The Petite Basic System™ is a sequential pneumatic compression therapy system for treatment of lymphedema, venous insufficiency, venous stasis ulcers and dysfunction of the "muscle pump". The Petite Basic System™ consists of:

The pressure control unit (sometimes called "compressor" or . "pump"), supplies air at regulated pressure to a compression garment that is worn over the area to be treated.
Hoses that transfer the air from the pressure control unit to each of the . cells in the compression garment.
The compression garment (sometimes called a "sleeve"), fastened 0 around the area to be treated. Each garment contains 4 overlapping air cells. These air cells are filled with air from the pressure control unit in sequence, applying a compressive massage. Once the entire area has been compressed, the Petite Basic System™ pressure control unit releases the pressure, and there is a brief pause. Then the process starts over again, and is repeated until the treatment session is complete.
The compress-and-release massage action of Petite Basic System™ stimulates lymphatic vessels in the treated area to take up and transport lymphatic fluid. The directional massage action encourages transport of the fluid towards the torso for collection by healthy lymphatics and return to the blood circulation. The directional compressive massage also helps reduce venous edema and stimulates venous return.

AI/ML Overview

Here's an analysis of the provided text regarding the Petite Basic System 701ELT, addressing the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a 510(k) submission for a medical device (Petite Basic System 701ELT), which focuses on demonstrating substantial equivalence to a predicate device rather than setting and meeting specific quantitative clinical performance acceptance criteria in the typical sense of a novel device. The "acceptance criteria" here are effectively the demonstration of safety and effectiveness being equivalent to the predicate device, relying heavily on non-clinical testing and comparison of technological characteristics.

Acceptance Criterion (Implicit)	Reported Device Performance
Technological Equivalence to Predicate Device	Substantially equivalent. - Air Distribution Method: Uses a diaphragm (predicate uses rotating disc, but "Both devices provide the same output. No impact on safety & effectiveness as demonstrated by verification/validation testing performed"). - Accessories: 4-cell garments (predicate uses 4-12 cell garments). "Treated body areas are equivalent. Output is equivalent." - Cycle Time: Minimum 20 seconds, determined by pressure and pause settings (predicate: 30 seconds full cycle, 24 sec inflation, 2 sec hold, 4 sec deflation). "The 701ELT allows the physician to predefine the pressure level & pause time. 201Max allows the physician to predefine the pressure level." (Implies flexibility, not a degradation). - Display: Dial Selector (predicate: LCD). "Both display pressure values." - Software/Firmware: Proprietary (like predicate). Changes made "to remove the digital display feature, add overpressure timeout." (Implies improvements/simplifications, not degradation).
Safety and Effectiveness (Non-clinical)	Passed all tests based on pre-determined Pass/Fail criteria. - Standards Applied: IEC60601-1, IEC60601-2, and IEC TR-60721-2.
Maintain Intended Use	Same as predicate device: Primary lymphedema, Secondary lymphedema, Venous insufficiency, Venous stasis ulcers, Dysfunction of the "muscle pump."
Clinical Equivalence (Implicit from substantial equivalence)	No direct clinical study was conducted for this 510(k) submission, as substantial equivalence to a legally marketed predicate device (Lympha Press 201Max) was asserted based on technological and non-clinical performance.

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

Sample Size for Test Set: Not applicable in the context of a clinical test set. The submission relies on non-clinical engineering and performance testing.
Data Provenance: The studies were non-clinical engineering tests (e.g., electrical safety, electromagnetic compatibility, environmental testing based on standards like IEC60601-1, IEC60601-2, and IEC TR-60721-2). The specific location of this testing is not detailed, but the manufacturer is based in Israel. This is a submission for a medical device in the USA.

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

This information is not provided. For non-clinical engineering tests (like those against IEC standards), the "ground truth" is established by the design specifications and the requirements of the standards themselves, not by expert medical opinion. The "experts" would be the engineers and quality assurance professionals performing and evaluating the tests.

4. Adjudication Method for the Test Set

Not applicable. Testing against engineering standards typically involves pass/fail criteria based on objective measurements, not a consensus or adjudication process among experts in the way clinical ground truth is often established.

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

No MRMC study was done. This device is a pneumatic compression therapy system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI" is not applicable.

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

No standalone algorithm performance study was done. This device does not feature an "algorithm-only" component in the way AI/ML devices might. Its operation is purely mechanical/electronic, providing pneumatic compression therapy.

7. The Type of Ground Truth Used

For the non-clinical performance and safety testing, the "ground truth" was the compliance with established international standards (IEC60601 series, IEC TR-60721-2) and the design specifications of the device. This is a regulatory "ground truth" indicating the device meets recognized safety and performance benchmarks for its classification.

