(175 days)
These devices are designed to increase blood flow in the non-ambulatory patient in order to prevent deep vein thromboses or pulmonary embolism.
The description of JSA's Reprocessed Compression Sleeves is substantially equivalent to the above described Kendall CSD. The primary descriptive difference between the two products is that JSA's Reprocessed Compression Sleeves have been reprocessed as many as eleven (11) times and are labeled pasteurized and Kendall product is a non-sterile 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 JSA'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.
Here's a breakdown of the acceptance criteria and study information for the JSA's Reprocessed Compression Sleeve Devices, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Functional Equivalence | The CSDs can be reprocessed several times with no functional characteristic changes that would pose any substantial equivalency differences from the predicate devices. |
| Intermediate Disinfection | The pasteurization procedure used for reprocessing CSDs is deemed fully capable of and qualified for intermediate disinfection of the CSDs. |
| Seal Strength | The seal strength of the samples reprocessed was reduced slightly due to reprocessing. This reduction did not affect the function of the product in a simulated functional use test. |
| Biocompatibility/Toxicology | Reprocessed CSDs may be used on patients without posing any new biocompatibility or toxicological hazard. |
| Cleaning Efficacy | The cleaning efficacy of the washer was capable of meeting the required cleaning efficacy end-point, and cleaned reprocessed CSDs pose no new safety or efficacy issues to the patient over the predicate device. |
| Overall Substantial Equivalence | The reprocessed device was tested for biocompatibility and performance and found substantially equivalent in all required categories to the predicate device. The only difference was slightly less seal strength, which did not affect safety and efficacy. The reprocessed device being pasteurized (versus non-sterile predicate) also did not affect safety and efficacy. |
Study Information
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Sample size used for the test set and the data provenance:
- The document mentions "samples reprocessed" for seal strength testing and "test results" for other criteria. However, specific sample sizes for each test set are not explicitly provided in the given text.
- The data provenance (e.g., country of origin, retrospective/prospective) is not specified. The studies were likely conducted by JSA as part of their 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. The studies described are engineering and biological validations of reprocessing effectiveness and material performance, not diagnostic assessments requiring human expert ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to consensus-based ground truth establishment, which is not relevant to the type of testing performed for this device.
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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 study is not for an AI device or a diagnostic device where human reader performance would be a factor.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical accessory, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, the "ground truth" for the tests was based on established engineering standards, material science properties, biological safety standards (biocompatibility, toxicology), and disinfection efficacy protocols. For example, seal strength "ground truth" would be the expected functional performance, and cleaning efficacy "ground truth" would be a defined end-point of cleanliness. The comparison was primarily against the predicate device's performance characteristics.
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The sample size for the training set:
- Not applicable. This device is not an AI algorithm requiring a training set. The studies focus on validation of the reprocessing procedure and device characteristics.
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How the ground truth for the training set was established:
- Not applicable. As above, 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).