(51 days)
The Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach to facilitate electrophysiology studies.
The Epicardial Access System by Baylis Medical Company Inc. is a single use device that is supplied sterile to the user. The System is comprised of the following devices:
- Epicardial Access Needle
- Epicardial Steerable Guiding Sheath containing:
- Steerable Sheath,
- Dilator and
- J-Tip Guidewire
- Epicardial Introducer and Stylet
The device is designed to provide access to the epicardial surface of the heart via a subxiphoid approach. It is used in percutaneous access procedures primarily by Electrophysiologists and Interventional Cardiologists trained in the subxiphoid approach. Procedures using the devices are performed in fully equipped catheter labs with imaging equipment, including fluoroscopy under sterile technique.
Here's an analysis of the provided text regarding acceptance criteria and the study proving device performance, specifically focusing on the Epicardial Access System.
It's important to note that the provided FDA 510(k) summary primarily focuses on benchtop and mechanical testing for substantial equivalence rather than a clinical study evaluating the device's accuracy or effectiveness in a diagnostic or AI-assisted context. Therefore, many of the requested elements (like MRMC studies, specific performance metrics for an AI algorithm, or detailed ground truth establishment for a diagnostic output) are not applicable or not explicitly stated in this type of submission. This document describes a medical device, a catheter introducer, not an AI/ML-driven diagnostic device.
Acceptance Criteria and Device Performance (Based on available information)
Since this is a submission for a Catheter Introducer (Epicardial Access System), the acceptance criteria are related to its physical and functional performance, ensuring it can safely and effectively provide access as intended. It is not an AI/ML diagnostic device, so criteria like sensitivity, specificity, or reader improvement with AI assistance are not relevant here.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests / Requirements | Reported Device Performance |
|---|---|---|
| Mechanical Performance | - Air and Liquid Leakage (Needle, Sheath, Dilator, Introducer) | "All test requirements were met as specified by applicable standard and the test protocols." |
| - Resistance to Separation (Needle) | (Implicitly met, as above) | |
| - Stress Cracking (Needle) | (Implicitly met, as above) | |
| - Strength of Union (Various components: Hub to Hypotube, Stylet Cap, Tip to Sheath Body, etc.) | (Implicitly met, as above) | |
| - Torque Transmission (Sheath, Dilator) | (Implicitly met, as above) | |
| - Flow Rate (Introducer) | (Implicitly met, as above) | |
| - Tip Integrity (Introducer) | (Implicitly met, as above) | |
| - Three-Point Bend (Introducer) | (Implicitly met, as above) | |
| - Torque Withstand Test (Introducer) | (Implicitly met, as above) | |
| - Tensile Test (Various components) | (Implicitly met, as above) | |
| General Physical Performance | - Corrosion Resistance (Needle, Introducer) | (Implicitly met, as above) |
| - Surface Defects (Sheath, Dilator) | (Implicitly met, as above) | |
| - Range of Motion and Geometry (Sheath) | (Implicitly met, as above) | |
| - Curve Retention and Integrity (Sheath) | (Implicitly met, as above) | |
| - Friction (Sheath) | (Implicitly met, as above) | |
| - Handle Lubricity (Sheath) | (Implicitly met, as above) | |
| - Tip Stiffness (Sheath) | (Implicitly met, as above) | |
| - Compatibility | (Implicitly met, as above) | |
| - Flexural Modulus (Dilator) | (Implicitly met, as above) | |
| - Clinical Valve (Sheath) | (Implicitly met, as above) | |
| Biocompatibility | - ISO 10993-1:2009/Cor.1:2010 compliance | "The biological safety... was verified in accordance with the requirements." |
| Sterilization | - ISO 11134-1:2014 & SAL of 10-6 via Ethylene Oxide | "Sterilization verification was completed... to the requirements." |
| - Residual limits per ISO 10993-7:2008/Cor.1:2009 | (Implicitly met, as above) | |
| Pyrogenicity | - Meet current FDA and USP pyrogen limit specifications (LAL testing) | "The Epicardial Access System is supplied non-pyrogenic." |
| Packaging Validation | - Integrity through shipping/handling (ANSI/AAMI/ISO 11607:2006) | "Ship testing was performed... to ensure the integrity... through the rigors of shipping and handling." |
| - Sterile barrier integrity over shelf life | "The sterile barrier integrity was validated." | |
| Bench-top Validation (Usability/Clinical Workflow) | - Ease of use, errors made in simulated clinical workflow by "users familiar with catheter-based procedures." | "The validation testing demonstrated the devices contained in the Epicardial Access System meet the intended use to support substantial equivalence." |
Study Details (as per the document):
-
Sample Size Used for the Test Set and Data Provenance:
- For Mechanical and General Physical Testing: The document states "All test requirements were met as specified by applicable standard and the test protocols." It doesn't specify an exact sample size for each individual test (e.g., number of needles tested for leakage). These typically involve a statistically determined sample size per test characteristic as per the relevant ISO standards (e.g., ISO 11070:2014).
