(16 days)
These needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues through a combination of cutting and/or aspirating.
The breast localization needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain breast lesion tissue.
The biopsy needles can be used in MRI, Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues through a combination of cutting and/or aspirating.
The breast localization need in MRI, Fluoroscopic, CT and Mammographic procedures to obtain breast lesion tissue.
The provided text pertains to a 510(k) submission for various medical needles (biopsy and breast localization needles) and focuses on the "Substantial Equivalence" claim, rather than a study demonstrating performance against specific acceptance criteria for a novel device. The document identifies substantially equivalent predicate devices but does not detail a study conducted to prove the performance of the new device.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because the document does not contain this type of performance study data. The 510(k) summary explicitly states "SUBSTANTIAL EQUIVALENCE" and lists predicate devices, indicating the regulatory pathway chosen.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set or data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Stand-alone algorithm performance data.
- The type of ground truth used in a performance study.
- Sample size for a training set.
- How ground truth for a training set was established.
§ 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.