(132 days)
The ViewCath™ Catheter Pullback is a device used for motorized pullback of medical Ultrasound intravascular imaging catheters to assist in consistent, selectable speed, 2-D image acquisition for use by medical imaging software for longitudinal view display or 3-D reconstruction and rendering and volumetric presentation of 3-D images for diagnostic review.
The ViewCath™ Catheter Pullback is a medical Ultrasound Intravascular transducer catheter pullback device used in conjunction with Intravascular Ultrasound system devices. The ViewCath™ Catheter has a cradle that firmly holds various catheter transducer drive motors. Upon actuation, the device pulls the motor cradle at one of two selected speeds. A medical Intravascular Ultrasound catheter attached to the drive motor is pulled back at a consistent speed to obtain multiple 2-D ultrasound images. It is similar in design to other such catheter pullback devices. It has a motor driven mechanical screw mechanism, Intravascular Ultrasound catheter motor drive cradle, control switch and travel readout scale.
This document is a 510(k) summary for the ViewCath™ Catheter Pullback device, submitted to the FDA in 1997. It describes the device, its intended use, and states its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Performance tests were conducted by testing the system to the requirements of the design specifications and comparison to the predicate devices." and "The performance evaluations indicated that the system consistently performed within its design parameters, and equivalently to the predicate devices."
However, specific numerical acceptance criteria (e.g., maximum speed variation, accuracy of travel readout) and their corresponding reported device performance values are not explicitly provided in the provided text. The submission focuses on demonstrating substantial equivalence rather than detailed performance metrics.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of typical AI device testing with a distinct dataset of images or cases. The performance evaluation appears to be based on engineering tests of the device's mechanical and electrical functions and comparison to the predicate device.
- No information on data provenance (country of origin, retrospective/prospective) is provided, as no clinical data or image-based test set is mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The "ground truth" for this device would be its mechanical and functional specifications (e.g., the actual speed it pulls the catheter, the accuracy of its travel readout). This is assessed through engineering tests, not expert interpretation of medical data.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of adjudication, as no expert review of cases or images is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This device is a mechanical catheter pullback system, not an AI software intended to assist human readers in interpreting medical images. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable in the context of AI algorithms. The device itself operates "standalone" in performing its mechanical function (pulling the catheter), but this is not analogous to an AI algorithm's standalone diagnostic performance. The document describes the device's operational performance, stating it "consistently performed within its design parameters."
7. Type of Ground Truth Used:
The ground truth used for this device's performance evaluation would be its engineering design specifications (e.g., specified pullback speeds, travel readout accuracy, mechanical stability). The performance tests would have verified that the device's output (actual speed, actual travel distance) matched these specified parameters.
8. Sample Size for the Training Set:
Not applicable. This device is a mechanical medical instrument, 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 this device. Its design and operation are based on mechanical and electrical engineering principles, not machine learning from data.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.