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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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(184 days)
UUHC's reprocessing methods do not change the intended use of the compression sfeeve devices (CSDs) from the intended use of, Kendall's K890938 model 5325 and K94664 model 6325 predicate devices. Both UUHC's reprocessed device and Kendall's predicate CSDs are intended to be placed on the intact skin of the patient's limb and to be periodically inflated for preventing pooling of blood in the patient's limb.
The description of UUHC's Reprocessed Compression Sleeves is substantially equivalent to the above described Kendall CSD. The primary descriptive difference between the two products is that UUHC's Reprocessed Compression Sleeves have been reprocessed as many as eleven (11) times and are labeled pasteurized and Kendall product is a nonsterile product that has not been reprocessed. The studies summarized in section 9,0 Safety and Efficacy and the comparison tables in section 5 demonstrate that UUHC's Reprocessed Compression Sleeves are substantially equivalent in physical, performance and safety characteristics to Kendall's CSDs.
Kendall's compression sleeve device (CSD) is an SUD and it is a component of Kendall's CSD System. The compression sleeve is an inflatable device generally made of PVC or Polyolefin attached to a pneumatic compression device called a controller that 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. The sleeves are constructed with a series of cells running the length of the patient's thigh or calf that are sequentially inflated 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.
The provided 510(k) summary for UUHC's Reprocessed Compression Sleeve Devices describes a submission for substantial equivalence to legally marketed predicate devices (Kendall K94664 and K890938 Compression Sleeve Predicate Devices). This type of submission focuses on demonstrating that the reprocessed device is as safe and effective as the predicate, rather than establishing de novo performance criteria against a disease state or clinical outcome.
Therefore, the "acceptance criteria" here are essentially showing that the reprocessed device does not perform worse than the predicate device across several key attributes. The "study" refers to the testing performed to demonstrate this equivalence.
Here's an analysis of the provided information, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Functional Equivalence: No functional characteristic changes that would pose substantial equivalency differences from the predicate devices after reprocessing multiple times. | Functional Testing: "The results of this test indicated that the CSDs can be reprocessed several times through the reprocessing steps with no functional characteristic changes that would pose any substantial equivalency differences from the predicate devices." |
| Intermediate Disinfection Capability: The pasteurization procedure is fully capable of and qualified for intermediate disinfection of the CSDs. | Intermediate Disinfection: "Based on test results the pasteurization procedure used for reprocessing CSDs is deemed fully capable of and qualified for intermediate disinfection of the CSDs." |
| Seal Strength: Seal strength, even if reduced after reprocessing, must not affect the function of the product in a simulated functional use test. | Seal Strength: "The seal strength of the samples reprocessed were reduced slightly due to reprocessing. The reduction of strength did not affect the function of the product in a simulated functional use test." |
| Biocompatibility/Toxicological Characteristics: Reprocessed CSDs can be used on patients without posing any new biocompatibility or toxicological hazard compared to the predicate device. | Biocompatibility/Toxicological Characteristics: "Based on test results, we conclude that the 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: The cleaning process must effectively remove contaminants, ensuring no new safety or efficacy issues over the predicate device. | Cleaning Efficacy: "Based on test results, we conclude that the 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." |
| Overall Safety and Efficacy: The reprocessed device is substantially equivalent in physical, performance, and safety characteristics to the predicate. | Substantial Equivalency: "The performance data and the safety data indicated that UUHC's Reprocessed CSDs were technically substantially equivalent. The reprocessed device was tested for biocompatibility and performance and they were substantially equivalent in all required categories to the predicate device." |
| Intended Use: The reprocessing methods do not change the intended use of the CSDs from that of the predicate devices. | Intended Use: "UUHC's reprocessing methods do not change the intended use of the CSDs from the intended use of, Kendall's K890938 model 5325 and K94664 model 6325 predicate devices." |
2. Sample size used for the test set and the data provenance
The document states that the devices can be reprocessed "as many as eleven (11) times" and that "the CSDs can be reprocessed several times". It also mentions "the seal strength of the samples reprocessed." However, specific sample sizes for each test (functional, disinfection, seal strength, biocompatibility, cleaning efficacy) are not provided in this summary. The provenance of the data is from UUHC's internal testing as part of their 510(k) submission. This is a prospective set of tests conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This submission is not clinical in nature in the sense of diagnosing a disease, but rather demonstrating the safety and effectiveness of a reprocessed medical device through bench testing. Therefore, there is no concept of "ground truth" derived from expert consensus like in an imaging study. The "ground truth" for each test is the objective measurement against established standards or the performance of the predicate device. The experts involved would be the engineers, microbiologists, and other technical specialists who conducted the tests and interpreted the results according to validated protocols. Their qualifications are not specified in the summary but would be relevant to the specific testing performed (e.g., a microbiologist for disinfection testing, material scientist for seal strength).
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of clinical findings or diagnoses.
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 is a 510(k) submission for a reprocessed physical medical device (compression sleeve), not an AI algorithm or a diagnostic imaging device requiring human reader interpretation. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used
The "ground truth" for the various tests was based on:
- Objective measurements and engineering specifications: For functional performance, seal strength, and cleaning efficacy, tests would have compared physical properties and cleanliness against predefined acceptable ranges or against the performance of new predicate devices.
- Microbiological standards: For intermediate disinfection, the "ground truth" would be the demonstrated reduction in microbial load to meet specific disinfection levels.
- Biocompatibility standards: For biocompatibility, the "ground truth" would be passing assays and tests against established ISO standards (e.g., ISO 10993).
- Intended Use of Predicate Devices: For intended use, the "ground truth" is the established indications for use of the original, legally marketed predicate devices.
Essentially, the ground truth is the performance of the predicate device and relevant industry/regulatory standards for medical device safety and effectiveness.
8. The sample size for the training set
Not applicable. This is not a machine learning model; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set.
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