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510(k) Data Aggregation
(92 days)
The intended use of this device, as well as the predicate device, is to provide external limb compression in order to artificially imitate the pumping action of the leg muscles. This provides muscle contraction required by the venous return system, thereby helping to prevent venous stasis and subsequent thrombosis and embolism. The cyclic and alternating inflation of the garments closely simulates the normal healthy pumping action of the limb muscles to stimulate deep venous blood flow and the reactivation or increase in the body's fibrinolytic system.
The Currie Medical Reprocessed ALP Calf, Thigh and Foot Compression Sleeves (all sizes) are recommended for the use in patients for whom external compression therapy using the ALTERNATING LEG PRESSURE® (ALP®) SYSTEM is indicated to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism due to the presence of risk factors for thrombosis formation.
Currie Medical Specialties (CMS) ALP reprocessed compression sleeves are compression devices, which when attached to the ALP 501 Pump System, provide intermittent, sequentially gradient pressure to a patients leg/foot for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse which forces blood to move upward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the calf, thigh or foot. The inflation and deflation sequence is predicated by the ALP 501 Pump System controller.
This document is a 510(k) summary for the Currie Medical Reprocessed ALP® Calf, Thigh and Foot Compression Sleeves. It describes the device's technical characteristics, intended use, and the "Summary of Comparison Tests (Non-Clinical Tests)" conducted to demonstrate substantial equivalence to predicate devices.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and the specified performance characteristics that were tested.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Bladder Leak Test: Bladders do not leak when pressurized to 3 psi. | "Bladders were pressurized to 3 psi to ensure the bladders did not leak at this pressure and were not affected by reprocessing." (Implied: Passed, no leaks detected) |
| Bladder Seal Pull Test: Bladder seals remain intact at > 5 lbs of force. | "Bladder seal was pulled apart at > 5 lbs of force to demonstrate the seals wore intact and were not affected by reprocessing." (Implied: Passed, seals intact at > 5 lbs) |
| Velcro Functionality Test: Velcro adhesion remains intact when bladders are pressurized to 2 psi. | "Velcro functionality test was performed where bladders were pressurized to 2 psi to determine velcro adhesion remained intact at this pressure and were not affected by reprocessing." (Implied: Passed, velcro adhesion remained intact) |
| Inflation-Deflation Time Test: Product integrity (inflation to 40 mm Hg and pressure monitoring over time) remains the same as the predicate device. | "Inflation-deflation time test was performed to demonstrate product integrity remained the same in comparison to the predicate device. This required the devices to be inflated to 40 mm Hg and monitor the pressure over time. The series of data demonstrated that the reprocessing did not affect the performance, or the safety and efficacy of the device." (Implied: Passed, consistent with predicate) |
| Biocompatibility: Reprocessing does not affect biocompatibility. | "Reprocessing did not affect the biocompatibility of the device." (Implied: Passed) |
| Overall Performance/Safety/Efficacy: Substantially equivalent to predicate devices (K955853 & K964188). | "The Currie Medical Specialties ALP® Reprocessed Calf, Thigh, and Foot Compression Sleeves have demonstrated that they perform as safe and effective as the ALP® non-sterile predicate devices (K955853 & K964188) and are substantially equivalent to the predicate devices." (Claimed) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of devices) used for each bench test. It refers to "bladders," "bladder seal," and "bladders" for the respective tests, implying multiple units were tested, but no specific number is given.
- Data Provenance: The document describes "Bench testing was conducted." This implies the tests were performed in a laboratory or controlled setting. There is no information regarding country of origin for the data or if it was retrospective/prospective, as it's not clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This document describes non-clinical bench testing for device reprocessing validation, not a study involving human experts for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. This document describes non-clinical bench testing. Adjudication methods are typically associated with human review or clinical study endpoints.
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. This document describes non-clinical bench testing of a reprocessed medical device, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This document pertains to a physical medical device (compression sleeves), not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for this study is the performance of the predicate device. The reprocessed device's performance was compared against the known performance characteristics of the original, new device to demonstrate substantial equivalence. The tests also established "ground truth" for specific mechanical properties (no leaks at 3 psi, seals intact at > 5 lbs force, velcro intact at 2 psi).
8. The Sample Size for the Training Set
Not applicable. This document describes validation testing for a reprocessed medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a machine learning model in this context.
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