ACTIVECARE ++ SYSTEM

K060146 · Medical Compression Systems (Dbn) , Ltd. · JOW · Mar 8, 2006 · Cardiovascular

Device Facts

• Record ID: K060146
• Device Name: ACTIVECARE ++ SYSTEM
• Applicant: Medical Compression Systems (Dbn) , Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: Mar 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

ActiveCare®++ is a portable, pneumatic compression system for lower limb therapy. Device applies sequential intermittent pressure via sleeves (foot, calf, or thigh) to induce continuous enhanced circulation. System operates on battery or mains power; features a control unit with LCD interface and compliance status indicator. Healthcare providers prescribe the device for use in clinical or home settings. Device includes a synchronization feature for compression cycles relative to respiratory-related natural phasic venous flow. Output consists of controlled pressure pulses to limbs, aiding in DVT prevention, edema reduction, and wound healing. Clinical benefit derived from improved venous/lymphatic return.

Clinical Evidence

Clinical comparison performed in healthy volunteers to validate performance of the modified system. Bench testing included electrical/electromagnetic safety, software verification/validation, and performance testing of output pressure profiles. No adverse safety or efficacy issues identified.

Technological Characteristics

Pneumatic compression system; portable control unit with LCD. Materials: unspecified. Energy: battery or mains. Connectivity: standalone. Software: ANSI C. Standards: IEC 60601-1, IEC 60601-2, AAMI/ISO 14971-1. Features: sequential intermittent pressure pulse (foot) and gradient application (calf/thigh).

Indications for Use

Indicated for patients requiring lower limb circulation therapy to prevent DVT, enhance blood flow, reduce edema, manage post-operative pain/swelling, and treat chronic venous insufficiency or leg ulcers (stasis, arterial, diabetic). Contraindicated in patients with fresh pre-existing 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® System (K023573)
• Wizair Compression System (K012994)
• Wizair DVT (K002287)
• ProAir 3000 (K993758)

Submission Summary (Full Text)

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K060146

2006 MAR 8

# 510(K) SUMMARY Medical Compression Systems (DBN) Ltd ActiveCare®++ 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:

Dorit Winitz, Ph. D Biomedical Strategy (2004) Ltd. Moshe Aviv Tower, 34th Floor, 7 Jabotinsky Street Ramat Gan 52520, Israel Tel: [phone] Fax: [phone] [e-mail]

#### 7.1.3 Date Prepared:

January, 2006

7.1.4 Trade Name:

ActiveCare®++ System

# 7.1.5 Classification Name:

Sleeve, Limb, Compressible

### 7.1.6 Classification:

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

### 7.1.7 Predicate Devices

Medical Compression Systems (DBN) Ltd. Systems (ActiveCare® System, incured - Compression System, Wizair DVT or ProAir 3000), cleared under K023573, K012994, K002287 and K993758.

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### 7.1.8 Device Description:

The ActiveCare®++ is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The control unit of the ActiveCare®++ is light and compact, thus making it a portable ambulant system. The ActiveCare®++ provides the user with an option of battery operation in addition to the operation from the mains option. The ActiveCare®++ is easy to use and provides the user with several treatment options: compression of the foot - single or double (either regular foot or foot booster), 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 sequential intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent gradient application of a pressure (s) a three-celled calf sleeve.

### 7.1.9 Intended Use:

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

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

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#### 8.11 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®++ System complies with the voluntary standards such as IEC 60601-1, IEC 60601-2 and AAMI / ISO 14971-1.

## 8.11 Performance Data & Substantial Equivalence

The ActiveCare®++ 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 Systems (ActiveCare® System, previously named WizAir Compression System, Wizair DVT or ProAir 3000), cleared under K023573, K012994, K002287 and K993758.

The principle changes between the devices include:

- The software programming language was changed from Assembler to ■ ANSI C.
- A capability to synchronize the compression cycles with the respiratory 배 related. natural phasic venous flow, was added
- The user interface of the Control Unit was modified to include a Liquid 트 Crystal Display (LCD).
- I A Compliance status indicator was added.
- A new calf sleeve, the TripleActive, was added. 트

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

- Electrical and electromagnetic testing 트
- Software verification and validation 트
- Performance testing of the output parameters and pressure profile ■

Based on these tests results, Medical Compression Systems (DBN) Ltd. believes that the modified ActiveCare®++ System is substantially equivalení to the cleared ActiveCare® Systems (WizAir Compression System, Wizair DVT or ProAir 3000 Systems), without raising new safety and/or effectiveness issues.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 8 2006

BioMedical Strategy (2004) Ltd. c/o Dorit Winitz, Ph.D. Company Consultant Moshe Aviv Street, 34th Floor 7 Jabotinsky Street Ramat Gan 52520, Israel

Re: K060146

Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (Two) Product Code: JOW Dated: January 16, 2006 Reccived: January 19, 2006

Dear Dr. Winitz:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Codc of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the

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#### Page 2 - Dorit Winitz, Ph.D.

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation extilled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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

Sincerely yours,

Dona R. Victner

1 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): K06014-6

ActiveCare®++ System Device Name:

#### Indications for Use:

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

Duma 12 Johner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K060146