(100 days)
For use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Ablacath™ Mapping Catheter may also be used for delivery of externally generated pacing stimuli.
The Ablacath™ Mapping Catheter is a sterile, single use device used to detect electrical potentials from the endocardial surfaces of the heart. They may also be used to deliver externally generated pacing stimuli. These signals may be used for analysis with a 3-D mapping system. The catheter's distal end is an expandable basket with eight (8) longitudinal splines each having eight (8) electrodes spaced equal distance along the length of the spline. When expanded it forms a spherical or basket shape. An integrated Introducer Tool collapses the basket for insertion into an 8.5 F sheath. The Ablacath Mapping Catheters are available in two (2) model numbers representing two (2) basket sizes.
This document describes the premarket notification for the Ablacath™ Mapping Catheter, a Class II medical device. The information provided outlines the device's technical specifications, intended use, and substantial equivalence to a predicate device (FIRMap® Catheter K163709). The document focuses on performance data derived from bench testing, preclinical animal studies, biocompatibility testing, and sterilization validation to demonstrate the device's safety and effectiveness.
Acceptance Criteria and Device Performance:
The document primarily relies on the concept of "substantial equivalence" to a predicate device (FIRMap® Catheter K163709) and the fulfillment of predefined acceptance criteria for various tests. The general statement "All tests met the predefined acceptance criteria" indicates the device performance and acceptance.
Table of Acceptance Criteria and Reported Device Performance:
While a direct quantitative table of acceptance criteria and specific numerical reported device performance for all tests is not explicitly provided in the excerpt, the document states that all tests met their predefined acceptance criteria. The comparison table (page 5-6) implicitly serves as a comparison of characteristics against the predicate, which can be seen as meeting the criteria of "similar technological characteristics."
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Bench Testing | Meet predefined acceptance criteria for: Visual/Dimensional, Mechanical Integrity (flexibility, kink, spline radial strength, etc.), Torque Resistance/Strength, Track Force/Withdrawal Cycling & Force, Radiopacity, Corrosion, Fluid Leak, Mating/Uncoupling Force, Tensile Testing, Continuity/Resistance/Pin Short, Electrical Safety. | "All tests met the predefined acceptance criteria." |
| Packaging | Meet predefined acceptance criteria for: Distribution, Environmental Conditioning, Aging, Packaging (Visual, Bubble Leak, Seal Strength). | "All tests met the predefined acceptance criteria." |
| Pre-clinical Studies | Ablacath Mapping Catheter conforms to intended user needs and indications for use, meets acute safety attributes, and is clinically acceptable with performance equivalent to predicate; No User Errors/Close Calls in usability. | "The Ablacath Mapping Catheter met all study endpoints; performance and acute safety requirements and was found to be clinically acceptable by all evaluators with the performance equivalent to the predicate device. No User Errors or Close Calls were observed..." |
| Biocompatibility | Meet endpoints based on ISO 10993 series for: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Materials Mediated Rabbit Pyrogen Test, Hemocompatibility (Hemolysis, C3a and SC5b-9 Complement Activation, In Vivo Thromboresistance). | "All devices met their endpoints." |
| Sterilization | Meet endpoints based on ANSI/AAMI/ISO 11135-1:2014. | "Testing demonstrated that all endpoints were met." |
| Electrical Rating | Typical = ±27 V, 25 mA (Predicate) | Maximum = ±30 V, 25 mA (Ablacath) (Note: differences reflect actual testing, deemed not to raise new questions of safety/effectiveness). |
| Basket Dimensions | 50 mm, 60 mm, 70 mm (Predicate) | 50 mm, 60 mm (Ablacath) |
| All Other Device Characteristics | Identical to predicate device where stated (e.g., Catheter Shaft Diameter, Length, Number of Splines, Material, Number of Electrodes, Electrode Material, Electrode Configuration, Dielectric Strength, Sterility, SAL, Biocompatible). | "Identical" or "Yes" as stated in the comparison table. |
Study Details:
The provided document describes pre-clinical studies, primarily bench testing and animal studies, rather than a clinical study evaluating human patient outcomes or a comparative effectiveness study involving human readers and AI. Thus, several of the requested points are not applicable or cannot be extracted from this specific 510(k) summary.
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Sample Size Used for the Test Set and Data Provenance:
- Bench Testing: The document does not specify exact sample sizes for each type of bench test (e.g., number of catheters tested for tensile strength). It implies that sufficient samples were used to demonstrate adherence to acceptance criteria.
- Preclinical Animal Studies: A "swine model" was used. The specific number of animals is not provided.
- Data Provenance: The preclinical animal studies were conducted in accordance with "CFR 21 Part 58" guidelines, which suggests they were conducted in the US or under US regulatory standards. The document does not specify if these were retrospective or prospective studies, but GLP (Good Laboratory Practice) validation and usability testing are typically prospective.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- For the preclinical animal studies, "physician end-users" were involved as evaluators. The number of physicians and their specific qualifications (e.g., number of years of experience, sub-specialty) are not specified.
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Adjudication Method for the Test Set:
- Not described. For the preclinical animal studies, it states "found to be clinically acceptable by all evaluators," implying consensus rather than formal adjudication by differing opinions. However, the exact adjudication method is not provided.
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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 MRMC study described. This clearance is for a mapping catheter, not an AI-assisted diagnostic imaging device. Therefore, a study of human readers' improvement with AI assistance is not relevant to this submission and was not performed.
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If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device (catheter) for mapping, not a standalone algorithm.
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The Type of Ground Truth Used:
- Bench Testing: Ground truth is defined by engineering specifications, material properties, and physical performance standards (e.g., ASTM, ISO standards).
- Preclinical Animal Studies: "Acute safety attributes" and "performance requirements" were evaluated against predefined endpoints and comparison to the predicate device's expected performance in a simulated clinical environment. The "ground truth" here would be the successful demonstration of functionality and safety in a living system according to expert clinical assessment and observed physiological responses.
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The Sample Size for the Training Set:
- Not applicable. As this is a hardware device and not an AI/ML algorithm requiring a training set, this question is not relevant to the information provided.
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How the Ground Truth for the Training Set was Established:
- Not applicable. (See point 7).
In summary, the document demonstrates the device's substantial equivalence to a legally marketed predicate through adherence to predefined acceptance criteria in rigorous bench testing and preclinical animal studies. It does not involve AI or human reader studies.
§ 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).