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510(k) Data Aggregation
(90 days)
The University Health Care Reprocessed Alternating Leg Pressure (UHC APL) sleeve device reprocessing methods do not change the intended use of the original manufacturer Healthcare Service and Supply ALP® (K000303) alternating leg pressure sleeve device. Both are sequential compression sleeves to be used by patients as a non-invasive therapeutic method to prevent deep vein thrombosis and resulting pulmonary embolism.
UHC APL is the compression sleeve component of a non-invasive external compression system consisting of a pump/controller, connecting tube and limb sleeve/garment device.
The provided text describes the 510(k) premarket notification for the University Health Care Reprocessed Alternating Leg Pressure (UHC APL) sleeve device. The focus of the submission is to demonstrate that the reprocessed device is substantially equivalent to legally marketed predicate devices, specifically the Healthcare Service and Supply ALP® Alternating Leg Pressure Garment (K000303), after being reprocessed multiple times.
Here's an analysis of the acceptance criteria and the study as per the request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material/Design Equivalence | Overall design, materials, energy source, mode of operation, performance technique, and reprocessing methods are substantially equivalent to predicate devices. | "The UHC APL reprocessed sleeve device is substantially equivalent in overall design, materials, energy source, mode of operation, performance technique, and reprocessing methods as the predicate devices." |
| Bladder Function | Bladder function of the UHC APL reprocessed compression sleeve after reprocessing six (6) times demonstrates substantial equivalence to new original ALP® Sleeves. | "Test results... demonstrate that the bladder function of the UHC APL reprocessed compression sleeve after reprocessing six (6) times were substantially equivalent to the new original ALP® Sleeves." |
| Safety and Efficacy | No adverse effects or complications resulting from reprocessing the UHC APL sleeve device six (6) times. The device is safe and effective and performs substantially equivalent to legally marketed new original ALP® sleeve device. | "Testing indicated no adverse effects or complications resulting from reprocessing the UHC APL sleeve device six (6) times. The tests conclude that the UHC APL reprocessed sleeve device is safe and effective, and performs substantially equivalent to legally marketed new original ALP® sleeve device." |
| Biocompatibility | The UHC APL reprocessed sleeve device meets ISO 10993-1 test Matrix requirements for biocompatibility, indicating substantial equivalence to the predicate device in all required categories. | "The UHC APL reprocessed sleeve device was tested for biocompatibility according to the ISO 10993-1 test Matrix. The results indicate substantial equivalence in all required categories to the predicate device." |
| Intermediate Disinfection and Cleaning Efficacy | The UHC APL reprocessed sleeve device passes intermediate level of disinfection testing. | "Tests conclude that UHC APL reprocessed sleeve device passed the intermediate level of disinfection testing." |
| Cleaning Efficacy (TOC) | The UHC APL reprocessed sleeve device, after contamination and cleaning using the Kendall K031189 cleaning process, demonstrates Total Organic Carbons (TOC) ppb equal to or less than the PBB (presumably initial level or acceptable limit for particulate burden) of the new sleeve. | "Nelson Labs' TOC Procedure SOP/CHM/0411.1 was used to test Total Organic Carbons (TOC) ppb of the reprocessed sleeves that have been contaminated on 44 in 2 and cleaned using the Kendall K031189 cleaning process. UHC APL reprocessed sleeve device passed having scored equal to or less than the PBB of TOC on the new sleeve." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It mentions "reprocessed sleeve device six (6) times" for bladder function and safety/efficacy testing. This implies at least one device was reprocessed six times and tested after each reprocessing cycle, or multiple devices were tested after six reprocesses. However, the exact number of individual sleeve devices tested is not specified.
The data provenance is retrospective in the sense that it's comparing a reprocessed device to an already marketed new device. The testing itself would have been prospective to generate the new data for the reprocessed device. However, the origin of the data (e.g., country) is not specified beyond being submitted by the University of Utah Hospitals and Clinics in Salt Lake City, UT, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study focuses on technical performance testing (e.g., bladder function, biocompatibility, cleaning efficacy) rather than diagnostic accuracy involving expert interpretation. Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., for image interpretation) does not apply here.
4. Adjudication Method for the Test Set
This information is not applicable for this type of technical performance testing. Adjudication methods like "2+1" or "3+1" are typically used in studies where human readers provide interpretations (e.g., diagnostic image reading), and disagreements need to be resolved. This study involves objective laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This information is not applicable. This submission is for a medical device (compression sleeve) and its reprocessing, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as this is not an algorithm or AI-based device.
7. The Type of Ground Truth Used
The ground truth used for comparison is the performance and characteristics of the new, original ALP® sleeve device (K000303), which is the predicate device. This is a form of "predicate performance" or "established equivalent performance." For instance:
- For bladder function: The performance of new ALP® sleeves.
- For biocompatibility: The known biocompatibility profile of the predicate device.
- For cleaning efficacy: The cleanliness/TOC levels of new sleeves or an established acceptable limit.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI/machine learning device that requires a training set. The "training" in this context would refer to the development and validation of the reprocessing protocol itself, but a "training set" in the computational sense is not relevant.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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