(45 days)
Used for soft tissue biopsy. Supplied sterile in peel-open packages. Intended for single procedure use.
The Quick-Core™ Biopsy Needle is used for soft tissue biopsy procedures. The device will be constructed of stainless steel and polycarbonate in 14, 15, 16, 18, 19 and 20 gauge and 6, 9, 15, 20 and 48 cm lengths. It will be supplied sterile, intended for onetime use.
The provided text describes a 510(k) premarket notification for a biopsy needle and provides general regulatory information from the FDA. It does not contain information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample sizes and data provenance
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
The document focuses on demonstrating substantial equivalence to a predicate device based on intended use, materials, and technological characteristics, rather than presenting a detailed performance study against defined acceptance criteria.
§ 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.