Lympha Press Optimal Plus

K170658 · Mego Afek AC , Ltd. · JOW · May 31, 2017 · Cardiovascular

Device Facts

• Record ID: K170658
• Device Name: Lympha Press Optimal Plus
• Applicant: Mego Afek AC , Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: May 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as: - Primary lymphedema - Secondary lymphedema - Venous insufficiency - Venous stasis ulcers - Dysfunction of the muscle pump - Post mastectomy edema - Edema following trauma and sports issues - Post immobilization edema - Reduction of wound healing time - Reduction of pain and swelling after injury and surgery - The device may also be beneficial in the management of Lipoedema The device is intended for hospital, home, and clinic use.

Device Story

Lympha Press Optimal Plus Model 912 is a pneumatic compression device for limb edema management. System consists of a control unit and inflatable garments (sleeves) applied to limbs. Device operates by cyclically inflating and deflating garment chambers to provide external compression, simulating muscle pump action to facilitate lymphatic and venous drainage. Used in hospitals, clinics, or home settings under medical supervision. Operated by clinicians or patients. Output is mechanical compression; clinical benefit includes reduced swelling, pain, and improved wound healing. Device is a prescription-only system.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Pneumatic compression system consisting of a control unit and inflatable limb sleeves. Operates via cyclic inflation/deflation of air chambers. Intended for hospital, clinic, and home use. Prescription-only device.

Indications for Use

Indicated for patients requiring treatment for primary/secondary lymphedema, venous insufficiency, venous stasis ulcers, muscle pump dysfunction, post-mastectomy edema, post-trauma/sports injury edema, post-immobilization edema, and lipoedema. Used for reduction of wound healing time and post-surgical/injury pain and swelling. Intended for use by medical professionals or patients under medical supervision.

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)

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

May 31, 2017

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

Mego Afek Ac Ltd. % Ilan Sharon Consultant Ilan Sharon A 109 Neot Golf Caesarea, 3088900 IL

Re: K170658

Trade/Device Name: Lympha Press Optimal Plus Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: February 26, 2017 Received: March 3, 2017

Dear Ilan Sharon:

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.

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

{1}------------------------------------------------

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Fernando Aguel
-S
Fernando Aguel

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

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K170658

#### Device Name

Lympha Press Optimal Plus Model 912

#### Indications for Use (Describe)

The device is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as:

- Primary lymphedema
- Secondary lymphedema
- · Venous insufficiency
- Venous stasis ulcers
- · Dysfunction of the muscle pump
- Post mastectomy edema
- · Edema following trauma and sports issues
- · Post immobilization edema
- · Reduction of wound healing time
- · Reduction of pain and swelling after injury and surgery
- · The device may also be beneficial in the management of Lipoedema

The device is intended for hospital, home, and clinic use.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."