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510(k) Data Aggregation
(146 days)
The Trinias is an angiographic X-ray system, which is used for diagnostic imaging and interventional procedures. The Trinias is intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.
This notification is for a modified device. The modifications are: Updated user interfaces (wireless mouse, keyboard) A new model of catheterization table A new type of digital system console Additional x-ray tube choices Add alternate choices for the same sizes of digital flat panel detectors An additional size of available flat panel detector (12" x 16") An additional type of control cabinet.
This document is a 510(k) summary for the Shimadzu Trinias angiographic X-ray system. It describes modifications to an existing device and demonstrates substantial equivalence to a predicate device (K123508).
Based on the provided document, the device in question is a medical imaging system (angiographic X-ray system), not an AI/ML-based device. Therefore, the typical acceptance criteria and study designs associated with AI/ML systems (e.g., performance metrics like sensitivity/specificity, multi-reader multi-case studies, ground truth establishment by experts, training/test set provenance) are not applicable here.
The regulatory approval for this device is based on showing substantial equivalence to a previously cleared predicate device, rather than proving performance against specific AI/ML acceptance criteria. The modifications are hardware and software updates to the existing X-ray system.
Here's an analysis of the provided information in the context of device approval, highlighting why AI/ML-specific criteria are not met or relevant:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable (for AI/ML performance).
Since this is not an AI/ML device, there are no acceptance criteria related to typical AI/ML performance metrics (e.g., accuracy, sensitivity, specificity, AUC).
The "acceptance criteria" for this submission are compliance with various safety and performance standards for X-ray systems. The reported "performance" is that the modified device meets these standards and is comparable to the predicate.
| Acceptance Criteria (based on standards compliance) | Reported Device Performance |
|---|---|
| Compliance with US Performance Standard 21CFR1020.30, .31, .32 | Device tested and certified to comply. |
| Compliance with IEC 60601-1 (general safety) | Device found to comply. |
| Compliance with IEC 60601-1-2 (EMC) | Device found to comply. |
| Compliance with IEC 60601-1-3 (radiation protection) | Device found to comply. |
| Compliance with IEC 60601-1-6 (usability) | Device found to comply. |
| Compliance with IEC 60601-2-43 (interventional procedures) | Device found to comply. |
| Compliance with IEC 62366 (usability engineering) | Evaluated in accordance with and found to comply. |
| Compliance with IEC 62304 (software life cycle processes) | Evaluated in accordance with and found to comply. |
| Software validation (FDA Guidance May 11, 2005) | Software was validated. |
| Cybersecurity management (FDA Guidance Oct 2, 2014) | Recommendations observed for Wi-Fi and Ethernet. |
| Pediatric Information Labeling (FDA Guidance Nov 2017) | Labeling developed in accordance, includes Image Gently. |
| Wireless Technology Recommendations (FDA Guidance Aug 2013) | Recommendations incorporated into labeling. |
| Safety and effectiveness comparable to predicate device K123508 | "as safe and effective as the predicate device," "few technological differences," "same indications for use." |
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable (for AI/ML test set data).
There is no "test set" in the sense of a clinical image dataset used to evaluate an AI algorithm's diagnostic performance. The testing performed was non-clinical bench and standards testing. This involves engineering tests, electrical safety tests, radiation safety compliance tests, and software validation tests.
The data provenance refers to the origin of the device's design, manufacturing, and testing; it does not refer to clinical image data. The manufacturer is Shimadzu Corporation, based in Kyoto, Japan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not Applicable.
No "ground truth" derived from expert interpretation of medical images was established for this submission, as it's not an AI/ML diagnostic aid. The device's performance is validated against engineering specifications, safety standards, and functional requirements.
4. Adjudication Method for the Test Set
Not Applicable.
Since there's no expert interpretation of a test set, there is no adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A MRMC study was not done.
MRMC studies are typically performed for AI/ML diagnostic devices to assess how human reader performance (e.g., radiologists) improves with AI assistance compared to without it. This submission is for an X-ray imaging system itself, not an AI-assisted diagnostic tool.
Therefore, there is no effect size of how human readers improve with AI vs. without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No.
This concept applies to AI/ML algorithms that can produce an output independently. The Trinias is an imaging system; its "performance" is its ability to acquire images, comply with safety standards, and function as intended.
7. The Type of Ground Truth Used
Compliance with regulated standards and functional specifications.
The "ground truth" for this device's approval lies in its adherence to international safety standards (e.g., IEC 60601 series, IEC 62304 for software) and U.S. performance standards (21 CFR 1020.30, .31, .32), as well as verification of its mechanical and electrical functions. This is demonstrated through "bench and standards testing" and "proper system operation is fully verified upon installation."
