(123 days)
The SafeSept Transseptal Trocar Guldewire is indicated for use In procedures where access to the left atrium via the transseptal technique is desired. The SafeSept Transseptal Trocar Guidewire is Indicated for single use only.
Not Found
This document is an FDA 510(k) clearance letter for a medical device (SafeSept Transseptal Trocar Guidewire). It indicates that the device has been found substantially equivalent to a predicate device.
However, the provided text does NOT contain information about acceptance criteria, device performance, a study design, or any of the detailed analytical performance metrics requested in your prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies).
The letter primarily focuses on the regulatory aspects of the clearance, such as:
- Confirmation of substantial equivalence.
- The device's classification (Class II).
- Applicable regulations (e.g., annual registration, GMP, labeling).
- Contact information for various FDA offices.
- The device's indications for use.
Therefore, I cannot extract the specific information you requested from this document. To answer your prompt, I would need a different type of document, such as:
- A scientific publication detailing the device's validation study.
- The 510(k) summary document, which often contains a brief overview of performance data.
- The full 510(k) submission, which includes detailed testing protocols and results.
§ 870.1390 Trocar.
(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.