MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE

K101330 · Midwest Reprocessing Center, LLC · JOW · Aug 27, 2010 · Cardiovascular

Device Facts

• Record ID: K101330
• Device Name: MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE
• 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; used with external pneumatic controller to provide intermittent, sequentially gradient pressure to lower limbs. Compression collapses veins to force blood toward heart; deflation allows venous refill. Used in home and institutional settings; operated by patients or healthcare providers. Device functions as non-invasive therapy for DVT prevention and venous insufficiency management. Reprocessing restores used OEM devices to original performance specifications.

Clinical Evidence

No clinical data. Evidence consists of 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. Identical to OEM devices in design, materials, and energy source. Operates via connection to an external pneumatic controller which dictates inflation/deflation sequences and pressure levels. Non-sterile or reprocessed to original specifications.

Indications for Use

Indicated for patients at risk of deep vein thrombosis (DVT), and for treatment of venous leg/foot ulcers and edema associated with venous insufficiency. Used as a non-invasive therapeutic method to enhance circulation, reduce wound healing time, and decrease compartmental pressures.

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

• Aircast Sleeves / Foot Cuffs (K992454)
• ALP® DVT Sleeves (K974318)
• Kendall SCD Express® Sleeves / Foot Cuffs (K040511, K040649)
• Novamedix ImPad® (K953648)
• SCD™ Sleeves (K890938)
• Reprocessed Aircast Sleeves / Foot Cuffs (K053575)
• Reprocessed ALP® DVT Sleeves (K053575)
• Reprocessed Kendall SCD Express® Sleeves / Foot Cuffs (K053575)
• Reprocessed Novamedix ImPad® (K021509)
• Reprocessed Kendall SCD™ Sleeves (K012417)
• Venodyne Sleeves (K011318, K001802, K930526)
• CTC VasoPress (K061967, K061814, K000147)
• Huntleigh Healthcare Inc. (K881632)
• Nutech (K981311, K944567)

Submission Summary (Full Text)

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# 510(k) Summary

In accordance with 21 CFR Part 807.92, this summary is submitted by: Midwest Midwestern Reprocessing Center, LLC. 3995 Fashion Square Blvd. Suite 11 Saginaw, MI 48603 Phone: [phone] Fax: [phone]

1. Contact Person

Date Prepared: May 10, 2010

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

2. Name of Device

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

3. Predicate Devices

Corresponding compression sleeves / foot cuffs legally marketed by the follow original equipment manufacturers under the following 510(k)s:

| K992454 | Aircast Sleeves / Foot Cuffs - Aircast, Inc. |
|------------------|--------------------------------------------------------------------------|
| K974318 | ALP® DVT Sleeves - Healthcare Service and Supply |
| K040511, K040649 | Kendall SCD Express® Sleeves / Foot Cuffs - Tyco<br>Healthcare / Kendall |
| K953648 | Novamedix ImPad® - Novamedix, Ltd. |
| K890938 | SCD™ Sleeves - Kendall Healthcare |

Corresponding reprocessed compression sleeves legally marketed by Hygia Health Services under the following 510(k)s:

.

AUG 2 7 2010

K101330

Pg1082

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K101330
pg 2 of 2

| K053575 | Reprocessed Aircast Sleeves / Foot Cuffs |
|---------|----------------------------------------------------------|
| K053575 | Reprocessed ALP® DVT Sleeves |
| K053575 | Reprocessed Kendall SCD Express® Sleeves / Foot<br>Cuffs |
| K021509 | Reprocessed Novamedix ImPad® |
| K012417 | Reprocessed Kendall SCD™ Sleeves |

#### 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.

#### 8. Conclusion

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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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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: K101330

Midwest Reprocessing Center Reprocessed Aircast Sleeves/Foot Cuffs Midwest Reprocessing Center Reprocessed ALP® DVT Sleeve Midwest Reprocessing Center Reprocessed Kendall SCD Express® Sleeves/Foot Cuffs Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeves Midwest Reprocessing Center Reprocessed Novamedix ImPad® Regulation Number: 21 CFR §870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: Class II Product Code: JOW Dated: May 11, 2010 Received: May 12, 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 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/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/ReportaProblem/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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Barry D. Zuckerman, 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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#### 510(k) Number (if known): K101330

Device Name: Midwest Reprocessing Center Reprocessed Aircast Sleeves/Foot Cuffs

Indications For Use:

The Midwest Reprocessing Center Reprocessed Aircast Sleeves/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 Aircast Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Dwision/Sign-Off)
Division of Cardiovas
510(k) Number K101330

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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510(k) Number (if known): K101330

Device Name: Midwest Reprocessing Center Reprocessed ALP® DVT Sleeve

Indications For Use:

The Midwest Reprocessing Center Reprocessed ALP® 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Number (if known): K101330

Device Name: Midwest Reprocessing Center Reprocessed Kendall SCD Express® Sleeves/Foot Cuffs

Indications For Use:

The Midwest Reprocessing Center Reprocessed Kendall SCD Express® Sleeves/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 Kendall SCD Express® Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{7}------------------------------------------------

510(k) Number (if known): K101330

Device Name: Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeves

Indications For Use:

The Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeve is used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency.

The Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeve is also a non-invasive therapeutic method for prevention of deep vein thrombosis.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{8}------------------------------------------------

510(k) Number (if known): K101330

Device Name: Midwest Reprocessing Center Reprocessed Novamedix ImPad®

Indications For Use:

The Midwest Reprocessing Center Reprocessed Novamedix ImPad® is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to:

- o Prevent deep vein thrombosis
- 0 Reduce wound healing time
- Treat and assist healing of venous leg ulcers O
- o 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Page A - Mr. Jerome James

### K101330

Applicant: Midwest Reprocessing Center 3995 Fashion Square Blvd., Suite 11 Saginaw, MI 48603 Consultant: Jerome James, Senior Consultant Ph: [phone] x114 Fax: [phone] Email: [e-mail]

Classification: Class II, 870.5800

Product Code: JOW

Common Name: Compressible Limb Sleeve

Device Name: Midwest Reprocessing Center Reprocessed Aircast Sleeves/Foot Cuffs Midwest Reprocessing Center Reprocessed ALP® DVT Sleeve Midwest Reprocessing Center Reprocessed Kendall SCD Express® Sleeves/Foot Cuffs

> Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeves Midwest Reprocessing Center Reprocessed Novamedix ImPad®

| Manufacturer | 510(k) | Models |
|---------------------------------------------------------------------------------------|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Aircast Inc. | K992454 | 3010, 3010-5, 3010-PL, 3012, 3012-5, 3012-PL, 3015, 3015-5, 3015-PL, 3016, 3016-5, 3016-PL |
| Healthcare Services and<br>Supply<br>(Currie Medical ALP®<br>DVT Sleeves) | K974318 | ALP-1, ALP-2, ALP-2XL, ALP-3, ALP-3(S), ALP-4, PVA-1, PVA-2 |
| Kendall & Kendall SCD<br>Sleeves & Express<br>Sleeves/Foot Cuffs<br>(Tyco Healthcare) | K890938,<br>K040511,<br>K040649 | 5065, 5075, 5107, 5329, 5330, 5345, 5480, 5489, 5897, 5898, 5329-M, 5489-M, 5330-M, 5345-M, 5480-M, 9529, 9789, 9530, 9545, 9780, 5046, 5048, 5057, 5059 |
| Novamedix ImPad<br>(Novamedix) | K953648 | |

### Indications for Use (IFU)

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

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KI01330 Page & - Mr. Jerome James

> The Midwest Reprocessing Center Reprocessed Aircast Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.

- 2. The Midwest Reprocessing Center Reprocessed ALP® 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.
- 3. The Midwest Reprocessing Center Reprocessed Kendall SCD Express® Sleeves/Foot Cuffs are used in the treatment of venous legfoot ulcers and edema which are disorders associated with venous insufficiency.

The Midwest Reprocessing Center Reprocessed Kendall SCD Express® Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.

- 4. The Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeve is used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency.
The Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeve is also a non-invasive therapeutic method for prevention of deep vein thrombosis.

- 5. The Midwest Reprocessing Center Reprocessed Novamedix ImPad® is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to:
- Prevent deep vein thrombosis o
- o Reduce wound healing time
- Treat and assist healing of venous leg ulcers o
- Reduce edema caused by venous insufficiency in the lower extremities o

{11}------------------------------------------------

Page 3 - Mr. Jerome James

### K101330

Applicant: Midwest Reprocessing Center 3995 Fashion Square Blvd., Suite 11 Saginaw, MI 48603 Consultant: Jerome James, Senior Consultant Ph: [phone] x114 Fax: [phone] Email: [e-mail]

Classification: Class II, 870.5800

Product Code: JOW

Common Name: Compressible Limb Sleeve

Device Name: 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

| Manufacturer | 510(k) | Models | |
|------------------|---------------------------------|-----------------------------------|------------------------------------|
| Venodyne Sleeves | K011318,<br>K001802,<br>K930526 | V3012, V3014, V3022, V3026, V6010 | |
| | CTC VasoPress | K061967,<br>K061814,<br>K000147 | VP 501M, VP 501L, VP 530M, VP 530L |
| | | Huntleigh<br>Healthcare Inc. | K881632 |
| Nutech | | | K981311,<br>K944567 |

#### Indications for Use (IFU)

- The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are used in the treatment of venous 1. leg ulcers and edema which are disorders associated with venous insufficiency.
The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are also a noninvasive therapeutic method for prevention of deep vein thrombosis.

- 2. 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.

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### Page 4 - Mr. Jerome James

The Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.

- 3. The Midwest Reprocessing Center Reprocessed CTC VasoPress Compression Sleeves are used as a noninvasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.
- 4. 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 O'
- o Reduce wound healing time
- o Treat and assist healing of venous leg ulcers
- O Reduce edema caused by venous insufficiency in the lower extremities
- 5. The Midwest Reprocessing Center Reprocessed Nutech® Calf Wrap is used as a non-invasive therapeutic method to be used by patients in the home or institutional setting in order to:
- o Prevent deep vein thrombosis
- Reduce wound healing time o
- ಂ Treat and assist healing of venous leg ulcers
- Reduce edema caused by venous insufficiency in the lower extremities 0
- 6. The Midwest Reprocessing Center Reprocessed Nutech® Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to prevent:
- o Deep vein thrombosis
- o Reduce wound healing time
- Treat and assist healing of venous leg ulcers ಂ
- o Reduce edema caused by venous insufficiency in the lower extremities
- o Decrease compartmental pressures
- 7. The Midwest Reprocessing Center Reprocessed Huntleigh Flowtron® Single Pulse DVT Sleve 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.
- 8. 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 patients in both the home and institutional settings as a non-invasive therapeutic method to prevent:
- o Deep vein thrombosis
- o Reduce wound healing time
- 0 Treat and assist healing of venous leg ulcers
- Reduce edema caused by venous insufficiency in the lower extremities O
- Decrease compartmental pressures 0

(K101330)