(165 days)
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)
- 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)
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.
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.
§ 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).