Search Results

Blazer Dx-20 Catheter Cable:

The BSC Cables are intended to be used with the BSC Cardiac Diagnostic Catheters during an electrophysiology procedure for intracardiac stimulation (pacing) and/or recording of electrical potentials.

Polaris X Catheter Cable:

The BSC Cables are intended to be used with the BSC Cardiac Diagnostic Catheters during an electrophysiology procedure for intracardiac stimulation (pacing) and/or recording of electrical potentials.

Blazer™ Dx-20 Cable:

The subject Blazer Dx-20 Catheter cable (sold separately) is used with the Blazer Dx-20 Bidirectional Duodecapolar Catheter during an electrophysiology procedure. The Blazer Dx-20 Catheter Cable provides an electrical connection between the Blazer Dx-20 Diagnostic Catheter and the Electrophysiology (EP) Recording System. The cable has one connector that directly connects to the diagnostic catheter and multiple connection points that connect to an EP Recording System.

The main trunk consists of a jacketed 20-conductor cable that is split into individual leads by means of an over-molded splitter yoke. The proximal end of the cable has 20 universal 2 mm shrouded male pins that are typical to electrophysiology recording and stimulation systems. The Blazer Dx-20 cable is provided sterile using an EO sterilization process. The cable is reusable and can be reprocessed (i.e. re-sterilized) up to 10 times using either EO or STERRAD™ sterilization methods. The Blazer Dx-20 cable is to be used in a fully-equipped electrophysiology lab by physicians thoroughly trained in invasive cardiac mapping and ablation procedures.

Polaris X™ Cable:

The subject Polaris X Catheter Cable (sold separately) is used with the Polaris X Steerable Decapolar Mapping Catheters during an electrophysiology procedure. The Polaris X cable provides an electrical connection between the Polaris X Catheter and the Electrophysiology (EP) Recording System. The cable has one connector that directly connects to the diagnostic catheter and multiple connection points that connect to an EP Recording System.

The main trunk consists of a jacketed 10-conductor cable that is split into individual leads by means of an over-molded splitter yoke. The proximal end of the cable has 10 universal 2 mm shrouded male pins that are typical to electrophysiology recording and stimulation systems. The Polaris X cable is provided sterile using an EO sterilization process. The cable is reusable and can be reprocessed (i.e. re-sterilized) up to 10 times using EO sterilization method. The Polaris X cable is to be used in a fully-equipped electrophysiology lab by physicians thoroughly trained in invasive cardiac mapping and ablation procedures.

The provided document, a 510(k) summary for the Blazer™ Dx-20 Catheter Cable and Polaris X™ Catheter Cable, does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML device performance. The document describes the device, its intended use, comparison with predicate devices, and performance testing related to bioburden, reusability (manual cleaning and resterilization), and general design verification.

Therefore, I cannot provide the detailed information requested in the prompt based on the provided text, as it pertains to medical device regulatory clearance for cables used in electrophysiology procedures, not an AI/ML powered device.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance for an AI/ML algorithm. The performance data section refers to bioburden testing, reusable device testing (cleaning and resterilization), and design verification testing for the physical cables.
2. Sample sizes used for a test set or data provenance related to AI/ML.
3. Number of experts or their qualifications for establishing ground truth for an AI/ML test set.
4. Adjudication methods for an AI/ML test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
6. Standalone (algorithm only) performance data.
7. Type of ground truth used for AI/ML (expert consensus, pathology, outcomes data, etc.).
8. Sample size for an AI/ML training set.
9. How ground truth for an AI/ML training set was established.

The document primarily focuses on demonstrating the substantial equivalence of the new catheter cables to existing predicate devices based on physical and functional characteristics, sterility, and reprocessing capabilities.

Ask a specific question about this device