REPROCESSED COMPRESSION SLEEVES

K053316 · Alliance Medical Corp. · JOW · Feb 13, 2006 · Cardiovascular

Device Facts

• Record ID: K053316
• Device Name: REPROCESSED COMPRESSION SLEEVES
• Applicant: Alliance Medical Corp.
• Product Code: JOW · Cardiovascular
• Decision Date: Feb 13, 2006
• 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 function as part of an external compression system consisting of a control unit (pump), inflatable limb sleeves, and conduit tubing. The device is applied to the lower extremities of recumbent patients. The control unit provides intermittent or sequential pressure to the sleeves, creating a gradient, repetitive squeezing and relaxing action that simulates normal muscle contractions. This process aids in preventing deep vein thrombosis (DVT) and pulmonary embolism, reduces post-operative pain and swelling, enhances blood circulation, and decreases wound healing time. The device is intended for clinical use. Alliance Medical Corporation reprocesses these sleeves by removing visible soil and decontaminating them, followed by functional testing of components prior to packaging and ethylene oxide (EO) sterilization.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing, functional component testing, and validation of the reprocessing/decontamination process to ensure performance specifications are met.

Technological Characteristics

Inflatable limb sleeves; mechanical compression via external pump/controller; ethylene oxide (EO) sterilization; identical materials and design to predicate device.

Indications for Use

Indicated for use in recumbent patients to prevent deep vein thrombosis (DVT), diminish post-operative pain and swelling, enhance blood circulation, and reduce wound healing time when coupled with an appropriate inflation system.

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 DVT™ Compressible Limb Sleeve (K012994)

Submission Summary (Full Text)

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K05 33/6

## FEB 1 3 2006

## SECTION B: 510(k) SUMMARY

| Submitter: | Alliance Medical Corporation<br>10232 South 51st Street<br>Phoenix, Arizona 85044 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Moira Barton<br>Regulatory Affairs Manager<br>[phone] (o)<br>[phone] (f)<br>[e-mail] |
| Date of preparation: | July 25, 2005 |
| Name of device: | Trade/Proprietary Name: Reprocessed Compression Sleeves<br>Common or Usual Name: Compression Sleeve<br>Classification Name: Compressible Limb Sleeve |
| Predicate device: | |
| K Number<br>K012994 | Device Description<br>WizAir DVT™ Compressible Limb Sleeve |
| Device description: | Compression sleeves are part of an external compression<br>system, in which intermittent or sequential compression is<br>provided using a pump/controller and limb garment. The system<br>consists of the following three main components: a control unit,<br>inflatable limb sleeves and conduit tubing with detachable<br>connections. Only the compression sleeves are reprocessed. |
| Intended use: | Reprocessed Compression Sleeves are intended to help<br>prevent deep vein thrombosis and pulmonary embolism by<br>supplying a measured, intermittent pressure into the<br>compression sleeves worn on the lower extremities of a<br>recumbent patient, resulting in a gradient, sequential, repetitive<br>squeezing and relaxing action, simulating normal muscle<br>contractions. |
| Indications<br>statement: | When coupled with an appropriate inflation system,<br>compression devices are intended for use in preventing deep<br>vein thrombosis (DVT), diminishing post-operative pain and<br>swelling, enhancing blood circulation, and reducing wound<br>healing time. |
| Technological<br>characteristics: | The design, materials, and intended use of Reprocessed<br>Compression Sleeves are identical to the predicate devices.<br>The mechanism of action of Reprocessed Compression Sleeves<br>is identical to the predicate devices in that the same standard<br>Alliance Medical Corporation<br>Reprocessed Compression Sleeves<br>Traditional 510(k) |

.

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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.

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, labeling, and EO exposure operations.

- Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of Reprocessed Compression Sleeves.
- Biocompatibility .
- Function Test(s) .
- Validation of Processing .

Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended.

Alliance Medical Corporation concludes that the modified Conclusion: devices (Reprocessed Compression Sleeves) are safe, effective and substantially equivalent to the predicate devices as described herein.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

FEB 1 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Allance Medical Corporation c/o Ms. Moira Barton Regulatory Affairs 10232 South 51st Street Phoenix, AZ 85044

Re: K053316

Reprocessed Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (Two) Product Code: JOW Dated: November 15, 2005 Received: November 29, 2005

Dear Ms. Barton:

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 - Ms. Moira Barton

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/industry/support/index.html.

Sincerely yours,

Dina R lochines

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 1.

510(k) Number (if known):

Device Name: Alliance Medical Corporation Reprocessed Compression Sleeves

Indications For Use: When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing postdovioo are intended log, enhancing blood circulation, and reducing wound healing time.

Prescription Use X (per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NONT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dana R. McAnes

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K053316

Confidential

Alliance Medical Corporation Reprocessed ActiveCare™ Compression Sleeves Traditional 510(k)

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