The ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems are prescriptive devices that induce Continuous Enhanced Circulation Therapy of the lower limbs. The Systems are 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 ActiveCare+DTx, ActiveCare+SFT and ActiveCare DVT Systems are prescriptive, pneumatic compression Systems designed to apply sequential compression to the lower limb. The control units of the Systems provide 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 an 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

This 510(k) summary describes modifications to an existing device, the ActiveCare DVT, ActiveCare+SFT, and ActiveCare+DTx Systems. The submission is a Special 510(k), which is used for modifications to a manufacturer's own legally marketed device where the modifications do not require scientific review of clinical data to determine substantial equivalence. Therefore, the information provided below will reflect the nature of a Special 510(k) rather than a de novo submission requiring extensive new performance data.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a Special 510(k) for minor modifications to an already cleared device, detailed performance metrics (like sensitivity, specificity, accuracy) and corresponding acceptance criteria are not typically presented in the same way as for a novel device. The acceptance criteria here are implicitly that the modified device performs demonstrably equal to or better than the predicate device and does not raise new questions of safety or efficacy.

Acceptance Criteria (Implied for Special 510(k))	Reported Device Performance
Functional Equivalence: Device continues to perform its intended physiological function (e.g., provide pneumatic compression for DVT prevention, enhance blood circulation) as effectively as the predicate device.	The submission states that the modified systems have the "same intended use and similar indications, principles of operation, and technological characteristics as the previously cleared systems."
Safety Equivalence: Modified components (hardware, software) and design changes do not introduce new safety risks (e.g., electrical safety, mechanical integrity).	"Testing, including risk analysis, electrical safety, software validation and internal testing were performed to demonstrate that the modified systems with the described modifications do not raise any new questions of safety and efficacy."
Efficacy Equivalence: The modified device is as effective for its intended uses as the predicate device.	"Performance data demonstrates that the ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems are as safe and effective as their predicates."
Compliance with Recognized Standards: Device adheres to relevant industry and regulatory standards.	"Electrical Testing updates per recognized Standards."
Software Validation: Minor software changes maintain intended functionality and do not introduce errors.	"Software validation" was performed.
Labeling Equivalence: Labeling remains accurate and reflects the device's capabilities and uses.	"Minor labelling changes" were made, implying these were reviewed for accuracy.

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

No external test set with human subjects or real-world data is described for this Special 510(k). The "testing" mentioned is primarily internal verification and validation against design specifications and safety standards for the modified components. This type of submission relies on demonstrating that the minor changes do not alter fundamental performance.

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

Not applicable. As described above, no external test set requiring expert-established ground truth was part of this particular submission. The "ground truth" for a Special 510(k) is the performance of the legally marketed predicate device, and the evaluation focuses on whether the modifications deviate from that established performance.

4. Adjudication Method for the Test Set

Not applicable for the same reasons as #3.

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 pneumatic compression system, not an imaging or diagnostic AI-assisted device. Therefore, MRMC studies and AI assistance comparisons are not relevant.

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

Not applicable. This is not an algorithmic diagnostic device. The "standalone" performance here refers to the device's ability to mechanically deliver compression according to its design specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this Special 510(k) is the established performance and safety of the legally marketed predicate devices (K113525, K110159). The submission aims to demonstrate that the modifications maintain this existing ground truth. The "Performance Data" section explicitly states that "Medical Compression Systems (DBN) Ltd. believes that the modified ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems are substantially equivalent to the previously cleared ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems without raising new safety and/or effectiveness issues."

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning or AI that would require a "training set" in the conventional sense.

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

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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510(k) SUMMARY

Medical Compression Systems (DBN) Ltd.'s ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems

Submitter's Name, Address, Telephone Number

Medical Compression Systems (DBN) Ltd. 12 Ha'ilan Street, PO Box 75 Or Akiva 30600, Israel Tel: +972 (4) 6266630 Fax: +972 (4) 6266640 E-mail: adely@mcsmed.com

Contact Person

Adely Levy 12 Ha'ilan Street, P.O. Box 75 Or Akiva 30600, Israel Telephone:+972 (4) 6266630 +972 (4) 6266640 Fax: E-mail: adely@mcsmed.com

Date Prepared: March 24, 2014

Name of Device and Name/Address of Sponsor

ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems

Common or Usual Name

Pneumatic Compression System

Classification Name

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

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Predicate Devices

Medical Compression Systems (DBN) Ltd. ActiveCare DVT (K113525) Medical Compression Systems (DBN) Ltd. ActiveCare+SFT(K113525) Medical Compression Systems (DBN) Ltd. ActiveCare+DTx (K110159)

Purpose of the Special 510(k) notice

This special 510(k), was submitted in order to clear minor modifications to the ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems. Specifically, the following modifications were made to the cleared systems: addition of secondary sources hardware components, minor SW changes, minor hardware changes and minor labelling changes, and Electrical Testing updates per recognized Standards.

Intended Use

The ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems are prescriptive devices that induce Continuous Enhanced Circulation Therapy of the lower limbs.

The Systems are 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. .

Technological Characteristics

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Performance Data

Testing, including risk analysis, electrical safety, software validation and internal testing were performed to demonstrate that the modified systems with the described modifications do not raise any new questions of safety and efficacy. Based on these tests results, Medical Compression Systems (DBN) Ltd. believes that the modified ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems are substantially equivalent to the previously cleared ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems without raising new safety and/or effectiveness issues.

Substantial Equivalence

The ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx systems have the same intended use and similar indications, principles of operation, and technological characteristics as the previously cleared systems. The minor differences in the hardware, software and labelling do not raise any new questions of safety or effectiveness. Performance data demonstrates that the ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems are as safe and effective as their predicates. Thus, the ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx systems are substantially equivalent to their predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/12 description: The image is a black and white circular seal. The seal contains the logo for the U.S. Department of Health & Human Services. The seal has the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Public Health Service

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

May 8, 2014

Medical Compression Systems (D.B.N.) Ltd. Adely Levy RA/QA Manager 12 Ha'ilan Street, P.O. Box 75 Or Akiva 30600, Israel

K140755 Re:

Trade/Device Name: ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: April 7, 2014 Received: April 8, 2014

Dear Adely Levy,

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

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Page 2 - Adely Levy

Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours

Kenneth J. Cavanaugh -S

for

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): K140755

Device Name: ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems

Indications for Use:

The ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems are prescriptive devices that induce Continuous Enhanced Circulation Therapy of the lower limbs.

The Systems are 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 _____________________________________________________________________________________________________________________________________________________________ AND/OR (Per 21 C.F.R. 801 Subpart D) Subpart C)

Over-The-Counter Use (Per 21 C.F.R. 807

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Concurrence of CDRH, Office of Device Evaluation (ODE) Page_I of _ 1

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).