Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema:
Reduction of edema associated with soft tissue injuries such as ligament sprains, postoperative edema, and burns;
Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions;
Decrease the risk of deep venous thrombosis (DVT); .
Aids the blood flow back to the heart;
Treat and assist healing of cutaneous ulceration (wounds), reduce wound healing time, . enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.
- Primary lymphedema (for example congenital/Milroy's Disease)
- Secondary lymphedema (for example post-mastectomy, chronic edema, post o traumatic edema)
- Venous disorders (for example venous insufficiency, varicose veins, venous stasis o ulcers)
- Dysfunction of the muscle pump (for example promotion of wound recovery, o reduction of edema and lower limb pain following trauma and sports injuries)

Device Description

The cuffs contain interconnected, segmented inflatable chambers constructed of latex-free brushed nylon with polyester foam backing and an internal coating of latex free polymer that creates an airtight seal. The inner lining is elastic, which allows for the inflation. The bladder is constructed of polyvinyl chloride (PVC), RF welded at the seams. The inflation/deflation tubes are also composed of PVC. The hook fasteners are made of polyethylene.

These are pneumatically controlled cuffs, actuated by an electronic pump unit and are designed for singleuse. Inflation of the garment is accomplished using air or water and a controller cycle that functions to alternately inflate and deflate the cuffs in a predetermined manner and interval. The garments have only been tested to be used with the ThermoTek, Inc. NanoTherm and VascuTherm pneumatic pumps. Air/water is delivered to the cuff through flexible plastic tubing, inflating it to a specified pressure, to compress the affected anatomical part, thus aiding venous return. Air/water pressure and delivery are monitored by elements within the pump unit. Immediately after the pump element detects that the cuff has achieved the current set pressure, the cuff deflates to ambient pressure, allowing the veins to refill bringing oxygenated blood back to the area. The process essentially simulates muscle contractions in the body area, facilitating appropriate venous flow. The foot cuff simulation. The cycle continues until the unit is turned off.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Implied)	Reported WMI Device Performance
Functional and Operational Performance	Substantially equivalent to predicate ThermoTek NanoTherm and VascuTherm wraps in compression, pressure control, and timing sequence.	Compression, Pressure Control, Timing Sequence: Found substantially equivalent to predicate devices.
Controller Connections (Safety & Operational)	Substantially equivalent to predicate devices.	Controller Connections: Found substantially equivalent.
Cyclic Therapy Delivery (Durability)	Acceptable cyclic therapy delivery with no differences between cuffs, no migration, and no degradation in performance for 3,000 minutes (50 cycles) at 0.35 psi for DVT cuffs (calf/foot) and 120 hours (7,200 minutes) at 1.9 psi for ankle cuffs.	Cyclic Therapy Delivery: Successfully completed. No differences between cuffs, no migration of cuffs, and no degradation in performance throughout testing.
Leakage	No variance in leakage between WMI and ThermoTek cuffs after cyclic life testing.	Leakage: No variance in leakage between WMI and ThermoTek cuffs after life cycle testing.
Burst Strength	Burst point to be dramatically higher than normal usage and substantially similar among cuffs.	Burst Strength: Burst point dramatically higher than normal usage; substantially similar among cuffs.
Single Patient Use	Yes	Yes
Non-Sterile (sterilized but not marketing as sterile)	Comparable to Sterile/Non-Sterile predicate	Non-Sterile (sterilized but not marketing as sterile)
Skin Contact Material	Comparable to 200 Denier Nylon Oxford & DuPont Softesse Medical Fabric (non-latex, non-woven) / "Soft nylon material" / Latex-free polyester-cotton fabric	200 Denier Nylon Oxford & DuPont Softesse Medical Fabric (non-latex, non-woven)
Skin Sensitization & Irritation Testing	Yes	Yes
Cuff/Controller Connectors	Quick-Lock Connectors	Quick-Lock Connectors
Inflation/Deflation Tubing	Comparable to Not specified / "Flexible plastic air tubes" / Polyethylene tubing	PVC
Intermittent Segmental	Comparable to Intermittent - both segmental and single chamber / Intermittent single chamber / Intermittent segmental	Intermittent Segmental
Energy Source	Approved controller pump units that utilize 110 VAC Mains or rechargeable battery	Approved controller pump units that utilize 110 VAC Mains or rechargeable battery

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document specifies "The ankle cuffs, as DVT sample" and "The predicate and WMI cuffs" were tested. While it doesn't give a specific numerical count of individual cuffs, it clearly indicates that multiple WMI cuffs (DVT: D-1000F, D-1000C, and Thermal: T-2000A, T-2000B, T-2000KF, T-2000KBM, T-2000KBS, T2000S, T-2000H) were compared against at least one predicate device cuff (ThermoTek NanoTherm). In the cyclic testing for DVT, the "ankle cuffs" were used as a DVT sample which implies that more than one ankle cuff was tested.
Data Provenance: The testing was bench testing conducted to prove similarity of function. This implies that the data was generated in a controlled laboratory setting, not from clinical patient data from a specific country, and it was prospective in nature (designed and executed specifically for this submission).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This submission relies on bench testing for substantial equivalence rather than a clinical study requiring expert assessment of patient data. The "ground truth" here is the performance of the predicate devices in a laboratory setting.

