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510(k) Data Aggregation
(60 days)
The catheter is intended for use in diagnostic electrophysiologic procedures in adult patients. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
The ViaCath* and the AcQRate Dx Steerable Catheters are temporary, steerable, multipolar catheters for sensing of intracardiac signals and diagnostic pacing, in combination with an electrophysiological investigation and recording device.
The main components of the ViaCath catheter are the distal catheter tip with electrodes, catheter shaft, handle, and connecting cable with pluq, which is a Redel connector. The ViaCath product family includes the ViaCath and the ViaCath NG models. Multiple electrode configurations are available with various numbers of electrodes, electrode shapes and electrode spacing.
- Unless otherwise noted, the term "ViaCath" is used throuqhout to represent either ViaCath or AcQRate Dx Steerable Catheter.
The document provided is a 510(k) summary for a medical device (ViaCath Catheter and AcQRate Dx Steerable Catheter) and a related patient cable (MPK-R). This type of submission to the FDA focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data. Therefore, many of the requested items related to AI/algorithm performance and clinical studies are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this type of medical device clearance are generally based on meeting recognized industry standards and demonstrating that the device performs as intended without raising new questions of safety or effectiveness compared to a predicate device. The "reported device performance" is essentially that the device successfully passed all the specified tests.
| Test Performed | Acceptance Criteria/Standard | Reported Device Performance |
|---|---|---|
| ViaCath Catheter | ||
| Dimensional and Visual Inspection | Requirements of EN ISO 10555-1 met and correspond to defined specifications. | Pass |
| Functional and Compatibility Testing | Leakage currents below limits given in IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012. | Pass |
| Electrical and Mechanical Testing | Applicable requirements of EN ISO 10555-1, EN 62366-1, and EN ISO 60601-1 met, ensuring catheter safety. | Pass |
| Shelf Life | Confirmation of device functional performance and sterile barrier pouch integrity (seal strength per ASTM F88 and bubble per ASTM F2096) with accelerated aging and simulated distribution per ASTM 4169-16. | Pass |
| Packaging | Sterile barrier package integrity evaluated using transport simulation, preconditioning, seal strength, peel, and bubble testing. | Pass |
| Biocompatibility | Requirements of ISO 10993 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and 2020 FDA Biocompatibility guidance met. | Pass |
| Sterilization Validation | Full Revalidation of Sterilization Process Performance Qualification ISO 11135:2014 Sterilization of health care products - Ethylene oxide: Requirements of development, validation and routine control of a sterilization process for medical devices. | Pass |
| MPK-4-R and MPK-10 Patient Cables | ||
| Functional testing (after real-time aging) | a) Visual inspection of packaging and product; b) Functional test of product; c) Electrical measurement. | a) Pass, b) Pass, c) Pass |
| Sterilization Validation | Full Revalidation of Sterilization Process Performance Qualification ISO 11135:2014 Sterilization of health care products - Ethylene oxide: Requirements of development, validation and routine control of a sterilization process for medical devices. | Pass |
| Reprocessing Validation | Cable can be reprocessed up to 50 times. | Pass |
2. Sample size used for the test set and the data provenance
The document describes nonclinical bench testing. It does not specify the exact sample sizes for each test. For instance, for "Dimensional and Visual Inspection," it likely involved a sample of manufactured catheters, but the number is not provided. Similarly for other tests like "Functional and Compatibility Testing" or "Mechanical Testing."
The data provenance is from bench testing conducted by the manufacturer, BIOTRONIK, Inc. and VascoMed GmbH. This is retrospective in the sense that it's performed on manufactured devices, but it's not data from patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a nonclinical bench testing study of a physical device (catheter and cables), not an AI algorithm or a study requiring expert interpretation of clinical data to establish ground truth.
4. Adjudication method for the test set
Not applicable for a nonclinical bench test of a physical device. Adjudication methods are relevant for studies involving human interpretation or subjective assessments.
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. This is not an AI-enabled device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This is not an AI-enabled device.
7. The type of ground truth used
For the nonclinical tests, the "ground truth" is defined by the established specifications of the device and recognized international standards. For example, for "Dimensional Inspection," the ground truth is the specified dimensions. For "Electrical and Mechanical Testing," the ground truth is compliance with standards like EN ISO 10555-1 and EN ISO 60601-1.
8. The sample size for the training set
Not applicable. This is not an AI-enabled device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI-enabled device that requires a training set.
In summary:
This 510(k) submission seeks substantial equivalence for a physical medical device (catheter and cables) based entirely on nonclinical bench testing. It clearly states "No clinical performance data was submitted or relied upon in support of the substantial equivalence determination." Therefore, questions pertaining to AI performance, clinical study design, expert ground truth, and training data are not relevant to this specific regulatory review. The device's performance is demonstrated through adherence to design specifications and relevant international standards.
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