REPROCESSED COMPRESSION SLEEVES

K024087 · Alliance Medical Corp. · JOW · Mar 11, 2003 · Cardiovascular

Device Facts

• Record ID: K024087
• Device Name: REPROCESSED COMPRESSION SLEEVES
• Applicant: Alliance Medical Corp.
• Product Code: JOW · Cardiovascular
• Decision Date: Mar 11, 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 function as part of an external compression system comprising a pump/controller, inflatable limb sleeves, and conduit tubing. Sleeves are worn on lower extremities of recumbent patients. System provides intermittent or sequential pressure, creating gradient, repetitive squeezing and relaxing action to simulate muscle contractions. Device aids in preventing deep vein thrombosis and pulmonary embolism. Reprocessing involves removal of adherent visible soil, decontamination, and functional testing of components prior to sterilization and packaging. Healthcare providers use the system in clinical settings to manage thrombosis risk.

Clinical Evidence

Bench testing only. Testing included biocompatibility, sterilization validation, and functional tests to demonstrate that reprocessed sleeves perform as originally intended.

Technological Characteristics

Mechanical compression sleeve; identical design, materials, and sizes to predicate. Components include inflatable sleeve and conduit tubing. Sterilization performed as part of reprocessing. No software or electronic sensing components integral to the sleeve itself.

Indications for Use

Indicated for external compression therapy to reduce incidence of deep vein thrombosis and 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

• PlexiPulse Acute Care Unit (K944567)

Submission Summary (Full Text)

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MAR 11 2003

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## PART B: 510(k) SUMMARY

Submitter:

Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044

- Contact: Moira Barton Regulatory Affairs Specialist [phone] (o) [phone] (f)
Phoenix, Arizona 85044

TEL [phone]

10232 South 51st Street

FAX [phone] Toll Free 888,888,3433 v.alliance-medical.com

KC024087

- Date of preparation: December 10, 2002
Name of device: Trade/Proprietary Name: Reprocessed Compression Sleeves Common or Usual Name: Compression Sleeve Classification Name: Compressible Limb Sleeve

## Predicate device(s):

as a comprehensive the control of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of

| K Number | Device Description |
|----------|----------------------------|
| K944567 | PlexiPulse Acute Care Unit |

Device Compression sleeves are part of an external compression system, in description: 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. Only the compression sleeves are reprocessed.

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

## Technological The design, materials, and intended use of Reprocessed Compression Sleeves are identical to the predicate devices. The characteristics: 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.

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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 sterilization operations.

Performance data:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Compression Sleeves.

- Biocompatibilitv ●
- Sterilization Validation ●
- . Function Test(s)

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

Conclusion:

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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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a way that they appear to be connected or overlapping. The profiles are simple and abstract, with no distinct facial features. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 11 2003

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

Re: K024087

Reprocessed Compression Sleeves. Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: December 10, 2002 Received: December 11, 2002

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 (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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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,

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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ll. Indications for Use Statement

510(k) Number (if known): KO24-087

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.

| Pump Model | Compression Sleeve Model |
|-----------------|--------------------------|
| KCI 2110 | 112491, 112492, 112497 |
| KCI 2600 | 112453, 112452 |
| KCI PlexiPulse® | 235342, 235343, U40010 |

and Neurological Devices

510(k) Number_KO24087

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109) or

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________