(29 days)
The ViewFlex™ Eco Reprocessed 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™ Eco Reprocessed ICE 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™ Eco Reprocessed ICE 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™ Eco Reprocessed ICE Catheter is compatible with the ViewMate™ Z, ViewMate™, ViewMate™ Multi and Philips CX50 ultrasound consoles.
The ViewFlex™ Eco Reprocessed ICE Catheter is reprocessed by Abbott no more than two (2) times. Each catheter includes marking on the proximal handle and connector that identify the catheter status. The device is taken out of service after reaching the maximum number of reprocessing cycles. Abbott restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.
Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary for the ViewFlex™ Eco Reprocessed ICE Catheter:
Summary of Acceptance Criteria and Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Met established performance specifications. |
| Design Validation | Met established performance specifications. |
| Design Verification | Met established performance specifications. |
| Cleaning Validation | Met established performance specifications. |
| Risk Management | No new or modified hazards identified as a result of the proposed modification (additional reprocessing cycle). |
Study Information:
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Table of Acceptance Criteria and Reported Device Performance: This information is provided in the table above. The document states that all testing performed met the established performance specifications for each category.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the sample size for the test set used in the non-clinical performance evaluation. It only mentions that "Design verification activities were performed with their respective acceptance criteria."
- Data Provenance: Not specified, but generally, non-clinical tests like these are conducted in a laboratory setting by the manufacturer (Abbott Medical, USA).
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Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This device is a medical catheter and the tests described are primarily engineering and biocompatibility evaluations, not diagnostic image interpretation studies requiring expert clinicians to establish ground truth.
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Adjudication Method for the Test Set:
- Not applicable. The tests are objective measurements against predefined engineering and material specifications, not subjective interpretations requiring adjudication.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. The document explicitly states: "No clinical investigations have been performed for the subject or predicate devices. Clinical data is not required for the demonstration of substantial equivalent based on the risk assessment in Section 10 and verification in Section 12 and validation in Section 13 summarized in this 510(k)." Therefore, no MRMC study was conducted.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This is a physical medical device (catheter), not an AI algorithm. Its performance is evaluated through engineering, material, and reprocessing verification and validation, not standalone algorithmic performance.
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The Type of Ground Truth Used:
- The "ground truth" for the non-clinical studies (biocompatibility, design validation/verification, cleaning validation) would be defined by established engineering specifications, material standards, and regulatory guidance documents. For example, for biocompatibility, it would be adherence to ISO 10993 standards and a lack of adverse biological responses. For cleaning validation, it would be a verifiable reduction in contaminants below a specified threshold.
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The Sample Size for the Training Set:
- Not applicable. As this is not an AI/algorithm-based device, there is no "training set" in the context of machine learning. The "development" and "testing" referred to are related to engineering design and physical performance testing.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for an AI algorithm.
§ 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).