8. The Sample Size for the Training Set
Not Applicable.
This refers to training data for AI/ML models. The Trinias is a hardware and software system. While its internal software components undergo development and testing, there isn't a "training set" in the AI/ML sense.
9. How the Ground Truth for the Training Set Was Established
Not Applicable.
As there is no AI/ML training set, there is no ground truth established for it. Software validation (IEC 62304) and adherence to design specifications guide the software development, but this is distinct from training an AI model.
In summary: The provided document is a 510(k) submission for an updated medical imaging hardware system (X-ray). Its approval focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and safety testing, and compliance with established regulatory standards. It does not involve AI/ML technology or associated clinical performance studies with diagnostic accuracy endpoints.
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(165 days)
The Sonicath Ultra Imaging Catheter is intended for the ultrasound examination of peripheral and coronary intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
The BSC Sonicath Ultra Imaging Catheter is a sterile, single-use disposable device used for the ultrasound examination of intravascular pathology in both the coronary and peripheral vasculatures. The Sonicath Ultra 2.9 F and 3.2 F Imaging Catheters and predicate devices consist of two main components: (1) the catheter body and (2) the imaging core. The imaging core of both the Sonicath Ultra and the predicate device imaging catheters is comprised of a hitorque, flexible, rotating drive cable with an outward looking ultrasonic transducer at the distal tip.
The Boston Scientific Corporation's Sonicath Ultra™ Imaging Catheter (K970049) was subjected to various non-clinical tests to demonstrate its safety and effectiveness. The device's acceptance criteria and performance are detailed below based on the provided 510(k) summary.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Bench Testing | |
| Catheter Shaft Tensile Strength | Determined to be acceptable and consistent with intended use. |
| Catheter Joint Tensile Strength | Determined to be acceptable and consistent with intended use. |
| Imaging Core Weld Joint Tensile Strength | Determined to be acceptable and consistent with intended use. |
| Acoustic Output Testing | |
| Acoustic Output Limits (FDA Track 1 limits) | Test results are below the FDA Track 1 limits. |
| Animal Testing | |
| In-vivo functional and imaging characteristics | Performance was consistent with the intended clinical use of the device. |
| Biocompatibility | |
| Compliance with ISO 10993-1 Part 1 | Meets the requirements for biocompatibility testing outlined in ISO 10993-1 Part 1. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the exact sample sizes for the test sets used in the bench, acoustic output, and animal testing.
- Bench Testing: The summary indicates "bench testing was included" without detailing the number of catheters or components tested.
- Acoustic Output Testing: "The Sonicath Ultra Imaging Catheter was tested for acoustic output" again without specific numbers.
- Animal Testing: "Animal testing was performed" without specifying the number of animals or the type of animal model.
The data provenance is from non-clinical studies (bench and animal testing) conducted by Boston Scientific Corporation, Sunnyvale. The report does not specify countries of origin for test data, but it is implied to be internal testing for regulatory submission in the U.S. It is prospective for the purposes of device evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The 510(k) summary focuses on non-clinical performance and substantial equivalence to predicate devices, not on diagnostic accuracy based on expert interpretation of images. Therefore, it does not mention a number of experts used to establish ground truth for a test set, nor their qualifications, as this type of study was not conducted or reported for this submission.
4. Adjudication Method for the Test Set
As there was no specific test set involving human interpretation requiring ground truth establishment or expert consensus on diagnostic findings, no adjudication method (like 2+1 or 3+1) was reported.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported in this 510(k) submission. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance, as AI is not a component of, nor is it mentioned in relation to, this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study (algorithm only) was not done, as this device is an imaging catheter and not an AI or algorithm-based diagnostic tool. The performance evaluated was of the physical device itself.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the non-clinical tests was established as follows:
- Bench Testing: Engineering specifications and physical integrity standards (e.g., tensile strength values) for catheter components.
- Acoustic Output Testing: Governed by FDA Guidance (Revised 510(k) Diagnostic Ultrasound Guidance for 1993, and 510(k) Guide for Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices, December, 1985). The "ground truth" here is compliance with defined safety limits.
- Animal Testing: In-vivo functional and imaging characteristics were assessed against the "intended clinical use" of the device, likely by direct observation of imaging quality and catheter performance by the researchers conducting the animal studies.
8. The Sample Size for the Training Set
This submission is for a physical medical device (an imaging catheter), not a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable here, and no training set sample size is provided.
9. How the Ground Truth for the Training Set Was Established
Since there was no "training set" in the context of an AI/ML algorithm, this question is not applicable. The device's design and manufacturing are based on established engineering principles and prior predicate device designs for which safety and effectiveness were already accepted.
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