ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES

K060091 · Alliance Medical Corp. · JOW · Feb 17, 2006 · Cardiovascular

Device Facts

• Record ID: K060091
• Device Name: ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES
• Applicant: Alliance Medical Corp.
• Product Code: JOW · Cardiovascular
• Decision Date: Feb 17, 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 pneumatic compression system. The system includes 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 air inflation to the sleeves, creating a gradient, repetitive squeezing and relaxing action that simulates muscle contractions to promote blood flow. The device is used in clinical settings to prevent deep vein thrombosis (DVT) and pulmonary embolism, reduce post-operative pain/swelling, and improve wound healing. Alliance Medical Corporation reprocesses these sleeves by removing visible soil and decontaminating them. Each sleeve undergoes functional testing prior to packaging, labeling, and ethylene oxide (EO) sterilization.

Clinical Evidence

Bench testing only. Testing included biocompatibility, functional performance tests, and validation of the reprocessing/decontamination process to ensure the sleeves perform as originally intended.

Technological Characteristics

Mechanical compression sleeve; consists of inflatable limb garment and conduit tubing. Materials and design are identical to predicate devices. Sterilization via ethylene oxide (EO). No software or electronic components integral to the sleeve itself; operates via external pump/controller.

Indications for Use

Indicated for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time in recumbent patients 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

• PlexiPulse Acute Care Unit (K944567)
• Talley TM300 Sequential Multicom Compression System (K915092)

Submission Summary (Full Text)

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Ko60091/

## FEB 1 7 2006 1 1 1 2

## 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: | November 2, 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>K944567<br>K915092 | Device Description<br>PlexiPulse Acute Care Unit<br>Talley TM300 Sequential Multicom Compression System |
| 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 |
| | Alliance Medical Corporation<br>Reprocessed Medline Compression Sleeves<br>Traditional 510(k) 9 of 200 |
| | is identical to the predicate devices in that the same standard<br>mechanical design, materials and sizes are utilized. There are<br>no changes to the claims, intended use, clinical applications,<br>patient population, performance specifications, or method of<br>operation. |
| | Alliance Medical Corporation's reprocessing of compression<br>sleeves includes removal of adherent visible soil and<br>decontamination. Each individual compression sleeve is tested<br>for appropriate function of its components prior to packaging,<br>labeling, and EO exposure operations. |
| Performance data: | Bench and laboratory testing was conducted to demonstrate<br>performance (safety and effectiveness) of Reprocessed<br>Compression Sleeves. |
| | • Biocompatibility<br>• Function Test(s)<br>• Validation of Processing |
| | Performance testing demonstrates that Reprocessed<br>Compression Sleeves perform as originally intended. |
| Conclusion: | Alliance Medical Corporation concludes that the modified<br>devices (Reprocessed Compression Sleeves) are safe, effective<br>and substantially equivalent to the predicate devices as<br>described herein. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 2006

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

Re: K060091

Reprocessed Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (Two) Product Code: JOW Dated: January 10, 2006 Received: January 12, 2006

Dear Ms. Barton:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication we nave reviewed your Section 9 ro(x) premaince is substantially equivalent (for the indications felerenced above and nave determined have and marketed predicate devices marketed in interstate for use stated in the enclosure) to regars and ment date of the Medical Device American proc commerce prior to May 26, 1776, the enastinent with the provisions of the Federal Food. Drug, devices that have been reclassince in accessaries was a premarket approval application (PMA). and Cosmetic Act (Act) market the device, subject to the general controls provisions of the Act. The You may, merclore, market the devices, boojes to annual registration, listing of general controls provisions of the line, 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 device is classified (500 a0070) als. Existing major regulations affecting your device can Inay be subject to suen additional controliations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous overning 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 I lease be advised that 1 Dris and over device complies with other requirements of the Act that I Dri has made a doted regulations administered by other Federal agencies. You must or any I cut all the Act's requirements ancluding, but not limited to: registration and listing (21 Configity with an the 11et 3 requirements, as a manufacturing practice requirements as set CFN i art 607); adomig (21 OFR Part 820); and if applicable, the electronic forul in the quanty bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control provisions (overiens (overies as described in your Section 510(k) This icter will anow you to ocgin mading of substantial equivalence of your device to a legally prematics notification. The PDF interest on 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 11 you desire specific acries ion your 240) 276-0120. Also, please note the regulation entitled, Connation of Collied of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,

unma R. Jochner

A 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): K060091

Device Name: Alliance Medical Corporation Reprocessed Compression Sleeves

Indications For Use: When coupled with an appropriate inflation system, compression Indications For USe. When Coupleting deep vein thrombosis (DVT), diminishing postdevices are intended for use in preventing deep von thrombols ( = 1), 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Dana R. Vochner
(Division Sign Off)
Cardiovascular Devices

(Division S
vision of Cardiovascular Devices

් ((x) Number_

CONFIDENTIAL

Alliance Medical Corporation Reprocessed Medline Compression Sleeves Traditional 510(k)

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