(87 days)
The Reprocessed ClosureFast RF Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
The Reprocessed ClosureFast RF Catheter relies on the delivery of radiofrequency (RF) energy via an intravascular catheter that delivers temperature controlled heat to a predetermined length of superficial vessel. The ClosureFast RF Catheter is a sterile device with a 7cm radiofrequency heating element, a molded handle with start/stop switch, a flexible shaft and an integrated instrument cable, and is designed for use with the ClosureRFG (RF) Generator.
This document is a 510(k) summary for a reprocessed medical device, the Reprocessed ClosureFast Radiofrequency (RF) Catheter, and does not describe a study involving AI or machine learning.
Therefore, I cannot provide information on the following points:
- A table of acceptance criteria and the reported device performance (no AI performance metrics are discussed).
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study (not applicable).
- Standalone (algorithm only) performance (not applicable).
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
However, I can extract information related to the device's performance data and acceptance criteria as described in this 510(k) summary:
1. Acceptance Criteria and Device Performance:
The document states that the Reprocessed ClosureFast RF Catheter was tested to demonstrate appropriate functional characteristics and that process validation testing was performed to validate the cleaning process in line with AAMI TIR 30:2011 requirements. The manufacturing process includes visual and validated functional testing of all products.
While specific numerical acceptance criteria (e.g., minimum tensile strength, maximum leakage current, etc.) for functional characteristics are not detailed in this summary, the implicit acceptance criterion is that the reprocessed device performs identically and safely to the new predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Appropriate functional characteristics (identical to predicate device in design and operation) | "Representative samples of Reprocessed ClosureFast RF Catheters were tested to demonstrate appropriate functional characteristics through bench top verification testing." The document also states, "The Reprocessed ClosureFast RF Catheters are identical to the predicate device in design, materials of construction, and intended use. There are no changes to the clinical applications, patient population, performance specifications, or method of operation." Additionally, "The manufacturing process includes...validated functional testing of all products produced prior to release." |
| Validated cleaning process | "Process validation testing was performed to validate the cleaning process in line with AAMI TIR 30:2011 requirements." |
| Visual integrity | "The manufacturing process includes visual...testing of all products produced prior to release." |
| Substantially Equivalent to Predicate Device | "Covidien concludes that the Reprocessed ClosureFast RF Catheter is safe, effective, and substantially equivalent to the predicate device, ClosureFast RF Catheters K061373..." |
2. Study Description:
The summary refers to bench top verification testing and process validation testing as the studies conducted. These are not clinical trials, but rather engineering and quality control studies.
- Bench Top Verification Testing: This type of testing involves evaluating the device's functional performance in a laboratory setting. It would assess physical and electrical properties relevant to the device's intended use.
- Process Validation Testing: Specifically mentions validating the cleaning process in line with AAMI TIR 30:2011 requirements. AAMI TIR 30:2011 provides guidance on processing reusable medical devices in health care settings.
Summary of what's provided in the document regarding the "study":
- Study Goal: Demonstrate appropriate functional characteristics and validate the cleaning process to ensure the reprocessed device is safe, effective, and substantially equivalent to the predicate device.
- Type of Study: Bench top verification testing and process validation testing.
- "Test Set" / Samples Used: "Representative samples of Reprocessed ClosureFast RF Catheters." (Specific number of samples not provided).
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing by the manufacturer (Covidien) in Mansfield, MA, USA. This is an internal, prospective testing of reprocessed devices.
- Ground Truth: For the "functional characteristics," the ground truth is likely the performance specifications of the original predicate device (ClosureFast RF Catheter K061373). For the cleaning process, the ground truth is adherence to the standards outlined in AAMI TIR 30:2011.
§ 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.