(29 days)
The Blazer Dx-20 Catheter is indicated for use to diagnose cardiac arrhythmia.
The Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter is a sterile, single use, steerable, diagnostic catheter intended for temporary use in electrophysiological studies for intracardiac stimulation (pacing) and/or recording of electrical potentials. The catheter is provided in two different bidirectional curve configurations, Medium (25 mm diameter) and Super Large (56 mm diameter), to assist the physician in reaching the desired anatomical location.
The distal electrode segment of the catheter contains an electrode tip and 19 electrode rings which are designed to carry electrical signals for endocardial stimulation (pacing) and/or recording. The electrode rings are placed on the distal segment of the catheter in various electrode spacing configurations, as described in Table 1. A 7F torqueable shaft connects the distal electrode segment to an ergonomically designed cylindrical handle.
The catheter handle contains both a steering knob and tension control knob. The degree of tip deflection of the catheter is controlled by the steering knob. The adjustable tension control knob can be tightened to hold the tip in the desired position
This catheter is compatible with most commercially available recording and mapping systems and connects to these systems via a cable, which is available separately.
The provided document describes a 510(k) premarket notification for the BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter. This type of submission, particularly a "Special 510(k)," is often used when modifications to a previously cleared device do not affect its fundamental safety or effectiveness.
Based on the information given, the document does not contain the detailed performance study information requested in the prompt. The text explicitly states:
- "8. Performance Data: Not applicable for this Special 510(k)."
This indicates that clinical performance data and acceptance criteria for a new study were not required for this particular regulatory submission because the device modifications were minor ("The proposed labeling modifications of the Blazer Dx-20 catheter do not impact the device's substantial equivalence to the previously cleared version of this device."). The submission primarily relies on the substantial equivalence to a predicate device (K211375).
Therefore, it is not possible to fill out a table of acceptance criteria and reported device performance or describe a study that proves the device meets the acceptance criteria using only the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance.
- Number of experts, their qualifications, or adjudication methods for ground truth.
- Whether MRMC studies were done, or their effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets or how ground truth was established for training sets (as this is a medical device, not an AI/ML algorithm requiring training sets).
The document is a regulatory notice for a physical medical device, not an AI/ML algorithm, which explains why many of the questions (especially those related to AI model training and ground truth establishment) are not applicable. The primary evidence presented is the substantial equivalence to a predicate device, not new performance study data.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).