(42 days)
The instrument is designed to be used to provide access to lesions to be biopsied.
Coaxial Introducer
This document is an FDA 510(k) clearance letter for the "Coaxial Introducer" and does not contain the acceptance criteria or study details requested in the prompt.
The letter explicitly states:
- Trade Name: Coaxial Introducer
- Regulatory Class: II
- Product Code: KNW
- Indications for Use: The instrument is designed to be used to provide access to lesions to be biopsied.
- Date of Clearance: July 29, 1997
The letter confirms that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This is a regulatory determination, not a clinical performance study. The letter does not describe any specific performance criteria, testing, or studies, as it is solely focused on the regulatory clearance process.
Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria from the provided text.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.