(287 days)
Indicated for use in procedures where access to the left atrium via the transseptal technique is desired. The SafeSept® Transseptal Guidewire is intended for single use only.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Oscor Inc. regarding their SafeSept® NF Transseptal Trocar Guidewire. This document primarily focuses on regulatory approval and equivalence to a predicate device. It does not contain any information regarding acceptance criteria, study details, device performance, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information based on the input text. The document confirms the device's regulatory classification, its intended use, and that a substantial equivalence determination has been made, but it does not detail the technical performance studies that would typically include acceptance criteria and study 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.