Prevention of Deep Vein Thrombosis (DVT) in susceptible patients; Reduction of pain and swelling after injury and surgery; Enhancement of venous and arterial circulation; Prevention of venous stasis; Assist healing of cutaneous ulcers; Reduction of compartmental pressures.

Device Description

The Model 601 Compression Therapy Device utilizes a software controlled air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) that is put around a limb. This helps to push excessive interstitial fluid in the treated limb, back into the venous and lymphatic systems; improve limb circulation; and thus treat the symptoms of a variety of venous disorders and dysfunction of the "muscle pump". The device consists of a main console and compression garments. The main console 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. In the Model 601 device, each garment contains up to 4 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

This 510(k) submission for the Mego Afek PHLEBOPRESS DVT MODEL 601A Compressible Limb Sleeve Device does not contain the kind of detailed information typically found in a study proving a device meets specific acceptance criteria that usually involves rigorous performance metrics and statistical analysis.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices. It relies on a comparison of features, intended use, and existing safety and performance standards.

Therefore, many of the requested sections (e.g., acceptance criteria table with reported performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable or not provided in the given text.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Specific Performance Metrics (e.g., pressure accuracy, inflation/deflation timing, efficacy in DVT prevention as measured by clinical outcomes)	Not explicitly stated as quantifiable acceptance criteria within this document.
General Safety and Performance Testing (ensuring functional specifications are met and compliance with industry/safety standards)	"The Model 601A Compression Therapy device has been subjected to extensive safety, performance testing, and validation before release. Final testing of the Model 601A Compression Therapy device included various performance tests and software validation tests, designed to ensure that the device met all its functional specifications. Tests have been performed to ensure the device complies with industry and safety standards."
Similarity to Predicate Devices (in terms of inflation/deflation pressures, sequences, operating modes, and features)	"Inflation/ Deflation pressures and sequences are similar to those of predicate devices. Operating modes are similar to those of predicate devices. All of the above features are similar to these features in the predicate devices."

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

Sample Size: Not specified. This document refers to "various performance tests and software validation tests," but does not provide details on the number of subjects or test units involved.
Data Provenance: Not specified. The testing was conducted by Mego Afek Ltd. in Israel, but no details about the origin of any clinical data (if collected) are provided. It appears to be product validation testing, not a clinical study involving human patients to prove efficacy against acceptance criteria.

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

Not Applicable. The document describes device-level performance and software validation tests, not a clinical study requiring expert-established ground truth for disease detection or diagnosis.

4. Adjudication Method for the Test Set:

Not Applicable. As there's no clinical test set with human data requiring expert review for ground truth, no adjudication method is mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

Not Applicable. This device is a physical compression therapy device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not Applicable. This is a physical medical device. While it has software controls, the "standalone performance" concept as applied to AI algorithms is not relevant here. The device's performance is inherently "standalone" in that it operates independently of human interpretation of its outputs for diagnosis.

7. The Type of Ground Truth Used:

For the described "performance tests and software validation tests," the "ground truth" would be the engineering specifications and design requirements of the device (e.g., target pressure levels, cycle times, software logic correctness). There is no "ground truth" in the sense of clinical outcomes or disease states for a diagnostic AI.

8. The Sample Size for the Training Set:

Not Applicable. This device does not use machine learning or AI that would require a "training set" of data in the conventional sense. The software validation tests ensure its programmed functions work correctly, not that it "learns" from data.

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

Not Applicable. As there is no training set, there's no ground truth to establish for it.

Summary of the Study/Evidence Provided:

The provided document describes a technical validation and substantial equivalence argument, rather than a clinical study with detailed performance metrics against specific acceptance criteria.

The "study" cited is:

"extensive safety, performance testing, and validation before release."
"various performance tests and software validation tests, designed to ensure that the device met all its functional specifications."
Tests were performed to ensure compliance with "industry and safety standards."

The conclusions drawn are based on:

This internal performance testing.
A direct comparison of its features, intended use, and operating parameters (inflation/deflation pressures and sequences, operating modes) to currently legally marketed predicate devices (Mego Afek's PhleboPress Model 701A, Huntleigh Healthcare's Flowtron Excel Model AC550, and Flowtron Universal Model AC600).

The approval is based on the FDA's finding of substantial equivalence to these predicate devices in terms of safety and efficacy. Specific quantitative acceptance criteria or clinical outcome data from trials are not detailed in this 510(k) summary.

