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The Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. The Transseptal Needle is intended for single use only.

The Transseptal Sharp Needle consists of a stainless-steel needle and nitinol stylet. The needle comes in two lengths equivalent to the lengths of the TSN Transseptal Needle (predicate) - 71cm and 98cm, and two curves, Curve0 (59°) and Curve1 (72°). The size is 18 gauge with an inner diameter of .0325" at the proximal body and necks down to 21 gauge with an inner diameter of 0.0230" at the distal end with a sharp a-bevel offset tip. The transseptal sharp needle includes a 0.018" diameter nitinol stylet wire with an intermediate 0.013" section, a bulbous distal tip, and a proximal clear plastic handle with an internal mechanism configured to both provide feedback on the position of the stylet tip and as well as to maintain the stylet tip in the extended position to reduce the possibility for further penetration of the needle after the initial crossing of the septum. The components of the Transseptal Sharp Needle include the transseptal sharp needle, stylet. sterile packaqing, and labeling.

There are four model numbers for the transseptal sharp needle: CLICK071, CLICK098, CLICK171, and CLICK198. The Transseptal Sharp Needle is sterilized by 100% ethylene oxide cycle and is for single use-only. The Transseptal Sharp Needle is used in a healthcare facility/hospital.

The transseptal sharp needle is used in transseptal procedures to puncture the fossa ovalis and gain access to the left atrium through the right side of the heart. The device is used by inserting the device through a transseptal dilator assembly. The devices are inserted in the femoral vein. The transeptal sharp needle is then advanced to the fossa ovalis. This mimics the procedure with the predicate device, TSN Transseptal Needle. Both the proposed device and the predicate device (K17950) have a needle point, made of stainless steel, have similar hub and handle, and have similar dimensions, design, and functionality. The needle's duration in the body is less than 24 hours.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "SafeSharp Transseptal Needle." It details the device's indications for use, its comparison to a predicate device, and the performance testing conducted to demonstrate substantial equivalence.

However, the request asks for specific information related to acceptance criteria and a study that proves the device meets acceptance criteria, particularly in the context of an AI/Software as a Medical Device (SaMD).

Reading through the entire document, there is no mention of an AI or software component for the "SafeSharp Transseptal Needle." The device is a physical medical instrument (a needle and stylet) used for puncturing the interatrial septum. The performance testing outlined (visual/dimensional inspection, particulate testing, pull tests, leak testing, simulated use) are all standard engineering and material tests for a physical device, not for evaluating an AI algorithm's performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/SaMD.

The document does not describe:

1. A table of acceptance criteria and reported device performance for an AI/SaMD.
2. Sample size, data provenance, number of experts, or adjudication methods for an AI/SaMD test set.
3. MRMC comparative effectiveness study or standalone AI performance.
4. Type of ground truth, training set size, or how ground truth was established for an AI/SaMD.

It seems there might be a misunderstanding or a misapplication of the prompt to this specific document, which describes a conventional hardware medical device.

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