ACTIVECARE SFT

K110159 · Medical Compression Systems (Dbn) , Ltd. · JOW · May 12, 2011 · Cardiovascular

Device Facts

• Record ID: K110159
• Device Name: ACTIVECARE SFT
• Applicant: Medical Compression Systems (Dbn) , Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: May 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Portable, prescriptive pneumatic compression system; provides sequential compression to lower limbs via foot, calf, or thigh sleeves. Operates via mains or battery. System includes 'Venous Obstruction Detection' software module; collects/correlates existing device data to identify potential venous flow obstructions during prophylaxis. Used in clinical or home settings; operated by patients or clinicians. Output informs providers of potential obstruction development; aids in monitoring treatment efficacy and patient safety.

Clinical Evidence

Clinical comparison performed in healthy volunteers to validate the Venous Obstruction Detection software module. Bench testing included software verification and validation. No specific performance metrics (sensitivity/specificity) provided in summary.

Technological Characteristics

Pneumatic compression system; sequential intermittent pressure application. Components: control unit, single-celled foot sleeves, three-celled calf/thigh sleeves. Power: mains or battery. Connectivity: not specified. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, ISO 14971. Software: Venous Obstruction Detection module.

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, or manage edema/ulcers (stasis, arterial, diabetic). Contraindicated in patients with fresh DVT, pulmonary embolism, leg gangrene, recent skin grafts, acute thrombophlebitis, or conditions where increased venous/lymphatic return is undesirable.

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+SFT® System (K060146)

Submission Summary (Full Text)

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

## 7.1.2 Contact Person:

Orly Maor 25A Sirkin Street Kfar Saba 44421, Israel Tel: [phone] Fax: [phone] 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:

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.

#### 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 [phone] or [phone] 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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