(222 days)
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The Medtronic Marinr catheter is intended for use in diagnostic electrophysiologic procedures. The Medtronic Marinr catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
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The Medtronic StableMapr catheter is intended for use in diagnostic electrophysiologic procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
Medtronic diagnostic catheters are flexible radiopaque catheters constructed of extruded polymer over a stainless-steel braid. The catheters contain platinum-iridium sensing band electrodes and are designed for intracardiac recording or stimulation.
This premarket notification covers changes impacting Medtronic diagnostic catheters, including labeling updates, packaging design and packaging material changes, and product requirement updates.
This document is a 510(k) premarket notification review for a medical device. It does not contain information about studies involving AI or human reader performance. The document describes changes to existing devices (Marinr and StableMapr Steerable Intracardiac Electrode Catheters) and demonstrates substantial equivalence to predicate devices through a series of performance (bench) and packaging tests.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable as this document does not describe a study involving an AI algorithm that produces diagnostic outputs requiring such analyses.
Here's the available information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists "product requirement changes" and "product requirement testing," implying that the tests performed served as acceptance criteria. However, explicit numerical acceptance criteria values are not provided within this document. Instead, the document states: "The results of the design verification testing completed in support of the proposed changes demonstrate that the diagnostic catheters in scope of this premarket notification meet all applicable proposed product requirements."
| Item Tested (Implied Acceptance Criteria) | Reported Device Performance |
|---|---|
| Corrosion resistance | Met all applicable proposed product requirements |
| Visual inspections (Foreign Material and Defects, Butt Joint, Band Electrodes, Tip Assembly, Serial Number) | Met all applicable proposed product requirements |
| Catheter outer diameter | Met all applicable proposed product requirements |
| Electrode Band Spacing | Met all applicable proposed product requirements |
| Working Length | Met all applicable proposed product requirements |
| Actuation force for linearly activated controls | Met all applicable proposed product requirements |
| Tip Springback | Met all applicable proposed product requirements |
| Reverse deflection (StableMapr only) | Met all applicable proposed product requirements |
| Extent & Rate of Tip Deflection | Met all applicable proposed product requirements |
| Proximal curve reach | Met all applicable proposed product requirements |
| Proximal curve planarity | Met all applicable proposed product requirements |
| Lateral deflection control (Marinr only) | Met all applicable proposed product requirements |
| Tip lateral deflection travel (Marinr only) | Met all applicable proposed product requirements |
| Distal tip stiffness | Met all applicable proposed product requirements |
| Proximal shaft flexibility in 37°C | Met all applicable proposed product requirements |
| Tip transition kinking | Met all applicable proposed product requirements |
| Lateral Stability (StableMapr only) | Met all applicable proposed product requirements |
| Shaft Torque-ability | Met all applicable proposed product requirements |
| Joint - Tip Composite (Marinr only) | Met all applicable proposed product requirements |
| Joint- Proximal Shaft to Distal Deflectable Tip Tubing | Met all applicable proposed product requirements |
| Electrode path AC impedance (Marinr only) | Met all applicable proposed product requirements |
| Band Electrode Path DC Resistance | Met all applicable proposed product requirements |
| Simulated use: catheter pushability (StableMapr only) | Met all applicable proposed product requirements |
| Simulated use: catheter shaft repeated torqueing (StableMapr only) | Met all applicable proposed product requirements |
| Handle Control Requirements | Met all applicable proposed product requirements |
| Connector Interface Requirements | Met all applicable proposed product requirements |
| Packaging Configuration | Met all applicable proposed product requirements |
| Traceability | Met all applicable proposed product requirements |
| Material Sterilization Compatibility | Met all applicable proposed product requirements |
| Packaging Performance (Marinr only) | Met all applicable proposed product requirements |
| Sterile Barrier Integrity | Met all applicable proposed product requirements |
| Seal strength | Met all applicable proposed product requirements |
| Specified loading configuration | Met all applicable proposed product requirements |
| Storage and Shipping Conditions | Met all applicable proposed product requirements |
| Sterilization pre-conditioning (Packaging) | Met all applicable proposed product requirements |
| Environmental pre-conditioning (Packaging) | Met all applicable proposed product requirements |
| Label legibility testing (Packaging) | Met all applicable proposed product requirements |
| Label durability testing (Packaging) | Met all applicable proposed product requirements |
| Bubble leak testing (Packaging) | Met all applicable proposed product requirements |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "test samples exposed to accelerated aging conditions equivalent to the product shelf life of 2 years" for product requirement testing. However, the specific sample sizes for each test are not provided. Data provenance (country of origin, retrospective/prospective) is not applicable as these are bench tests on manufactured products.
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. This is a bench testing study for substantial equivalence of physical medical devices, not a diagnostic study requiring expert ground truth or a human-in-the-loop performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a bench testing study.
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
No such study was done. This document pertains to the physical and packaging characteristics of diagnostic catheters, not an AI-assisted diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is not about an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests would be the established engineering and materials specifications and accepted standards for medical device performance. For packaging, it would be packaging integrity and labeling standards.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning study.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning study.
§ 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).