AIRCAST, MODEL #3011

K013297 · Millenium Reprocessing Services, Inc. · JOW · Jun 14, 2002 · Cardiovascular

Device Facts

• Record ID: K013297
• Device Name: AIRCAST, MODEL #3011
• Applicant: Millenium Reprocessing Services, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Jun 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To apply compression to the lower limbs to help prevent deep vein thrombosis in patients at risk.

Device Story

MRSI Compressible Limb Sleeve is a reprocessed medical device designed to apply external pneumatic compression to lower limbs. Used in clinical settings to aid in deep vein thrombosis (DVT) prevention. Device functions by wrapping around patient limbs and connecting to a compatible pneumatic compression pump (not included). The sleeve inflates and deflates in cycles to promote venous blood flow, reducing stasis and DVT risk. Operated by healthcare professionals. Benefits include non-invasive prophylaxis against venous thromboembolism.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and validation of the reprocessing process to ensure the device meets original manufacturer specifications.

Technological Characteristics

Compressible limb sleeve consisting of flexible, inflatable chambers. Operates via external pneumatic pump. Materials are consistent with original OEM specifications for biocompatibility and mechanical integrity. Sterilization is performed via validated processes to ensure safety for clinical reuse.

Indications for Use

Indicated for patients at risk of deep vein thrombosis to apply compression to the lower limbs for prevention.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of a human figure, represented by three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 4 2002

Millenium Reprocessing Services, Inc. c/o Mr. Gary J. Sfeir, RAC President Gary J. Sfeir & Associates 8850 Woodside Drive Clarence, NY 14031

Re: K013297

Trade Name: MRSI Compressible Limb Sleeve Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: May 10, 2002 Received: May 13, 2002

Dear Mr. Sfeir:

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. Gary J. Sfeir, RAC

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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 vours.

Nola Teller

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:

MRSI Compressible Limb Sleeve

Kols297

の 2007年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時

Indications for Use:

To apply compression to the lower limbs to help prevent deep vein thrombosis in patients at risk.

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH; Office of Device Evaluation (ODE)

| Prescription Use | <div style="text-align:center;">X</div> | OR... | Over-The-Counter Use |
|----------------------|-----------------------------------------|-------|------------------------|
| (Per 21 CFR 801.109) | | | Optional Format 1-2-96 |

Division of Cardiovascular & Respiratory Devices

| 510(k) Number | K03297 |
|---------------|--------|
|---------------|--------|

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