(108 days)
The VersaCross™ RF Wire is indicated for creation of an atrial septal defect in the heart.
The subject VersaCross™ RF Wire is a single-use device that is supplied sterile to the user. The subject device is comprised of an RF Wire and separately cleared Connector Cable (K023334) that are packaged together. The RF Wire is indicated for the creation of an atrial septal defect in the heart. The RF Wire delivers radiofrequency (RF) power in a monopolar mode between its distal active electrode and a commercially available external Disposable Indifferent (Dispersive) Patch (DIP) Electrode/grounding pad. The RF Wire is used with a separately cleared compatible generator, such as the Baylis RF Puncture Generator (K12278). The VersaCross™ RF Wire is comprised of a core stainless steel wire. The RF Wire body is covered with an insulating material to facilitate smooth advancement of the device in conjunction with providing electrical insulation. The floppy distal end of the RF Wire is curved and the active tip is rounded to be atraumatic to cardiac tissue unless RF energy is applied. A marker coil and radio-opaque band is positioned on the distal curve and distal tip, respectively, to facilitate RF Wire placement at the target puncture site during procedures under appropriate imaging quidance such as fluoroscopy, echocardiography and/or electroanatomic mapping (EAM) quidance. The main body of the RF Wire provides a rail for advancing ancillary devices into the left atrium following creation of an atrial septal defect. The RF Wire features visible proximal markers along its length to assist with aligning the wire tip in compatible transseptal sheath and/or dilator assemblies. The proximal end of the RF Wire is bare metal to facilitate connection with the included connector cable. The other end of the included connector cable connects to the compatible Baylis RF Puncture Generator.
The provided document is an FDA 510(k) clearance letter and a 510(k) summary for the VersaCross™ RF Wire. This document pertains to the clearance of a medical device and describes its testing and comparison to a predicate device, rather than the evaluation of an AI/ML powered device.
Therefore, the information typically requested for AI/ML device evaluations (such as acceptance criteria for AI performance, sample sizes for test sets, establishment of ground truth by experts, MRMC studies, standalone performance, training set details, etc.) is not provided in this document.
The document focuses on non-clinical performance testing for a physical medical device (a guidewire) to demonstrate its safety, effectiveness, and substantial equivalence to an existing predicate device. The tests described are mechanical, electrical, thermal, biocompatibility, sterilization, pyrogenicity, packaging, and benchtop validation, all of which are standard for traditional medical devices.
Summary of available information relevant to device testing (but not AI/ML performance):
- Device Name: VersaCross™ RF Wire
- Predicate Device: ProTrack™ RF Anchor Wire (K150709)
- Purpose of Testing: To demonstrate safety, effectiveness, and substantial equivalence of the subject device to the predicate device.
- Type of Ground Truth Used: Not applicable in the context of AI/ML. For a physical device, "ground truth" would relate to meeting pre-defined physical, chemical, electrical, and biological specifications and performance criteria.
- Sample Size for Training/Test Sets: Not applicable in the context of AI/ML. The document refers to "verification and validation activities" and "test protocols" for specific mechanical, electrical, and other physical tests, but does not specify sample sizes for these tests in the way one would for an AI/ML model's test set. The tests performed are laboratory-based and follow established standards (e.g., ISO, IEC).
In conclusion, this document does not contain the information required to answer your specific questions regarding acceptance criteria and study details for an AI/ML powered device.
§ 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).