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510(k) Data Aggregation
(196 days)
VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)
The Visions catheters are designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels.
The Visions ultrasound imaging catheter is designed for use as an adjunct to conventional angiographic procedures to provide:
- An image of the vessel lumen and wall structures. (1)
- (2) Dimensional measurements from the image.
The Visions 8.2F PV catheter is a diagnostic device intended for use in diagnostic ultrasound imaging of the peripheral vasculature.
The Visions 8.2F PV is available in an over-the-wire design. The catheter has a 7.0F shaft with a maximum distal diameter of 8.2F.
The provided text describes a 510(k) premarket notification for the EndoSonics Visions 8.2F PV Intravascular Imaging Catheter. The submission aims to establish substantial equivalence to predicate devices, rather than proving performance against specific acceptance criteria through a clinical study for an AI/ML device.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable and not found within this document. This is because the device being reviewed is a physical medical device (an ultrasonic imaging catheter), not an AI/ML software.
However, I can extract information related to the device's technical specifications and the testing performed to demonstrate its safety and performance based on the provided text.
Here's a summary of the available information structured to best fit your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Meets/Exceeds Specification: "All catheters are manufactured from similar biocompatible materials. Biocompatability testing has been performed." (Implies meeting the standard criteria for biocompatibility, though specific thresholds are not listed) |
| Radiopacity | Meets/Exceeds Specification: "Testing of the EndoSonics Visions catheters include radiopacity... These tests demonstrated the devices meet or exceed specification..." (Specific values not provided, but indicated as satisfactory) |
| Tensile Strength (Catheter Shaft) | Meets/Exceeds Specification: "Testing of the EndoSonics Visions catheters include... tensile strength of the catheter shaft... These tests demonstrated the devices meet or exceed specification..." and "Tensile strength of the catheter shaft... show that the catheter tip met design specifications." (Specific values not provided, but indicated as satisfactory) |
| Tensile Strength (Catheter Distal End) | Meets/Exceeds Specification: "Testing of the EndoSonics Visions catheters include... catheter distal end tensile strength... These tests demonstrated the devices meet or exceed specification..." and "Tensile strength of the... catheter tip show that the catheter tip met design specifications." (Specific values not provided, but indicated as satisfactory) |
| Profile Measurements (Catheter Tip) | Within Specification Tolerances: "Testing of the EndoSonics Visions catheters include... profile measurements... as well as catheter tip profiles were within specification tolerances." (Specific values not provided, but indicated as satisfactory) |
| Acoustic Output (Thermal Index) | Reported Value: TI = 0.012 MI (This is a measured value; implied to be within acceptable safety limits, though specific acceptance criteria for TI are not stated in the document directly) |
| Acoustic Output (Spatial-Peak Temporal-Average Intensity) | Reported Value: ISPTA = 0.0158 mW/cm^2 (This is a measured value; implied to be within acceptable safety limits, though specific acceptance criteria for ISPTA are not stated in the document directly) |
| Acoustic Output (Spatial-Peak Pulse-Average Intensity) | Reported Value: ISPPA = 0.044 W/cm^2 (This is a measured value; implied to be within acceptable safety limits, though specific acceptance criteria for ISPPA are not stated in the document directly) |
| Substantial Equivalence | Achieved: The FDA letter explicitly states, "We have determined the device is substantially equivalent... to legally marketed predicate devices." This is the ultimate "acceptance criterion" for a 510(k) submission. |
Regarding the other requested points (relevant for AI/ML studies):
- 2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device submission, not an AI/ML study. The testing mentioned (radiopacity, tensile strength, etc.) would be performed on a sample of manufactured devices, not on a "test set" of patients or data in the AI sense.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for diagnostic accuracy in the AI/ML context is being established here. Performance is based on engineering and safety specifications.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is not an AI-assisted device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device type would relate to objective engineering measurements rather than clinical interpretations/diagnoses.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
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