8. The Sample Size for the Training Set

Not applicable. This submission describes a hardware medical device; it is not an AI/ML device that requires a training set of data.

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

Not applicable. As established in point 8, there is no training set for this type of device.

Summary

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Exhibit 1

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5|0(k) number is: K131420

Submitter's Identification: 1. MEGO AFEK LTD. Kibbutz Afek 30042 ISRAEL Phone: 972-77-9084276 Fax: 972-4-877-3523
NOV 0 1 2013

Date Summary Prepared: May 13, 2013

2. Name of the Device:

Proprietary name: Petite Basic System 701 ELT

Common Name: Compressible Limb Sleeve

3. Common or Usual Name/Classification:

Common name: Compressible Limb Sleeve Classification name: Compressible Limb Sleeve Regulation: 21 CFR 870.5800 Product Code: JOW

4. Predicate Device Information:

Lympha Press 201Max Previously cleared 510(k) number: K100677

5. Description:

The pressure control unit (sometimes called "compressor" or . "pump"), supplies air at regulated pressure to a compression garment that is worn over the area to be treated.

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Hoses that transfer the air from the pressure control unit to each of the . cells in the compression garment.
The compression garment (sometimes called a "sleeve"), fastened 0 around the area to be treated. Each garment contains 4 overlapping air cells. These air cells are filled with air from the pressure control unit in sequence, applying a compressive massage. Once the entire area has been compressed, the Petite Basic System™ pressure control unit releases the pressure, and there is a brief pause. Then the process starts over again, and is repeated until the treatment session is complete.

The compress-and-release massage action of Petite Basic System™ stimulates lymphatic vessels in the treated area to take up and transport lymphatic fluid. The directional massage action encourages transport of the fluid towards the torso for collection by healthy lymphatics and return to the blood circulation. The directional compressive massage also helps reduce venous edema and stimulates venous return.

6. Intended Use:

. Primary lymphedema
Secondary lymphedema .
Venous insufficiency .
Venous stasis ulcers .
Dysfunction of the "muscle pump" .

7. Technological Characteristics

The technological characteristics of the Petite Basic System 701ELT are substantially equivalent to the predicate device. Both systems have the same specifications -

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Comparison to Predicate Device

ltem	Lympha-Press201 Max	Petite Basic System701ELT	Comments
Air Distributionmethod	rotating disc whichdistributes air in apredefined sequence	diaphragm whichdistributes air in apredefined sequence	Both devices providethe same output.No impact on safety &effectiveness asdemonstrated byverification/validationtesting performed
Accessories	4 - 12 cell garments	4 cell garments	Treated body areasare equivalent.Output is equivalent.
Cycle time	30 seconds full cycle,of which:24 sec Inflation (2sec per cell)2 sec Hold4 sec Deflation	Minimum Cycle Time:20 seconds.Determined bypressure and pausesettings, dependingon garment size	The 701ELT allowsthe physician topredefine thepressure level &pause time.201Max allows thephysician to predefinethe pressure level.
Display	LCD	Dial Selector	Both display pressurevalues.
Software/firmware	Proprietary	Proprietary	Changes were madeto remove the digitaldisplay feature, addoverpressure timeout.

8. Performance Data:

Non-clinical: As required by the risk analysis, verification, validation and testing activities were conducted to establish that the changes made to the device perform as designed. The following standards were included as part of the testing: IEC60601-1, IEC60601-2 and IEC TR-60721-2. The device passed all of the tests based on pre-determined Pass/Fail criteria.

9. Conclusions:

The data from consensus standard testing and comparison to the predicate device show that the Petite Basic System 701ELT is as safe and effective as the legally marketed predicate device.

Therefore Mego Afek, Ltd. conclude that the Petite Basic System 701ELT is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

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

November 1. 2013

MEGO AFEK LTD. Ms. Maria F. Griffin mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021

Re: K131420

Trade/Device Name: Petite Basic System 701 ELT Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: June 12, 2013 Received: June 14, 2013

Dear Ms. Griffin:

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 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

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Page 2 – Maria F. Griffin

forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman -S

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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Exhibit 3

Indications for Use

Page 11

510(k) Number (if known): _ K131420

Device Name Petite Basic System 701ELT

Indications For Use:

. Primary lymphedema
. Secondary lymphedema
t Venous insufficiency
. Venous stasis ulcers
Dysfunction of the "muscle pump" ●

Prescription Use × Over-The Counter Use (Per 21 CFR 801 Subpart D) OR (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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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).