(71 days)
The Midwestern Reprocessing Center reprocessed sleeves/foot garments are intended to be used in the same manner as the predicated devices. They are designed to apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis in patients at risk. The devices are intended to be used in both the home and institutional settings on patient populations for which these devices are applicable.
The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are used in the treatment of venous leg ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are also a non-invasive therapeutic method for prevention of deep vein thrombosis.
The Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs are used in the treatment of venous leg / foot ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.
The Midwest Reprocessing Center Reprocessed CTC VasoPress Compression Sleeves are used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat vanous leg ulcers and edema that result from venous insufficiency.
The Midwest Reprocessing Center Reprocessed NuTech® Combo is used as a non-invasive therapeutic method by patients in the home or institutional setting in order 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.
The Midwest Reprocessing Center Reprocessed NuTech® Calf Wrap is used as a noninvasive therapeutic method to be used by patients in the home or institutional so thiosi order 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.
The Midwest Reprocessing Center Reprocessed NuTech® Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It 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 Midwest Reprocessing Center Reprocessed Huntleigh Flowtron® Single Pulse DVT Sleeve is used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency.
The Midwest Reprocessing Center Reprocessed Huntleigh Foot Wrap is designed to enhance circulation of blood in the venules 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 Midwestern Reprocessing Center reprocessed sleeves/foot garments are compression devices that, when attached to an approved controller, provide intermittent, sequentially gradient pressure to a patient's leg/foot for the prevention of Deep Vein Thrombosis (DVT). As the sleeves/cuffs compress the legs/feet, veins collapse, forcing the blood to move upward towards the heart. After compression, the sleeves/cuffs deflate which allows the veins to reopen and bring oxygenated blood to the region. The inflation and deflation sequence is predetermined by the product's specific controller. The pressure of compression is determined by the controller.
This is a 510(k) summary for the reprocessing of various compression sleeves and foot cuffs. The document focuses on demonstrating substantial equivalence to already marketed predicate devices, rather than establishing performance criteria for a novel AI/ML device or providing a detailed study methodology with acceptance criteria and results in the format requested.
Therefore, many of the requested points are not applicable or cannot be extracted from the provided text.
Here is a summary of what can be gleaned:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Functional Equivalence | The reprocessed devices should perform as intended, identical to original OEM devices in overall design, materials, energy sources, modes of operation, and performance characteristics. | "Functional Testing... demonstrates that the reprocessed sleeves/foot cuffs perform as intended." "The Midwestern Reprocessing Center reprocessed sleeves/foot garments are identical to the original OEM devices in reference to the technological characteristics." | Functional Testing |
| Safety - Biocompatibility | Reprocessed devices must be safe. | "Biocompatibility testing demonstrates that the reprocessed sleeves/foot cuffs are safe and effective." | Biocompatibility Testing |
| Safety - Cleaning Validation | Reprocessed devices must be safe (specifically regarding cleanliness). | "Cleaning validation... demonstrates that the reprocessed sleeves/foot cuffs are safe and effective." | Cleaning Validation |
| Effectiveness | Reprocessed devices should be effective. | "Functional Testing, cleaning validation, and biocompatibility testing demonstrates that the reprocessed sleeves/foot cuffs perform as intended and are safe and effective." | Functional Testing, Cleaning Validation, Biocompatibility Testing |
Breakdown of Study Information:
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Sample size used for the test set and the data provenance: Not specified. The document mentions "Functional Testing, cleaning validation, and biocompatibility testing" but does not provide details on the sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature) for these tests. This is typical for a 510(k) where the focus is on substantial equivalence, and detailed study protocols and results are usually submitted as part of the full 510(k) rather than summarized in the public-facing summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe the establishment of ground truth for an AI/ML or diagnostic device. The evaluation is based on standard engineering and biological testing (functional, cleaning, biocompatibility).
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Adjudication method for the test set: Not applicable. There is no mention of expert adjudication as this is not a diagnostic device or an AI/ML performance study.
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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 is not an AI/ML device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic "ground truth." The ground truth for this device's performance would be established by objective measurements in functional testing, sterility/cleanliness assays for cleaning validation, and standard biological tests for biocompatibility, compared against specifications or predicate device performance.
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The sample size for the training set: Not applicable. This is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
§ 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).