Search Results

The ViaOne Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach to deliver diagnostic and therapeutic interventions for ventricular tachycardia.

ViaOne Epicardial Access System is a sterile, single-use access tool consisting of a concealed needle within a leading channel to facilitate guidewire access into the pericardium through a subxiphoid incision. The device consists of a radiopaque distal tip designed to retract a portion of the pericardial tissue into the device, and away from the heart muscle, where it is punctured by the concealed needle and a guidewire is introduced into the pericardial space.

The provided text describes the 510(k) premarket notification for the ViaOne Epicardial Access System. However, it does not contain the detailed acceptance criteria and the specific study results in a format that would allow for a complete table of acceptance criteria and reported device performance.

The text generally states that the device "met the predetermined acceptance criteria" and "All tests were successfully completed and passed, and the device met the defined acceptance criteria." but does not quantify these criteria or results.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document lists performance tests but does not state the specific acceptance criteria (e.g., "tensile strength > X N") nor the quantitative results from those tests (e.g., "tensile strength Y N").

2. Sample size used for the test set and the data provenance

• Biocompatibility: Not specified.
• Sterilization, Packaging and Shelf Life Testing: Not specified.
• Performance Testing: Not specified for individual tests.
• Animal Study: Not specified (e.g., number and type of animals).
• Clinical Information: "multi-central clinical trial which included VT subjects." The exact number of subjects is not specified. Data provenance (country of origin, retrospective/prospective) explicitly is not specified, though "multi-central" implies a prospective clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided for any of the studies mentioned.

4. Adjudication method for the test set

This information is not provided for any of the studies mentioned.

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

An MRMC study is not applicable to this device. The ViaOne Epicardial Access System is an access tool, not an AI-powered diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

A standalone performance study of an algorithm is not applicable to this device as it is a physical medical device, not an AI algorithm.

7. The type of ground truth used

• Biocompatibility: Established by ISO 10993-1 standards.
• Sterilization, Packaging and Shelf Life Testing: Established by ISO 11135-1 standards and internal performance criteria.
• Performance Testing: Established by internal design specifications and ISO 11070:2014 standards.
• Animal Study: Ground truth was based on observation of device performance, malfunction, and Histopathology evaluation and pathological examination.
• Clinical Information: Ground truth for adverse events would be clinical observation and diagnosis by medical professionals. Ground truth for pericardial space access success would be confirmed during the procedure.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable as this is a physical medical device.

Summary of available and missing information:

Ask a specific question about this device

The Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach.

The subject Epicardial Access System represents device modifications made to the Epicardial Steerable Guiding Sheath and Epicardial Introducer and Stylet components of the legally marketed Epicardial Access System (K191546). The Epicardial Access Needle component remains unchanged. The System is comprised of the following devices, which are single-use and supplied sterile to the user:

• Epicardial Access Needle
• Epicardial Steerable Guiding Sheath containing:
  • Steerable Sheath
  • Dilator
  • J-tip Guidewire
• Epicardial Introducer and Stylet
  The subject 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.

The provided document is a 510(k) premarket notification for a medical device (Epicardial Access System), which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a new product validation with acceptance criteria based on clinical outcomes or performance metrics like accuracy, sensitivity, or specificity, as would be typical for AI/ML-based devices.

Therefore, the supplied text does not contain the information requested for acceptance criteria and a study proving a device meets those criteria, specifically concerning data provenance, clinical performance metrics, expert adjudication, or MRMC studies. The document primarily details non-clinical performance testing (mechanical, general physical, biocompatibility, sterilization, pyrogen, and packaging verification) to show the modified device performs similarly to its predicate.

It describes hardware modifications to an existing system, not the development or validation of an AI/ML algorithm.

Here's a breakdown of why each requested point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance:

   • Does not exist in the document. The document describes various non-clinical tests performed (mechanical, physical, biocompatibility, etc.) but does not list pre-defined quantitative acceptance criteria (e.g., success rates, tolerance levels, specific metric thresholds) for these tests, nor does it provide the reported performance values from these tests beyond a general statement that "Epicardial Access System met all test requirements."
   • This type of detailed performance data and acceptance criteria would typically be found in internal test reports, not in an FDA 510(k) summary focused on substantial equivalence.

2. Sample sizes used for the test set and the data provenance:

   • Not applicable/Not present. The performance testing described is primarily non-clinical (benchtop mechanical, physical, etc.). There is no "test set" in the sense of a clinical dataset with patient data.
   • There is no mention of "data provenance" (country of origin, retrospective/prospective) because no clinical data or clinical test sets are used or described for device acceptance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not present. Since there is no clinical test set requiring human expert ground truth establishment, this information is not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not present. No clinical test set.

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:

   • Not applicable/Not present. This document discusses a physical medical device (catheter introducer system), not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable/Not present. Not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable/Not present. The "ground truth" for the non-clinical tests would be defined by engineering specifications and established test methods, not clinical outcomes or expert consensus.

8. The sample size for the training set:

   • Not applicable/Not present. This is not an AI/ML device; therefore, there is no training set mentioned.

9. How the ground truth for the training set was established:

   • Not applicable/Not present. No training set.

In summary, the provided FDA document pertains to a hardware medical device (Epicardial Access System) undergoing modifications and seeking 510(k) clearance by demonstrating substantial equivalence through non-clinical performance and engineering tests, not a software/AI device validated with clinical performance metrics against ground truth data.

Ask a specific question about this device

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

Study Details (as per the document):

1. 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.

2. 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."

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

Ask a specific question about this device