HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS

K090074 · Hygia Health Services, Inc. · JOW · Apr 22, 2009 · Cardiovascular

Device Facts

• Record ID: K090074
• Device Name: HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS
• Applicant: Hygia Health Services, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Apr 22, 2009
• 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 predicated devices. They are designed to apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis in patients at risk. The devices are intended to be used in both the home and institutional settings on patient populations for which these devices are applicable.

Device Story

Reprocessed pneumatic compression sleeves/foot cuffs; used with external controller to provide intermittent, sequentially gradient pressure to lower limbs. Mechanism: sleeve inflation compresses veins to force blood toward heart; deflation allows venous refill. Used in home and institutional settings; operated by clinicians or patients. Benefits: DVT prevention; treatment of venous ulcers and edema. Device is reprocessed version of OEM products.

Clinical Evidence

Bench testing only. Evidence includes functional testing, cleaning validation, and biocompatibility testing to demonstrate that reprocessed devices maintain the performance and safety profile of the original OEM devices.

Technological Characteristics

Pneumatic compression sleeves/foot cuffs. Energy source: external pneumatic controller. Materials and design identical to OEM devices. Reprocessing involves cleaning and validation protocols. No software or electronic components integral to the sleeve itself.

Indications for Use

Indicated for patients at risk of deep vein thrombosis (DVT), and for the treatment of venous leg/foot ulcers and 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

• Compression Therapy Concepts (K061967)
• Compression Therapy Concepts (K061814)
• Compression Therapy Concepts (K000147)
• Huntleigh Healthcare (K022786)
• Huntleigh Healthcare (K010744)
• Healthcare Services and Supply (K974318)
• Microtek Medical, Inc. (K011318)
• Microtek Medical, Inc. (K001802)
• Microtek Medical, Inc. (K930526)

Reference Devices

• HHS Reprocessed Sleeves/Foot Cuffs (K053575)
• HHS Reprocessed Kendall SCD™ Sleeves (K012417)
• HHS Reprocessed Huntleigh Flowtron® (K012654)
• HHS Reprocessed Huntleigh Foot Cuff (K012651)

Submission Summary (Full Text)

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K090074

pg 1 of 2

# 510(k) Summary

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]

APR 2 2 2009

Date Prepared: November 26, 2008

1. Contact Person

Jerome James Director, R&D Phone: [phone] Fax: [phone] Email: [e-mail]

2. Name of Device

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

3. Predicate Device

Corresponding CTC and Venodyne Compression Sleeves/Foot Cuffs legally marketed under various 510(k) premarket notifications:

| K061967 | Compression Therapy Concepts |
|---------|--------------------------------|
| K061814 | Compression Therapy Concepts |
| K000147 | Compression Therapy Concepts |
| K022786 | Huntleigh Healthcare |
| K010744 | Huntleigh Healthcare |
| K974318 | Healthcare Services and Supply |
| K011318 | Microtek Medical, Inc. |
| K001802 | Microtek Medical, Inc. |
| K930526 | Microtek Medical, Inc. |

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K090074
Pg 2 of 2

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

| HHS Reprocessed Sleeves/Foot Cuffs | K053575 |
|--------------------------------------|---------|
| HHS Reprocessed Kendall SCD™ Sleeves | K012417 |
| HHS Reprocessed Huntleigh Flowtron® | K012654 |
| HHS Reprocessed Huntleigh Foot Cuff | K012651 |

## 4. Device Description

The Hygia Health Services reprocessed sleeves/foot garments are compression devices that, when attached to an approved controller, provide intermittent, sequentially gradient pressure to a patient's leg/foot for the prevention of Deep Vein Thrombosis (DVT). As the sleeves/cuffs compress the legs/feet, veins collapse, forcing the blood to move upward towards the heart. After compression, the sleeves/cuffs deflate which allows the veins to reopen and bring oxygenated blood to the region. The inflation and deflation sequence is predetermined by the product's specific controller. The pressure of compression is determined by the controller.

## 5. Device Intended Use

The Hygia Health Services reprocessed sleeves/foot garments are intended to be used in the same manner as the predicated devices. They are designed to apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis in patients at risk. The devices are intended to be used in both the home and institutional settings on patient populations for which these devices are applicable.

