(76 days)
The VNUS® ClosureFAST™ Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
Not Found
The provided text describes the 510(k) premarket notification for the VNUS® ClosureFAST™ Catheter. However, it does not include detailed information regarding acceptance criteria, a specific study proving device performance against those criteria, or the methodology typically associated with such studies (sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance).
Instead, the submission focuses on establishing substantial equivalence to a predicate device.
Here's an attempt to answer your questions based only on the provided text, highlighting what is implicitly or explicitly stated and what is missing:
Acceptance Criteria and Study Information
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative metrics or thresholds. | "Performance is substantially equivalent to the predicate device and effective for its intended function." |
| Specific functional or clinical endpoints with predefined success rates are not provided. | Biocompatibility: "The materials used in the VNUS ClosureFAST Catheters have been shown to be biocompatible." |
| Bench test results or clinical study outcomes against specific criteria are not detailed in the summary. | The device's technological characteristics and principles of operation are considered substantially equivalent to the predicate device, relying on RF energy delivery to heat a blood vessel to a specific temperature. |
Missing Information: The document does not provide explicit numerical acceptance criteria (e.g., "The device must achieve X% vein closure rate" or "Temperature control must be within Y degrees"). The primary "acceptance" is based on substantial equivalence to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. (The submission does not detail any specific clinical or in-vitro tests that would involve a "test set" in the context of algorithm evaluation).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable/Not specified. This information is typically relevant for studies involving human interpretation or expert review, which is not described as part of the evidence provided in this 510(k) summary.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. (Likely not relevant as no expert consensus or ground truth establishment based on human review is described).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. The document makes no mention of an MRMC study or any comparison of human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable/Not specified. The device is a physical catheter, not an AI algorithm, so the concept of "standalone performance" for an algorithm doesn't apply here. The performance evaluation is implicitly around the device's physical and functional capabilities, as compared to a predicate device.
7. The Type of Ground Truth Used
- The "ground truth" for the device's functional performance is implicitly established by the performance of the predicate device (VNUS® ClosurePlus™ Catheter, K030557) and the underlying scientific understanding of RF energy's effect on blood vessels for coagulation. There's no mention of pathology, outcomes data, or expert consensus being specifically used as "ground truth" in new studies for this 510(k). The focus is on substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable/Not specified. This concept applies to algorithms that learn from data, which is not the case for this device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not specified, as there is no training set mentioned.
Summary of Device and Evidence Presented:
The VNUS® ClosureFAST™ Catheter's acceptance criteria and proof of effectiveness are primarily based on its substantial equivalence to an existing, legally marketed predicate device (VNUS® ClosurePlus™ Catheter, K030557). The 510(k) summary states:
- "The subject device is substantially equivalent in intended use and/or method of operation to the VNUS® ClosurePlus™ Catheter (K030557)."
- "The technological characteristics and principals of operation of the VNUS ClosureFAST catheter are substantially equivalent to the noted predicate devices rely on the delivery of RF energy to an intravascular catheter that heats a blood vessel to a specific temperature to achieve the intended use."
- "Performance is substantially equivalent to the predicate device effective for its intended function."
- Biocompatibility of materials was confirmed.
Therefore, the "study" for acceptance is an argument for substantial equivalence, rather than a detailed presentation of new clinical trial data against novel, explicit acceptance criteria. The FDA agreed with this assessment, stating, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices..."
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.