TRAVELAIR PORTABLE COMPRESSION SYSTEM

K022340 · Dynamic Air, Inc. · JOW · Feb 19, 2003 · Cardiovascular

Device Facts

• Record ID: K022340
• Device Name: TRAVELAIR PORTABLE COMPRESSION SYSTEM
• Applicant: Dynamic Air, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Feb 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TravelAir Portable Compression System is intended to assist in the relief of the following: Fatigue in the lower limbs Venous congestion in the lower legs Edema in the lower legs Edema in the lower legs post injury or trauma Prevention of Deep Vein Thrombosis

Device Story

TravelAir Portable Compression System is a battery-operated device providing intermittent pneumatic compression to lower legs. System comprises a micro-pump connected via plastic tubing to inflatable leg wraps. Wraps consist of PVC air bladders encapsulated in VelFoam. Microchip controller regulates preset pressure and compression cycles. Device operation forces blood toward the heart, enhancing venous return and allowing capillary refill during deflation. Used to relieve fatigue, venous congestion, and edema, and to prevent DVT. Operated by patient or clinician; intended for portable use. Output is mechanical compression of soft tissue. Benefits include improved circulation and reduced swelling.

Clinical Evidence

Bench testing only. No clinical data provided. Performance equivalence established through side-by-side bench testing comparisons with predicate devices.

Technological Characteristics

Battery-operated micro-pump; microchip controller board; PVC air bladder; VelFoam outer material; CPC quick connectors. Operates via intermittent pneumatic compression. Non-sterile, clean packaging.

Indications for Use

Indicated for patients requiring intermittent compression of lower legs to enhance venous return, relieve aches/fatigue from immobility, and reduce edema/swelling post-injury or trauma. Contraindicated in patients with acute congestive heart failure, acute pulmonary edema, existing DVT, acute limb infection, or skin ulceration on the compression area.

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

• Wizair (K002287)
• Medical Compression Systems' DVT275 (K915638)
• Talley Medical Group Progressive Medical Technology, Inc (K915638)

Submission Summary (Full Text)

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K022340

### 510k Summary July 2, 2002

FEB 1 9 2003

### TravelAir Portable Compression System

In accordance with 21 CFR 807.92 this summary is submitted by:

I. Name of Submitter

> Dynamic Air Incorporated 3485 BankHead Highway Atlanta, GA 30331

Contact: Brent Knight ERN: 232094

#### II Device Name and Classification

Proprietary Name: TravelAir Portable Compression System Common or Usual Name: Compressible Limb Sleeve Classification: Class II: IRP 890.5650

#### III Predicate Device

The TravelAir Portable Compression System is substantially equivalent to devices currently in commercial distribution by the following company:

Wizair (K002287) Medical Compression Systems' 117 Ahuzah Street Ra'ananna, IS 43373 DVT275 (K915638) Talley Medical Group Progressive Medical Technology, Inc 815 Terminal Road

#### IV. Description of Device

Lansing, MI 48906

The Dynamic Air, Inc. TravelAir Portable Compression System consists of a battery operated compression pump connected to an inflatable leg wrap. The compression pump is connected to the leg wrap by plastic tubing connected by CPC quick connectors at the pump and at the tubing /wrap junction.

The leg wrap consists of a Polyvinyl chloride (PVC) air bladder encapsulated inside a VelFoam material; the color of the outer covering material is white. The VelFoam material is adhered to the PVC air bladder. The wrap is provided clean, non-sterile packaged in pairs for use.

The compression pump consists of a medical grade micro pump which delivers preset pressures to the leg wraps. The micro pump is controlled by a microchip controller board which regulates pressure and compression time on a set cycle.

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The compression pump inflates and deflates the leg wraps in a preset sequence intermittently compressing the soft tissue of the legs. This compression forces blood to move toward the heart and enhances venous return from the lower legs. After compression the wraps deflate and allow the veins and capillaries to refill. The cycle then repeats until the unit is deactivated.

#### V Intended Use and Contraindications

The TravelAir Portable Compression System is intended to assist in the relief of the following:

Fatigue in the lower limbs Venous congestion in the lower legs Edema in the lower legs Edema in the lower legs post injury or trauma

Prevention of Deep Vein Thrombosis

### Contraindications For Use of the TravelAir Portable Compression System

Acute pulmonary edema Acute congestive heart failure Acute diagnosis of DVT Acute infection of the limb to be compressed Open wounds of the limb to be compressed

#### VI Technical Characteristics

The TravelAir Portable Compression System is similar in to the predicate device in its operation characteristics. The material in the leg wrap is similar in make up to the predicate devices. The mode of operation and delivery of therapy is similar.

Bench testing performed by Dynamic Air has show that the leg wraps are substantially equivalent in performance to the predicate devices.

#### VII Performance Standards

There are no performance standards for this class of medical device (class II). Bench testing and side by side comparisons were done with predicate devices to assure equivalence in performance.

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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 features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them, resembling a stylized caduceus without the snake.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2003

Dynamic Air, Inc. c/o Mr. Brent Knight Vice President Products 3495 Bankhead Highway, Suite A Atlanta, GA 30331

Re: K022340

Trade Name: TravelAir Portable Compression System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: November 9, 2002 Received: November 21, 2002

Dear Mr. Knight:

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 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. Brent Knight

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 entitled, "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 http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

KelaTM

ram 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

K02234D

Device Name

TravelAir Portable Compression System

Indications forUse

The TravelAir Portable Compression System is designed to provide intermittent compression of the lower legs to enhance venous return toward the heart. This venous enhancement is meant to relieve aches and fatigue in the legs brought on by long periods of immobility and reduce edema or swelling after sports injury or minor trauma.

Contraindications for this Device Would Include:

Acute congestive heart failure Acute pulmonary edema Existing Deep Vein Thrombosis Acute infection of the leg to be compressed Presence of skin ulceration on area to be compressed

# PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE

# ON ANOTHER PAGE IF NEEDED

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
| (Division Sign-Off) |
| Division of Cardiovascular, Respitory, |
| And Neurological Devices |
| 510(k) K022340 |

**Prescription Use**
(per 21 CFR 801.109)

Over The Counter Use