The WizAir DVT™ is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs. The WizAir DVT™ is intended for use in: Preventing Deep Vein Thrombosis (DVT). Enhancing blood circulation. Diminishing post-operative pain and swelling. Reducing wound-healing time. Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers. Treatment of chronic venous insufficiency. Reducing edema.

Device Description

The WizAir DVT™ is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The control unit of the WizAir DVT™ is light and compact, thus making it a portable ambulant system. The WizAir DVT™ provides the user with an option of battery operation in addition to the operation from the mains option. The WizAir DVT™ is easy to use and provides the user with several treatment options: compression of the foot -- single or double (either regular foot or foot booster), compression of the calf - single or double, compression of the Thigh -- single or double, and combined compression of any combination of two cuffs. The foot compression program is sequential intermittent pressure pulse application to a single celled foot cuff. The calf and thigh compression program is a sequential intermittent gradient application of a pressure to a three-celled calf cuff.

AI/ML Overview

The provided text describes the WizAir DVT™ device and its substantial equivalence to a predicate device, focusing on the addition of a "Foot Booster cuff." However, it does not contain detailed information about acceptance criteria or a comprehensive study proving the device meets specific acceptance criteria in the way typically required for AI/algorithm performance. The document is a 510(k) summary for a medical device and primarily addresses substantial equivalence for a hardware modification.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Foot Booster performs according to its specifications	"Testing results showed that the Foot Booster performs according to its specifications in safe and effective manner." (Specific quantitative performance metrics are not provided in this summary.)
Similarity of pressure profile	"The pressure profile of the new cuff is similar to that of the A-V Impulse System." (No quantitative comparison or acceptance range given.)
Safety and Effectiveness	"The modified WizAir DVT™ System is substantially equivalent to its predicate devices without raising new safety and/or effectiveness issues." (General statement; no specific safety or effectiveness metrics or thresholds are defined as acceptance criteria.)

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

Sample Size: "clinical analysis that was performed on healthy volunteers." The specific number of volunteers is not specified.
Data Provenance: The study was a "clinical analysis" performed on "healthy volunteers." The country of origin is implicitly Israel, given the applicant's address, but this is not explicitly stated for the study data. The study appears to be prospective as it involved performing clinical analysis.

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

This information is not provided in the document. The study described is a clinical analysis on healthy volunteers to verify the performance of a pneumatic compression device, not an AI or diagnostic device that typically relies on expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to the type of device and study described.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiologists interpreting images), which is not the case for this pneumatic compression device.

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

This concept is not applicable to the WizAir DVT™. It is a hardware medical device with a software component to control pneumatic compression, not an "algorithm" in the sense of an AI model for diagnosis or prediction. The "performance" refers to the mechanical and physiological effects of the device.

7. The Type of Ground Truth Used

For the clinical analysis, the "ground truth" would likely involve physiological measurements related to blood circulation, pressure, or other relevant health indicators in healthy volunteers, comparing the device's performance to expected physiological responses or the predicate device. However, the specific type of ground truth used (e.g., specific physiological measurements) is not detailed in the document.

8. The Sample Size for the Training Set

This information is not provided and is not applicable as this is not an AI/machine learning device that requires a distinct "training set" in the conventional sense. The "software modification" was verified and validated, but no mention of a training set for an algorithm is made.

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

This information is not provided and is not applicable for the reasons mentioned above.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence for a physical device (pneumatic compression) with a minor modification (Foot Booster cuff). The "study" mentioned is a "clinical analysis...performed on healthy volunteers" and "bench testing" to ensure the new cuff performs "according to its specifications in safe and effective manner" and has a "similar" pressure profile to the predicate. The document doesn't provide the detailed methodological rigor, acceptance criteria, sample sizes, and ground truth establishment typically associated with the evaluation of AI/ML-based diagnostic algorithms.

Summary

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1023573

NOV 2 1 2002

510(K) SUMMARY

WizAir DVT™M

510(k) Number K_______________________________________________________________________________________________________________________________________________________________

Applicant's Name:

Medical Compression Systems (DBN) Ltd. 2 Ha-Ilan Street, P.O. Box 75 Or-Akiva 30600, Israel Tel: +972 (4) 6266630 Fax: +972 (4) 6266640 mcs@mcsmed.com

Contact Person:

Arava Hacohen Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: 972-9- 7718130 Fax: 972-9-7718131

Trade Name:

WizAir DVT™

Classification Name:

Compressible Limb Sleeve

Classification:

Class II; Product Code JOW; Regulation No. 870.5800.

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Device Description:

The foot compression program is sequential intermittent pressure pulse application to a single celled foot cuff. The calf and thigh compression program is a sequential intermittent gradient application of a pressure to a three-celled calf cuff.

Indications:

The WizAir DVT™ is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.

The WizAir DVT™ is intended for use in:

Preventing Deep Vein Thrombosis (DVT).
Enhancing blood circulation.
Diminishing post-operative pain and swelling.
Reducing wound-healing time. .
Treatment and assistance in healing: stasis dermatitis; ● venous stasis ulcers; arterial and diabetic leg ulcers.
Treatment of chronic venous insufficiency.
Reducing edema.

Contraindications:

The WizAir™ system should not be used in the following cases: fresh pre-existing DVT, pulmonary embolism, leg gangrene, recent skin graft, acute thrombophlebitis and in medical situations where increased venous and lymphatic return is undesirable

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Substantial Equivalence: Statement

The modified WizAir DVT™ System is substantially equivalent in all aspects. e.g., technological characteristics, modes of operation, performance characteristics, intended use, etc., to the commercially available WizAir DVT™. The modified WizAir DVT™ System includes an additional cuff -- the Foot Booster cuff for faster inflation of the cell.

The pressure profile of the new cuff is similar to that of the A-V Impulse System. Moreover, the additional cuff and software modification were verified through bench testing and validated through clinical analysis that was performed on healthy volunteers.

Testing results showed that the Foot Booster performs according to its specifications in safe and effective manner.

Performance Data:

A series of safety and performance testing including bench testing and clinical comparison between the Foot Booster cuff of the WizAir DVT™ and its predicate device demonstrated that the modified WizAir DVT™ System is substantially equivalent to its predicate devices without raising new safety and/or effectiveness issues

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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized design of three human profiles facing to the right, stacked on top of each other. The words "HUMAN SERVICES - USA" are arranged in a circular fashion around the top of the design, and the word "DEPARTMENT" is written vertically along the left side of the design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2002

Medical Compression Systems (D.B.N.) Ltd. c/o Mr. Arava Hacohen Project Manager Push-med Ltd. 117 Ahuzah St. Ra'ananna 43373 ISRAEL

Re: K023573 Trade Name: WizAir DVT™ Regulation Number: 21 CFR 870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: Class II (two) Product Code: JOW Dated: October 21, 2002 Received: October 24, 2002

Dear Mr. Hacohen:

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 – Mr. Arava Hacohen

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 (301) 594-4646. 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.

Dna Xlumberfu
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): __

WizAir DVT™ Device Name:

Indications for Use:

The WizAir DVT™ is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.

The WizAir DVT™ is intended for use in:

. Preventing Deep Vein Thrombosis (DVT).
Enhancing blood circulation.
Diminishing post-operative pain and swelling.
Reducing wound-healing time.
Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers.
Treatment of chronic venous insufficiency.
Reducing edema.

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

Division of C Respiratory Devices
510(k) Nu K023573

510(k) Number 11/20/02

Prescription Use (Per 21 CFR 801.109)

Over the Counter U

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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).