(92 days)
The Acuson AcuNav V Ultrasound Catheter is intended for intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
The AcuNav V has been designed to meet the following product safety standards: UL 60601-1, Safety Requirements for Medical Equipment; IEC 60601-2-37 Diagnostic Ultrasound Safety Standards; CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment; AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment; AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound; 93/42/EEC Medical Devices Directive; Safety and EMC Requirements for Medical Equipment - EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2; IEC 61157 Declaration of Acoustic Power; ISO 10993-1 Biocompatibility; ISO 14971 Risk Management; ISO 11607 Packaging for terminally sterilized medical devices. The AcuNav V catheter is to be used only on systems with which it has been tested and found compatible. Each of these system/transducer combinations shall be cleared through the 510(k) process and have a subsequent special report submitted.
This 510(k) summary submission describes the Siemens AcuNav V Ultrasound Catheter, a modified device, and its substantial equivalence to the original AcuNav Ultrasound Imaging Catheter. The submission does not include a study to prove acceptance criteria in the traditional sense of clinical performance metrics. Instead, it focuses on demonstrating that the modified device continues to meet established safety and performance standards through verification and validation activities conducted as part of the company's design control process.
Here's an analysis of the provided information relative to your requested categories:
1. A table of acceptance criteria and the reported device performance
The submission does not provide quantitative "acceptance criteria" for clinical performance metrics (e.g., sensitivity, specificity, accuracy) or "reported device performance" in terms of those metrics. Instead, the acceptance criteria are related to compliance with product safety standards and design control processes. The reported "performance" is that the device has been verified and validated against these standards.
| Acceptance Criteria (Standards Compliance) | Reported Device Performance |
|---|---|
| UL 60601-1, Safety Requirements for Medical Equipment | Designed to meet / Verified and validated |
| IEC 60601-2-37 Diagnostic Ultrasound Safety Standards | Designed to meet / Verified and validated |
| CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment | Designed to meet / Verified and validated |
| AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment | Designed to meet / Verified and validated |
| AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound | Designed to meet / Verified and validated |
| 93/42/EEC Medical Devices Directive | Designed to meet / Verified and validated |
| EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2 (Safety & EMC) | Designed to meet / Verified and validated |
| IEC 61157 Declaration of Acoustic Power | Designed to meet / Verified and validated |
| ISO 10993-1 Biocompatibility | Designed to meet / Verified and validated |
| ISO 14971 Risk Management | Designed to meet / Verified and validated |
| ISO 11607 Packaging for terminally sterilized medical devices | Designed to meet / Verified and validated |
| Compatibility with specified ultrasound systems | Tested and found compatible (each system/transducer combo to be cleared via 510(k)) |
| Intended Use: intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients | The device maintains this intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the submission. The submission states "The AcuNav modifications are verified and validated according to the company's design control process," but details on specific test sets, sample sizes, or data provenance (e.g., in-vitro, in-vivo, animal, human, retrospective/prospective) for these verification and validation activities are not included in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As no clinical performance study with a test set requiring expert ground truth is described, details about experts are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided, as no clinical performance study with a test set requiring expert adjudication is described.
5. 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
An MRMC comparative effectiveness study was not done, and it is not applicable here. The device is a diagnostic ultrasound catheter, not an AI-powered diagnostic tool. The submission is for a modification to an existing device, focusing on safety and technical equivalence rather than comparative clinical effectiveness studies with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study was not done, and it is not applicable. The device is a physical ultrasound catheter, which always requires a human operator (human-in-the-loop).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The submission does not explicitly state the type of ground truth used for specific performance metrics of the catheter, as it primarily focuses on compliance with technical and safety standards. For electrical safety, acoustic output, biocompatibility, and risk management, the "ground truth" is adherence to the specified international and national standards, which would be verified through specific testing methodologies (e.g., electrical measurements, acoustic power measurements, biological assays, risk assessments). For imaging performance, if evaluated, it would likely involve phantom studies or in-vivo animal/human imaging compared to established imaging benchmarks or other validated imaging modalities, but these details are not provided.
8. The sample size for the training set
This information is not provided, and it is not applicable in the context of this device type and submission. The AcuNav V catheter is not an AI/machine learning device that requires a "training set" in the computational sense.
9. How the ground truth for the training set was established
This information is not provided, and again, it is not applicable as the device does not employ machine learning or AI that would require a training set and associated ground truth establishment.
Summary of the Study and Acceptance Criteria in the Context of a 510(k) for Device Modification:
The provided 510(k) submission (K081808) is for a modified diagnostic ultrasound catheter (AcuNav V), establishing its substantial equivalence to a legally marketed predicate device (original AcuNav Ultrasound Imaging Catheter). For such submissions, especially for modifications to an existing device where the intended use remains the same, the "study" demonstrating adherence to "acceptance criteria" primarily revolves around technical verification and validation against recognized product safety and performance standards, rather than new clinical trials measuring diagnostic accuracy or effectiveness against a clinical ground truth.
The "acceptance criteria" here are the comprehensive list of national and international safety, biocompatibility, and performance standards (e.g., UL 60601-1, IEC 60601-2-37, ISO 10993-1, AIUM/NEMA standards) that the device must meet. The "study that proves the device meets the acceptance criteria" is the "company's design control process," which includes the "verification and validation" activities confirming the modified device's compliance with all these product safety and performance specifications. This implicitly involves various engineering tests, material evaluations, and functional assessments without necessarily requiring a large-scale clinical study for this specific type of modification and submission. Compatibility with systems is also an acceptance criterion, met by testing and subsequent 510(k) clearance for each specific system/transducer combination.
§ 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).