UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE

K080551 · University of Utah Hospitals and Clinics · JOW · May 28, 2008 · Cardiovascular

Device Facts

• Record ID: K080551
• Device Name: UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE
• Applicant: University of Utah Hospitals and Clinics
• Product Code: JOW · Cardiovascular
• Decision Date: May 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To be used for patients for whom external compression therapy is indicated for the prevention of deep vein thrombosis and resulting pulmonary embolism due to the present risk factors for thrombosis formation.

Device Story

UHC APL is a reprocessed, non-invasive, external compression sleeve component of an alternating leg pressure system. System includes pump/controller, connecting tubing, and limb sleeve/garment. Device functions by applying sequential compression to patient limbs to prevent DVT and PE. Used in clinical settings; operated by healthcare providers. Reprocessing involves cleaning and disinfection of previously used sleeves. Output is mechanical compression of the limb. Benefits include DVT/PE prophylaxis for at-risk patients.

Clinical Evidence

Bench testing only. Performance testing demonstrated that bladder function of reprocessed sleeves (after 6 cycles) is equivalent to new original sleeves. Biocompatibility testing per ISO 10993-1 showed no adverse effects. Cleaning efficacy validated via TOC (Total Organic Carbon) analysis using Kendall K031189 process, showing results equal to or less than new sleeves. Intermediate level disinfection efficacy confirmed.

Technological Characteristics

Reprocessed limb compression sleeve. Materials and design identical to predicate. Biocompatibility per ISO 10993-1. Cleaning/disinfection validated via TOC analysis (SOP/CHM/0411.1). Mechanical actuation via external pump/controller (not part of sleeve).

Indications for Use

Indicated for patients requiring external compression therapy to prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) due to risk factors 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

• Healthcare Service and Supply ALP® Alternating Leg Pressure Garment (K000303)
• ReNu Medical Reprocessed ALP® Calf Garment (K051227)
• UUHC's Reprocessed Compression Sleeve Device (K031189)

Submission Summary (Full Text)

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K080551

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MAY 2 8 2008

## Pre-Market Notification 510 (K) Summary

| Submitter Name: | University of Utah Hospitals and Clinics<br>50 North Medical Drive<br>Salt Lake City, UT 84132 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Brent Alm<br>University of Utah Hospitals and Clinics<br>50 North Medical Drive<br>Salt Lake City, UT 84132<br>801-581-2847 |
| FDA Registration: | 3004595606 |
| Device Name: | Trade Proprietary Name - University Health Care Reprocessed Alternating<br>Leg Pressure (UHC APL) sleeve device |
| | Common or Usual Name - (ALP®) Alternating Leg Pressure Device |
| Classification: | Class II: Medical Device<br>Regulation: 21 CFR 870.5800<br>Panel Number: Panel 70<br>Product Code: JOW<br>Classification Name: Sleeve, Limb, Compression |
| Predicate Device: | Healthcare Service and Supply ALP® Alternating Leg Pressure Garment<br>K000303 |
| | ReNu Medical Reprocessed ALP® Calf Garment K051227 |
| | UUHC's Reprocessed Compression Sleeve Device K031189 |
| Device Description: | UHC APL is the compression sleeve component of a non-invasive<br>external compression system consisting of a pump/controller, connecting<br>tube and limb sleeve/garment device. |
| Intended Use: | To be used for patients for whom external compression therapy is<br>indicated for the prevention of deep vein thrombosis and resulting<br>pulmonary embolism due to the present risk factors for thrombosis<br>formation. |

University Health Care 510(k) Summary

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Technical Characteristics: The UHC APL reprocessed sleeve device is substantially equivalent in overall design, materials, energy source, mode of operation, performance technique, and reprocessing methods as the predicate devices.

Testing and Standards: Performance Test: Test results in the report demonstrate that the bladder function of the UHC APL reprocessed compression sleeve after reprocessing six (6) times were substantially equivalent to the new original ALP® Sleeves.

> Safety Efficacy: Testing indicated no adverse effects or complications resulting from reprocessing the UHC APL sleeve device six (6) times. The tests conclude that the UHC APL reprocessed sleeve device is safe and effective, and performs substantially equivalent to legally marketed new original ALP® sleeve device.

> Biocompatibility: The UHC APL reprocessed sleeve device was tested for biocompatibility according to the ISO 10993-1 test Matrix. The results indicate substantial equivalence in all required categories to the predicate device.

> Intermediate Disinfection and Cleaning Efficacy: Tests conclude that UHC APL reprocessed sleeve device passed the intermediate level of disinfection testing. The new original ALP® sleeve predicate has the technological advantage over the reprocessed device, having never been reprocessed.

> Cleaning Efficacy: Nelson Labs' TOC Procedure SOP/CHM/0411.1 was used to test Total Organic Carbons (TOC) ppb of the reprocessed sleeves that have been contaminated on 44 in 2 and cleaned using the Kendall K031189 cleaning process. UHC APL reprocessed sleeve device passed having scored equal to or less than the PBB of TOC on the new sleeve.

Conclusion: Device testing and comparisons of specification determined that UHC APL reprocessed sleeve devices are substantially equivalent to the predicate devices with respect to device intended use and performance, as well as product disinfection, packaging, labeling and safety and efficacy.

University Health Care 510(k) Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 2008

University of Utah Hospitals and Clinics c/o Mr. Brent Alm 50 North Medical Drive Salt Lake City, UT 84132

Re: K080551

University Health Care Processed Alternating Leg Pressure Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: February 28, 2008 Received: February 28, 2008

Dear Mr. Alm:

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. Brent Alm

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), 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 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/industry/support/index.html.

Sincerely yours,

R. vc Mner

ABram 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

510(k) Number (if known): K080551

Device Name: UHC APL

Indications for Use: The University Health Care Reprocessed Alternating Leg Pressure (UHC APL) sleeve device reprocessing methods do not change the intended use of the original manufacturer Healthcare Service and Supply ALP® (K000303) alternating leg pressure sleeve device. Both are sequential compression sleeves to be used by patients as a non-invasive therapeutic method to prevent deep vein thrombosis and resulting pulmonary embolism.

Prescription Use X (Part 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)

Donna R. Lo Jones

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K08055)

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