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510(k) Data Aggregation
(88 days)
The AviaFit 110 Device is intended for use to help prevent the onset of DVT in patients by stimulating blood flow in the legs (simulating muscle contractions). Furthermore, the unit can be used as an aid in the prophylaxis for DVT by persons traveling, or those expecting to be stationary for long periods of time (> 4 hours). This device can also be used to aid in the prevention of DVT, enhance blood circulation, diminish postoperative pain and swelling, reduce wound healing time, and aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, and reduction of edema in the lower limbs.
The FlowMedic AviaFit™ is a battery operated portable device integrating a patented mechanical intermittent compression technology to improve blood circulation in the lower limbs and reduce the risk of deep vein thrombosis, edema and leg discomfort during limited mobility conditions. The device is comprised of an actuator and is externally mounted on the calf.
The anatomical concave shaped control unit is connected to the leg strap and applied to the calf. Using an innovative low power consumption mechanism, the system tugs and releases the leg strap placed around the calf muscle, thus exerting intermittent cycles of external pressure build-up on the tissue, and a subsequent release, thus aiding venous return. Strap tug and release are controlled by a system of gears, springs, a motor and integrated microprocessor contained in the plastic control unit.
The device mimics the muscle activity during walking by acting sequentially in cycles of an active interval of exerting pressure on the muscle, thus augmenting blood flow. followed by a loose state for a period of time, allowing blood flow to return to the limb.
The provided text describes a 510(k) premarket notification for the AviaFit™ Device, a compressible limb sleeve intended to prevent DVT and improve blood circulation.
Here's an analysis of the acceptance criteria and study information, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission explicitly states:
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance | Device operating characteristics and performance are in accordance with its specifications. | "The performance tests performed on the original, cleared and identical AviaFit™ device verified that the operating characteristics and performance of the device are in accordance with its specifications." |
| Clinical Performance | Not Applicable. | "Not Applicable." |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Clinical Performance Tests: Not Applicable." This implies that no specific test set of patients or data was used for clinical evaluation by the applicant in this 510(k) submission. Acceptance was based on non-clinical tests and substantial equivalence to previously cleared devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical performance tests were conducted for this submission.
4. Adjudication Method for the Test Set
Not applicable, as no clinical performance tests were conducted for this submission.
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. The AviaFit™ device is a mechanical device, not an AI-assisted diagnostic tool, and no clinical studies, including MRMC studies, were performed for this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm-only device. The assessment was based on non-clinical performance and substantial equivalence to predicate devices, which are also mechanical.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the non-clinical performance, the "ground truth" was the device's own specifications. The performance tests verified that the device met these engineering and design specifications. For the overall regulatory acceptance, the ground truth was "substantial equivalence" to predicate devices, meaning that the new device is as safe and effective as existing legally marketed devices, based on comparative technological characteristics and intended use.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI models that require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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(90 days)
The Aviafit™ is intended to improve blood circulation in the lower limbs and reduce the risk of deep vein thrombosis, edema and leg discomfort during limited mobility conditions at home, at the office and during mid-long haul flights.
AviaFit™ Pulsating Legband
This document is a 510(k) summary for the AviaFit™ Pulsating Legband. It primarily focuses on regulatory approval and does not contain detailed information about acceptance criteria, device performance studies, or the methodologies used to establish ground truth.
Therefore, the requested information cannot be extracted from the provided text. The document confirms the FDA has found the device substantially equivalent to a legally marketed predicate device, but it lacks the specific study details needed to answer the questions about acceptance criteria and performance data.
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