(165 days)
Not Found
No
The device description details a pneumatically controlled system with a predetermined inflation/deflation cycle, and the performance studies focus on mechanical and pressure characteristics. There is no mention of AI or ML in the document.
Yes
The device is intended for the "Treatment of disorders associated with vascular or lymphatic insufficiency," "Reduction of edema," "Localized thermal therapy," and to "Decrease the risk of deep venous thrombosis (DVT)," all of which are therapeutic indications.
No
The device description and intended use indicate that this device is a therapeutic device used for treatment, not for diagnosis. It helps with conditions like edema and DVT by applying compression.
No
The device description clearly details physical components like cuffs, chambers, tubing, and an electronic pump unit, indicating it is a hardware-based device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The intended uses all relate to the physical treatment of conditions affecting the vascular and lymphatic systems, soft tissue injuries, and localized thermal therapy. These are all therapeutic applications performed directly on the patient's body.
- Device Description: The device is a pneumatically controlled cuff system that applies pressure and potentially temperature to the body. This is a physical intervention, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / 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.
- 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)
Product codes (comma separated list FDA assigned to the subject device)
JOW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K061866, K023800, K061125, K012650, K881632
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
510(k) Summary K100969
Prepared: 9/13/10
| Submitter: | WMI Enterprises, Inc.
1017 W. Washington, 2J
Chicago, IL 60607
Phone – (888) 253-2555 | | Fax – (888) 456-8670 | | SEP 20 2010 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------|--|-------------|
| Contact Person: | Mike Wilford
(773) 744-1578 mike.wilford@yahoo.com
Or 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:
1
- . 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
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.
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
2 of 3
2
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 Orders
K061125 | Aircast K023800 |
|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Single Patient Use | Yes | Yes | Yes |
| Non-Sterile (sterilized but
not marketing as sterile) | Sterile/Non-Sterile | Sterile/Non-Sterile | Sterile/Non-Sterile |
| Skin Contact = 200 Denier
Nylon Oxford & DuPont
Softesse Medical Fabric
(non-latex, non-woven) | 200 Denier Nylon
Oxford & DuPont
Softesse Medical
Fabric (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-Lock
Connectors | Quick-Lock
Connectors | Quick-Lock Connectors |
| Inflation/Deflation Tubing
= PVC | Not specified | "Flexible plastic air
tubes" | Polyethylene tubing |
| Intermittent Segmental | Intermittent - both
segmental and single
chamber | Intermittent single
chamber | 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 | Approved controller
pump units that utilize
110 VAC Mains or
rechargeable battery | Approved controller
pump units that utilize
110 VAC Mains or
rechargeable battery |
Summary Comparison Chart
3
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
4
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
5
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
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