(242 days)
The Hygia Health Services 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 Hygia Health Services Reprocessed Huntleigh Flowtron® DVT sleeve is a compressible limb device that, when attached to an approved controller, provides intermittent pneumatic compression. The sleeve is constructed out of brushed nylon with a polyester foam lining. The single bladder is constructed of poly vinyl chloride (PVC), as is the inflation/deflation tube. The binding is a polyester/cotton blend, and the hook fasteners are made of polyethylene. The tube terminates in a snap lock connector. The sleeves are placed around the leg and secured with a hook and loop fastener. As the sleeves compress the leg, veins collapse, increasing the venous pressure thus ejecting the blood upward toward the heart. After compression, the sleeves deflate allowing the veins to refill and bring oxygenated blood to the lower limbs. The controller predetermines the inflation and deflation sequence. The pressure of compression is determined by the controller and is adjusted by altering the readout on the controller.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Hygia Health Services Reprocessed Huntleigh Flowtron® DVT Compression Sleeves:
1. Table of Acceptance Criteria and Reported Device Performance
The submission is for a reprocessed medical device, and the primary "acceptance criteria" revolve around demonstrating substantial equivalence to the predicate device, the Huntleigh Flowtron® DVT Garment. This means the reprocessed device must perform functionally and safely in the same way as the original. Specific quantitative acceptance criteria (e.g., a specific pressure range with a tolerance) are not explicitly stated in the provided text as they would be for a novel device, but rather implied by the concept of "substantial equivalence."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional and Operational Performance | All tests found that functional and operational performance characteristics including compression, pressure control, timing sequence, and both safety and operational parameters used when connected to a controller were substantially equivalent. |
| Material Integrity | The Hygia Health Services HLD protocol does not alter the device's efficacy, safety, composition, or intended use. |
| Intended Use | Designed to operate in the identical manner as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Comparative bench testing" and "Clinical tests were summarized," but does not provide a specific number of units tested for either bench or clinical evaluation.
- Data Provenance: Not explicitly stated. It describes "bench testing" and "clinical tests," which would typically be conducted by the manufacturer or a contracted lab. The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission for a reprocessed device, studies would likely be prospective specifically for reprocessing validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For device reprocessing, "ground truth" would typically relate to objective measures of device performance, material integrity, and sterility, rather than expert interpretation of images or clinical outcomes in the same way an AI diagnostic tool might require. The testing relies on established engineering and clinical measures, not expert consensus on qualitative data.
4. Adjudication Method for the Test Set
This information is not applicable/not provided in the context of this device. Adjudication methods like 2+1 or 3+1 are common in studies where expert interpretation (e.g., reading medical images) forms the ground truth and there's a need to resolve disagreements. For a reprocessed mechanical device, performance is assessed through objective measurements, not by expert consensus on interpretive data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. These studies are typically used for diagnostic or assistive AI tools where the performance of human readers (e.g., radiologists) with and without AI assistance is compared. This submission is for a reprocessed mechanical compression sleeve, which does not involve human "readers" interpreting data in the same way.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is not applicable in the context of this device. This is not an AI algorithm. Its "performance" is assessed through its mechanical function, material integrity, and ability to achieve intended physiological effects. The device itself (the reprocessed sleeve) is standalone in that it performs its compression function when connected to a controller, but "standalone" in the AI sense does not apply.
7. The Type of Ground Truth Used
The ground truth used for this type of device (a reprocessed compression sleeve) is based on objective measurements of performance characteristics and material properties compared against the specifications and performance of the original, new device. This includes:
- Compression pressure profiles
- Timing sequences (inflation/deflation cycles)
- Material integrity after reprocessing (e.g., no degradation affecting safety or efficacy)
- Safety parameters
- Operational parameters
- Efficacy in preventing DVT (implied by equivalence to predicate device with established efficacy).
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is a reprocessed physical medical device, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided. As stated above, this is not an AI model.
§ 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).