(30 days)
The Disposable Semi-Automated Temno® Biopsy Device is a system used for tissue sampling from several different organs, including, but not limited to, the Kidney, Liver, Breast and Prostate.
This biopsy device is used to remove, by cutting, a specimen of tissue for microscopic evaluation.
Needles are permanently attached to an automated device comprised of a spring that activates a stylet and cannula in a specified cutting sequence. The needle cuts and traps the tissue samples, which are substantially equivalent to samples obtained with similar devices currently in the market.
The provided text is a 510(k) summary for the Disposable Semi-Automated Temno® Biopsy Device, indicating its substantial equivalence to a predicate device. This type of regulatory document focuses on establishing equivalence and does not contain information about acceptance criteria, detailed study designs, or performance metrics typically found in clinical studies or validation reports.
Therefore, I cannot provide the requested information from the given input. The document explicitly states:
- "Performance attributes are the same" as the predicate device, but does not quantify these attributes or provide acceptance criteria.
- "Summary of testing: All materials used in the manufacturing of the Disposable Semi-Automated Temno® Biopsy Device have been evaluated as outlined in the ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The materials were found to be acceptable for this intended use." This refers to biocompatibility testing, not performance testing of the device's efficacy in obtaining tissue samples.
To answer your questions, I would need a different type of document, such as a detailed pre-clinical or clinical study report, or a validation plan that explicitly defines performance metrics and their 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.