(49 days)
Reprocessed Compression Sleeves are intended to help prevent deep vein thrombosis and pulmonary embolism by supplying a measured, intermittent pressure into the compression sleeves worn on the lower extremities of a recumbent patient, resulting in a gradient, sequential, repetitive squeezing and relaxing action, simulating normal muscle contractions.
When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.
Compression sleeves are part of an external compression system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with detachable connections. Only the compression sleeves are reprocessed.
Here's an analysis of the provided 510(k) summary regarding the Reprocessed Compression Sleeves, focusing on acceptance criteria and the supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or detailed performance metrics in a tabular format. Instead, it makes a general statement about the testing performed and the conclusion reached.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety: Biocompatibility | Testing conducted to demonstrate safety. |
| Effectiveness: Function as originally intended | Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended. |
| Effectiveness: Equivalence to predicate device function | Identical design, materials, sizes, mechanism of action, and performance as predicate devices. |
| Processing Validation: Removal of soil & decontamination | Reprocessing includes removal of adherent visible soil and decontamination. |
| Processing Validation: Appropriate function of components | Each individual compression sleeve is tested for appropriate function of its components prior to packaging, labeling, and E.O. exposure. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states that "Bench and laboratory testing was conducted," but no sample sizes for these tests are provided.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. This type of device (reprocessed compression sleeves) typically relies on objective physical, chemical, and functional testing rather than expert interpretation of images or clinical data for ground truth establishment in this context.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As noted above, the assessment of this device type does not typically involve human expert adjudication in the way medical imaging software might. The performance testing would likely involve standardized measurements and observations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No. This type of study is not relevant for this device. MRMC studies are typically used to assess the impact of AI on human reader performance, especially in diagnostic imaging.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done? Not applicable. This device is not an algorithm or AI system. Its performance is assessed through physical and functional testing of the reprocessed sleeves.
7. Type of Ground Truth Used
The ground truth for this device's performance would be established through a combination of:
- Objective Measurements: Physical dimensions, material integrity tests, pressure characteristics, flow rates, etc.
- Chemical Analysis: To confirm cleanliness and absence of contaminants after reprocessing.
- Microbiological Testing: To confirm effective decontamination/sterilization.
- Functional Testing: To ensure the sleeve inflates and deflates correctly, holds pressure, and delivers compression as designed, mimicking original device performance.
- Comparison to Predicate Device Specifications: The reprocessed device is intended to perform identically to the original, so the "ground truth" implicitly references the established performance characteristics of a new, predicate device.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This product does not involve machine learning or AI, and therefore no "training set" in that sense. The manufacturing process itself could be seen as "trained" through process validation, but this term is not used in the context of device performance data for this product.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Established: Not applicable, as there is no "training set" for an AI algorithm. The methods used to validate the reprocessing procedure would involve standard engineering and quality control practices to ensure consistent and safe reprocessing outcomes.
§ 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).