HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS

K053575 · Hygia Health Services, Inc. · JOW · Feb 15, 2006 · Cardiovascular

Device Facts

• Record ID: K053575
• Device Name: HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS
• Applicant: Hygia Health Services, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Feb 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hygia Health Services reprocessed sleeves/foot garments are intended to be used in the same manner as the predicate devices. They are designed to apply compression to the lower limbs to help prevent deep vein thrombosis in patients at risk. The Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs are used in the treatment of edema which are disorders associated with venous insufficiency. The Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.

Device Story

Reprocessed compression sleeves/foot cuffs; attach to external pneumatic controller; provide intermittent, sequentially graduated compression to lower limbs. Compression forces blood upward toward heart; deflation allows venous refill. Used in clinical settings for DVT prevention and edema treatment. Device is a reprocessed version of legally marketed predicate sleeves; operation and performance identical to original manufacturer specifications.

Clinical Evidence

No clinical data. Evidence consists of functional testing, cleaning validation, and biocompatibility testing to demonstrate that reprocessed sleeves perform as intended and are safe and effective.

Technological Characteristics

Compressible limb sleeve/foot cuff; pneumatic operation via external controller. Identical to original manufacturer device specifications regarding materials, form factor, and performance. Sterilization and cleaning processes validated for reprocessing.

Indications for Use

Indicated for patients at risk of deep vein thrombosis (DVT) and patients with edema associated with venous insufficiency.

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

• Tyco Healthcare/Kendall (K040511)
• Tyco Healthcare/Kendall (K040649)
• Healthcare Service and Supply (K974318)
• Aircast, Inc. (K992454)
• HHS Reprocessed Kendall SCD™ Sleeves (K012417)
• HHS Reprocessed Huntleigh Flowtron® (K012654)
• HHS Reprocessed Novamedix Impad® (K021509)

Submission Summary (Full Text)

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## FEB 1 5 2006

# 510(k) Summary

K 053575

In accordance with 21 CFR Part 807.92, this summary is submitted by:

Hygia Health Services, Inc. 434 Industrial Lane Birmingham, Alabama 35211 Phone: [phone] Fax: [phone]

Date Prepared: December 19, 2005

- Contact Person 1 .
Mr. Kyle Ferguson R&D Director Phone: [phone] Fax: [phone] Email: kyle [e-mail]

- 2. Name of Device

| Classification Name: | Sleeve, Limb, Compressible |
|-------------------------------|------------------------------------------------------|
| Common Name: | Compressible Limb Sleeve Device |
| Trade or<br>Proprietary Name: | Hygia Health Services Reprocessed Sleeves/Foot Cuffs |

- 3. Predicate Device
Corresponding Kendall, Aircast, and Healthcare Service and Supply Sleeves/Foot Cuffs legally marketed under various 510(k) premarket notifications:

| Tyco Healthcare/Kendall | K040511 |
|----------------------------------|---------|
| Tyco Healthcare/Kendall | K040649 |
| Healthcare Service and<br>Supply | K974318 |
| | |
| Aircast, Inc. | K992454 |

Previous Hygia Health Services (HHS) devices which are found to be substantially equivalent:

HHS Reprocessed Kendali SCD™ Sleeves K012417

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| HHS Reprocessed Huntleigh Flowtron® | K012654 |
|-------------------------------------|---------|
| HHS Reprocessed Novamedix Impad® | K021509 |

#### Device Description 4.

The Hygia Health Services reprocessed sleeves/foot garments are compression The Hygia Ficann Scriveds reproved controller, provide intermittent, devices that, which attactica to an appro re's leg/foot for the prevention of Deep sequentially gradion prossare to e sleeves/cuffs compress the legs/feet, veins vem Thromoosis (DVT). As the slectrosreations ords the heart. After compression,
collapse, forcing the blood to move upward towards the heart. After compression, conapse, forcing the blood to move ap-has to reopen and bring oxygenated
the sleeves/cuffs deflate which allows the veins to reopen and bring wines by a the sleeves/curls deflate whilen and deflation sequence is predetermined by the blood to the region. The mination and deliation of compression is determined by the controller.

#### 5. Device Intended Use

The Hygia Health Services reprocessed sleeves/foot garments are intended to be The Frygia Health Del rioco reprevedicated devices. They are designed to apply used in the Same mainer as the predication to the lower limbs to help prevent deep vein
the same micrinttein pilculiare compressee are intended to be used in both the thrombosis in patients at fish - There - The applicable.

#### Technological Characteristics 6.

The Hygia Health Services reprocessed sleeves/foot garments are identical to the The Trygin Freann Des in reference to the technological characteristics. The original OLM devices in references sources, modes of operation, and performance characteristics are no different than the original devices.

#### 7. Performance Data

Functional Testing, cleaning validation, and biocompatibility testing demonstrates r unctional Testing, creating var cuffs perform as intended and are safe and effective.

#### Conclusion 8.

Based on the assessment of functional testing, cleaning validation, and Dasca on the ussessment or farmed, Hygia Health Services concludes that the blocompatibility tobility tobally and and the to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2006

Hygia Health Services c/o Mr. Kyle Ferguson 434 Industrial Lane Birmingham, Alabama 35211

Re: K053575

K03375
Hygia Health Services Reprocessed Sleeves/Foot Cuffs Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (Two) Product Code: JOW Dated: December 19, 2005 Received: December 23, 2005

### Dear Mr. Ferguson:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 710(x) prematice is substantially equivalent (for the indications
referenced above and have determined the device marketed in interstate referenced and nave decemined the arrived the devices marketed in interstate for use stated in the enclosure) to regally mancede prouver and Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food Drug commerce prior to May 28, 1970, the charge with the provisions of the Federal Food, Drug, devices that have been reciassince in accordance while approval approval applications (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, listing of You may, therefore, market the device, subject to tire generat michrending and general controls provisions of the Fet merator required in the magainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mio exist case in cregulations affecting your device can
may be subject to such additional controls. Existing major regulations affe may be subject to such additional controlis. Extremgion of 898 In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Pederal Regarders in the Federal Register.

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## Page 2 - Mr. Kyle Ferguson

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 or any I 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 OFF Part 807), its ensigned (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 premance medicate 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/indcx.html.

Sincerely yours,

R. Z. A., M.D.

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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# Indications for Use

510(k) Number (if known):_K053575

Device Name: Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs

Indications For Use:

The Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs are used in the The Trygia Health Octvlood Reprosessor and edema which are disorders associated with venous insufficiency.

The Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.

Prescription Use X (Part 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)
(Division Sign-Off)
Division of Cardiovascular Devices

| 510(k) Number | K053575 |
|---------------|---------|
|---------------|---------|

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