(68 days)
The ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
The ViewFlex™ Xtra ICE Catheter ("ViewFlex™ Catheter") is a temporary intracardiac ultrasound catheter intended for use in patients to accurately visualize cardiac structures, blood flow and other devices within the heart when connected to a compatible intracardiac ultrasound console via the compatible ViewFlex™ Catheter Interface Module. Examples of the types of other devices that can be visualized include, and are not limited to, intracardiac catheters, septal occluders, delivery wires, delivery sheaths, sizing balloons and transseptal needles. The use of these images is limited to visualization with no direct or indirect diagnostic use. The ViewFlex™ Catheter has a useable length of 90 cm, with a 9 French (F) shaft with an ultrasound transducer. A 10F introducer is recommended for use with this catheter for insertion into the femoral or jugular veins. The catheter tip has four-directional deflection allowing for Left-Right and Posterior-Anterior deflection, with an angle of at least 120 degrees in each direction. The ViewFlex™ Catheter is compatible with the ViewMate™ Z, ViewMate™, ViewMate™ Multi, and Philips CX50 ultrasound consoles.
Here's a breakdown of the acceptance criteria and the study information for the ViewFlex™ Xtra ICE Catheter, based on the provided document:
This document is a 510(k) clearance letter and a summary of the special 510(k) submission for the ViewFlex™ Xtra ICE Catheter's compatibility with the ViewMate™ Multi Ultrasound System. It describes the testing performed to ensure the updated device (the ViewFlex™ Xtra ICE Catheter when used with the new ViewMate™ Multi Ultrasound System) does not raise new questions of safety or effectiveness compared to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "Design verification activities were performed with their respective acceptance criteria to ensure that the use of the ViewFlex™ Xtra ICE Catheter in conjunction with the ViewMate™ Multi Ultrasound System does not affect the safety or effectiveness of the device. All testing performed met the established performance specifications."
While specific, granular acceptance criteria values are not explicitly listed in this summary, the general acceptance criteria are implicitly that the device, when used with the new console, performs safely and effectively within established performance specifications, and meets relevant industry standards.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Ensure safety and effectiveness when used with ViewMate™ Multi Ultrasound System | "All testing performed met the established performance specifications." |
| Compliance with BS EN 60601-2-37 (basic safety & essential performance of ultrasonic medical diagnostic and monitoring equipment) | No adverse findings reported; compliance affirmed implicitly by FDA clearance, and statement "All testing performed met the established performance specifications." |
| Compliance with BS EN 60601-1 (general requirements for basic safety and essential performance of medical electrical equipment) | No adverse findings reported; compliance affirmed implicitly by FDA clearance, and statement "All testing performed met the established performance specifications." |
| Compliance with BS EN 60601-1-2 (electromagnetic compatibility) | No adverse findings reported; compliance affirmed implicitly by FDA clearance, and statement "All testing performed met the established performance specifications." |
| No new or increased hazards identified as a result of modifications | "There were no new or modified hazards identified as a result of the proposed modifications. Abbott has reviewed the applicable risk management documentation... and determined that the changes... do not increase existing risks or create new risks to the user or patient, and that the residual risk remains acceptable following verification and validation activities." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for the test set in terms of number of patients, cases, or images. The testing described is primarily non-clinical design verification and validation testing rather than clinical performance testing with patient data.
The data provenance is for non-clinical testing (bench testing, performance evaluations) related to device compatibility and adherence to standards. It does not involve human patient data from a specific country, nor is it described as retrospective or prospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to this submission. The ground truth for this type of special 510(k) submission for device compatibility is established through objective engineering and performance testing, comparing the device's output and safety metrics against predefined specifications and industry standards, rather than expert interpretation of clinical data to establish a "ground truth" diagnosis.
4. Adjudication Method for the Test Set:
This information is not applicable. Since the testing focuses on technical performance and compliance with standards, there is no need for expert adjudication in the traditional sense of resolving discrepancies in diagnostic interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to evaluate the diagnostic performance of an AI-powered device or a new imaging modality and compare it to existing methods or human readers. The ViewFlex™ Xtra ICE Catheter is a diagnostic intravascular catheter, and this particular submission focuses on its compatibility with a new ultrasound console, not on comparing its diagnostic performance or an AI component to human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The ViewFlex™ Xtra ICE Catheter is a medical device (a catheter with an ultrasound transducer) that requires a human operator and an ultrasound console to function. It is not an AI algorithm or a standalone diagnostic tool in that sense. The device's performance is inherently tied to its use by a human and with supporting equipment.
7. The Type of Ground Truth Used:
The ground truth used for this type of non-clinical testing is based on established engineering specifications, industry standards, and validated test methods. For example, measuring a deflection angle would use a calibrated measurement system (engineering ground truth), or testing electrical safety complies with specific limits defined in the referenced standards (standard-based ground truth).
8. The Sample Size for the Training Set:
Not applicable. This submission is for a medical device (a catheter) and its compatibility with an ultrasound system. It does not involve machine learning or AI algorithms that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI algorithm in this submission.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).