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510(k) Data Aggregation
(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.
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(55 days)
The Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs are used in the management of lymphedema and edema which are disorders associated with venous insufficiency.
The Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs are also a noninvasive therapeutic method for prevention of deep vein thrombosis.
The Hygia Health Services reprocessed sleeves/foot garments are compression devices that, which attached to an appropriate controller, provide intermittent, sequentially graded pressure to the patient's leg/foot for the prevention of Deep Vein Thrombosis (DVT). As the sleeves/cuffs compress the legs/feet, they 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 timing and deflation of compression is determined by the controller.
The provided text describes a 510(k) premarket notification for Hygia Health Services Reprocessed Sleeves/Foot Cuffs. This submission focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for a new device.
Therefore, many of the requested sections (e.g., acceptance criteria, detailed device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not explicitly present in the provided document.
However, based on the information available, here's a breakdown:
Acceptance Criteria and Device Performance
The document does not specify quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating that the reprocessed devices perform as intended and are safe and effective, consistent with their predicate devices. The "acceptance" is based on functional equivalence and safety verification rather than numerical performance thresholds.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance (Summarized) |
|---|---|---|
| Functional Equivalence | Device operates identically to original equipment manufacturer (OEM) devices in terms of compression mechanism, pressure delivery, and cycle. | Performs "as intended," with "sources, modes of operation, and performance characteristics no different than the original devices." |
| Cleaning Validation | Reprocessing effectively removes contaminants and renders the device safe for reuse. | "Cleaning validation demonstrates reprocessed cuffs perform as intended and are safe and effective." |
| Biocompatibility | Reprocessed materials are safe for patient contact and do not induce adverse biological reactions. | "Biocompatibility testing demonstrates reprocessed cuffs perform as intended and are safe and effective." |
| Intended Use | Retains the same indications for use as the predicate devices (prevention of deep vein thrombosis, treatment of lymphedema and edema). | Intended to be used "in the same manner as the predicate devices." |
| Safety and Effectiveness | Overall, the reprocessing process does not compromise the safety or effectiveness of the device compared to the original devices. | "Functional Testing, cleaning validation, and biocompatibility testing demonstrates reprocessed cuffs perform as intended and are safe and effective." |
| Substantial Equivalence | Demonstrates that the reprocessed device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. | Conclusion: "Hygia Health Services concludes that the reprocessed sleeves are substantially equivalent to the predicate devices." |
Study Details
The provided document describes a 510(k) submission, which is a regulatory pathway to demonstrate substantial equivalence to a predicate device. It does not detail a clinical study in the traditional sense with test sets, ground truth, or statistical power calculations for performance metrics as might be found for a novel AI/diagnostic device.
1. Sample Sized used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. The performance data section vaguely mentions "Functional Testing, cleaning validation, and biocompatibility testing." These are likely laboratory tests on a sample of reprocessed devices, but the exact number of units tested is not provided.
- Data Provenance: Not specified, but generally, such tests would be conducted internally by the manufacturer. The data is retrospective in the sense that the predicate devices have established performance, and the goal is to certify the reprocessed devices meet that standard.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Experts and Qualifications: Not applicable/not specified. For this type of submission, "ground truth" refers to established performance standards for the predicate devices, and the objective is to show the reprocessed devices meet those standards through various tests. It does not involve expert consensus on medical images or clinical outcomes for a "test set" in the diagnostic sense.
3. Adjudication method for the test set:
- Adjudication Method: Not applicable/not specified. No human reader review or adjudication process is mentioned for evaluating the performance of the reprocessed sleeves.
4. 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:
- MRMC Study: No. This is not an AI/diagnostic device. The submission is for reprocessed medical devices (compressible limb sleeves), not an AI-powered diagnostic tool. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant and not part of this submission.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This document pertains to a physical medical device. There is no "algorithm only" performance to evaluate.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth Type: For this submission, the "ground truth" is the established safety and effectiveness of the legally marketed predicate devices. The reprocessed device's performance is compared against these established characteristics through functional, cleaning, and biocompatibility tests. It does not involve "expert consensus, pathology, or outcomes data" in the context of diagnostic accuracy.
7. The sample size for the training set:
- Sample Size (Training Set): Not applicable. There is no AI model being trained, so no "training set" exists.
8. How the ground truth for the training set was established:
- Ground Truth Establishment (Training Set): Not applicable, as there is no training set.
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