FLOWMEDIC, MODEL 220

K042217 · Flowmedic (Israel), Ltd. · JOW · Jan 12, 2005 · Cardiovascular

Device Facts

• Record ID: K042217
• Device Name: FLOWMEDIC, MODEL 220
• Applicant: Flowmedic (Israel), Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: Jan 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FlowMedic™ FM220 System is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation.

Device Story

FlowMedic FM220 is a portable, battery-operated, microprocessor-controlled mechanical system for intermittent calf compression. The device consists of a control unit, disposable sleeve, and charger. The control unit mounts directly onto the sleeve on the patient's calf. Upon activation, the unit pulls straps connected to the sleeve, applying intermittent compressive pressure to the limb to improve blood circulation. It is intended for use in clinical or home settings to help prevent and reduce complications of poor circulation. Healthcare providers or patients use the device to deliver therapy; the output is the mechanical compression of the limb, which aids venous return and circulation.

Clinical Evidence

Bench testing only. Includes electrical safety and electromagnetic compatibility testing per IEC 60601-1 and IEC 60601-1-2, software verification and validation, and side-by-side bench performance comparison to predicate devices regarding pressure output, duration, and frequency.

Technological Characteristics

Portable, battery-operated, microprocessor-controlled mechanical compression system. Components: control unit, disposable sleeve, charger. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, EN 1441, and ISO 14971. Operates via intermittent mechanical compression of the calf.

Indications for Use

Indicated for patients requiring improved blood circulation in the lower extremities to prevent or reduce complications associated with poor circulation.

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

• ArterialFlow™ System (K024019)
• ArtAssist® Model AA-1000 (K942530)
• WizAir DVT™ (K012994)

Submission Summary (Full Text)

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K 042217

#### 7-1 510(k) Summary

:

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# 510(K) SUMMARY

# FlowMedic (USA) Inc.

# 510(k) Number K0422 17

## Applicant's Name:

Flowmedic (USA) Inc. 40 Ramland Road South, Suite 10 Orangeburg, NY 10962, USA [phone] (phone) [phone] (fax)

#### Contact Person:

Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: [phone] Fax: [phone]

#### And/Or

Dorit Winitz Ph.D Biomedical Strategy Ltd. 11 Menachem Begin Street. Ramat Gan 52521, Israel Tel: [phone] Fax: [phone]

### Date Prepared:

July 2004

## Trade Name:

FlowMedic™ FM220 System

## Classification Name:

Sleeve, Limb, Compressible

# Classification:

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

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#### Predicate Devices:

- The ArterialFlow™ System (Aircast, Inc), cleared under 매 K024019
- 트 The ArtAssist® Model AA-1000 (ACI Medical, Inc.), cleared under K942530
- 트 WizAir DVT™ (Medical Compression Systems (DBN) Ltd.), cleared under K012994

#### Performance Standards:

No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, the FlowMedic™ FM220 System complies with the following voluntary standards:

- 트 IEC 60601-1 (1988) + A1 (1991) + A2 (1995)
- IEC/EN 60601-1-2 (2001) E
- IEC 60601-1-4 (1996) + A1 (1999)
- EN 1441 (1997) ■
- l ISO 14971 (2000)

#### Intended Use / Indication for Use:

The FlowMedic™ FM220 System is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation.

#### Device Description:

The FlowMedic™ FM220 System is a small, battery operated, microprocessor controlled, portable and simple mechanical system, intended for the improvement of blood circulation in the lower extremities through the application of intermittent compression to the calf.

The FlowMedic™ FM220 System consists of the following basic components:

- 1. FlowMedic™ FM220 System Control Unit and Straps
- 2. FlowMedic™ FM220 System Disposable Sleeve
- 3. Charger

The anatomical concave-convex shaped Control Unit is directly mounted on a pre-positioned Sleeve on the calf. Upon Control Unit activation, the straps are periodically pulled into the Control Unit base and subsequently pull the underneath sleeve, generating an intermittent compressive pressure on the patient's limb.

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## Substantial Equivalence:

The FlowMedic™ FM220 System and its predicate devices share the same intended use and similar materials and design. In addition, the mode of operation and delivery of therapy is similar in all the devices. A comprehensive testing program was developed and performed in order to verify that the FlowMedic™ FM220 System does not raise any new safety and effectiveness issues in comparison to its predicate devices. This includes the following testing and activities:

- Electrical safety and electromagnetic compatibility testing 에 according to IEC 60601-1 (and amendments), and IEC 60601-1-2 standards
- Software verification and validation testing .
- 프 A set of in vitro (bench) performance testing and side by side comparison to the predicate devices
- Hazard analysis including risk level and solutions performed 트 in compliance with EN 1441 (1997) and AAMI/ISO 14971-1, 2000 for the entire system and for the software

Tests results indicated that the FlowMedic™ FM220 System performs according to its specifications and share very similar operational characteristics, including applied pressure output, pressure duration and frequency, with its predicate devices.

In conclusion, FlowMedic (USA) Inc. believes that the FlowMedic™ FM220 System is as safe and effective as its predicate devices for its intended use and is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness issues.

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 2005

FlowMedic (Israel) Ltd. c/o Mr. Jonathan S. Kahan Hogan & Hartson, LLP 555 13th Street, N.W. Washington, DC 20004-1109

K042217 Re: FlowMedic™ FM220 System Regulation Number: 21 CFR 868.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: November 19, 2004 Received: November 19, 2004

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becalent be device is substantially equivalent (for the indications ferenced uboro and harrsviro legally marketed predicate devices marketed in interstate for ass suated in the encreases of the enactment date of the Medical Device Amendments, or to conniner of they 20, 2017 11:37 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 I ou may, ateres, include requirements for annual reguirements 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 If your de roo to such 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.

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Page 2 - Mr. Jonathan S. Kahan

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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Duna R. Lochner

Image /page/5/Picture/5 description: The image shows a portion of a document with the text "Bram D. Zuc", followed by "Director", "Division of", and "Office of". The text is aligned to the left and appears to be part of a formal document or letterhead. There is also a signature above the name.

Bram D. Zuckerman, M.D. 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):____________________________________________________________________________________________________________________________________________________

Device Name: FlowMedic™ FM220 System

Indications for Use:

The FlowMedic™ FM220 System is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation.

Prescription Use V (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (Part 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)

Duma R. Vachner

Division Sign-Off) ് vision of Cardiovascular Devices

10(k) Number K042217