(90 days)
The ProTrack RF Anchor Wire is indicated for the creation of an atrial septal defect in the heart.
The ProTrack RF Anchor Wire is a sterile, single-use device that delivers radiofrequency (RF) power in a monopolar mode to its distal electrode. The device connects to a separately cleared Baylis Medical Company (BMC) RF Puncture Generator at its proximal end through a compatible BMC Connector Cable.
The ProTrack RF Anchor Wire is comprised of a core stainless steel wire. The body of the wire is coated with an insulating material to facilitate smooth advancement of the device and to provide electrical insulation. The wire's distal end is atraumatic and curved to prevent the wire from slipping back into the right atrium through the atrial septal defect when devices are being retracted or advanced over it. A marker coil is positioned on the distal curve for visualization under fluoroscopy. The main body of the RF Anchor Wire provides a stiff rail for advancing ancillary devices into the left atrium following creation of an atrial septal defect. The proximal end is curved and is bare metal to connect with the included BMC Connector Cable for connection to the compatible BMC RF Puncture Generator.
The provided text does not contain information about acceptance criteria and a study that proves a digital health device meets those criteria. Instead, it describes a medical device, the "ProTrack RF Anchor Wire," and its 510(k) submission to the FDA for market clearance.
The document discusses:
- Device Name: ProTrack RF Anchor Wire
- Indications for Use: Creation of an atrial septal defect in the heart.
- Comparison to Predicate Devices: Nykanen Radiofrequency Wire (K990284) and NRG Transseptal Needle (K073326).
- Performance Testing: Biocompatibility, Mechanical, Electrical, Arc Integrity, and Benchtop Validation. These tests were conducted to demonstrate compliance with standards (e.g., ISO 10993-1, ISO 11070, IEC 60601-2-2) and internal requirements, and to show compatibility and performance comparable to predicate devices.
However, the questions posed in the prompt relate specifically to a study evaluating the performance of a digital health device (e.g., AI in radiology), including acceptance criteria for performance metrics, sample sizes for test and training sets, expert adjudication, and comparative effectiveness studies. None of this information is present in the provided text, as the "ProTrack RF Anchor Wire" is a physical medical device, not a digital health/AI product.
Therefore, I cannot fulfill the request based on the provided input.
§ 870.5175 Septostomy catheter.
(a)
Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.(b)
Classification. Class II (performance standards).