(30 days)
The Tru-Core™ Disposable Automatic Biopsy Instrument is intended for use in obtaining multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.
The Tru-Core™ Disposable Automatic Biopsy Instrument is intended for use in obtaining multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.
This document is a 510(k) summary for the Tru-Core™ Disposable Automatic Biopsy Instrument and does not contain information about acceptance criteria or a study proving device performance against acceptance criteria.
The 510(k) summary focuses on the device's substantial equivalence to previously marketed devices and its intended use. It does not include details on:
- A table of acceptance criteria and reported device performance.
- Sample size or data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used in a performance study.
- Sample size for a training set.
- How ground truth for a training set was established.
Therefore, I cannot provide the requested information based on 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.