REPROCESSED COMPRESSION SLEEVE

K021654 · Alliance Medical, Inc. · JOW · Feb 5, 2003 · Cardiovascular

Device Facts

• Record ID: K021654
• Device Name: REPROCESSED COMPRESSION SLEEVE
• Applicant: Alliance Medical, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Feb 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Reprocessed Compression Sleeves are intended to help prevent deep vein thrombosis and pulmonary embolism by supplying a measured, intermittent pressure into the compression sleeves worn on the lower extremities of a recumbent patient, resulting in a gradient, sequential, repetitive squeezing and relaxing action, simulating normal muscle contractions.

Device Story

Reprocessed compression sleeves; part of external compression system including pump/controller and conduit tubing. Device worn on lower extremities of recumbent patients. Provides measured, intermittent, gradient, sequential, repetitive squeezing and relaxing pressure; simulates normal muscle contractions. Used to prevent deep vein thrombosis and pulmonary embolism. Reprocessing involves removal of visible soil and decontamination; functional testing performed on each sleeve prior to packaging. No clinical operation changes from original predicate devices.

Clinical Evidence

Bench testing only. Laboratory testing conducted to demonstrate safety and effectiveness of reprocessed sleeves, confirming performance matches original intended use.

Technological Characteristics

Mechanical compression sleeve; identical design, materials, and sizes to predicate devices. Operates via external pump/controller system. Reprocessing includes cleaning, decontamination, and functional testing of components.

Indications for Use

Indicated for use in providing external compression therapy to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism in patients at risk for thrombosis formation.

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

• VenaFlow® System, Model 30A (K992454)
• Aircast® Sterile VenaFlow® Disposable Cuff (K964238)
• Aircast® VenaFlow® System (Modification) (K961676)
• Aircast® VenaFlow® System (K932900)
• Alliance Medical Corporation Reprocessed Compression Sleeves (K011192)

Submission Summary (Full Text)

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K021654

FEB 0 5 2003

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| Submitter: | Alliance Medical Corporation<br>10232 South 51st Street<br>Phoenix, Arizona 85044 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Lorri Chavez<br>Regulatory Affairs Manager<br>[phone] (o)<br>[phone] (f) |
| Date of preparation: May 16, 2002 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Compression Sleeve<br>Common or Usual Name: Compression Sleeve<br>Classification Name: Compressible Limb Sleeve |

## Predicate device(s):

| K Number | Device Description |
|----------|--------------------------------------------------------------|
| K992454 | VenaFlow® System, Model 30A |
| K964238 | Aircast® Sterile VenaFlow® Disposable Cuff |
| K961676 | Aircast® VenaFlow® System (Modification) |
| K932900 | Aircast® VenaFlow® System |
| K011192 | Alliance Medical Corporation Reprocessed Compression Sleeves |

Compression sleeves are part of an external compression Device description: system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with detachable connections.

Intended use: Reprocessed Compression Sleeves are intended to help prevent deep vein thrombosis and pulmonary embolism by supplying a measured, intermittent pressure into the compression sleeves worn on the lower extremities of a recumbent patient, resulting in a gradient, sequential, repetitive squeezing and relaxing action, simulating normal muscle contractions.

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| Indications statement: | Reprocessed Compression Sleeves are indicated for use in providing external compression therapy to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism in patients at risk for thrombosis formation. |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological characteristics: | The design, materials, and intended use of Reprocessed Compression Sleeves are identical to the predicate devices. The mechanism of action of Reprocessed Compression Sleeves is identical to the predicate devices in that the same standard mechanical design, materials and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation.<br>Alliance Medical Corporation's reprocessing of compression sleeves includes removal of adherent visible soil and decontamination. Each individual compression sleeve is tested for appropriate function of its components prior to packaging and labeling operations. |
| Performance data: | Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Compression Sleeves. Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended. |
| Conclusion: | In accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Part 807 and based on the information provided in this premarket notification, Alliance Medical Corporation concludes that the modified devices (Reprocessed Compression Sleeves) are safe, effective and substantially equivalent to the predicate devices as described herein. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 5 2003

Alliance Medical Corporation c/o Mr. Don Selvey Vice President, Regulatory Affairs and Quality Assurance 10232 South 51st Street Phoenix, AZ 85044

Re: K021654

Trade Name: Reprocessed Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: November 6, 2002 Received: November 7, 2002

## Dear Mr. Selvey:

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. Don Selvey

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 (OS) 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,

V. Oala Tule

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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## II. Indications for Use Statement

510(k) Number (if known):

Device Name: Alliance Medical Corporation Reprocessed Compression Sleeves

Indications for Use: Reprocessed Compression Sleeves are indicated for use in providing external compression therapy to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism in patients at risk for thrombosis formation.

Concurrence of CDRH, Office of Device Evaluation (ODB

tion (ODE)

**510(k) Number** K021654

Prescription Use
(per 21 CFR 801.109)

or

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

CONFIDENTIAL

Alliance Medical Corporation Reprocessed Compression Sleeves Traditional 510(k)