(231 days)
The Scout catheter is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
M2440A intravascular ultrasound imaging catheter has equivalent functionality to the predicate Boston Scientific catheters now cleared for use with M2400A: acoustic output for the M2440A operating on the M2400A is within FDA limits. The pullback functionality incorporated into the M2440A catheter and the M2401B PIU are equivalent to the predicate Boston Scientific catheters and pullback devices listed above.
This submission is a 510(k) premarket notification for the Hewlett-Packard Scout Catheter. It claims substantial equivalence to predicate devices and focuses on modifications to patient contact materials and the ergonomic configuration of the motorized pullback system. As a 510(k), this document primarily focuses on demonstrating substantial equivalence to pre-existing devices, rather than establishing acceptance criteria and conducting a detailed study with specific performance metrics against those criteria in the way a de novo or PMA submission might.
Therefore, the requested information, which is typical for AI/ML device submissions involving performance metrics and clinical studies, is not explicitly available in this 510(k) submission.
Here's why and what information can be extracted:
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Acceptance Criteria and Reported Performance: A 510(k) for a device like a catheter typically relies on demonstrating that the new device performs "as intended" and is as safe and effective as the predicate. This often involves bench testing (e.g., biocompatibility, physical properties, acoustic output) to confirm it meets engineering specifications, rather than clinical performance metrics like sensitivity/specificity for a diagnostic AI. The document states:
- "Submission includes acceptable biocompatibility and bench testing results for all changes to design and materials."
- "acoustic output for the M2440A operating on the M2400A is within FDA limits."
- "The pullback functionality incorporated into the M2440A catheter and the M2401B PIU are equivalent to the predicate Boston Scientific catheters and pullback devices listed above."
- "M2440A is substantially equivalent to the predicate 6) Boston Scientific catheters."
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Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied from 510(k) context) | Reported Device Performance (as stated in 510(k)) |
|---|---|
| Biocompatibility of new patient contact materials | "acceptable biocompatibility...results for all changes to design and materials." |
| Acoustic output within FDA limits | "acoustic output for the M2440A operating on the M2400A is within FDA limits." |
| Equivalent functionality to predicate devices for intravascular ultrasound | "equivalent functionality to the predicate Boston Scientific catheters now cleared for use with M2400A" |
| Equivalent functionality of motorized pullback system | "The pullback functionality incorporated into the M2440A catheter and the M2401B PIU are equivalent to the predicate Boston Scientific catheters and pullback devices" |
| Substantial equivalence to predicate devices | "M2440A is substantially equivalent to the predicate 6) Boston Scientific catheters." |
The 510(k) process typically doesn't require the detailed breakdown of clinical study designs (sample size, ground truth, expert qualifications, etc.) that would be expected for novel AI/ML devices or higher-risk devices requiring PMA. The "proof" here is primarily based on engineering and biocompatibility testing, along with comparison to a legally marketed predicate device.
Given the nature of this 510(k) for an intravascular ultrasound catheter, the following information is not present and would not typically be required for this type of submission:
- Sample size used for the test set and the data provenance: Not applicable in the context of a "test set" for performance metrics as you would see with AI. The testing would be bench/biocompatibility.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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 not an AI device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance claims in this submission. For biocompatibility, the "ground truth" would be established by industry standards and validated testing protocols.
- The sample size for the training set: Not applicable as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.