COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS

K100521 · Mego Afek AC , Ltd. · JOW · May 14, 2010 · Cardiovascular

Device Facts

• Record ID: K100521
• Device Name: COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS
• Applicant: Mego Afek AC , Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: May 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Primary lymphedema (for example congenital/ milroy's disease) Secondary lymphedema (for example post-mastectomy, chronic edema, post-traumatic edema) Venous disorders (for example venous insufficiency, varicose veins, venous stasis ulcers) Dysfunction of the muscle pump (for example promotion of wound recovery, reduction of edema and lower limb pain following trauma and sports injuries.) The garments are intended to be used by the patient at home, as well as by physicians at clinics or hospitals.

Device Story

Compression therapy system consisting of main control unit and inflatable garments (ComfySleeve 1-75, LymphaPod). System uses software-controlled air pump to sequentially inflate garment cells; moves interstitial fluid into venous/lymphatic systems; improves limb circulation. Used in home, clinic, or hospital settings by patients or clinicians. Control unit contains air compressor, pressure sensors, and solenoid valves; transfers air via distributor and hoses to garments. Healthcare providers use system to treat lymphedema, venous disorders, and muscle pump dysfunction. Benefits include edema reduction, pain relief, and wound recovery support.

Clinical Evidence

Bench testing only. Testing confirmed garment pressure accuracy compared to set pressure for ComfySleeve 1-75 and LymphaPress Pod when used with Lympha Press Plus and Optimal consoles. User comfort and safety (bruising/irritation) evaluated for ComfySleeve 1-75; results indicated suitability for user without adverse effects.

Technological Characteristics

System comprises electro-mechanical control unit with air compressor, pressure sensors, and solenoid valves. Garments are inflatable sleeves (ComfySleeve 1-75 for arm/thorax, LymphaPod for legs/abdomen). Software-controlled sequential inflation. Connectivity via air hoses. No specific material standards or software architecture details provided.

Indications for Use

Indicated for patients with primary lymphedema (e.g., Milroy's disease), secondary lymphedema (e.g., post-mastectomy, chronic/post-traumatic edema), venous disorders (e.g., insufficiency, varicose veins, stasis ulcers), and muscle pump dysfunction (e.g., wound recovery, edema/pain reduction post-trauma/sports injury).

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 Optimal device (K082149)
• Lympha Press Plus device (K013331)

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS

K100521 (Premarket Notification [510(k)] Number)

Date: April 28, 2010

### 1. Applicant

MAY 1 4 2010

- Mego Afek Ltd. Kibbutz Afek Post Afek ISRAEL 30042 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] Email: [e-mail]

| 2. Device Name: | Compression Therapy Device |
|--------------------------------|--------------------------------------------------------------------|
| Device trade/proprietary name: | Compression Therapy Device sleeves:<br>ComfySleeve 1-75; LymphaPod |
| Common Name: | Compression Therapy Device |
| Classification Name: | Compressible Limb Sleeve (product code JOW,<br>Class II, 870.5800 |

#### 3. Predicate Devices

The modified sleeves of the Compression Therapy devices are substantially equivalent to the original sleeves; and the combination of the modified sleeves with the original consoles is substantially equivalent to the combination of the original sleeves with the original consoles of the following devices:

| Device | Manufacturer | 510(k) No. |
|-----------------------------|----------------|------------|
| Lympha Press Optimal device | Mego Afek Ltd. | K082149 |
| Lympha Press Plus device | Mego Afek Ltd. | K013331 |

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# 4. Indications for Use

# Lympha Press Optimal (Model 1201AP) Compression Therapy device:

- . Primary Lymphedema (for example, congenital/ milroy's disease)
- Secondary Lymphedema (for example, post mastectomy, chronic edema, post-. traumatic edema)
- Venous disorders (for example, venous insufficiency, varicose veins, venous static . ulcers)
- Dysfunction of the muscle pump (for example, promotion of wound recovery, . reduction of edema and lower limb pain following trauma and sports injuries)

The device is intended to be used by the patient at home, as well as by physicians at clinics or hospitals.

#### Lympha Press Plus:

Treatment of Lymphatic Disorders, Venous disorders, Post-mastectomy Lymphedema and Dysfunction of the "Muscle Pump".

#### 5. Description of the Device

The Lympha Press Plus and Optimal Compression Therapy devices utilize a software controlled air compression pump, which sequentially inflates cells within a compression garment (sleeve) that is put around the area to be treated. This helps to move excessive interstitial fluid back into the venous and lymphatic systems; improve limb circulation: and thus treat the symptoms of lymphedema, a variety of venous disorders and dysfunction of the "muscle pump". The devices consist of a main control unit and compression garments. The main control unit contains an air compressor that is regulated by an electro-mechanical mechanism, including pressure sensors and solenoid valves. The regulated compressed air is transferred via an air distributor through a series of hoses to the sleeve garments. Additional garments include the ComfySleeve 1-75 (a jacket sleeve to treat the arm and thorax) and the LymphaPod (a pant sleeve to treat the legs and abdomen).

## 6. 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 Compression Therapy device with the modified sleeves are substantially equivalent to the predicate device cited above.

# 7. Performance Testing

The ComfySleeve 1-75 and the LymphaPress Pod garments were each tested with the LymphaPress Plus and with the Lympha Press Optimal devices. The garment pressure was measured and found comparable to the set pressure. The ComfySleeve I-75 was also tested for user comfort and to ensure that it does not cause any bruising or irritation during or after treatment. The ComfySleeve™ 1-75 garment was found suitable for the user and did not cause any bruising or irritation during or after treatment.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its head turned to the left. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAY 1 4 2010

Mego Afek Ltd. c/o Ms. Ahava Stein · Regulatory Consultant Beit Hapa'amon Box 124 20 Hata'as Street 44425 Kfar Saba Israel

K100521 Re:

ComfySleeve 1-75 and LymphaPod Therapy devices Regulation Number: 21 CFR 870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: Class II Product Code: JOW Dated: April 29, 2010 Received: May 4, 2010

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. 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

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Page 2 - Ms. Ahava Stein

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 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/CDRH0ffices/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,

Diner R. behmer

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): K100521

Device Name: ComfySleeve 1-75 and LymphaPod garments for use with the Lympha Press Optimal (Model 1201AP) Compression Therapy device and with the Lympha Press Plus Compression Therapy Device.

Indications For Use:

- Primary lymphedema (for example congenital/ milroy's disease) o
- Secondary lymphedema (for example post-mastectomy, chronic edema, post-0 traumatic edema)
- O Venous disorders (for example venous insufficiency, varicose veins, venous stasis ulcers)
- 0 Dysfunction of the muscle pump (for example promotion of wound recovery, reduction of edema and lower limb pain following trauma and sports injuries.)

The garments are intended to be used by the patient at home, as well as by physicians at clinics or hospitals.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna D. Varner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K 10052

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