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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

AI/ML Overview

This is a 510(k) summary for the reprocessing of various compression sleeves and foot cuffs. The document focuses on demonstrating substantial equivalence to already marketed predicate devices, rather than establishing performance criteria for a novel AI/ML device or providing a detailed study methodology with acceptance criteria and results in the format requested.

Therefore, many of the requested points are not applicable or cannot be extracted from the provided text.

Here is a summary of what can be gleaned:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Type
Functional Equivalence	The reprocessed devices should perform as intended, identical to original OEM devices in overall design, materials, energy sources, modes of operation, and performance characteristics.	"Functional Testing... demonstrates that the reprocessed sleeves/foot cuffs perform as intended." "The Midwestern Reprocessing Center reprocessed sleeves/foot garments are identical to the original OEM devices in reference to the technological characteristics."	Functional Testing
Safety - Biocompatibility	Reprocessed devices must be safe.	"Biocompatibility testing demonstrates that the reprocessed sleeves/foot cuffs are safe and effective."	Biocompatibility Testing
Safety - Cleaning Validation	Reprocessed devices must be safe (specifically regarding cleanliness).	"Cleaning validation... demonstrates that the reprocessed sleeves/foot cuffs are safe and effective."	Cleaning Validation
Effectiveness	Reprocessed devices should be effective.	"Functional Testing, cleaning validation, and biocompatibility testing demonstrates that the reprocessed sleeves/foot cuffs perform as intended and are safe and effective."	Functional Testing, Cleaning Validation, Biocompatibility Testing

Breakdown of Study Information:

Sample size used for the test set and the data provenance: Not specified. The document mentions "Functional Testing, cleaning validation, and biocompatibility testing" but does not provide details on the sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature) for these tests. This is typical for a 510(k) where the focus is on substantial equivalence, and detailed study protocols and results are usually submitted as part of the full 510(k) rather than summarized in the public-facing summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe the establishment of ground truth for an AI/ML or diagnostic device. The evaluation is based on standard engineering and biological testing (functional, cleaning, biocompatibility).
Adjudication method for the test set: Not applicable. There is no mention of expert adjudication as this is not a diagnostic device or an AI/ML performance study.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic "ground truth." The ground truth for this device's performance would be established by objective measurements in functional testing, sterility/cleanliness assays for cleaning validation, and standard biological tests for biocompatibility, compared against specifications or predicate device performance.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary

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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: (989) 583-4623 Fax: (989) 583-4633

Date Prepared: June 16, 2010

Contact Person

Jerome James Consultant Phone: (205) 314-3920 Fax: (205) 314-3959 Email: jerry.james@hygia.net

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

Predicate Devices

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

510(k)	Product	Manufacturer
K090074, K012956, K012657,K012654, K012651, K012650	Reprocessed CompressionSleeves and Foot Cuffs	Hygia Health Services, Inc.
K061967, K061814, K000147	VasoPress CompressionSleeve	Compression TherapyConcepts
K011318, K001802, K930526	Venodyne Sleeves andFoot Cuffs	Microtek Medical, Inc.
K881632	Flowtron Garments	Huntleigh Healthcare
K981311, K944567	Nutech Combo, CalfWrap, and Foot Wrap	Kinetic Concepts, Inc.

3-2

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4. Device Description

5. Device Intended Use

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.

{3}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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

{5}------------------------------------------------

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)

{6}------------------------------------------------

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

Device Name:

Midwest Reprocessing Center Reprocessed CTC VasoPress Compression Sleeves

Indications For Use:

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)

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

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)

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

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

{9}------------------------------------------------

510(k) Number (if known): ____________________

Device Name: Midwest Reprocessing Center Reprocessed Nutech® Foot Wrap

Indications For Use:

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)

{10}------------------------------------------------

510(k) Number (if known): ______________________

Device Name:

Midwest Reprocessing Center Reprocessed Huntleigh Flowtron® Single Pulse DVT Sleeve

Indications For Use:

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)

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

510(k) Number (if known):

Midwest Reprocessing Center Reprocessed Huntleigh Foot Wrap Device Name:

Indications For Use:

. 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)

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
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.(b)
Classification. Class II (performance standards).