(661 days)
to be used for histological biopsy on soft tissues. to retrieve bone marrow and bone samples from illac crest. to retrieve bone marrow and bone samples from iliac crest. histological biopsy on soft tissues histological biopsy on soft tissues histological biopsy on soft tissues. histological biopsy on soft tissues. aspiration bone marrow from sternum or illac crest. histological biopsy on soft tissues histological biopsy on soft tissues histological and cytological biopsies of soft tissue Aspiration needle for cyto - histological biopsies on soft tissue. histological biopsy on soft tissues histological biopsy on soft tissues histological biopsy on soft tissues
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This document is a 510(k) premarket notification for the "Medax Biopsy System - Guns and Needles" and related devices. It is largely a regulatory approval letter and a list of intended uses for various biopsy devices.
Unfortunately, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.
Specifically, the requested information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not present in this regulatory notice.
The document primarily focuses on:
- The FDA's decision that the device is "substantially equivalent" to predicate devices.
- Regulatory requirements and contact information.
- A list of various Medax biopsy device names and their intended uses (e.g., "histological biopsy on soft tissues," "retrieve bone marrow and bone samples").
To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a design validation report, or a clinical study report.
§ 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.