(88 days)
The Wheaton Franciscan Huntleigh Reprocessed Compression Sleeve is recommended for use in whom The Wheath Flanciscan Trancisco Compression Compresses of the prevention of deep vein external compression theraly using the riaming. I to the presence of risk factors for thrombus formation. Intrathromoosis and resuming pumitonaly indicated, sometimes adjunctively with medical measures, during operative compression therepy d general surgery, particularly in patients over the age of 40.
Huntleigh's compression sleeve device (CSD) is an SUD component of Huntleigh's CSD System. The compression sleeve is an inflatable device generally made of PVC or Polyolefin with a bladder that is attached to a pneumatic compression device called a controller and it is capable of performing multiple low pressure inflation cycles. It is offered in four different sizes that are configured to fit on the patient's thigh or calf (see diagrams in appendix 6). The sleeves are constructed with cells running the length of the patient's thigh or calf that are sequentially inflated and deflated to impart intermittent compression to the respective section of the limb. This "milking" action forces the blood flow in the direction of the heart and prevents back flow of blood. The sleeves are wrapped around the patient's limb and secured with valcor tabs.
Because the Huntleigh CSD is placed on the patient's intact skin., it falls under the Spaulding non-critical device classification. The CSD procedure is considered a safe, non invasive, less expensive and simple alternative to anti-coagulant drug therapy and it is one of the least expensive, yet most effective non invasive systems available for the prevention of venous thrombosis.
The description of WFSI's Reprocessed Compression Sleeves is substantially equivalent to the above described Huntleigh CSD. The primary descriptive difference between the two products is that WFSI's Reprocessed Compression Sleeves have been reprocessed as several times and are labeled pasteurized and Huntleigh's CSD is a non-sterile product that has not been reprocessed.
The provided text describes the reprocessing and re-marketing of compression sleeve devices (CSDs) by WFSI, asserting their substantial equivalence to Huntleigh's predicate CSDs. This is a medical device submission, primarily focused on regulatory approval rather than a traditional research study with specific acceptance criteria and performance metrics in the way a diagnostic algorithm or new drug might be evaluated.
Here's a breakdown of the requested information based on the provided text, recognizing that some points may not be directly applicable due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate device) | Reported Device Performance (WFSI Reprocessed CSDs) |
|---|---|---|
| Functional Testing | No substantial equivalency differences in pressure deflation, bladder leakage, or burst strength. | "no functional pressure deflation, bladder leakage or burst strength characteristic changes that would pose any substantial equivalency differences from the predicate devices." |
| Intermediate Disinfection | Capable of effective intermediate disinfection. | "pasteurization procedure used for reprocessing CSDs is deemed fully capable of and qualified for intermediate disinfection of the CSDs." (Note: this is a technological advantage over the non-sterile predicate). |
| Biocompatibility/Toxicological Characteristics | No new biocompatibility or toxicological hazards. | "CSDs can be reprocessed and may then be used on the patient without posing any new biocompatibility or toxicological hazard to the patient." |
| Cleaning Efficacy | Capable of meeting required cleaning efficacy endpoint. | "cleaning efficacy of the washer was capable or meeting the required cleaning efficacy end-point and that the cleaned reprocessed CSDs pose no new safety or efficacy issues to the patient over the predicate device." |
| Seal Strength | Equivalent to predicate new device. | "reduced from the predicate device." (Acknowledged, but deemed acceptable for substantial equivalence). |
| Elongation | Equivalent to predicate new device. | "slightly greater than the predicate device." (Acknowledged, but deemed acceptable for substantial equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "sample size" for a test set in the way a clinical trial or algorithm validation would. Instead, it refers to:
- "Functional Testing": Implies a set of reprocessed CSDs were tested. The number of CSDs or repetitions of the reprocessing cycles isn't specified. It mentions they "can be reprocessed several times."
- "Intermediate Disinfection": Tests were performed on reprocessed CSDs.
- "Biocompatibility/Toxicological Characteristics": Tests were performed on reprocessed CSDs.
- "Cleaning Efficacy": Refers to the cleaning efficacy of the "washer," implying tests were done on CSDs after reprocessing.
The data provenance is internal to WFSI, generated during their reprocessing and testing procedures. It is prospective in the sense that they performed these tests specifically to support this 510(k) submission, rather than analyzing existing data. The country of origin is not explicitly stated but assumed to be the USA, given the FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" here is established through engineering and laboratory testing against established physical, chemical, and biological standards and comparison to the predicate device's characteristics. There's no subjective interpretation by human experts (like radiologists or pathologists) to establish ground truth for performance metrics in this context.
4. Adjudication Method for the Test Set
This is not applicable as there is no subjective assessment or multiple expert opinions requiring adjudication for the type of testing performed (e.g., burst strength, disinfection efficacy, cytotoxicity).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating human performance, often with or without AI assistance, in interpreting medical images or making diagnostic decisions. The WFSI submission is for a physical medical device (compression sleeves) and its reprocessing, requiring engineering and laboratory validation, not human interpretation studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. This submission is about a reprocessed physical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for evaluating the WFSI Reprocessed CSDs is based on:
- Physical performance standards: E.g., pressure deflation, bladder leakage, burst strength, seal strength, elongation (compared to new predicate device and manufacturing specifications).
- Chemical/Biological performance standards: E.g., intermediate disinfection efficacy (meeting defined reduction targets for microorganisms), cleaning efficacy (meeting defined residuals targets), and biocompatibility/toxicological characteristics (meeting ISO standards or equivalent for medical devices).
- Comparison to the predicate device: The fundamental "ground truth" for substantial equivalence is demonstrating that the reprocessed device performs comparably to the original, legally marketed predicate device (Huntleigh K881632 Compression Sleeve).
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of an AI or algorithm as this submission is for a physical medical device. Manufacturing and reprocessing processes are typically validated through process validation, which involves testing a certain number of units or batches, but this isn't analogous to an AI training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set" in this context.
§ 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).