(30 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 VersaCross Connect™ Transseptal Dilator is a single-use device that is supplied sterile to the user. The device is comprised of a single dilator.
The subject VersaCross Connect™ Transseptal Dilator represents modifications made to the dilator component of the legally marketed VersaCross Connect™ Transseptal Dilator (K220414) (comprising of a dilator and J-tipped guidewire). A quidewire is not supplied with the subject device. However, the end user can use a separately cleared compatible 0.035″ quidewire.
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 in procedures.
The dilator can be used with separately cleared compatible access sheaths such as FARADRIVE™ Steerable sheaths. The dilator may also be used as a standalone device to facilitate access to the left atrium following transseptal puncture. The dilator provides support and helps quide 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.
This document describes the premarket notification (K233647) for the VersaCross Connect™ Transseptal Dilator. It is an updated version of a previously cleared device (K220414), with modifications primarily in dimensions and design for compatibility and the absence of a supplied guidewire. The FDA's review confirms substantial equivalence to the predicate device due to identical indications for use, fundamental scientific technology, and operating principles, supported by a comprehensive suite of non-clinical performance tests.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Requirement | Performance Standard/Requirement | Reported Device Performance/Conclusion |
|---|---|---|---|
| Mechanical Testing | Torque Transmission | Compliance with ISO 11070:2014/Amd.1:2018 and Baylis Medical Co. Inc. requirements. | All test requirements met. |
| Torque Withstand | Compliance with ISO 11070:2014/Amd.1:2018 and Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Hub-Shaft Tensile | Compliance with ISO 11070:2014/Amd.1:2018 and Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Flexural Rigidity | Compliance with ISO 11070:2014/Amd.1:2018 and Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Shapeability | Compliance with ISO 11070:2014/Amd.1:2018 and Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Curve Retention | Compliance with ISO 11070:2014/Amd.1:2018 and Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Tip to Tip Cap Cantilever and Tensile | Compliance with Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Clamshell Tensile | Compliance with Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Clamshell Cantilever | Compliance with Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Shaft Joint Tensile Strength | Compliance with Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Shaft Friction test | Compliance with Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| General Physical Testing | Luer Tests | Compliance with ISO 11070:2014/Amd.1:2018, ISO 80369-7:2021, and Baylis Medical Co. Inc. requirements. | All test requirements met. |
| Air and Liquid Leakage Tests | Compliance with ISO 11070:2014/Amd.1:2018, ISO 80369-7:2021, and Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Corrosion Test | Compliance with ISO 11070:2014/Amd.1:2018, ISO 80369-7:2021, and Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| System Verification | Compatibility Test (with guidewires, introducer, sheaths) | Compatibility with compatible guidewires, introducer, and accessory sheaths, as per Baylis Medical Co. Inc. requirements. | All test requirements met. |
| Snap Force Test (with accessory sheath) | Verification of force required to snap and unsnap with compatible accessory sheaths, as per Baylis Medical Co. Inc. requirements. | All test requirements met. | |
| Biocompatibility | Biological Safety | Compliance with ISO 10993-1:2020 and FDA guidance document (Sept 8, 2023). | Conducted through adopted biological data of the predicate device (K220414). Compliant. |
| Sterilization | Sterilization Assurance Level | Ethylene Oxide sterilization to a SAL of 10-6, compliant with ISO 11135:2014/A1:2019 and ISO 10993-7:2008/A1:2022. | Compliant. |
| Residual Limit Verification | Compliance with ISO 10993-7:2008/A1:2022. | Compliant. | |
| Pyrogen Testing | Endotoxin Levels (LAL testing) | Meets current FDA and USP pyrogen limit specifications, as per ANSI/AAMI ST72:2019 and FDA guidance. | Supplied non-pyrogenic; test requirements met. |
| Packaging Verification | Shipping and Handling Integrity | Maintains packaging integrity through shipping/handling and storage, compliant with ISO 11607-1:2020. | All test requirements met. |
| Sterile Barrier Integrity | Maintains sterile barrier integrity over proposed shelf life, compliant with ISO 11607-1:2020. | All test requirements met. | |
| Benchtop Validation | Performance during normal intended use | Validated performance as per ISO 11070:2014/Amd.1:2018 and Baylis requirements. Customer requirements were validated through benchtop validation. | All test requirements met. (Validation confirms performance for intended use). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify exact sample sizes for each mechanical, physical, or system verification test conducted. It generally refers to "test requirements" being met. The data provenance is not explicitly stated in terms of country of origin, but the tests were conducted by Baylis Medical Company Inc., which is based in Canada. These tests are non-clinical (benchtop) and are typically performed in a laboratory setting. They would be considered prospective in the sense that they were designed and executed to evaluate the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a medical dilator, not an AI or diagnostic imaging device that requires expert interpretation for "ground truth" in the traditional sense of clinical data. The "ground truth" for this device's performance is established through adherence to recognized international standards (e.g., ISO, ANSI/AAMI) and the manufacturer's internal engineering requirements. Therefore, the "experts" involved would be a team of engineers, regulatory affairs specialists, quality assurance personnel, and potentially design validation specialists from Baylis Medical Company Inc. with expertise in medical device design, testing, and regulatory compliance. The document does not specify the number or specific qualifications of these individuals, as it's typically understood to be part of standard manufacturing and quality system practices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., reading medical images) to resolve discrepancies among experts. For a physical medical device undergoing non-clinical benchtop testing, the results are objectively measured against predefined scientific and engineering standards, not subject to subjective adjudication among experts.
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. This is a physical medical device (dilator), not an AI algorithm for diagnostic interpretation or a device designed to assist human readers. Therefore, an MRMC comparative effectiveness study, which is relevant for AI-powered diagnostic tools, was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. Benchtop tests are inherently "standalone" in the sense that the device's physical properties and performance are measured objectively without human-in-the-loop clinical scenarios.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests conducted on the VersaCross Connect™ Transseptal Dilator is based on:
- International Standards: e.g., ISO 11070:2014/Amd.1:2018 (Vessel Dilators), ISO 80369-7:2021 (Luer connectors), ISO 10993-1:2020 (Biocompatibility), ISO 11135:2014/A1:2019 (Sterilization), ISO 10993-7:2008/A1:2022 (EO residuals), ANSI/AAMI ST72:2019 (Pyrogen testing), ISO 11607-1:2020 (Packaging).
- Manufacturer's Internal Requirements: Baylis Medical Company Inc. requirements, often derived from risk assessments and design specifications.
- Predicate Device Data: For biocompatibility, data from the predicate device (K220414) was adopted, indicating that prior established safety profiles serve as a ground truth baseline.
8. The sample size for the training set
Not applicable. This is a physical medical device undergoing non-clinical testing, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical medical device.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).