## 6. Technological Characteristics

The Hygia Health Services reprocessed sleeves/foot garments are identical to the original OEM devices in reference to the technological characteristics. The overall designs, materials, energy 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 that the reprocessed sleeves/foot cuffs perform as intended and are safe and effective.

#### 8. Conclusion

Based on the assessment of functional testing, cleaning validation, and biocompatibility testing performed, Hygia Health Services concludes that the Hygia Health Services reprocessed sleeves/foot cuffs are substantially equivalent to the predicate devices.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2009

Hygia Health Services, Inc. c/o Mr. Jerome James Director of R&D 434 Industrial Lane Birmingham, AL 35211

Re: K090074

Hygia Health Services Reprocessed Venodyne Sleeves & Foot Cuffs and CTC VasoPress Compression Sleeves Regulation Number: 21 CFR §870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: Class II Product Code: JOW Dated: December 31, 2008 Received: January 12, 2009

Dear Mr. James:

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 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. Jerome James

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 vours.

C

Bram D. Zuckerman, M.D. Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# K090074

Applicant: Hygia Health Services, Inc. 434 Industrial Lane Birmingham, AL 35211

Classification: Class II, 870.5800 Product Code: JOW Common Name: Compressible Limb Sleeve

# Device Name: Hygia Health Services (HHS) Reprocessed Venodyne Sleeves Hygia Health Services (HHS) Reprocessed Venodyne Foot Cuffs Hygia Health Services (HHS) Reprocessed CTC VasoPress Compression Sleeves

| OEM Catalog # | Hygia Catalog # | Product Description | Max. #<br>Reprocessing<br>Cycles |
|---------------|-----------------|--------------------------------|----------------------------------|
| V3012 | HHS-V3012 | Venodyne Sleeve Size 12"-16" | 10 |
| V3014 | HHS-V3014 | Venodyne Sleeve Size 14"-18" | 10 |
| V3022 | HHS-V3022 | Venodyne Sleeve Size 14"-20.5" | 10 |
| V3026 | HHS-V3026 | Venodyne Sleeve Size 14"-24" | 10 |
| V6010 | HHS-V6010 | Venodyne Foot Cuff | 10 |
| VP501M | HHS-VP501M | VasoPress Calf Garment, Med. | 5 |
| VP501L | HHS-VP501L | VasoPress Calf Garment, Lg | 5 |
| VP530M | HHS-VP530M | VasoPress Thigh Garment, Med. | 5 |
| VP530L | HHS-VP530L | VasoPress Thigh Garment, Lg | 5 |

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K090074

# Indications for Use

510(k) Number (if known): _ < 0 9 6 0 7 4

Hygia Health Services Reprocessed Venodyne Sleeves Device Name:

#### Indications For Use:

The Hygia Health Services Reprocessed Venodyne Sleeves are used in the treatment of venous leg ulcers and edema which are disorders associated with venous insufficiency.

The Hygia Health Services Reprocessed Venodyne Sleeves are also a non-invasive 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division/Sign-Off) | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K090074 |

Page 1 of 1

2-2

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K090074

# Indications for Use

510(k) Number (if known): Kog co7-4

Device Name:

Hygia Health Services Reprocessed CTC VasoPress Compression Sleeves

#### Indications For Use:

The Hygia Health Services Reprocessed CTC VasoPress Compression Sleeves are used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Division/Sign-Off)
Division of Cardlovascular Devices
510(k) Number K090074

2-6

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KD900074

# Indications for Use

510(k) Number (if known): _(co 9 00 74

Hygia Health Services Reprocessed Venodyne Foot Cuffs Device Name:

Indications For Use:

The Hygia Health Services Reprocessed Venodyne Foot Cuffs are used in the treatment of venous leg / foot ulcers and edema which are disorders associated with venous insufficiency.

The Hygia Health Services Reprocessed Venodyne Foot Cuffs are also a non-invasive 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | Page 1 of 1 |
|-----------------------------------------------------|-----------------|
| Division of Cardiovascular Devices<br>510(k) Number | K0900701<br>2-4 |