MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS

K101702 · Midwest Reprocessing Center, LLC · JOW · Aug 27, 2010 · Cardiovascular

Device Facts

• Record ID: K101702
• Device Name: MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS
• Applicant: Midwest Reprocessing Center, LLC
• Product Code: JOW · Cardiovascular
• Decision Date: Aug 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Midwestern Reprocessing Center 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 compression sleeves/foot cuffs; attach to external controller for intermittent, sequentially gradient pneumatic compression of lower limbs. Controller dictates inflation/deflation sequence and pressure levels. Compression collapses veins to force blood flow toward heart; deflation allows venous refill. Used in home/institutional settings to prevent DVT, treat venous ulcers, reduce edema, and decrease compartmental pressures. Benefits include improved circulation and DVT prophylaxis. Device is reprocessed version of OEM products.

Clinical Evidence

Bench testing only. Evidence includes functional testing, cleaning validation, and biocompatibility testing to demonstrate safety and effectiveness equivalent to OEM devices.

Technological Characteristics

Intermittent pneumatic compression sleeves/foot cuffs. Materials, design, and energy sources are identical to OEM devices. Operates via external controller for sequential gradient pressure. Non-sterile or reprocessed to maintain original performance specifications.

Indications for Use

Indicated for patients at risk of deep vein thrombosis (DVT), venous leg/foot ulcers, edema associated with venous insufficiency, and for decreasing compartmental pressures. Used in home and institutional settings.

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

• Hygia Health Services, Inc. Reprocessed Compression Sleeves and Foot Cuffs (K090074, K012956, K012657, K012654, K012651, K012650)
• Compression Therapy Concepts VasoPress Compression Sleeve (K061967, K061814, K000147)
• Microtek Medical, Inc. Venodyne Sleeves and Foot Cuffs (K011318, K001802, K930526)
• Huntleigh Healthcare Flowtron Garments (K881632)
• Kinetic Concepts, Inc. Nutech Combo, Calf Wrap, and Foot Wrap (K981311, K944567)

Submission Summary (Full Text)

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# 510(k) Summary

AUG 2 7 2010

K101702 pg10f2

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

Midwest Reprocessing Center, LLC. 3995 Fashion Square Blvd. Suite 11 Saginaw, MI 48603 Phone: [phone] Fax: [phone]

Date Prepared: June 16, 2010

1. Contact Person

Jerome James Consultant Phone: [phone] Fax: [phone] Email: [e-mail]

2. Name of Device

Classification Name: Sleeve, Limb, Compressible Classification Product Code: JOW Compressible Limb Sleeve Device Common Name: Midwestern Reprocessing Center Reprocessed Trade or Proprietary Name: Sleeves/Foot Cuffs

3. Predicate Devices

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

| 510(k) | Product | Manufacturer |
|---------------------------------------------------------|---------------------------------------------------|---------------------------------|
| K090074, K012956, K012657,<br>K012654, K012651, K012650 | Reprocessed Compression<br>Sleeves and Foot Cuffs | Hygia Health Services, Inc. |
| K061967, K061814, K000147 | VasoPress Compression<br>Sleeve | Compression Therapy<br>Concepts |
| K011318, K001802, K930526 | Venodyne Sleeves and<br>Foot Cuffs | Microtek Medical, Inc. |
| K881632 | Flowtron Garments | Huntleigh Healthcare |
| K981311, K944567 | Nutech Combo, Calf<br>Wrap, and Foot Wrap | Kinetic Concepts, Inc. |

3-2

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#### 4. Device Description

The Midwestern Reprocessing Center 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 Midwestern Reprocessing Center 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 Midwestern Reprocessing Center 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.

