(138 days)
The Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through interatrial septum.
The Steerable Guide Catheter (including a dilator) consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a dilator with a single central lumen. The device provides a conduit into the left side of the heart through the interatrial septum. The Steerable Guide Catheter is provided EtO sterile and for single use only.
This document is a 510(k) Premarket Notification from the FDA regarding a MitraClip G4 Steerable Guide Catheter. It focuses on establishing substantial equivalence to a predicate device, rather than proving the performance of a novel AI/ML-driven device against specified acceptance criteria using a study.
Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, and types of ground truth cannot be extracted from this document.
This document primarily discusses:
- Regulatory Classification: Class II device, product code DRA.
- Device Description: A steerable guide catheter, including a dilator, used for introducing other catheters into the left side of the heart through the interatrial septum.
- Predicate Device: K190167 Steerable Guide Catheter.
- Comparison of Technological Characteristics: Stating that the subject device has the "same technological characteristics" as the predicate device in terms of intended use, indications for use, principles of operation, fundamental technology, materials, dimensions, and sterilization. Minor design modifications and shelf-life changes are noted.
- Performance Data: Only states that "Testing was performed to support substantial equivalence, including: Performance Shelf Life." It does not provide details of these tests, specific acceptance criteria, or performance results.
- Conclusion: The device is equivalent to the predicate device, with no differences raising new safety or effectiveness questions.
In summary, this document is a regulatory approval letter based on substantial equivalence, not a study report detailing performance metrics against specific acceptance criteria for an AI/ML-driven medical device.
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).