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Combined End Multilateral Holes (CEMLH) Epidural Catheter

This document does not contain the detailed technical information required to describe the acceptance criteria and the study that proves the device meets those criteria. The provided text is a letter from the FDA regarding a 510(k) premarket notification for an epidural catheter, stating that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information, as the input document focuses on regulatory approval rather than a description of a scientific study characterizing device performance.

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Double-Holed Pencil Point Spinal Needle (DHPP)

This is an FDA premarket notification (510(k)) letter for a medical device. This type of document is a clearance letter, not a study report or a detailed description of device performance or clinical trials. Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from this document.

This letter only states that the device, a "Double-Holed Pencil Point Spinal Needle (DHPP)," has been found "substantially equivalent" to legally marketed predicate devices. It does not contain details about specific acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

To answer your questions, one would need access to the 510(k) submission document itself, which would include the performance data and the comparison to the predicate device.

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