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510(k) Data Aggregation
(84 days)
The VersaCross Connect™ Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired
The subject device is comprised of the following components, which are single-use and supplied sterile to the user:
- One Dilator
- One J-tipped Guidewire
The subject VersaCross Connect™ Transseptal Dilator represents modifications made to the legally marketed ExpanSure™ Large Access Transseptal Dilator (K201288) (comprising a dilator and J-tipped Guidewire).
The VersaCross Connect™ Transseptal Dilator is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator provides torque control and is flexible. The dilator features a tapered tip and a shaft that can be reshaped manually. The echogenic shaft and tip and radiopaque tip maximize visualization of the dilator during manipulation.
The dilator can be used with separately cleared compatible introducer/access sheaths such as WATCHMAN™ Access sheaths. The dilator provides support and helps guide separately cleared compatible transseptal wires to the atrial septum for puncture. The dilator subsequently dilates the atrial septal defect to enable larger diameter devices to cross the septum.
The provided text is a 510(k) summary for a medical device called the VersaCross Connect™ Transseptal Dilator. It describes the device's characteristics, its comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria in a table format alongside specific device performance values. Instead, it states that the device "met all test requirements as specified by applicable standards and test protocols" for various tests. The acceptance criteria are implicitly defined by compliance with specified ISO standards and "Baylis self-enforced requirements."
A summary based on the provided text would look like this:
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Compliance with ISO 11070:2014/Amd.1:2018 and Baylis self-enforced requirements for specific mechanical properties. | Met all test requirements. |
| Torque Transmission | (Defined by standard/internal protocol) | Met all test requirements. |
| Torque Withstand | (Defined by standard/internal protocol) | Met all test requirements. |
| Hub-Shaft Tensile | (Defined by standard/internal protocol) | Met all test requirements. |
| Flexural Rigidity | (Defined by standard/internal protocol) | Met all test requirements. |
| Shapeability | (Defined by standard/internal protocol) | Met all test requirements. |
| Curve Retention | (Defined by standard/internal protocol) | Met all test requirements. |
| Tip to Tip Cap Cantilever and Tensile | (Defined by standard/internal protocol) | Met all test requirements. |
| Clamshell Tensile | (Defined by standard/internal protocol) | Met all test requirements. |
| Clamshell Cantilever | (Defined by standard/internal protocol) | Met all test requirements. |
| General Physical Testing | Compliance with ISO 11070:2014/Amd.1:2018, ISO 80369-7, and Baylis self-enforced requirements. | Met all test requirements. |
| Luer Tests | (Defined by standards/internal protocol) | Met all test requirements. |
| Air and Liquid Leakage Tests | (Defined by standards/internal protocol) | Met all test requirements. |
| Corrosion Test | (Defined by standard/internal protocol) | Met all test requirements. |
| System Verification Testing | Compliance with Baylis self-enforced requirements for compatibility and snap force. | Met all test requirements. |
| Compatibility Test | (Defined by internal protocol) | Met all test requirements. |
| Snap Force Test | (Defined by internal protocol) | Met all test requirements. |
| Biocompatibility Verification | Compliance with ISO 10993-1:2020 and September 4, 2020 FDA guidance document. | Performed through adoption of biological data from predicate and reference devices. |
| Sterilization Verification | Compliance with ISO 11135:2014 and ISO 10993-7:2008/Cor.1:2009; SAL of 10-6. | Met all test requirements. Sterilization with Ethylene Oxide achieved SAL of 10-6. |
| Pyrogen Testing | Compliance with ANSI/AAMI ST72:2011/(R)2016 and FDA guidance, meeting FDA and USP pyrogen limit specifications. | Met current FDA and USP pyrogen limit specifications. |
| Packaging Verification | Compliance with ISO 11607-1:2020 for integrity, seal strength, and sterile barrier integrity over shelf life. | Met all test requirements over proposed intended shelf life. |
| Benchtop Validation | Compliance with 11070:2014/Amd.1:2018 and Baylis self-enforced requirements for performance during intended use. | Met all test requirements. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for any of the non-clinical performance tests (mechanical, physical, system verification, biocompatibility, sterilization, pyrogen, packaging, benchtop).
The data provenance is from non-clinical performance testing conducted by Baylis Medical Company Inc. It is not patient or human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this document. The studies described are non-clinical performance tests on the device itself, not studies involving human interpretation or clinical data where "ground truth" would be established by medical experts for diagnostic or treatment purposes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically employed in clinical studies involving human assessments (e.g., radiology reads) to resolve discrepancies among experts. The studies here are objective engineering and laboratory tests.
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
This question is not applicable. The document describes the 510(k) submission for a physical medical device (Transseptal Dilator), not an AI/software device that assists human readers with interpretation. No MRMC study was conducted or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical dilator, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This question is not applicable in the sense of clinical "ground truth." For the non-clinical tests, the "ground truth" is established by the specified ISO standards and internal Baylis requirements/protocols, which define the expected performance characteristics of the device.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this is a physical medical device, not an AI or machine learning model.
9. How the ground truth for the training set was established
This question is not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply.
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