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510(k) Data Aggregation
(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 (VXA-AG) is a single-use device that is supplied sterile to the user.
The subject VersaCross Connect™ Transseptal Dilator (VXA-AG) represents modifications to the legally marketed VersaCross Connect™ Transseptal Dilator (K241720).
The VersaCross Connect™ Transseptal Dilator (VXA-AG) 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 Agilis™ NxT Steerable Introducer (K061363 or K081645). 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 subject device can be used by electrophysiologists, interventional cardiologists, and other users trained in catheter techniques for any procedure that requires left atrial access via transseptal puncture. Procedures using the devices are performed in fully equipped catheter labs with imaging equipment, including fluoroscopy and echocardiography under sterile technique.
The provided FDA 510(k) Clearance Letter for the VersaCross Connect™ Transseptal Dilator does not contain information related to an AI/ML-driven medical device. The clearance is for a physical medical device (a vessel dilator) which has undergone design modifications.
Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance, human reader improvement with AI assistance, standalone algorithm performance, and ground truth establishment for training and test sets, is not applicable to this document.
The document details the following for the physical device:
- Device: VersaCross Connect™ Transseptal Dilator
- Purpose: Used for procedures requiring access to the left atrium via the transseptal technique.
- Modifications: Design changes (hub color, dilator shaft dimensions, snap fit hub geometry, hub length) and non-patient contacting material changes from its predicate device (K241720).
- Verification and Validation Activities: These focused on the physical and material properties of the dilator, ensuring it meets performance, safety, and biocompatibility standards. Examples include:
- Torque Transmission, Dilator Protrusion Length, Shaft Outer Diameter, Flexural Rigidity, etc.
- Biocompatibility, Sterilization, Pyrogen testing, Packaging integrity.
- Benchtop validation to confirm performance during normal intended use.
- Substantial Equivalence: The submission demonstrates that the modified device is substantially equivalent to its predicate, sharing the same intended use, indications for use, fundamental scientific technology, operating principles, and mechanism of action. The changes do not raise new questions of safety or effectiveness.
In summary, there is no AI/ML component described or evaluated in this 510(k) clearance document, and thus, no information is available to address the specific questions about AI/ML acceptance criteria and performance studies.
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(83 days)
The 82cm Agilis NxT™ Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart via the venous anatomy, including the left side of the heart through the interatrial septum.
The Agilis NxT Steerable Introducer consists of a steerable sheath, dilator and guidewire, which is indicated for introducing various cardiovascular catheters into the heart via the venous anatomy, including the left side of the heart through the interatrial septum. It is an 8.5F asymmetrical bi-directional steerable introducer with a large curl at the distal tip and a useable length of 82 cm. The proximal end of the device sheath is fitted with a hemostasis valve to minimize blood loss during catheter insertion and/or exchange over a quidewire. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the large curl 90° in the counterclockwise direction and 180° in the clockwise direction. The sheath is filled with radiopaque material for visualization under fluoroscopy.
A dilator and guidewire are packaged with the introducer and are designed to facilitate the introduction and passage of the introducer through the vasculature.
This document describes the acceptance criteria and the study for the 82cm Agilis NxT™ Steerable Introducer.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Surface Visual Standard | Pass | Pass |
| Usable Shaft Length | Pass | Pass |
| Curve Angle | Pass | Pass |
| Deflection Durability | Pass | Pass |
| Shaft Kink | Pass | Pass |
| Curve Retention | Pass | Pass |
| Shaft Torque Test | Pass | Pass |
| Tip Tensile | Pass | Pass |
| Sheath/Dilator | Pass | Pass |
| Distal tip inner diameter | Pass | Pass |
| Insertion Forces | Pass | Pass |
| Radiopacity | Pass | Pass |
| 3-way Stopcock | Pass | Pass |
| Shaft to Hub Tensile | Pass | Pass |
| Stopcock to Hub bond | Pass | Pass |
| Freedom from Leaks | Pass | Pass |
| Luer Taper | Pass | Pass |
| Lure Stress Cracking | Pass | Pass |
| Sterilization | ||
| EtO residuals | Meets specifications | Pass |
| Lethality | Meets specifications | Pass |
| Natural product sterility | Meets specifications | Pass |
| Bacteriostasis | Meets specifications | Pass |
| Fungistasis | Meets specifications | Pass |
| Bioburden | Meets specifications | Pass |
| LAL testing | Meets specifications | Pass |
| Packaging | ||
| Performance Testing of Shipping Containers (ASTM D4169-05) | Maintain integrity and sterile barrier | No failures reported |
| Visual Inspection (ASTM F1886-98) | Maintain integrity and sterile barrier | No failures reported |
| Seal Strength (ASTM F88-00) | Maintain integrity and sterile barrier | No failures reported |
| Bubble Leak (ASTM F2096-04) | Maintain integrity and sterile barrier | No failures reported |
| Product shelf life testing | Meets specifications | Pass |
| Biocompatibility | ||
| Cytotoxicity | Pass | Pass |
| Sensitization | Pass | Pass |
| Intracutaneous Reactivity (Irritation) | Pass | Pass |
| Systemic Toxicity (acute, includes pyrogenicity) | Pass | Pass |
| Chemical Characterization / Gas Chromatography with Mass Spectrometry | Pass | Pass |
| Chemical Characterization / Inductively Coupled Plasma (ICP) | Pass | Pass |
| Partial Thromboplastin Time - PTT | Pass | Pass |
| Pyrogenicity | Pass | Pass |
| Hemocompatibility - Hemolysis | Pass | Pass |
| Hemocompatibility - Complement Activation System | Pass | Pass |
| Hemocompatibility - Thrombosis | Pass | Pass |
| Chemical Characterization / Fourier Transform Infrared Spectroscopy (FTIR) | Pass | Pass |
| Chemical Characterization / Physicochemical Non-volatile Residue (NVR) | Pass | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes bench testing for the device, not a human clinical trial involving a "test set" of patients or data in the typical sense for evaluating diagnostic accuracy or clinical outcomes. The "test set" here refers to the actual devices or components tested.
- Sample Size: The specific sample size for each individual bench test (e.g., how many devices underwent a Shaft Kink test) is not explicitly stated in the provided text. The results are simply reported as "Pass."
- Data Provenance: The tests are conducted by the manufacturer, St. Jude Medical, which implies internal testing. The data provenance is retrospective in the sense that these tests were performed on manufactured devices to verify their specifications. The country of origin of the data is implicitly the manufacturing or testing location of St. Jude Medical, likely the United States (Minnetonka, MN, as listed for the submitter).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the evaluation is based on bench testing of device specifications, not on diagnostic accuracy requiring expert interpretation or ground truth establishment in a clinical context.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable. Adjudication methods are typically used in clinical studies, particularly for interpreting diagnostic images or clinical endpoints where multiple experts might disagree. Bench tests have objective Pass/Fail criteria based on predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not performed. This type of study assesses the impact of a device (like an AI algorithm) on human reader performance, which is not relevant for a steerable introducer device's bench testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is an electro-mechanical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests is the defined product specifications and performance requirements. For example, the "Curve Angle" test would have a specific angle tolerance as its ground truth, and the device either meets it ("Pass") or fails to. For biocompatibility tests, the ground truth is established by standards (e.g., ISO 10993) and the biological response observed meets the defined acceptable limits.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this device's development as it is not an AI/ML algorithm. The device design and materials are based on engineering principles and previous predicate devices.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as above.
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