REPROCESSED COMPRESSION SLEEVES

K060049 · Alliance Medical Corp. · JOW · Feb 24, 2006 · Cardiovascular

Device Facts

• Record ID: K060049
• Device Name: REPROCESSED COMPRESSION SLEEVES
• Applicant: Alliance Medical Corp.
• Product Code: JOW · Cardiovascular
• Decision Date: Feb 24, 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; system includes control unit (pump), inflatable limb sleeves, and conduit tubing. Device provides intermittent or sequential pressure to lower extremities of recumbent patients; simulates normal muscle contractions to prevent deep vein thrombosis and pulmonary embolism. Reprocessing involves removal of visible soil and decontamination of used sleeves; each sleeve undergoes functional testing prior to repackaging and EO sterilization. Device is used in clinical settings; operated by healthcare professionals. Output is mechanical compression; healthcare providers use device to manage post-operative recovery and circulation. Benefits include reduced DVT risk, pain, and swelling.

Clinical Evidence

Bench testing only. Performance data includes biocompatibility testing and functional validation of the reprocessing process to ensure the device performs as originally intended.

Technological Characteristics

Mechanical compression sleeve; utilizes standard mechanical design and materials identical to predicate. Reprocessing involves cleaning, decontamination, and functional testing. Sterilization method: Ethylene Oxide (EO).

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

• SCD Express Portable Compression System (K040511)

Submission Summary (Full Text)

{0}------------------------------------------------

K060049

## FEB 2 4 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: | October 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>K040511 | Device Description<br>SCD Express Portable 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<br>is identical to the predicate devices in that the same standard |
| | 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 Function Test(s) 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. |

{1}------------------------------------------------

:

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract design of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2006

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

Re: K060049

Reprocessed Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (Two) Product Code: JOW Dated: December 28, 2005 Received: January 6, 2006

Dear Ms. Barton:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused in device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of to regists the Medical Device Amendments, or to conninered prior to May 20, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 1 devices that have been recuire in asse e approval of a premarket approval application (PMA). and Cosmetic (110) the (110) that the device, subject to the general controls provisions of the Act. The r ou may, arorerere, mans 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 may be subject to basil adable in Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Ms. Moira Barton

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualite of a substition with other requirements of the Act
that FDA has made a determination that your device also accomples . You must that FDA has made a determination that your arres by other Federal agencies. You must or any Federal statutes and regulations administered of registration and listing (21
comply with all the Act's requirements, including, but not manirements as set comply with all the Act s requirements, monamas manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); end if englicable, the electronic CFR Part 807); labeling (21 CFR Part 801); good manaxasing (2008); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path, 11 CFF) 1000, forth in the quality systems (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (Scctions 31 device as described in your Section 510(k)
This letter will allow you to begin marketing your device to a leval This letter will allow you to begin harkemig your artial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalse and thus, p premarket notification. The FDA inding of substantial equivaliation wour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r the regulation and 1100 m 11 comments on any more the regulation entitled If you desire specific advice for your de not on an a more the regulation entitled,
contact the Office of Compliance at [phone]. ↑ Also, please note the may obtain contact the Office of Complance at [phone] (21CFR Part 807.97). You may obtain "Misbranding by relevence to premanse notificansity of the Act from the Division of Sm?!
other general information on your responsibilities under the Act from the 4800 638, 2 other general information on your responsionner Assistance at its toll-free number [phone] or Manufacturers, International and Consulter Abolance area consideralindustry/support/index.html.

Sincerely yours,

Dmn R. Lachner

A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications For Use Statement 1.

## 510(k) Number (if known): K060049

Device Name: Alliance Medical Corporation Reprocessed Compression Sleeves

Indications For Use: When coupled with an appropriate inflation system, compressions in Indications I of OSE. Vinch outplou man an uppopramating deep very of healing time devices are intended for use in preventing doop for and reducing wound healing time.

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Le Jones

Devices

510(K) Number K66(0044

CONFIDENTIAL

Alliance Medical Corporation Traditional 510(k)

13 of 374