(107 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 Aircast Sleeves/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 Aircast Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.
The Midwest Reprocessing Center Reprocessed ALP® 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 Kendall SCD Express® Sleeves/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 Kendall SCD Express® Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.
The Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeve is used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Kendall SCD™ Sleeve is also a non-invasive therapeutic method for prevention of deep vein thrombosis.
The Midwest Reprocessing Center Reprocessed Novamedix ImPad® is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patients 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.
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 noninvasive 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 noninvasive therapeutic method to prevent deep vein thrombosis, and treat venous 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 non-invasive therapeutic method to be used 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® Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patients 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 Sleve 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 patients 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.
The provided 510(k) summary describes the Midwestern Reprocessing Center Reprocessed Sleeves/Foot Cuffs, which are medical devices intended for the prevention of Deep Vein Thrombosis (DVT) and the treatment of venous leg/foot ulcers and edema. The submission aims to establish substantial equivalence to predicate devices, which are also compression sleeves/foot cuffs.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state specific numerical acceptance criteria (e.g., pressure ranges, durability metrics with defined pass/fail thresholds) for the reprocessed sleeves/foot cuffs. Instead, it makes a general claim of equivalence to original equipment manufacturer (OEM) devices and relies on functional, cleaning, and biocompatibility testing to demonstrate this.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Performance: | |
| Maintain original design and mode of operation | "The Midwestern Reprocessing Center reprocessed sleeves/foot garments are identical to the original OEM devices in reference to the technological characteristics. The overall designs, materials, energy sources, modes of operation, and performance characteristics are no different than the original devices." |
| Effective compression for DVT prevention and ulcer/edema treatment | "Functional Testing... demonstrates that the reprocessed sleeves/foot cuffs perform as intended and are safe and effective." |
| Cleaning Validation: | "cleaning validation... demonstrates that the reprocessed sleeves/foot cuffs perform as intended and are safe and effective." |
| Safe and effective after reprocessing | |
| Biocompatibility: | "biocompatibility testing demonstrates that the reprocessed sleeves/foot cuffs perform as intended and are safe and effective." |
| Biologically safe after reprocessing |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any functional, cleaning, or biocompatibility testing. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature) for these tests. The submission mentions "Performance Data" but elaborates neither on the methodology nor the data itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given text. Establishing ground truth typically applies to diagnostic or prognostic devices where expert review (e.g., radiologists, pathologists) is used to classify or evaluate cases. The device in question is a therapeutic, reprocessed medical device, and the evaluation relies on functional and material testing rather than expert-derived ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not applicable/provided in the context of this device and the type of testing described. Adjudication methods like 2+1 or 3+1 are relevant for studies involving human readers and interpretations, particularly in diagnostic imaging. The submission focuses on physical and biological performance rather than interpretative tasks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
An MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on diagnostic performance of human readers. The device presented is a reprocessed compression sleeve, not an AI-powered diagnostic or interpretive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done.
A standalone study (in the context of an algorithm's performance) was not done. As mentioned, the product is a physical reprocessed medical device, not an algorithm. The "functional testing, cleaning validation, and biocompatibility testing" could be considered "standalone" in the sense that they assess the device's inherent properties and performance, but not in the AI/algorithm context.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data, expert consensus) is not directly applicable here. For this reprocessed device, the "ground truth" for performance is implicitly defined by the characteristics and performance expected of the original, new OEM devices.
- Functional Testing: The ground truth would be the expected pressure profiles, inflation/deflation cycles, and durability characteristics matching the original, new sleeves.
- Cleaning Validation: The ground truth would be the absence of contaminants and residues below specified safe levels, and effective sterilization (if applicable).
- Biocompatibility Testing: The ground truth would be the absence of toxic or allergenic reactions, corresponding to established biocompatibility standards for medical devices and matching the performance of the original devices' materials.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this submission. This is a reprocessed physical medical device, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set for an AI algorithm.
§ 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).