(174 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.
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 is related to the 510(k) submission for a Reprocessed Diagnostic Ultrasound Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of a novel device to meet specific performance criteria. Therefore, most of the information requested in your prompt (e.g., sample sizes, expert ground truth, MRMC study, training set details) is not applicable or cannot be extracted from this type of document.
The document states that the reprocessed device is "identical to the predicate devices" in terms of design, materials, intended use, mechanism of action, and performance specifications. The performance data presented are primarily bench and laboratory tests to confirm that the reprocessing maintains the original device's performance, safety, and effectiveness.
Here's an attempt to answer your questions based on the provided text, with many fields marked as "Not Applicable" or "Not Provided" due to the nature of the submission.
Acceptance Criteria and Study Details for Reprocessed Diagnostic Ultrasound Catheter (K063076)
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are implied by the need to demonstrate that the reprocessed device performs "as originally intended" and is "safe and effective" and "substantially equivalent" to the predicate device. Specific quantitative acceptance criteria are not explicitly stated in a table format in the provided text. The "reported device performance" is a general confirmation that these criteria were met through various tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility maintained | Biocompatibility testing conducted and passed |
| Reprocessing validation successful | Validation of reprocessing conducted and passed |
| Sterility maintained | Sterilization Validation conducted and passed |
| Functional performance equivalent to new device | Function test(s) conducted and passed |
| Packaging integrity maintained | Packaging Validation conducted and passed |
| Device is safe and effective when reprocessed | Performance testing demonstrates Reprocessed Ultrasound Catheters perform as originally intended. |
| Device is substantially equivalent to predicate device (K992631) | Ascent Healthcare Solutions concludes substantial equivalence. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "bench and laboratory testing" but does not quantify the number of units or tests performed.
- Data Provenance: Not explicitly stated. Given it's internal testing for a 510(k) submission, it's presumed to be internal, prospective testing related to the reprocessing procedure. The country of origin of the data is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. This type of submission relies on objective engineering and biological tests (biocompatibility, sterility, function) rather than expert interpretation of medical images or outcomes.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Adjudication methods like "2+1" typically apply to expert reviews of medical data, which is not the primary focus of this submission. The tests performed have definitive pass/fail criteria.
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
- MRMC Comparative Effectiveness Study: No, this was not done. The device is a diagnostic ultrasound catheter, not an AI-powered diagnostic tool.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device (a reprocessed catheter), not an algorithm.
7. The type of ground truth used
The "ground truth" for this submission is established through objective engineering, chemical, and biological testing standards to confirm the device's physical and functional integrity, sterility, and biocompatibility after reprocessing. It relies on:
- Standardized methods for evaluating biocompatibility.
- Validation protocols for reprocessing efficacy (e.g., cleaning effectiveness).
- Sterilization validation protocols.
- Functional test specifications to ensure the catheter performs as intended (e.g., imaging capability, steering mechanism).
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document describes the reprocessability validation of an existing device, not the development of a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: 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).