(114 days)
The LiiSA Lever Integrated Interventional System Adaptor™ is a Y-Connector and hemostasis valve which is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic or interventional devices (i.e., guide wires, balloon catheters, stents) used in angioplasty procedures. It is compatible with guiding catheters 9 F or smaller and 0.014" - 0.038" guide wires.
The LiiSA Lever Integrated Interventional System AdaptorTM is an Adaptor designed for use in all interventional applications where a hemostasis valve is required and has an inner diameter of up to 9 F ( 3.0 mm / 0.118"). It has a seal which can be opened and closed by control of a lever. Pushing the lever will open the seal; releasing the lever will close the seal. The lever can be rested in a partially open position or a fully open position. These positions can easily be identified by the position of the lever and by an audible "click". The lever can be further controlled with great sensitivity to have the optimal seal around the interventional device (i.e., guide wire, balloon catheter, stent). This enables the user to experience a minimum of back bleeding with maximum security for his introduced device. The LiiSA Lever Integrated Interventional System AdaptorTM offers two external arms for the purpose of locking introduced devices (i.e., guide wire) to enable users to introduce additional devices without the need to manually hold and secure the devices already introduced and secured. The LiiSA Lever Integrated Interventional System AdaptorTM has a "Y" side arm to facilitate contrast media injection, saline flush and blood pressure monitoring.
The provided text describes a 510(k) submission for the LiiSA Lever Integrated Interventional System AdaptorTM, a hemostasis valve. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria that would typically involve human readers or AI performance metrics.
Therefore, many of the requested categories related to AI performance, expert review, MRMC studies, and standalone algorithm performance are not applicable to this 510(k) summary. The "acceptance criteria" here refer to demonstrating that the device is as safe and effective as the predicate devices through non-clinical bench tests and analysis.
Here's the information based on the provided text, with explanations for the inapplicable sections:
Acceptance Criteria and Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Substantial Equivalence: Same or similar intended use, indications for use, principle of operation, and performance characteristics as predicate devices. | The LiiSA hemostasis valve has the same or similar intended use, indications for use, principle of operation, and performance characteristics as predicate devices (CoPilot Bleedback Control Valve - K991102 and Y-Click Connector - K060759). |
| Safety and Effectiveness: Demonstration through data collected from nonclinical bench tests and analysis. | The safety and effectiveness of the LiiSA hemostasis valve has been demonstrated through data collected from nonclinical bench tests and analysis. The evaluation does not raise any additional concerns regarding safety and effectiveness and is considered substantially equivalent to the predicate devices. (Specific performance values from the bench tests are not detailed in this 510(k) summary; the summary only states that the data demonstrated safety and effectiveness to meet the equivalence criterion). |
| Compatibility: Guiding catheters 9 F or smaller. | Compatible with guiding catheters 9 F or smaller. |
| Compatibility: Guide wires 0.014" - 0.038". | Compatible with 0.014" - 0.038" guide wires. |
| Hemostasis Maintenance: Ability to maintain hemostasis during introduction, use, and withdrawal of diagnostic or interventional devices. | The device is intended to maintain hemostasis during these procedures, and its substantial equivalence and "performance data" (from bench tests) are stated to have demonstrated this capability. (Specific quantitative results of hemostasis performance are not included in this summary). |
Study Details
-
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as this was a 510(k) submission relying on non-clinical bench tests and analysis, not a clinical study with a "test set" of patient data in the typical sense. The "test set" would consist of the devices tested during bench assays.
- Data Provenance: The data comes from "nonclinical bench tests and analysis." The country of origin for the data is not specified, but it would have been conducted by or for Device Partners International (USA) to support their submission to the FDA. The nature of these tests is prospective for the purpose of the submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This submission is for a physical medical device (hemostasis valve) and relies on bench testing and engineering analysis, not expert interpretation of medical images or clinical data to establish a "ground truth." Safety and effectiveness are evaluated based on physical and functional performance criteria.
-
Adjudication method for the test set:
- Not Applicable. See point 2. No expert adjudication of data was performed in the context of this 510(k) summary.
-
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:
- Not Applicable. This is a physical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm or AI system.
-
The type of ground truth used:
- Bench Test Performance Standards/Engineering Specifications. The "ground truth" for this device would be its ability to meet predetermined engineering specifications for sealing, compatibility, durability, and other functional attributes during non-clinical bench testing, as well as adherence to relevant industry standards.
-
The sample size for the training set:
- Not Applicable. This is a physical device, not a machine learning model. There is no "training set" in the context of AI development.
-
How the ground truth for the training set was established:
- Not Applicable. See point 7.
§ 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.