(88 days)
Intermittent Pneumatic Compression (IPC) is indicated for use for the prevention of deep vein thrombosis due to the presence of risk factors for thrombus formation during orthopedic, trauma, urologic, neurology, critical care, general medicine, obstetrics, and general surgery.
The Restep Deep Vein Thrombosis (DVT) System, consists of the Restep pump and compatible leg and foot compression garments. The system is a lightweight, portable, prescriptive pneumatic compression device that helps to stimulate blood flow in the deep veins of the legs through the use of pneumatically controlled single chamber pressure cuffs, actuated by an electronically controlled pump unit and solenoid valves.
Note: Only the compression sleeves (garments) are the subject of this submission, the pump is not included in the scope of this submission.
This document describes the 510(k) submission for Ascent Healthcare Solutions' Reprocessed Restep Compression Sleeves. The submission focuses on demonstrating substantial equivalence to predicate devices for these reprocessed sleeves, which are part of a Deep Vein Thrombosis (DVT) prevention system.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state numerical acceptance criteria in the format of a table with thresholds and reported values for specific performance metrics. Instead, it describes types of tests conducted to demonstrate that the reprocessed sleeves perform "as originally intended."
| Area of Performance | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Safety | Biocompatibility requirements met | Biocompatibility testing conducted. |
| Effective reprocessing and decontamination | Validation of reprocessing conducted, including removal of adherent visible soil and decontamination. | |
| Effectiveness/Functionality | Appropriate function of components | Each individual compression sleeve tested for appropriate function of its components prior to packaging and labeling. |
| Performance equivalent to original intended use | Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended. |
2. Sample size(s) used for the test set and the data provenance:
The document does not specify the sample sizes used for the biocompatibility, reprocessing validation, or function tests. It also does not provide information on the data provenance (e.g., country of origin of the data, retrospective or prospective). The testing appears to be bench and laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The studies described are not clinical studies that would involve expert review for ground truth establishment. They are bench and laboratory tests.
4. Adjudication method for the test set:
This information is not applicable as there is no mention of a test set requiring adjudication in the context of clinical expert review.
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:
This information is not applicable. The device is a reprocessed medical device (compression sleeves), not an AI-powered diagnostic tool, and therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests (biocompatibility, reprocessing validation, function tests) would be defined by established engineering, materials science, and microbiology standards for safety and functionality of medical devices. For example:
- Biocompatibility: Adherence to ISO standards (e.g., ISO 10993) or FDA guidance for medical device biocompatibility.
- Reprocessing Validation: Demonstrated removal of soil and inactivation of microorganisms to acceptable levels.
- Function Test: Meeting predefined specifications for pressure, fit, and integrity as per the original device's design.
8. The sample size for the training set:
This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
This information is not applicable.
§ 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).