Search Results

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.

Ask a specific question about this device