- For Bench-top Validation (Usability): "A minimum of 15 users drawn from populations familiar with catheter-based procedures."
- Data Provenance: The and testing was conducted by Baylis Medical Company Inc., based in Mississauga, Ontario, Canada. The nature of these tests (mechanical, physical, chemical, and simulated usability) means that "country of origin of the data" in the sense of patient data is not applicable. These are in-vitro/ex-vivo tests. All studies described are prospective tests performed on the device prototypes/production samples.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This question is not applicable in the context of this device and study. The "ground truth" for mechanical testing is defined by engineering specifications and objective measurements (e.g., a specific force to failure, a specific leakage rate). For biocompatibility, it's defined by the biological response in standardized tests. For usability, it's based on observed user performance against pre-defined success criteria.
- For the bench-top validation, the "experts" were "users drawn from populations familiar with catheter-based procedures" (e.g., Electrophysiologists and Interventional Cardiologists, as mentioned in the device description). Their "errors made" and "ease of use" observations would contribute to validating the device's usability in a simulated environment, rather than establishing a diagnostic "ground truth."
-
Adjudication Method for the Test Set:
- None applicable in the sense of physician adjudication of image interpretations. For mechanical and physical tests, results are objectively measured against predefined pass/fail criteria. For the bench-top validation, observations were "recorded and evaluated to conclude if customer requirement were met." This implies internal evaluation against a benchmark rather than multi-expert adjudication for a diagnostic task.
-
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 was done, and it is not applicable for this type of device. The Epicardial Access System is a physical medical device (catheter introducer), not an AI-driven diagnostic tool or an imaging software. Its performance is related to its ability to provide access to the heart, not to improve human reading accuracy of images.
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm for standalone performance.
-
The Type of Ground Truth Used:
- For Mechanical and Physical Tests: Engineering specifications, ISO standards, and predefined pass/fail criteria (e.g., "Strength of Union," "Air and Liquid Leakage" within specified limits).
- For Biocompatibility: Standardized in-vitro and in-vivo biological tests (e.g., hemolysis, cytotoxicity, irritation) with results compared against established safety benchmarks (ISO 10993).
- For Sterilization: Confirmation of Sterility Assurance Level (SAL 10^-6) through validated methods.
- For Pyrogenicity: LAL testing against FDA and USP limits.
- For Packaging: Integrity under simulated shipping conditions per ANSI/AAMI/ISO 11607.
- For Bench-top Validation: User performance against pre-defined tasks and operational criteria in a simulated environment. The "ground truth" is whether users can successfully perform the intended actions and if critical errors occur.
-
The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set. The device design and manufacturing process are based on engineering principles and material science, not machine learning.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for an AI/ML algorithm.
Summary Conclusion:
The document describes the regulatory submission for a physical medical device, an Epicardial Access System, used for catheter introduction. The acceptance criteria and performance evaluation are primarily focused on the device's mechanical, physical, material, and usability characteristics to demonstrate substantial equivalence to a predicate device. It does not involve AI or diagnostic imaging, and therefore, many of the typical questions for AI medical devices (like MRMC, training sets, or expert ground truth for diagnostic accuracy) are not relevant to this submission. The "study" here is a series of comprehensive engineering and simulated-use verification and validation activities.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).