4. Adjudication Method for the Test Set

Not applicable. There was no expert adjudication process for this bench testing. The assessment was based on direct measurement and comparison of physical characteristics and performance.

5. 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 device (compressible limb sleeve) is not an AI-powered diagnostic or interpretive tool that would involve human readers or MRMC studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a passive mechanical component (cuff) that works in conjunction with an electronic pump. It does not have an "algorithm" in the sense of a standalone AI system. The testing focused on the performance of the cuff as actuated by a pump, comparing it to predicate cuffs used with similar pumps.

7. The Type of Ground Truth Used

Comparison to Predicate Device Performance: The "ground truth" for this submission is the established and accepted performance characteristics of the legally marketed predicate devices (ThermoTek, Inc. NanoTherm and VascuTherm, Aircast VenaFlow system Disposable Cuffs, Doctor's Orders, Inc. DVTcare CA5, Hygia Health Services, Inc. NuTech Foot Wrap, Huntleigh Flowtron Excel). The WMI cuffs were evaluated against the functional and operational parameters of these predicates.

8. The Sample Size for the Training Set

Not applicable. This submission describes bench testing for a mechanical device, not an AI/machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/machine learning model, there is no ground truth establishment for a training set.

Summary

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510(k) Summary K100969

Prepared: 9/13/10

Submitter:	WMI Enterprises, Inc.1017 W. Washington, 2JChicago, IL 60607Phone – (888) 253-2555		Fax – (888) 456-8670		SEP 20 2010
Contact Person:	Mike Wilford(773) 744-1578 mike.wilford@yahoo.comOr Joy Long(317) 496-8647 joyslong@gonowmail.com
Device Name:
	Regulation No.: CFR Part 870.5800
	Classification: Class II
	Panel: 870 Cardiovascular
	Classification Name: Compressible Limb Sleeve
	Common or usual name: Compressible Limb Sleeve Device
	Product Code: JOW
	Model #'s: 1000 Series - DVT: D-1000F (foot), D-1000C (calf)2000 Series - Thermal: T-2000A (ankle), T-2000B (back), T-2000KF (knee full), T-2000KBM (knee, butterfly, medium), T-2000KBS (knee, butterfly, small), T2000S (shoulder), T-2000H (hip)

Indication of Predicate Devices and Statement of Substantial Equivalence:

The 510(k) approval for some of the following listed predicate devices, included approval for electronically controlled pump units and accompanying bladders (wraps, cuffs, sleeves). Our application is for like cuffs only and does not include any electronically controlled pump units. Therefore, our statement of substantial equivalence applies to the cuffs themselves. Our cuffs will be used with the ThermoTek, Inc. NanoTherm and VascuTherm or the Doctors Orders DVTCare units. However, we reserve the right to use the WMI cuffs with other, FDA approved as substantially equivalent electronically controlled pump units in the future.

Based upon safety and performance testing, compliance with voluntary standards, and comparison to the predicate devices in terms of features, functionality, and bench comparison testing, we believe that the WMI intermittent segmental cuffs are substantially equivalent to the wrap portion of the following predicate devices, and do not raise any new questions of safety or effectiveness.

• ThermoTek, Inc. NanoTherm and VascuTherm	K061866
• Aircast VenaFlow system Disposable Cuffs	K023800
• Doctor's Orders, Inc. DVTcare CA5	K061125
• Hygia Health Services, Inc. NuTech Foot Wrap	K012650
• Huntleigh Flowtron Excel	K881632

Indications for Use

Indications For Use:

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. Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema:
. Reduction of edema associated with soft tissue injuries such as ligament sprains, postoperative edema, and burns;
. Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions;
Decrease the risk of deep venous thrombosis (DVT); .
. Aids the blood flow back to the heart;
Treat and assist healing of cutaneous ulceration (wounds), reduce wound healing time, . enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.
- o Primary lymphedema (for example congenital/Milroy's Disease)
- Secondary lymphedema (for example post-mastectomy, chronic edema, post o traumatic edema)
- Venous disorders (for example venous insufficiency, varicose veins, venous stasis o ulcers)
- Dysfunction of the muscle pump (for example promotion of wound recovery, o reduction of edema and lower limb pain following trauma and sports injuries)

