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510(k) Data Aggregation
(193 days)
The FOCUS™-PV Balloon Dilatation Catheter is a balloon dilatation catheter intended for use in percutaneous transluminal balloon dilatation (PTA) of large vessels of the peripheral vasculature.
The FOCUSTM PV Balloon Dilatation Catheter, styled after the Grüntzig technique, is a double lumen catheter with a balloon mounted at the distal tip. Dilatation Balloon catheters are used to exert radial force to dilate narrow vessel segments, based on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end of a catheter.
The provided text describes a 510(k) premarket notification for the FOCUS™-PV Balloon Dilatation Catheter. This document is a submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device. It is not a clinical study report proving device performance against acceptance criteria in the traditional sense of a clinical trial. Instead, it relies on demonstrating equivalence through comparison to existing devices and engineering testing.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, ground truth for training set) are not applicable to this type of regulatory submission and device.
Here's an analysis based on the information provided:
Acceptance Criteria and Reported Device Performance
The document describes the device, its intended use, and compares it to predicate devices. The "acceptance criteria" for a 510(k) submission primarily revolve around demonstrating substantial equivalence to existing, legally marketed devices and successful completion of engineering (bench) testing to ensure safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Demonstrated through testing or comparison) | Reported Device Performance (Summary from text) |
|---|---|
| Substantial Equivalence: | |
| - Indications for Use | "intended for use in percutaneous transluminal balloon dilatation (PTA) of large vessels of the peripheral vasculature." This is the same use as predicate devices. |
| - Intended Use | "intended for use in exactly the same manner" as predicate devices. |
| - Technological Characteristics (Design, Materials, Performance) | Compared to predicate devices in a table (e.g., balloon size, length, shaft size, materials, guidewire size). Modifications from previous versions (K944016, K952064, K954313) included larger balloon sizes, reduced balloon compliance, a change in balloon material to single layer PET, different bonding method, and coaxial tubing configuration for the shaft. The submission aims to show these modifications do not raise new questions of safety or effectiveness. |
| Engineering (Bench) Testing: | All tests demonstrated that the FOCUS™-PV Balloon Dilatation Catheter is safe and effective. |
| - Balloon Burst Strength | "demonstrated the balloons meet or exceed specification" |
| - Balloon Cycle Endurance | "demonstrated the balloons meet or exceed specification" |
| - Radiopacity | Met specifications |
| - Tensile Strength (connector to catheter distal end) | "met design specifications" |
| - Tensile Strength (catheter shaft and tip) | "met design specifications" |
| - Torsion Strength (catheter tip) | "met design specifications" |
| - Profile Measurements | "within specification tolerances" |
| - Biocompatibility | Met specifications |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to this 510(k) submission, as it primarily relies on bench testing and comparison to predicate devices, not clinical data from a "test set" as would be used in a diagnostic algorithm study. The "test set" for the engineering tests would be the manufactured devices themselves, but specific numbers are not provided.
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)
This is not applicable. Ground truth, in the context of expert consensus, is typically used for diagnostic or screening devices. For a catheter, performance is evaluated through engineering specifications and comparison to existing devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication is relevant for interpreting clinical data, not for engineering bench tests or demonstrating substantial equivalence.
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
This is not applicable. The FOCUS™-PV Balloon Dilatation Catheter is a medical device for intervention (angioplasty), not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as it is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For engineering tests, the "ground truth" is typically the established engineering specifications and accepted industry standards for medical device safety and performance. For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
This is not applicable, as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
This is not applicable, as this is not an AI/machine learning device.
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