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 Description

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.

AI/ML Overview

Acceptance Criteria and Device Performance Study for the Lympha Press Plus Device

This document describes the acceptance criteria and the study that proves the Lympha Press Plus device meets these criteria, based on the provided FDA 510(k) summary.

Evaluation Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study with specific acceptance criteria, statistical analysis, and performance metrics as typically found in a clinical trial report for novel devices. Therefore, the information below is derived from the context of substantial equivalence and assumes that the "acceptance criteria" for a 510(k) submission are met by showing similar technological characteristics and intended use to existing devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit for 510(k))	Reported Device Performance (as per 510(k) justification)
Intended Use	Device is intended for specific medical conditions.	"Treatment of Lymphatic Disorders, Venous Disorders, Postmastectomy Lymphedema and Dysfunction of the 'Muscle Pump'."
Technological Characteristics	Mechanism of action, overall design, materials, mode of operation, and performance characteristics are similar to predicate devices.	"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 device are substantially equivalent to the predicate devices cited above."
Safety and Effectiveness	Device is as safe and effective as the predicate devices for its intended use.	Demonstrated by substantial equivalence to legally marketed predicate devices (Lympha Press, Jobst Extremity Pump, Sequential Circulator). The FDA's issuance of a substantial equivalence determination signifies this.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not describe a specific clinical test set, corresponding sample size, or data provenance (e.g., country of origin, retrospective/prospective). 510(k) submissions for substantial equivalence often rely on comparative analysis of technical specifications, existing clinical data for predicate devices, and sometimes bench testing, rather than a new clinical trial with a "test set" in the context of AI/diagnostic algorithm validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

As there is no specific test set or clinical study described in detail, there is no information about experts used to establish ground truth. Substantial equivalence for this type of device typically relies on regulatory review of technical specifications and comparison to predicate devices, not expert consensus on a diagnostic outcome.

4. Adjudication Method for the Test Set

Given the lack of a defined test set for a clinical study, no adjudication method is described in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. This type of study is more common for diagnostic imaging AI devices where human reader performance is a key metric. The Lympha Press Plus is a therapeutic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The Lympha Press Plus is a mechanical therapeutic device, not an algorithm or AI system. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply to this device.

7. The Type of Ground Truth Used

For this 510(k) submission, the "ground truth" implicitly refers to the established safety and effectiveness of the legally marketed predicate devices (Lympha Press, Jobst Extremity Pump, and Sequential Circulator). The Lympha Press Plus device claims substantial equivalence to these devices, meaning its
"ground truth" for regulatory approval is based on its similarity to products already proven safe and effective through their own regulatory pathways (which could have included clinical trials, post-market surveillance, or pre-amendment status).

8. The Sample Size for the Training Set

The Lympha Press Plus device is a mechanical therapeutic device, not an AI/machine learning model. Therefore, the concept of a "training set" does not apply.

9. How the Ground Truth for the Training Set Was Established

As stated above, the concept of a "training set" does not apply to this device.

Summary

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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: +972-4-878 4277 Fax: +972-4-878 4148

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: +972-9-767 0002 Fax: +972-9-766 8534

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

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 (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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

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

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
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.(b)
Classification. Class II (performance standards).