(505 days)
Reprocessed Diagnostic Ultrasound Catheters are intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart. The device is intended for use in the right heart only.
Reprocessed Diagnostic Ultrasound Catheters are indicated for visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart, as well as measurement of blood flow. The Reprocessed Diagnostic Ultrasound Catheter is intended for use in the right side of the heart only.
Diagnostic ultrasound catheters are specially designed ultrasonic catheters that provide two-dimensional imaging using an ultrasound transducer. The ultrasound transducer is at the distal tip of the catheter and can be positioned for ultrasound imaging by a steering mechanism that rotates the catheter tip and variable deflection. Diagnostic ultrasound catheters incorporate a handpiece, a flexible shaft and a distal tip section containing an ultrasound transducer. The ultrasound catheter is 10 French with 90 cm insertion length.
The provided text describes the reprocessed ultrasound catheter by Alliance Medical Corporation and references a 510(k) submission (K033436). However, the document does not contain specific acceptance criteria, detailed results of a study proving the device meets those criteria, or information on specific statistical analyses like MRMC studies or effect sizes for human readers.
The document primarily focuses on establishing substantial equivalence to a predicate device (AcuNav™ Diagnostic Ultrasound Catheter, K992631) based on identical design, materials, intended use, clinical applications, performance specifications, and method of operation.
Here's an attempt to answer the questions based on the available information, noting where data is absent:
1. A table of acceptance criteria and the reported device performance
The document states that "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Ultrasound Catheters." The performance data reported are categories of testing, not specific quantitative criteria or results.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility requirements met | Biocompatibility testing performed. Conclusion: "Reprocessed Ultrasound Catheters perform as originally intended." |
| Reprocessing process validated | Validation of reprocessing performed. Conclusion: "Reprocessed Ultrasound Catheters perform as originally intended." |
| Sterilization process validated | Sterilization Validation performed. Conclusion: "Reprocessed Ultrasound Catheters perform as originally intended." |
| Functional equivalence to original device | Function test(s) performed. Conclusion: "Reprocessed Ultrasound Catheters perform as originally intended." (Also states "same standard," "identical") |
| Packaging integrity maintained after reprocessing/sterilization | Packaging Validation performed. Conclusion: "Reprocessed Ultrasound Catheters perform as originally intended." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for any of the performance tests (biocompatibility, reprocessing validation, sterilization validation, function tests, packaging validation). It also does not explicitly state the provenance of the data (country of origin) or whether the tests were retrospective or prospective. Given the nature of bench and laboratory testing, it is generally prospective.
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 in the document. The document describes technical performance tests, not studies involving expert interpretation of medical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. The testing described is technical performance validation, not human-read clinical evaluation requiring adjudication.
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
No such study (MRMC comparative effectiveness with human readers and AI assistance) is mentioned or implied in the document. This device is a reprocessed physical medical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a reprocessed physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the technical performance tests mentioned (biocompatibility, reprocessing, sterilization, function, packaging), the "ground truth" would be established by validated test methodologies and specifications, comparing the reprocessed device's performance against the original device's specifications or established safety standards. It does not involve expert consensus on medical images, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
This question is not applicable to this type of device. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
§ 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).