(182 days)
Sequential compression sleeves are intended to increase venous return from the lower extemities in as a prophylaxis for the formation of deep vein thrombosis or pulmonary embolism in non ambulatory patients. Sequential compression sleeves are single patient use devices only.
AMI intends to market reprocessed sequential compression sleeves and wraps. Reprocessing sequential compression sleeves and wraps is performed by AMI to AMI protocol Number 40009. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals). AMI is a "third party reprocessor" and reprocesses used single-used medical devices. AMI believes that sequential compression sleeves and wraps can be considered "reusable" - by AMI, as defined in the Food and Drug Administration Compliance Policy Guide #7124.16: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use. Sequential compression sleeves and wraps are designed to increase venous blood flow in the non-ambulatory patient in order to help prevent deep vein thrombosis and pulmonary embolism. AMI intends to reprocess disposable sequential compression sleeves and wraps manufactured by Kendall (sleeves and foot wraps), Huntleigh and Plexipulse.
The provided text describes a 510(k) summary for "Reprocessed Used Disposable Sequential Compression Sleeves / Wraps" by 4dven Medical, Inc. This document focuses on the reprocessing of medical devices, specifically sequential compression sleeves and wraps, rather than the development and performance of entirely new medical devices.
Therefore, the typical acceptance criteria and study data associated with demonstrating the performance of a novel device (e.g., accuracy, sensitivity, specificity studies with ground truth) are not applicable in this context.
Instead, the documentation addresses the substantial equivalence of the reprocessed devices to legally marketed predicate devices, focusing on the reprocessing process itself to ensure the reprocessed devices are safe and effective for their intended use.
Here's a breakdown of why many of your requested points are not directly addressed and what aspects are covered:
1. A table of acceptance criteria and the reported device performance
- Not applicable in the traditional sense. For reprocessed devices, the "acceptance criteria" relate to the ability of the reprocessing procedure to restore the device to a patient-ready state without adversely affecting its physical characteristics, quality, safety, and effectiveness. The performance goal is to match that of the new, predicate device.
- The document states: "AMI believes that sequential compression sleeves and wraps can be considered "reusable" - by AMI, as defined in the Food and Drug Administration Compliance Policy Guide #7124.16: they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use."
- Implied Acceptance Criteria:
- Withstand cleaning and sterilization.
- Physical characteristics unaffected.
- Quality unaffected.
- Safety maintained.
- Effectiveness maintained.
- Reported Device Performance: The document does not provide quantitative performance metrics for the reprocessed devices in the way a new device would (e.g., specific flow rates, pressure measurements after reprocessing vs. new). Instead, the "performance" is implicitly demonstrated by comparing them to the predicate devices. The FDA's 510(k) clearance implies that these criteria were met through the submitted reprocessing protocol.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. This type of information is typically for clinical performance studies of new devices. For reprocessing, the "test set" would be samples of reprocessed devices that undergo various validation tests (e.g., sterility testing, material integrity, functional testing) to ensure they meet specifications after reprocessing. The document does not detail these validation sample sizes or provenance.
3. 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. Ground truth establishment using experts is for diagnostic or predictive devices. For reprocessed devices, compliance with engineering and material standards, sterility, and functional equivalence to the original device serves as the "truth." This is typically assessed through laboratory testing and engineering analysis rather than expert human interpretation of results.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are for resolving discrepancies in expert interpretations, usually in clinical image review or similar subjective assessments.
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. MRMC studies are for evaluating the performance of diagnostic imaging devices, often involving AI. This product is a reprocessed medical device, not a diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the traditional sense. For reprocessed devices, the "ground truth" for the reprocessing process itself is established by demonstrating that the reprocessed device meets the original device's specifications for safety, effectiveness, and performance. This involves:
- Sterility testing: Ensuring no microorganisms remain.
- Biocompatibility testing: Ensuring no harmful residues.
- Material integrity/functional testing: Ensuring the device still works as intended and its physical properties are not degraded.
- Comparison to original specifications: Proving the reprocessed device functions equivalently to a new device.
8. The sample size for the training set
- Not applicable. Training sets are for machine learning algorithms.
9. How the ground truth for the training set was established
- Not applicable. Training sets are for machine learning algorithms.
Summary of Relevant Information from the Provided Text:
- Device Name: Reprocessed Used Disposable Sequential Compression Sleeves / Wraps
- Intended Use (Indications for Use): To increase venous return from the lower extremities, as a prophylaxis for the formation of deep vein thrombosis or pulmonary embolism in non-ambulatory patients.
- Reprocessing Protocol: AMI Protocol Number 40009 (details not provided in the excerpt).
- Predicate Device: Sequential compression sleeves and wraps sold new by Kendall under 510K 942664.
- Substantial Equivalence Claim: AMI claims the reprocessed devices are substantially equivalent to the new Kendall sleeves/wraps.
- Basis for Substantial Equivalence (as per FDA CPG #7124.16 for reusability):
- Able to withstand necessary cleaning and sterilization.
- Physical characteristics or quality of the device will not be adversely affected.
- Device remains safe and effective for its intended use.
In conclusion, this 510(k) summary is for the reprocessing of an existing medical device, not for the development of a new device or an AI application. Therefore, the questions related to clinical study design, expert review, and AI performance metrics are not applicable to the information provided. The acceptance criteria revolve around the successful validation of the reprocessing procedure to ensure the device remains safe and effective, and substantially equivalent to its new counterpart. The study proving this would involve detailed engineering, sterility, and functional testing of the reprocessed devices, which are not detailed in this high-level 510(k) summary.
§ 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).