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510(k) Data Aggregation
(69 days)
VasCon Polaris™ Guiding Catheters, K033633
The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.
The VasCon Polaris™ Guiding Catheters are single lumen catheters, incorporating a nylon body reinforced with a stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip to reduce potential vessel injury. They are available in 5Fr, 6Fr, 7Fr, and 8Fr, 100 cm in length, and in a variety of shapes. The technological characteristics are equivalent to the predicate device.
Here's an analysis of the provided information regarding acceptance criteria and device performance:
Unfortunately, the provided document does not contain the specific information required to complete the detailed table and answer most of the questions about acceptance criteria and the study that proves the device meets them.
The document is a 510(k) Summary for a medical device (VasCon Polaris™ Guiding Catheter) and the FDA's clearance letter. While it mentions "Laboratory testing has been performed on the VasCon Polaris™ Guiding Catheters to assure compliance to the specifications," it does not elaborate on what those specifications (acceptance criteria) were, nor does it provide any specific performance data from the testing.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (VasCon Polaris™ Guiding Catheters, 510(k) K033633) based on similar technological characteristics and intended use, rather than a detailed performance study with explicit acceptance criteria and results.
Therefore, I cannot fill in the table or answer the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement.
Here's what I can provide based on the given text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|
| Mechanical Properties: (e.g., Tensile strength, kink resistance, burst pressure, torque response, pushability) | "Laboratory testing has been performed on the VasCon Polaris™ Guiding Catheters to assure compliance to the specifications." - Specific performance data not provided. |
| Biocompatibility: (e.g., Cytotoxicity, sensitization, irritation, hemocompatibility) | (Implied to be equivalent to predicate, but no specific testing results or criteria mentioned.) |
| Sterility: (e.g., Sterility Assurance Level) | (Standard for medical devices, but specific criteria/results not mentioned.) |
| Radiopacity: (Ability to be visualized under fluoroscopy) | "soft radiopaque tip" - No quantitative performance data. |
| Lubricity of Inner Lumen: (Ease of device passage) | "PTFE lubricious inner lumen" - No quantitative performance data. |
| Dimensional Specifications: (e.g., Diameter, length, French size) | "available in 5Fr, 6Fr, 7Fr, and 8Fr, 100 cm in length" - No specific performance data on precision or variability. |
| Functional Performance for Intended Use: (e.g., Ability to safely introduce and guide devices) | "safe and effective for its intended use" - No specific performance data or clinical study results. |
Summary of Device Performance (as stated in the document):
- Conclusion: "The testing as discussed above demonstrate that, like the predicate device, the VasCon Polaris™ Guiding Catheters are safe and effective for its intended use."
- Technological Characteristics: "The technological characteristics are equivalent to the predicate device."
Missing Information:
The document lacks the specific numerical acceptance criteria and the actual performance results from the laboratory testing. It states that testing was performed to assure compliance but does not detail the compliance itself.
Regarding the specific questions:
- 2. Sample sized used for the test set and the data provenance: Not mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no external expert review or ground truth establishment is described for performance testing of this type of device in the provided text. Device performance is typically assessed by engineers/technicians in a lab setting against technical specifications.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as this refers to clinical interpretation by experts, not laboratory testing of a guiding catheter.
- 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 device is a guiding catheter, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a guiding catheter, not an algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For guiding catheters, "ground truth" would typically be derived from engineering specifications and physical measurements, rather than clinical consensus or pathology. The document only states "compliance to the specifications."
- 8. The sample size for the training set: Not applicable, as this refers to a machine learning context.
- 9. How the ground truth for the training set was established: Not applicable.
In conclusion, while the document confirms that laboratory testing was performed and concluded the device is safe and effective and substantially equivalent to a predicate, it does not provide the detailed acceptance criteria or performance data of those tests.
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