#### Conclusion 8.

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

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved lines. The logo is black and white.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Midwest Reprocessing Center c/o Mr. Jerome James Regulatory Consultant 3995 Fashion Square Blvd., Suite 11 Saginaw, MI 48603

### AUG 2 7 2010

Re: K101702

Midwest Reprocessing Center Reprocessed Venodyne Sleeves Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs Midwest Reprocessing Center Reprocessed CTC VasoPress Compression Sleeves Midwest Reprocessing Center Reprocessed Nutech® Combo Midwest Reprocessing Center Reprocessed Nutech® Calf Wrap Midwest Reprocessing Center Reprocessed Nutech® Foot Wrap Midwest Reprocessing Center Reprocessed Huntleigh Flowtron® Single Pulse DVT Sleeves Midwest Reprocessing Center Reprocessed Huntleigh Foot Wrap Regulation Number: 21 CFR 8870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: Class II (two) Product Code: JOW Dated: June 16, 2010 Received: June 17, 2010

#### 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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#### Page 2 - Mr. Jerome James

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.

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Midwest Reprocessing Center Reprocessed Venodyne Sleeves Device Name:

#### Indications For Use:

The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are used in the treatment of venous leg ulcers and edema which are disorders associated with venous insufficiency.

The Midwest Reprocessing Center 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) | |
|--------------------------------------------------------|-------------|
| | Page 1 of 1 |
| of Cardiovascular Devices | |
| | 2-2 |
| K101702 | |

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs Device Name:

#### Indications For Use:

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

The Midwest Reprocessing Center Reprocessed Venodyne 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 OF NEEDED)

### Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Number (if known): _ . . . ____________________________________________________________________________________________________________________________________________

Device Name:

Midwest Reprocessing Center Reprocessed CTC VasoPress Compression Sleeves

#### Indications For Use:

The Midwest Reprocessing Center Reprocessed CTC VasoPress Compression Sleeves are used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat vanous 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)

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Midwest Reprocessing Center Reprocessed Nutech® Combo

### Indications For Use:

The Midwest Reprocessing Center Reprocessed NuTech® Combo is used as a non-invasive therapeutic method by patients in the home or institutional setting in order to:

- . Prevent deep vein thrombosis
- Reduce wound healing time .
- Treat and assist healing of venous leg ulcers .
- Reduce edema caused by venous insufficiency in the lower extremities .

Prescription Use » (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)

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Midwest Reprocessing Center Reprocessed Nutech® Calf Wrap

#### Indications For Use:

The Midwest Reprocessing Center Reprocessed NuTech® Calf Wrap is used as a noninvasive therapeutic method to be used by patients in the home or institutional so thiosi order to:

- . Prevent deep vein thrombosis
- Reduce wound healing time
- . Treat and assist healing of venous leg ulcers
- Reduce edema caused by venous insufficiency in the lower extremities .

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

2-6

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510(k) Number (if known): ____________________

Device Name: Midwest Reprocessing Center Reprocessed Nutech® Foot Wrap

#### Indications For Use:

The Midwest Reprocessing Center Reprocessed NuTech® Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It to be used by patient's in both the home and institutional settings as a non-invasive therapeutic method to prevent:

- Deep vein thrombosis
- . Reduce wound healing time
- . Treat and assist healing of venous leg ulcers
- . Reduce edema caused by venous insufficiency in the lower extremities
- . Decrease compartmental pressures

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)

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510(k) Number (if known): ______________________

Device Name:

Midwest Reprocessing Center Reprocessed Huntleigh Flowtron® Single Pulse DVT Sleeve

#### Indications For Use:

The Midwest Reprocessing Center Reprocessed Huntleigh Flowtron® Single Pulse DVT Sleeve is 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)

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510(k) Number (if known):

Midwest Reprocessing Center Reprocessed Huntleigh Foot Wrap Device Name:

#### Indications For Use:

The Midwest Reprocessing Center Reprocessed Huntleigh Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patient's in both the home and institutional settings as a non-invasive therapeutic method to prevent:

- . Deep vein thrombosis
- . Reduce wound healing time
- . Treat and assist healing of venous leg ulcers
- Reduce edema caused by venous insufficiency in the lower extremities .
- . Decrease compartmental pressures

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)