(63 days)
This device is a disposable biopsy needle and can be used in , CT, Mammographic Radiographic and Echographic procedures to obtain biopsies of various tissues including those from Prostate, Kidney, Breast and Liver using an automatic device.
This device is a disposable biopsy needle
This submission (K021525) is a Premarket Notification (510(k)) for the TOPCUT™ Cutting Biopsy Needle, indicating the device's substantial equivalence to a predicate device. However, the provided document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria.
The document primarily focuses on the administrative aspects of the 510(k) submission, including:
- Applicant and contact information.
- Device trade name, common name, and classification.
- Identification of a predicate device (MANAN Medical Products, Automatic Cutting Needle), implying that the new device is being compared to this existing, legally marketed device.
- The indication for use statement for the TOPCUT™ Biopsy Needle.
- FDA's determination of substantial equivalence and subsequent approval to market the device.
To provide the requested information about acceptance criteria and a study demonstrating compliance, the original 510(k) submission document or a more detailed technical file for K021525 would be needed. This type of information is typically found in the performance data section of a 510(k) submission, which is not present in the provided excerpt.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies 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.