(129 days)
The Blazer Dx-20 Catheter is intended for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.
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 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 text describes the Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter and its submission for 510(k) clearance. The focus of the submission is to demonstrate substantial equivalence to a predicate device, primarily by showing that an adhesive material change does not negatively impact the device's safety and effectiveness.
Here’s an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list quantitative acceptance criteria in a clear, tabular format for device performance metrics like sensitivity, specificity, or accuracy, which would be common for diagnostic AI/software devices. Instead, the "acceptance criteria" are implied by the types of tests performed to demonstrate safety and effectiveness for a physical medical device (catheter), particularly in comparison to its predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet biological safety standards | Passed a battery of tests per ISO 10993-1 and FDA Guidance (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen Testing, Genotoxicity (Bacterial Reverse Mutation, Mouse Lymphoma), Thrombogenicity, Hemolysis (Direct Contact & Extract), Platelet/Leukocyte Count, Complement Activation). |
| Ethylene Oxide Residuals: Remain within acceptable limits | Passed testing per ISO 10993-7. |
| Bacterial Endotoxin & Bioburden: Maintain safe levels | Passed testing per ANSI/AAMI ST72 (Bacterial Endotoxins) and ISO 11737-1 (Bioburden). |
| Mechanical Reliability (Introduction/Withdrawal): Maintain integrity | Passed "Reliability Cycle: Mechanical Integrity after Introduction / Withdrawal" test. |
| Mechanical Reliability (Steering Lifecycle): Maintain integrity | Passed "Reliability Cycle: Mechanical Integrity after Steering Lifecycle" test. |
| Mechanical Reliability (Twisting): Maintain integrity | Passed "Twisting" test. |
| Overall Equivalence: As safe and effective as predicate | "The performance data, including biocompatibility, sterilization, and design verification testing supports that the subject catheter is as safe and effective as its predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or clinical trials, as this is a physical device clearance (catheter) rather than an AI/software diagnostic. The performance data refers to bench testing and biological evaluations on device components or whole devices. Therefore, common sample size definitions for clinical studies don't apply directly here. The provenance of the data is from internal testing conducted by Boston Scientific Corporation. The studies are not described as retrospective or prospective clinical studies, but rather laboratory and engineering verification tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the provided document. The ground truth for this medical device submission involves established standards for biocompatibility (e.g., ISO 10993 series), sterilization (e.g., ISO 10993-7), and engineering specifications. These standards define the "ground truth" against which the device's physical and biological properties are measured, rather than expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies where human expert disagreement needs to be resolved for ground truth establishment. For physical device testing, adherence to a particular standard or engineering specification determines acceptance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI tools that assist human readers in making diagnoses. The Blazer™ Dx-20 is a physical diagnostic catheter.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this question does not apply. The device is a physical catheter, not an algorithm. Therefore, there is no "standalone performance" of an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on established international standards and regulatory guidelines for medical device safety and performance. This includes:
- ISO 10993-1, 10993-7
- FDA Guidance for ISO 10993-1
- ANSI/AAMI ST72
- ISO 11737-1
- Good Laboratory Practices (21 CFR Part 58)
- Internal engineering specifications for mechanical properties (reliability cycles, twisting).
These standards represent the accepted scientific and regulatory consensus on what constitutes a safe and effective medical device in terms of biocompatibility, sterilization, and mechanical integrity.
8. The Sample Size for the Training Set
This information is not applicable to this submission. "Training set" refers to data used to train machine learning models. The Blazer™ Dx-20 is a physical medical device, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reason stated in point 8.
§ 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).