(68 days)
The EasyPass™ US Y-connector Hemostatic Valve is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices that have an outer diameter of 7 French or smaller.
The guide wire insertion tool facilitates introduction of the guide wire through the hemostasis valve and into the guiding catheter.
The torquer, when inserted over the proximal end of the guide wire, provides a handle for easier manipulation of the guide wire.
The EasyPass™ US Y-connector Hemostatic Valve consists of a y-connector body with a rotating luer lock, a sidearm and a hemostasis valve. To open the hemostasis valve, a valve opener cap with a center passage tube is pushed distally. The hemostasis valve is closed by pulling the valve opener cap proximally. The passage tube on the valve opener provides a completely opened and smooth lumen for the insertion of interventional devices.
The provided text is a 510(k) summary for a medical device called the "EasyPass™ US Y-connector Hemostatic Valve." This type of document is filed with the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, thereby allowing it to be marketed without a full Pre-Market Approval (PMA) process.
Critically, a 510(k) summary does not typically contain detailed information about specific acceptance criteria or the comprehensive results of a device performance study as one would expect for an AI/ML medical device. The performance section found in a 510(k) often only states that testing was done and demonstrated safety and effectiveness, usually by comparing it to the predicate device.
Therefore, many of the requested items related to an AI/ML study (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable to this document because it describes a hardware medical device (a hemostatic valve), not an AI/ML algorithm.
Based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format typically used for AI/ML device studies. Instead, it states general findings related to the device's functionality compared to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device design is substantially equivalent to predicate device. | Comparisons of the new and predicate device show that technological characteristics such as device design and principle of operation are substantially equivalent to the currently marketed predicate device (Guidant Corporation's Copilot Bleedback Control Valve K991102). |
| Principle of operation is substantially equivalent. | Comparisons of the new and predicate device show that technological characteristics such as device design and principle of operation are substantially equivalent to the currently marketed predicate device (Guidant Corporation's Copilot Bleedback Control Valve K991102). |
| Device is safe and effective for its intended use. | The results of the performance testing demonstrated the safety and effectiveness of the EasyPass™ US Y-connector Hemostatic Valve. (Intended use: maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices that have an outer diameter of 7 French or smaller. The guidewire insertion tool facilitates introduction, and the torquer provides a handle for manipulation.) |
2. Sample size used for the test set and the data provenance
- Not Applicable (N/A). This document refers to a physical medical device (hemostatic valve), not an AI/ML algorithm. Therefore, there isn't a "test set" of data in the AI/ML sense. The "performance testing" mentioned would typically involve bench testing (e.g., flow rates, leak testing, material compatibility), not analysis of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. As this is not an AI/ML device, there are no "experts" establishing ground truth in this context. The evaluation would be engineering/performance-based against specifications, potentially with clinical input on usability, but not for "ground truth" labeling.
4. Adjudication method for the test set
- N/A. No test set or adjudication method as described for AI/ML devices is mentioned or applicable.
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
- N/A. This device is a passive hardware component, not an AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. This is a hardware device, not an algorithm.
7. The type of ground truth used
- N/A. For this physical device, "ground truth" would relate to its physical and functional performance against established engineering standards and specifications (e.g., no leaks, smooth passage of devices, consistent hemostasis), rather than clinical "ground truth" from pathology or outcomes data. The document focuses on demonstrating substantial equivalence to a predicate device based on design and principle of operation, supported by general performance testing findings.
8. The sample size for the training set
- N/A. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- N/A. This is not an AI/ML device, so there is no training set or ground truth in that context.
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.