(72 days)
This device is to be used for taking cyto-histological biopsies of soft tissue.
Pan® Aspirating Needle (Chiba)
This is a 510(k) clearance letter for the Pan® Aspirating Needle (Chiba), dated May 2, 1997. It indicates that the device has been found substantially equivalent to devices marketed prior to May 28, 1976. This document does NOT contain information regarding acceptance criteria, device performance, or any studies proving the device meets acceptance criteria.
The information provided confirms the following:
- Trade Name: Pan® Aspirating Needle (Chiba)
- Regulatory Class: II
- Product Code: KNW
- Indications for Use: To be used for taking cyto-histological biopsies of soft tissue.
- Submission Type: 510(k) premarket notification (K970872)
Since this document is a 510(k) clearance letter, it does not include the detailed information requested regarding:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
A 510(k) submission typically includes data demonstrating substantial equivalence, sometimes referencing existing predicate device performance or providing limited performance data for the new device. However, the clearance letter itself does not detail these studies. To obtain such information, one would need to review the full 510(k) submission (if publicly available or by freedom of information act request) or supporting documentation from the manufacturer.
§ 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.