(50 days)
The Metricath System is indicated for use as an adjunct to conventional angiographic procedures to provide measurements of arterial lumen cross sectional area and diameter of the coronary, renal, iliac and femoral arteries. The Metricath Balloon Catheter is indicated for use in patients who are candidates for percutaneous, transluminal interventional procedures to make arterial lumen measurements proximal to a lesion, or within a stented section of artery.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Angiometrix Inc. Metricath System, dated November 18, 2004. This type of document primarily confirms that a medical device is substantially equivalent to a predicate device already on the market and describes its intended use. It does not typically contain detailed information about specific acceptance criteria, study designs, or performance metrics in the way a clinical study report or a technical design document would.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: The letter does not specify quantitative acceptance criteria or detailed performance results. It only states that the device is "substantially equivalent."
- Sample size used for the test set and the data provenance: No information on test set size or data origin (e.g., country, retrospective/prospective) is present.
- Number of experts used to establish the ground truth for the test set and their qualifications: No details about ground truth establishment or expert involvement are provided.
- Adjudication method: The document does not describe any adjudication process.
- Multi-reader multi-case (MRMC) comparative effectiveness study: There is no mention of such a study or any associated effect size.
- Standalone (algorithm only) performance: This device is a physical catheter system, not a software algorithm, so standalone performance in the sense of AI models is not applicable.
- Type of ground truth used: Not specified.
- Sample size for the training set: Not applicable for this type of device and document.
- How the ground truth for the training set was established: Not applicable.
What the document does provide is:
- Device Name: The Metricath System
- Indications for Use: "The Metricath System is indicated for use as an adjunct to conventional angiographic procedures to provide measurements of arterial lumen cross sectional area and diameter of the coronary, renal, iliac and femoral arteries. The Metricath Balloon Catheter is indicated for use in patients who are candidates for percutaneous, transluminal interventional procedures to make arterial lumen measurements proximal to a lesion, or within a stented section of artery."
- Regulatory Classification: Class II (two), Product Code: DQO, Regulation Number: 21 CFR 870.1200 (Diagnostic Intravascular Catheter)
- Predicate Device: Not explicitly named, but the letter states the device is substantially equivalent to "legally marketed predicate devices."
- Date of Clearance: November 18, 2004
To get the specific information requested in the prompt, one would need to review the original 510(k) submission (K042685) itself, which would contain the technical data and study reports submitted to the FDA to demonstrate substantial equivalence. The clearance letter only summarizes the FDA's decision.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).