(229 days)
The Hygia Health Services Reprocessed Novamedix ImPad® is designed to enhance circulation of blood. It is to be used by patients in both the home and institutional settings as a non-invasive therapeutic method to:
- DVT prophylaxis
- Acute and chronic edema
- Extreme pain after trauma or surgery
- Treat leg ulcers and venous stasis/insuffic
The Hygia Health Services Reprocessed Novamedix ImPad® Garment is an intermittent compressible limb device that is placed around the patient's foot with the compression chamber placed under the plantar arch. The garment is constructed out of brushed nylon over a thin layer of closed cell foam. The device is secured using hook and loop fasteners made of polyethylene. As the garment compresses the plantar plexus, the veins collapse longitudinally, which increases the venous pressure thus ejecting the blood upward. After compression, the devices 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, hold time , and inflation/deflation time is determined by the controller.
The Hygia Health Services Reprocessed Novamedix ImPad® is a reprocessed medical device. The 510(k) summary focuses on demonstrating that the reprocessed device is substantially equivalent to the original, predicate device (Novamedix ImPad®), rather than providing detailed acceptance criteria and a study for de novo device performance.
Here's an analysis based on the provided document, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a typical "performance metric X must be Y" format. Instead, the acceptance is based on demonstrating "substantial equivalence" of the reprocessed device to the predicate device. The performance data presented indicates that the reprocessed device met the functional and operational characteristics of the predicate device.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional and Operational Performance | All functional and operational performance characteristics, including compression and pressure capabilities, were found to be substantially equivalent to the predicate device. |
| Safety Parameters | Safety parameters were found to be substantially equivalent to the predicate device. |
| Biocompatibility | No signs of irritation or sensitization were found in a human skin patch test, indicating the high-level disinfection program did not adversely affect biocompatibility. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Functional/Operational Tests: Not explicitly stated. The document refers to "comparative bench testing."
- Sample Size for Biocompatibility Test: Not explicitly stated, described as a "NIH level combination irritation/sensitization human skin patch test."
- Data Provenance: The tests conducted appear to be prospective bench tests and a human skin patch test specifically performed for this 510(k) submission. The location of these tests (e.g., country of origin) is not specified, but given the company location (Birmingham, Alabama) and FDA submission, it's implied to be within the US or compliant with US regulatory standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable for a device reprocessing and substantial equivalence submission like this. Ground truth in this context would implicitly be the established performance and safety profile of the original, predicate device, which is already FDA-cleared. The tests aim to confirm the reprocessed device matches that established profile, rather than independently establishing a new ground truth.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert interpretations (e.g., medical image reading).
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 is an intermittent pneumatic compressible limb sleeve, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device; there is no "algorithm" in the sense of AI software. The device itself operates "standalone" when connected to a controller, but the evaluation is on its physical performance rather than software algorithm performance.
7. The Type of Ground Truth Used
For the functional and operational tests, the "ground truth" was effectively the established performance and safety characteristics of the new, un-reprocessed Novamedix ImPad® (the predicate device). The goal was to prove the reprocessed device's performance was "substantially equivalent" to this predicate.
For biocompatibility, the ground truth was the absence of irritation or sensitization in human subjects, as assessed by standard dermatological evaluation in a skin patch test.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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).