ACTIVECARE DVT ACTIVECARE+SFT

K113525 · Medical Compression Systems (Dbn) , Ltd. · JOW · Jan 31, 2012 · Cardiovascular

Device Facts

• Record ID: K113525
• Device Name: ACTIVECARE DVT ACTIVECARE+SFT
• Applicant: Medical Compression Systems (Dbn) , Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: Jan 31, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ActiveCare DVT and ActiveCare+SFT Systems are prescription 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

Pneumatic compression system for lower limbs; applies sequential intermittent pressure via foot, calf, or thigh sleeves. Control unit manages compression programs: single/double foot (intermittent pressure pulse, single-cell sleeve) or calf/thigh (sequential intermittent pressure, three-celled cuff). Used in clinical or home settings under prescription; operated by patients or healthcare providers. Modifications include OVP circuit, secondary hardware, and minor software updates. Device enhances circulation to prevent DVT, reduce edema, and assist wound healing.

Clinical Evidence

Bench testing only. Includes risk analysis, electrical safety, and software validation to confirm modifications do not impact safety or efficacy compared to predicate devices.

Technological Characteristics

Pneumatic compression system; control unit with OVP circuit and secondary hardware components. Sequential intermittent pressure application via single-celled (foot) or three-celled (calf/thigh) sleeves. Prescription use. Software-controlled compression cycles.

Indications for Use

Indicated for patients requiring lower limb circulation therapy to prevent DVT, enhance blood flow, reduce post-op pain/swelling, accelerate wound healing, treat chronic venous insufficiency, edema, and assist in healing stasis dermatitis, venous stasis, arterial, and diabetic 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 (K023573)
• ActiveCare+SFT (K060146)

Submission Summary (Full Text)

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K113525 pg 1 of 2

# JAN 3 1 2012

# 510(k) SUMMARY

JAN 31 2012

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

# Submitter's Name, Address, and Telephone Number

Medical Compression Systems (DBN) Ltd. 2 Ha'llan Street, PO Box 75 Or Akiva 30600, Israel Tel: [phone] Fax: [phone] E-mail: [e-mail]

#### Contact Person

Jonathan S. Kahan Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004 Telephone: [phone] Fax: [phone] E-mail: [e-mail]

Date Prepared: January 24, 2012

### Name of Device and Name/Address of Sponsor

ActiveCare DVT and ActiveCare+SFT Systems

### Classification Name and Information

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

#### Predicate Devices

Medical Compression Systems (DBN) Ltd. ActiveCare DVT (K023573) Medical Compression Systems (DBN) Ltd. ActiveCare+SFT (K060146)

### Purpose of 510(k) Notice

This 510(k) was submitted in order to clear minor modifications to the ActiveCare DVT System and the ActiveCare+SFT System. Specifically, the following modifications were made to the cleared systems: addition of an OVP circuit, exterior device color change, addition of secondary source hardware components, minor software updates, and minor user manual clarifications.

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### Intended Use / Indications for Use

The ActiveCare DVT and ActiveCare+SFT Systems are prescription 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 / Principles of Operation

The ActiveCare DVT and ActiveCare+SFT Systems are prescription, pneumatic compression Systems designed to apply sequential compression to the lower limb. The control units of the ActiveCare DVT and ActiveCare+SFT Systems provide the user with several treatment options: compression of the foot - single or double, compression of the call - 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.

#### Performance Data

A series of performance testing, including risk analysis, electrical safety, software validation and field testing were performed to demonstrate that the modified ActiveCare DVT and ActiveCare+SFT 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 and ActiveCare+SFT Systems are substantially equivalent to the cleared ActiveCare DVT and ActiveCare+SFT Systems without raising new safety and/or effectiveness issues.

#### Substantial Equivalence

The ActiveCare DVT and ActiveCare+SFT Systems are substantially equivalent in all aspects, e.q., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available Medical Compression Systems (DBN) Ltd.'s ActiveCare DVT and ActiveCare+SFT Systems, previously cleared under K023573 and K060146, respectively.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding the top half of the circle.

#### Public Health Service

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

JAN 3 1 2012

Medical Compression Systems (DBN), LTD c/o Mr. Jonathan S. Kahan Hogan Lovells US LLP Columbia Square 555 13th Street, NW Washington, DC 20004

Re: K113525

Trade/Device Name: ActiveCare DVT and ActiveCare+SFT Systems Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeves Regulatory Class: Class II Product Code: JOW Dated: November 29, 2011 Received: November 29, 2011

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the energed of to the enactment date of the Medical Device Amendments, or to conninered price to May 20, 1978, and cannot with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Costicule Act (710) that ao not requently of the general controls provisions of the Act. The Tou may, merelore, manov of the Act include requirements for annual registration, listing of general controls provisions practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Trease note: UDTCP do so 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 If your device is elassified (boo acc +) Existing major regulations affecting your device can be

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Page 2 - Mr. Jonathan S. Kahan

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 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.fda.gov/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 [phone] or [phone] or at its Internet address http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

W.A. Hillemsen

Jay 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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K113525

# Indications for Use Statement

KII3525 510(k) Number (if known):

ActiveCare DVT and ActiveCare+SFT Systems Device Name:

Indications for Use:

The ActiveCare DVT and ActiveCare+SFT Systems are prescription 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 _ × (Per 21 C.F.R. 801.109) . AND/OR

Over-The-Counter Use (Per 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)

Mu of Helleven

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K113525