "Muscle Pump".

Device Story

Lympha Press Plus is a programmable sequential compression therapy device. System consists of a main console containing an air compressor and a mechanical air pressure regulator, connected via an air distributor and hoses to compression garments. Garments feature up to 12 overlapping pressure cells applied to affected limbs. Device operates by delivering regulated compressed air to cells to provide sequential compression. Used in clinical or home settings to treat lymphatic and venous disorders, post-mastectomy lymphedema, and muscle pump dysfunction. Output is physical compression of the limb, which assists fluid movement and circulation. Healthcare providers prescribe the device; patients or caregivers operate the system to manage edema and improve venous return.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Programmable sequential compression device. Components: main console with air compressor, mechanical air pressure regulator, air distributor, hoses, and compression garments with up to 12 overlapping pressure cells. Adjustable to limb size. Non-electronic/mechanical control logic.

Indications for Use

Indicated for patients requiring treatment for lymphatic disorders, venous disorders, post-mastectomy lymphedema, and muscle pump dysfunction.

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.

Predicate Devices

• Lympha Press device (K810338)
• Jobst Extremity Pump (K882683)
• Sequential Circulator device (Pre-Amendment Device)

Submission Summary (Full Text)

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## NOV 3 0 2001

# SECTION 7 - SUMMARY OF SAFETY AND EFFECTIVENESS

#### 1. Applicant

Mego Afek Ltd. Kibbutz Afek 30042 ISRAEL Tel: [phone] Fax: [phone]

Corresponding Official:

Name: Ahava M. Stein, Consultant Address: A. Stein - Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as St. 44425 Kfar Saba ISRAEL Tel: [phone] Fax: [phone]

#### 2. Device Name

| Device trade or proprietary name: | Lympha Press Plus device |
|-----------------------------------|----------------------------------------------|
| Common Name: | Compressible Sleeve Limb device |
| Classification Name: | Compressible Sleeve Limb, Class II, 870.5800 |

#### 3. Predicate Devices

The Lympha Press Plus device is substantially equivalent to a combination of the Lympha Press device (manufactured by Mego Afek and subject of 510(k) document no. K810338), the Jobst Extremity Pump (manufactured by Jobst, Inc. and subject of 510(k) document no. K882683) and the Sequential Circulator device (manufactured by Bio Compression Systems, Inc., a Pre-Amendment Device).

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#### 4. Intended Use

The Lympha Press Plus device is intended for treatment of lymphatic disorders, venous disorders, post- mastectomy lymph-edema and dysfunction of the "Muscle Pump".

#### 5. Description of the Device

The Lympha Press Plus Device is a programmable sequential compression therapy device with compression garments for the treatment of lymphatic and venous disorders. The Lympha Press Plus device consists of a main console and compression garments. The main console contains an air compressor that is regulated by a mechanical air pressure regulator. The regulated compressed air is transferred via an air distributor through a series of hoses to the sleeve garments containing up to 12 overlapping pressure cells. The sleeve fits on the affected limb and can be easily adjusted to any limb size within the sleeve tolerance.

### 5. Technological Characteristics Compared to Predicate Device

The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the Lympha Press Plus substantially equivalent to to the predicate above. devices cited device are

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2001

Ms. Ahava M. Stein Consultant Mego Afek Ltd. c/o A Stein Regulatory Affairs Consulting Beit Hapa' Amon (Box 124) 20 Hata' As St. Kfar Saba, Israel

Re: K013331

> Trade Name: Lympha Press Plus Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: II Product Code: JOW Dated: September 30, 2001 Received: October 5, 2001

#### Dear Ms. Stein:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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#### Page 2 - Ms. Ahava M. Stein

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

K. Oatha Teller

James E. Dillaro Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Lympha Press Plus Device Name:

Indications for use:

Treatment of Lymphatic Disorders, Venous Disorders, Postmastectomy Lymphedema and Dysfunction of the "Muscle Pump".

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 C.F.R. 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

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Division of Cardiovascular & Respiratory Devices
510(k) Number R013331