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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.

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