(30 days)
The AptiVue™ E series software is intended to be used only with compatible OPTIS™ imaging systems.
The OPTIS imaging system with a compatible Dragonfly™ imaging catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The compatible Dragonfly imaging catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly imaging catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The OPTIS imaging system is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.
OPTIS™ Systems with AptiVue™ Imaging Software (version E.6) perform Optical Coherence Tomography (OCT), Fractional Flow Reserve (FFR), and Resting Full-cycle Ratio (RFR) procedures and provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. Version E.6 adds cloud connectivity to enable remote installation of software updates and transmission of system telemetry data.
The provided document (K232386) describes the premarket notification for the "ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6". This submission primarily focuses on the addition of cloud connectivity features (remote software updates and telemetry data transmission) to an existing device (predicate device K183320).
Crucially, the document explicitly states that "No clinical testing is provided in this pre-market notification" (page 4). Therefore, the information requested regarding acceptance criteria and study proving device performance (including sample sizes, expert involvement, ground truth, MRMC studies, and standalone performance) cannot be extracted from this document, as such studies were not performed or reported for this particular submission.
The document focuses on demonstrating substantial equivalence based on the updated software's functional similarity and verification and validation (V&V) testing.
Here's what can be inferred from the document regarding the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the non-clinical testing performed:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Inferred from V&V) | Reported Device Performance (as stated in the document) |
|---|---|
| Functionality of new cloud connectivity features (remote software updates, telemetry data transmission) | The device performs the stated functions. The core intent of the submission is that "Version E.6 adds cloud connectivity to enable remote installation of software updates and transmission of system telemetry data." The acceptance for these features would be their successful operation and secure data transfer. |
| Adherence to user needs and product specifications | "The results demonstrate that the AptiVue Software version E.6 meets the user needs and product specifications and is appropriate for its intended use and does not raise any new issues of safety and effectiveness." This implies that the software performed as designed and met its functional and non-functional requirements. |
| Compliance with internal design control procedures | "Software verification and validation tests were performed on OPTIS Systems with AptiVue E.6 Software in compliance with internal design control procedures." This indicates that the testing followed the company's established quality system for software development and validation. |
| Safety and effectiveness (no new issues) | "does not raise any new issues of safety and effectiveness." This is a key regulatory acceptance criterion for 510(k) applications demonstrating substantial equivalence. The V&V testing confirms that the added features do not negatively impact the safety or effectiveness of the device compared to the predicate. This would involve risk analysis and mitigation for the new features. |
The remaining requested information (2-9) pertains to clinical studies and performance evaluation of an AI/ML algorithm against a ground truth, which is explicitly stated as not included in this submission.
Here's a breakdown of why the other points cannot be answered:
- Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set for AI/ML performance was used. The V&V testing would have involved engineering and software test cases, not patient data in the context of an AI performance study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth for AI/ML performance was established or reviewed for this submission.
- 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. The submission is about adding cloud connectivity, not about AI-assisted interpretation or improvement of human reader performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This submission concerns software and hardware systems for imaging, FFR, and RFR; the "AptiVue™ Imaging Software" is part of the system, but the document does not indicate a distinct AI/ML algorithm for standalone diagnostic performance beyond what the predicate device already provided. The predicate's capabilities (OCT, FFR, RFR) involve algorithms, but this submission does not describe a new or modified AI/ML algorithm requiring standalone clinical validation.
- The type of ground truth used: Not applicable, as no clinical ground truth assessment (e.g., pathology, outcomes data) was reported for this submission. The "ground truth" for the V&V of the new features would be the expected functional behavior according to design specifications.
- The sample size for the training set: Not applicable, as no machine learning model training was described or modified for this submission.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided FDA 510(k) clearance letter and summary primarily address an update to existing software with new cloud-based functionalities. It clearly states that "No clinical testing is provided." Therefore, the detailed questions about acceptance criteria for AI/ML performance, clinical test sets, experts, and ground truth are not relevant to the information contained within this specific document.
§ 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.