STERILMED REPROCESSED COMPRESSION SLEEVES

K012597 · Sterilmed, Inc. · JOW · Feb 11, 2002 · Cardiovascular

Device Facts

• Record ID: K012597
• Device Name: STERILMED REPROCESSED COMPRESSION SLEEVES
• Applicant: Sterilmed, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Feb 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Compression sleeves are designed to provide external intermittent or sequential limb compression to artificially imitate the pumping action of the lower limbs to prevent deep vein thrombosis, enhance venous and arterial circulation, and reduce lower limb pain and swelling.

Device Story

Reprocessed compression sleeves are inflatable garments fitted to a patient's foot or leg. The device connects to an external pneumatic compressor (not included) that provides intermittent or sequential pressure. During compression, the sleeve collapses veins to force blood flow; during deflation, veins refill. This cycle mimics the natural pumping action of lower limbs. The device is intended for clinical use to prevent deep vein thrombosis, improve circulation, and reduce pain and swelling. SterilMed reprocesses these sleeves from various original equipment manufacturers.

Clinical Evidence

Bench testing only. Representative samples underwent functional testing to demonstrate performance characteristics. Process validation was performed to verify cleaning and packaging procedures. Manufacturing includes visual inspection and functional testing of all units.

Technological Characteristics

Inflatable limb sleeves; pneumatic operation; connects to external compressor. Materials and construction are identical to original manufacturer specifications. Sterilization and cleaning processes are validated.

Indications for Use

Indicated for patients requiring external intermittent or sequential limb compression to prevent deep vein thrombosis, enhance venous and arterial circulation, and reduce lower limb pain and swelling.

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

• Kendall Company models 5329, 5330 (K781357)
• Kendall Company models 5065, 5066, 5075 (K953648)
• Kendall Company models 5065, 5066, 5075 (K951683)
• Huntleigh Technology Inc. models GS337M and GS334 (K910188)

Submission Summary (Full Text)

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## FEB 1 1 2002

K012597

## SECTION 2. SUMMARY AND CERTIFICATION

## 510(K) SUMMARY A.

| Submitter: | SterilMed, Inc. |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patrick Fleischhacker<br>11400 73rd Avenue North<br>Minneapolis, MN 55369<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | August 8, 2001 |
| Trade Name: | SterilMed Reprocessed Compression Sleeves |
| Classification Name:<br>and Number: | Class II, 21 CFR 870.5800 |
| Product Code: | JOW |
| Predicate Device(s): | SterilMed's reprocessed compression sleeves are<br>substantially equivalent to the Kendall Company models<br>5329, 5330 (K781357) 5065, 5066, and 5075 (K953648<br>and K951683), and the Huntleigh Technology Inc. models<br>GS337M and GS334 (K910188), and to the original<br>manufacturers' devices. |
| Device Description: | Reprocessed Compression Sleeves are inflatable devices<br>that are fitted to a patient's foot and/or leg. They are<br>connected to a separate pneumatic compressor, which<br>provides intermittent, graduated pressure. When the sleeve<br>compresses, the veins collapse, forcing blood to flow.<br>When pressure is reduced, the sleeve deflates, allowing the<br>veins to fill with blood. The cycle is then repeated.<br>It should be noted that this submission applies to the<br>compression sleeve only. It does not include any other<br>components in a compression system such as the pneumatic<br>compressor. |
| Intended Use: | Compression sleeves are designed to provide external<br>intermittent or sequential limb compression to artificially<br>imitate the pumping action of the lower limbs to prevent |

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deep vein thrombosis, enhance venous and arterial circulation, and reduce lower limb pain and swelling.

## Functional and Safety Testing:

Representative samples of reprocessed compression sleeves underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning procedures as well as the device's packaging. In addition, the manufacturing process includes visual inspection and functional testing of all products produced.

The compression sleeves reprocessed by SterilMed are substantially equivalent to the Kendall Company models 5329, 5330 (K781357) 5065,5066, and 5075 (K953648 and K951683), and the Huntleigh Technology Inc. models GS337M and GS334 (K910188), and their counterparts from the original manufacturers. This conclusion is based upon the fact that these devices' are essentially identical to the predicate devices in terms of functional design, materials, indications for use, construction, and principles of operation.

Conclusion:

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Image /page/2/Picture/1 description: The image is a black and white emblem. The emblem is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that resembles three stylized lines that are stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2002

Mr. Patrick Fleischhacker Vice President Regulatory and Quality Control SterilMed, Inc 11400 73rd Avenue North Minneapolis, MN 55369

Re: K012597

Trade Name: Reprocessed Compression Limb Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compression Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: December 6, 2001 Received: December 7, 2001

Dear Mr. Fleischhacker:

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. Patrick Fleischhacker

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a backed or a backed on the requirements of the Act
that FDA has made a determination that your device complies with other requireme that IDA has made a decormination administered by other Federal agencies. You must of any Federal Statutes and regulations daminities. So 10 limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fatt 607), labeling (21 CFR Part 820); and if applicable, the electronic ford in the quality systems (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) This letter will anow you to oogin mailoung of substantial equivalence of your device to a legally premarket nothcation. The PDA miding of bacasification 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 II you desire specific advice tor your dovices disenostic devices), please contact the Office of additionally 21 CFN Part 607.10 for mirrial creations on the promotion and advertising of Compliance at [phone]. Ticanal Compliance at [phone]. Also, please note the your device, prease comate and o thereference to premarket notification" (21CFR Part 807.97). Ingulation chitica, "Misoranang of responsibilities under the Act may be obtained from the Other general information on your responsional 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. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) Number (if known): KO12597

Reprocessed Pneumatic Compression Sleeves Device Name:

Indications For Use:

These devices are reprocessed compression sleeves from various original equipment manufacturers (OEM.) Compression sleeves are designed to provide external manufacturers (OEM) Compression to artificially imitate the pumping action of the lower limbs to: prevent deep vein thrombosis, enhance venous and arterial circulation, and reduce lower limb pain and swelling.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K612597

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)