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 ActiveCare+SFT® is a prescriptive, pneumatic compression system designed to apply sequential compression to the lower limb. The control unit of the ActiveCare+SFT® is light and compact, thus making it a portable ambulant system. The ActiveCare+SFT® provide the user with an option of battery operation in addition to the operation from the mains option. The ActiveCare+SFT® is easy to use and provides the user with several treatment options: compression of the foot - single or double, compression of the calf - single or double, compression of the Thigh - single or double, and combined compression of any combination of two sleeves.

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

AI/ML Overview

Acceptance Criteria and Device Performance Study for ActiveCare+SFT® System (K110159)

The submission for the ActiveCare+SFT® System (K110159) focuses on demonstrating substantial equivalence to a previously cleared device (K060146) with an added software module. Therefore, the acceptance criteria and performance data specifically address the new "Venous Obstruction Detection software module" rather than the core functionality of the compression system itself. As a result, the information provided in the document is limited for a detailed breakdown of acceptance criteria and a comprehensive study that proves all aspects of device performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission (modifying an already cleared device with a new software module), the "acceptance criteria" appear to be focused on ensuring the new software module does not raise new questions of safety and efficacy and performs as intended. Specific quantitative acceptance criteria are not explicitly stated in the provided text, but rather implied by the overall goal of demonstrating substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Software performs as intended and correlates data to detect possible venous flow obstruction.	"Lab 003 — Validation of the ActiveCare+SFT®'s Venous Obstruction Detection software module" was performed.
The modified system does not raise any new questions of safety and efficacy.	"A series of performance testing, including bench testing and clinical comparison in healthy volunteers, were performed to demonstrate that the modified ActiveCare+SFT® System does not raise any new questions of safety and efficacy."
Compliance with general safety and electromagnetic compatibility standards.	The ActiveCare+SFT® System complies with voluntary standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, and ISO 14971.

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

Sample Size: The document mentions "clinical comparison in healthy volunteers." However, it does not specify the sample size for this clinical comparison or the "Lab 003" validation study.
Data Provenance: The document does not explicitly state the country of origin of the data. It mentions "healthy volunteers," implying the study was prospective in nature.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth related to the "Venous Obstruction Detection software module." The nature of the device (a pneumatic compression system) and the added software's function (detecting potential obstruction) suggest that objective physiological measurements might have been used as ground truth rather than expert consensus on image interpretation.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a physical compression system with an added software module for detection, not an imaging AI diagnostic aid that would typically involve multiple readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

Yes, a standalone performance evaluation of the algorithm was conducted. The "Lab 003 - Validation of the ActiveCare+SFT®'s Venous Obstruction Detection software module" explicitly refers to validating the software module itself, implying an evaluation of the algorithm's performance.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the "Venous Obstruction Detection software module." Given the nature of detecting "venous flow obstruction," it is likely that objective physiological measurements (e.g., Doppler ultrasound, plethysmography, or other forms of vascular assessment) were used to establish the presence or absence of venous obstruction as ground truth in the healthy volunteers, rather than expert consensus on visual assessment or pathology.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set for the "Venous Obstruction Detection software module."

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

The document does not provide information on how the ground truth for the training set was established. Given the validation study involved "healthy volunteers," it's possible that the initial development (training) of the software module might have used data from a different cohort or internally generated data, or a portion of the "healthy volunteers" data was used for development and another for validation.

Summary

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K110159

MAY 1 2 2011

510(K) SUMMARY

Medical Compression Systems (DBN) Ltd

ActiveCare+SFT® System

7.1.1 Applicant's Name:

Medical Compression Systems (DBN) Ltd. 2 Ha'Ilan Street, PO Box 75, Or Akiva 30600, Israel Tel: +972 (4) 6266630 Fax: +972 (4) 6266640 E-mail: medical@mcsmed.com

7.1.2 Contact Person:

Orly Maor 25A Sirkin Street Kfar Saba 44421, Israel Tel: +972-9-7453607 Fax: +972-153-9-7453607 oram.ma(a)gmail.com

7.1.3 Date Prepared:

January 10, 2011

7.1.4 Trade Name:

ActiveCare+SFT® System (ActiveCare®++)

7.1.5 Classification Name:

Sleeve, Limb, Compressible

7.1.6 Classification:

Class II; Product Code JOW: Regulation No. 870.5800 Panel: Cardiovascular Devices

7.1.7 Predicate Devices

Medical Compression Systems (DBN) Ltd. ActiveCare+SFT® System, previously cleared as ActiveCare®++ under K060146.

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7.1.8 Device Description:

7.1.9 Intended Use:

The ActiveCare+SFT® System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.

The ActiveCare+SFT® System 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.

7.1.10 Contraindications:

The ActiveCare+SFT® System should not be used in the following cases: fresh preexisting DVT, pulmonary embolism, leg gangrene, recent skin graft, acute thrombophlebitis and in medical situations where increased venous and lymphatic return is undesirable

7.1.11 Performance Standards:

No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, the ActiveCare+SFT® System complies with the voluntary standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4 and ISO 14971.

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7.1.12 Performance Data & Substantial Equivalence

The ActiveCare+SFT® System is substantially equivalent in all aspects, e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available Medical Compression Systems (DBN) Ltd.'s ActiveCare+SFT® System, previously cleared under K060146.

The difference between the modified and the cleared ActiveCare+SFT® system is that the new model incorporates a modified software module designed to collect and correlate data already being measured by the device to detect possible conditions that may be indicative of the development of venous flow obstruction in the treated legs of those patients receiving the prophylaxis treatment (i.e., Venous Obstruction Detection software module).

A series of performance testing, including bench testing and clinical comparison in healthy volunteers, were performed to demonstrate that the modified ActiveCare+SFT® System does not raise any new questions of safety and efficacy. These tests include:

Software verification and validation ■
. Lab tests /Performance testing:

Lab 003- Validation of the ActiveCare+SFT®'s Venous Obstruction Detection software module.

Based on these tests results, Medical Compression Systems (DBN) Ltd. believes that the modified ActiveCare+SFT® System is substantially equivalent to the cleared ActiveCare+SFT® System without raising new safety and/or effectiveness issues.

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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 features a stylized eagle with three lines forming its body and wing. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

MAY 1 2 2011

Medical Compression Systems (DBN) Ltd. c/o Ms. Orly Maor Company Consultant 25 A Sirkin Street Kfar Saba ISRAEL 44421

Re: K110159

Trade/Device Name: ActiveCare+SFT® System Regulation Number: 21 CFR 870.5800 Regulation Name: Compression Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: April 1. 2011 Received: April 5, 2011

Dear Ms. Maor:

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 Foond, Or to 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 contractly and 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 devine (1) 1) 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. Orly Maor

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 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 go to http://www.fdagov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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, 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 STATEMENT

510(k) Number (if known):_K110159

ActiveCare+SFTT® System Device Name:

Indications for Use:

The ActiveCare+SFT® System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.

The ActiveCare+SFT® System 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.

Prescription Use _ र (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Siin-Off)
Division of Cardiovascular Devices
510(k) viber K110 1597-10

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).