Summary

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Mego Afek 510(k)

K072372

510(K) SUMMARY

PHLEBOPRESS DVT MODEL 601A

COMPRESSIBLE LIMB SLEEVE DEVICE

	510(k) Number K
Applicant's Name:	Mego Afek Ltd.Kibbutz AfekPost AfekPhone: (972)-4-8784277Fax: (972)-4-8784148E-mail: aharon@megoafek.co.il	NOV 2 1 2007
Contact Person:	Ahava Stein/ Ofer HornickA. Stein – Regulatory Affairs Consulting20 Hata'as St.Kfar Saba 44425IsraelTel. + 972-9-7670002Fax. +972-9-7668534e-mail: asteinra@netvision.net.il or oh_asra@netvision.net.il
Date Prepared:	August 2007
Trade Name:	Model 601A Compression Therapy Device
Device Common or Usual Names:	Compressible Limb Sleeve
	Classification Name: CFR Classification section 870.5800 (Product code JOW)
Classification:	Class II medical Device
Predicate Device:	The Model 601A Compression Therapy Device is substantiallyequivalent to a combination of the following predicate devices:- PhleboPress Model 701A (K060220) manufactured also by MegoAfek, Ltd (Israel). PhleboPress Model 701A is a compressible

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limb sleeve, similar to the Model 601 Compression Therapy Device.

Flowtron Excel Model AC550 (K961166), manufactured by Huntleigh Healthcare Inc.
Flowtron Universal Model AC600 (K010744), manufactured by Huntleigh Healthcare Inc.
Mego Afek's Model 601 Compression Therapy Device utilizes a Device Description: software controlled air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) that is put around a limb. This helps to push excessive interstitial fluid in the treated limb, back into the venous and lymphatic systems; improve limb circulation; and thus treat the symptoms of a variety of venous disorders and dysfunction of the "muscle pump". The device consists of a main console and compression garments. The main console 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. In the Model 601 device, each garment contains up to 4 overlapping pressure cells. The sleeve fits on the affected limb and can be easily adjusted to any limb size within the sleeve tolerance.
Intended Use / Indication for Use: Prevention of Deep Vein Thrombosis (DVT) in susceptible patients; Reduction of pain and swelling after injury and surgery; Enhancement of venous and arterial circulation; Prevention of venous stasis; Assist healing of cutaneous ulcers; Reduction of compartmental pressures.

Performance Standards:

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There are no performance standards under the Federal Food, Drug and Cosmetic Act, for a compressible limb sleeve device.

The Model 601A Compression Therapy device has been subjected Test Data: to extensive safety, performance testing, and validation before release. Final testing of the Model 601A Compression Therapy device included various performance tests and software validation tests, designed to ensure that the device met all its functional specifications. Tests have been performed to ensure the device complies with industry and safety standards.

Substantial Equivalence: The Model 601A Compression Therapy device is similar to currently distributed Compression Therapy devices intended for treatment of venous and lymphatic disorders, dysfunction of the "muscle pump" and prevention of deep venous thrombosis. The device uses sequential inflation and deflation of cells within compression sleeves put around a limb. Inflation/ Deflation pressures and sequences are similar to those of predicate devices. Operating modes are similar to those of predicate devices. All of the above features are similar to these features in the predicate devices.

Conclusions: The conclusions drawn from the above Performance Testing and comparison to predicate devices is that the Model 601A compression therapy device is substantially equivalent in safety and efficacy to the predicate devices listed above.

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Image /page/3/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

NOV 2 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MEGO AFEK c/o Ms. Ahava Stein Regulatory Affairs Counseling Beit Hapa' Amon (Box 124) 20 Hata'As St. Kfar Saba. Israel 44425

Re: K072372

Phlebopress Model 601A Compression Therapy Device Regulation Number: 21 CFR 870. 5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: August 17, 2007 Received: August 23, 2007

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.

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Page 2 - Ms. Ahava Stein

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); 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duna R. Wachner

Л 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): ko72372

Model 601A Compression Therapy device Device Name:

Indications for Use:

Prevention of Deep Vein Thrombosis (DVT) in susceptible patients.

Reduction of pain and swelling after injury and surgery.

Enhancement of venous and arterial circulation.

Prevention of venous stasis.

Assist healing of cutaneous ulcers.

Reduction of compartmental pressures.

Prescription Use V (Per 21 C.F.R. 801 Subpart D) C)

Over-The-Counter Use (Optional Format Subpart

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. hchmer

(Division Sign-Off) (Division Orgh Olyn Scular Devices

510(k) Number K072372

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).