Device Description

Testing

Comparative bench testing was utilized to assess and prove similarity of function between the WM1 cuffs and the predicate ThermoTek NanoTherm and VascuTherm wraps. All tests found that functional and operational performance characteristics including compression, pressure control, and timing sequence were substantially equivalent. Safety and operational parameters regarding controller connections were also found to be substantially equivalent. The predicate and WMI cuffs were connected to a ThermoTek

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VascuTherm 2 pneumatic compressor pump and cycle tested for 3,000 minutes (50 cycles) at .35 psi (normal usage pressure = .029 psi). The ankle cuffs, as DVT sample, were connected to a ThermoTek VascuTherm 2 pneumatic compressor pump and constant pressure tested for 120 hours (7,200) minutes at 1.9 psi (normal usage pressure = .97 psi). All cuffs demonstrated acceptable cyclic therapy delivery with no differences between cuffs, no migration of cuffs, and no degradation in performance throughout the testing. The testing was successfully completed and resulted in no variance in leakage or performance between the WMI and ThermoTek cuffs. Following life cycle testing, the cuffs were gas pressure tested (burst test). Pressure was introduced and continued until cuffs exhibited leakage or burst. In all cases, the burst point was dramatically higher than normal usage would ever place on the cuffs and the burst points were substantially similar among the cuffs. We believe that all testing supports the substantial equivalence of the cuffs to the predicates.

Parameter/WMI	Thermotek K061866	Doctor's OrdersK061125	Aircast K023800
Single Patient Use	Yes	Yes	Yes
Non-Sterile (sterilized butnot marketing as sterile)	Sterile/Non-Sterile	Sterile/Non-Sterile	Sterile/Non-Sterile
Skin Contact = 200 DenierNylon Oxford & DuPontSoftesse Medical Fabric(non-latex, non-woven)	200 Denier NylonOxford & DuPontSoftesse MedicalFabric (non-latex,non-woven)	"Soft nylon material"	Latex-free polyester-cotton fabric
Skin Sensitization &Irritation Testing = Yes	Yes	Unknown	Unknown
Cuff/Controller Connectors= Quick-Lock Connectors	Quick-LockConnectors	Quick-LockConnectors	Quick-Lock Connectors
Inflation/Deflation Tubing= PVC	Not specified	"Flexible plastic airtubes"	Polyethylene tubing
Intermittent Segmental	Intermittent - bothsegmental and singlechamber	Intermittent singlechamber	Intermittent segmental
Energy Source = approvedcontroller pump units thatutilize 110 VAC Mains orrechargeable battery	Approved controllerpump units thatutilize 110 VACMains orrechargeable battery	Approved controllerpump units that utilize110 VAC Mains orrechargeable battery	Approved controllerpump units that utilize110 VAC Mains orrechargeable battery

Summary Comparison Chart

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

SEP 2 0 2010

WMI Enterprises, Inc. c/o Ms. Joy Long DragonSlayer Strategies 1017 W. Washington, 2J Chicago, IL 60607

K100969 WMI Thermal Cuffs Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: August 9, 2010 Received: August 11, 2010

Dear Ms. Long:

Re:

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.

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

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Page 2 - Ms. Joy Long

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.html 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

R. Vachner

Image /page/4/Picture/8 description: The image contains a small portion of text on a white background. The text includes the abbreviation "Br" and the word "Di". There is also a curved line to the left of the text. The text is in a simple, sans-serif font and appears to be part of a larger document or label.

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):

KI00969

Device Name: WMI Thermal Cuffs

SEP 2 0. 2010

Indications For Use:

Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic ● Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema:
Reduction of edema associated with soft tissue injuries such as ligament sprains, ● postoperative edema, and burns;
Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or ● surgical conditions;
Decrease the risk of deep venous thrombosis (DVT); ●
� Aids the blood flow back to the heart;
Treat and assist healing of cutaneous ulceration (wounds), reduce wound healing time, � enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.
- Primary lymphedema (for example congenital/Milroy's Disease) 0
- Secondary lymphedema (for example post-mastectomy, chronic edema, post-O traumatic edema)
- Venous disorders (for example venous insufficiency, varicose veins, venous stasis O ulcers)
- Dysfunction of the muscle pump (for example promotion of wound recovery, o reduction of edema and lower limb pain following trauma and sports injuries)

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)

Donna D. Varner

sinn Sinn-Off Division of Cardiovascular Devices

510(k) Number K100964

Page 1 of 1

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).