(242 days)
The Hygia Health Services Reprocessed Huntleigh Foot Wrap is designed to enhance the circulation of blood in the veins and arterioles. It is to be used by patient's in both the home and institutional settings as a non-invasive therapeutic method to prevent:
- Deep vein thrombosis
- Reduce wound healing time
- Treat and assist healing of venous leg ulcers
- Reduce edema caused by venous insufficiency in the lower extremities
- Decrease compartmental pressures
The Hygia Health Services Reprocessed Huntleigh Foot Wrap Garment is a compressible limb device that is placed around the patient's foot and when attached to an approved controller, provides intermittent pneumatic compression. The garment is constructed out of brushed nylon with a polyester foam lining. The single bladder is constructed out of the garment itself using an internal polymer coating that provides an airtight surface. The garment does not use an inflation chamber of poly vinyl chloride (PVC). The inflation/deflation tube is however, composed of PVC. The hook fasteners are made of polyethylene. The tube terminates in a snap lock connector. The garments are placed around the foot at the area of the plantar arch and secured with a hook and loop fastener. 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 is determined by the controller and is adjusted by altering the readout on the controller.
The provided 510(k) summary for the Hygia Health Services Reprocessed Huntleigh Foot Wrap does not contain detailed information regarding acceptance criteria, specific performance metrics with numerical results, or the methodology of a formal study with a test set, ground truth establishment, or expert involvement as described in your request.
The submission focuses on demonstrating "substantial equivalence" to a predicate device based on nonclinical comparative bench testing. This type of submission relies on showing that the reprocessed device performs similarly to the original, rather than establishing de novo performance against a set of predefined clinical acceptance criteria.
However, I can extract the available information and, where specific details are missing, state that they are not present in the provided document.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (from "Performance Data" and "Test Conclusions") |
|---|---|
| Functional and operational performance characteristics (including inflation/deflation control, timing sequence) | "All tests found that functional and operational performance characteristics including round that renotional acontrol, timing sequence... were substantially equivalent." |
| Safety parameters | "All tests found that... both safety... parameters used when connected to a controller were substantially equivalent." |
| Operational parameters | "All tests found that... operational parameters used when connected to a controller were substantially equivalent." |
| Efficacy (not directly tested, but implied by substantial equivalence to predicate) | "The Hygia Health Services HLD protocol does not alter the device's efficacy, safety, composition, or intended use." (A statement, not a measured performance metric) |
| Safety (not directly tested, but implied by substantial equivalence to predicate) | "The Hygia Health Services HLD protocol does not alter the device's efficacy, safety, composition, or intended use." (A statement, not a measured performance metric) |
| Composition (not directly tested, but implied by substantial equivalence to predicate) | "The Hygia Health Services HLD protocol does not alter the device's efficacy, safety, composition, or intended use." (A statement, not a measured performance metric) |
| Intended Use (not directly tested, but implied by substantial equivalence to predicate) | "The Hygia Health Services HLD protocol does not alter the device's efficacy, safety, composition, or intended use." (A statement, not a measured performance metric) |
Note: The document only states that the reprocessed device was found "substantially equivalent" to the predicate device in these areas, without specifying numerical acceptance criteria for each characteristic or providing quantitative performance data.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document mentions "comparative bench testing" but does not detail the number of units or test conditions used.
- Data Provenance: The nature of "bench testing" implies laboratory-based data, which is neither retrospective nor prospective in the clinical sense. No country of origin for the data is mentioned, but the submitting company is based in Alabama, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable. Bench testing does not involve establishing ground truth through expert review in the way clinical studies often do. The "ground truth" for bench testing would be the measured properties of the predicate device.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, not for nonclinical bench testing as described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- MRMC Study: No. The document describes nonclinical comparative bench testing, not a clinical MRMC study.
- Effect Size of Human Readers: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Standalone Performance: Not applicable. This device is a physical, reprocessed medical garment, not a software algorithm. Its performance is inherent to its physical properties and function when connected to a controller, not a standalone algorithmic output.
7. The Type of Ground Truth Used:
- Type of Ground Truth: For the "comparative bench testing," the implicit ground truth was the established functional and operational characteristics of the predicate device (the original Huntleigh Foot Wrap Garment). The reprocessed device was compared against the original to demonstrate similarity.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. There is no mention of a "training set" as this is not an artificial intelligence or machine learning device. The "training" for the reprocessing protocol itself would be the validation studies for the "scientifically validated thermal kill pasteurization process," but details on that are not provided in terms of a "training set."
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth for Training Set Was Established: Not applicable. As there is no training set in the AI/ML context, this question is not relevant to the described device. The device's "training" relates to the validation of its reprocessing method, which is stated to be a "scientifically validated thermal kill pasteurization process," but the details of this validation (including how ground truth for its effectiveness was established) are not part of this 510(k) summary.
§ 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).