ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS

K140755 · Medical Compression Systems (Dbn) , Ltd. · JOW · May 8, 2014 · Cardiovascular

Device Facts

• Record ID: K140755
• Device Name: ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS
• Applicant: Medical Compression Systems (Dbn) , Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: May 8, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Prescriptive pneumatic compression system; applies sequential compression to lower limbs via foot and cuff sleeves. Control unit manages compression programs: intermittent pressure pulses for single-celled foot sleeves; sequential intermittent pressure for three-celled calf/thigh sleeves. Used to prevent DVT, enhance circulation, reduce pain/swelling/edema, and assist wound healing. Operated by clinicians or patients in clinical/home settings. Output is mechanical compression of limbs; aids clinical decision-making by providing therapeutic circulation support. Modifications include secondary hardware components, minor software/hardware updates, and electrical testing updates.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including risk analysis, electrical safety, and software validation to demonstrate substantial equivalence to previously cleared systems.

Technological Characteristics

Prescriptive pneumatic compression system. Control unit provides sequential/intermittent compression to foot (single-celled) or calf/thigh (three-celled) sleeves. Electrical safety testing performed per recognized standards. Software-controlled operation.

Indications for Use

Indicated for patients requiring lower limb circulation therapy to prevent DVT, enhance circulation, reduce post-operative pain/swelling, accelerate wound healing, treat chronic venous insufficiency, reduce edema, and assist in healing stasis dermatitis, venous stasis ulcers, and arterial/diabetic leg ulcers.

Regulatory Classification

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.

Predicate Devices

• ActiveCare DVT (K113525)
• ActiveCare+SFT (K113525)
• ActiveCare+DTx (K110159)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] E-mail: [e-mail]

#### Contact Person

Adely Levy 12 Ha'ilan Street, P.O. Box 75 Or Akiva 30600, Israel Telephone:[phone] [phone] Fax: E-mail: [e-mail]

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

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.

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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 [phone] or [phone] 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 [phone] or [phone] 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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