(243 days)
The Blazer Dx-20 is a diagnostic catheter indicated for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.
The Boston Scientific Corporation Blazer Dx-20 is a sterile, single use steerable diagnostic electrophysiology catheter used to record intracardiac electrical potentials. The Blazer Dx-20 Catheter is also used to deliver pacing stimuli from an external source. The Blazer Dx-20 Catheter is a bi-directionally steerable diagnostic catheter built on a modified SteeroCath Dx shaft platform with a molded handle. It has one tip electrode and up to 19 ring electrodes for a total of 20. The ring spacing configurations vary with each model. The catheter shaft of the Blazer Dx-20 is equivalent to the SteeroCath Dx Catheter, which is designed to allow for a standard curve of the catheter distal section. The catheter shaft has a soft distal section in order to minimize trauma and risk of perforation. The Blazer Dx-20 Catheters use a thumb-actuated bidirectional steering mechanism. contained within an ergonomically shaped cylindrical handle that is also utilized by the currently marketed SteeroCath Dx Diagnostic catheters. A thumb-level motion of the piston actuates the steering of the distal tip. The catheter is placed into the heart and is guided to location by steering the distal tip area of the catheter. Tip and ring electrodes come into contact with the endocardium where electrical contact is made and pacing and recording of electrograms becomes possible. No new technology or circuitry is associated with the transmission of electrical signals to or from the endocardium - the Blazer Dx-20 Catheter relies on platinum-iridium alloy, ring electrodes whose circuitry is identical to standard electrode and pacing catheters. Additionally, the electrical connections made (catheter to EP recorder) are similar to those for commercially available electrode recording and pacing v catheters.
The provided text describes a medical device submission (510(k)) for the Blazer Dx-20 Steerable Diagnostic Catheter. This is a submission for a physical medical device, not a software-based AI/ML device.
Therefore, most of the requested information (acceptance criteria, device performance tables, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable in the context of this document. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Here's a summary based on the provided text, highlighting what is and isn't applicable:
1. Table of acceptance criteria and reported device performance:
This information is not applicable as the submission is for a physical medical device, not an AI/ML system. The document states:
"Specifically, non-clinical tests adopted by and conducted for the Blazer Dx-20 Catheter included biocompatibility, sterility, packaging, physical integrity, and electrical integrity testing that all passed and have shown substantial equivalence to the predicate device, the SteeroCath Diagnostic Catheter."
The "acceptance criteria" are implied to be that these non-clinical tests "passed," demonstrating substantial equivalence, but specific quantitative criteria and performance metrics are not given in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No test set of data (in the context of an AI/ML algorithm) was used. The evaluation was based on non-clinical engineering and biological safety tests of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No "ground truth" in the context of expert consensus on data was established. The evaluation was based on non-clinical engineering and biological safety tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method for a data test set was used. The evaluation was based on non-clinical engineering and biological safety tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This relates to AI/ML software performance. The submission is for a physical diagnostic catheter, and no MRMC study, or human-in-the-loop AI assistance, was conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This relates to AI/ML software performance. The submission is for a physical medical device, and no standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No "ground truth" (in the context of AI/ML data) was used. The device's safety and effectiveness were evaluated via non-clinical tests (biocompatibility, sterility, packaging, physical integrity, and electrical integrity) to demonstrate substantial equivalence to a predicate device.
8. The sample size for the training set:
Not applicable. No training set was used. This is a physical medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established:
Not applicable. No training set or ground truth for it was established. This is a physical medical device.
§ 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).