(100 days)
The Y-Click Connector is a Y-connector Hemostatic Valve, which is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices used in angioplasty procedures such as; guide catheters, guide wires, balloons and stents. It is compatible with 9 Fr or smaller guide catheters and 0.014" -- 0.038" diameter guide wires.
The Y-Click connector is an accessory that can be connected, by a standard male luer-lock, to any standard Angiographic catheter, up to 9 Fr guiding catheters. The device has a septum that prevents blood loss. Common guide-wires (in diameter of 0.014" to 0.038") can be introduced via the device (through the slit septum) without bleeding due to the intra-catheter human arterial pressure. The septum can be opened to an unsealed position in order to enable introducing of various angioplasty devices (such as; balloons and stents). Unlike similar devices, The Y-Click can also be opened to a semi unsealed position. The semi unsealed position reduces the friction during catheter manipulation and makes the device more ergonomic and easy to use. The septum is opened to a semi unsealed position by one push of the cover (a "click" is heard). Pushing the cover twice (two "clicks" are heard) opens the device to an unsealed position (full open position). In order to return to a closed position, the Y-Click's lever should be pressed once. A "click" is heard and the device returns to a closed position. The injection of contrast media, saline flush and blood pressure monitoring can be performed through the Y side arm.
This 510(k) submission for the Elcam Y-Click Connector is a medical device application. Unlike AI/software-as-a-medical-device (SaMD) clearances, which typically involve extensive performance studies with specific statistical metrics, acceptance criteria, and ground truth establishment, this submission focuses on demonstrating substantial equivalence to a predicate device through device description and intended use.
Therefore, many of the requested categories in your prompt related to clinical study design, AI performance metrics, and human-in-the-loop analysis are not applicable to this type of traditional medical device clearance. The document does not contain information about acceptance criteria in the context of statistical performance, reported device performance in those terms, sample sizes for test or training sets, ground truth establishment for such sets, expert adjudication, or MRMC studies.
Here's an analysis based on the information provided, emphasizing where the requested categories are not applicable or not detailed in this type of submission:
Acceptance Criteria and Study for Elcam Y-Click Connector (K060759)
This 510(k) submission for the Elcam Y-Click Connector is a traditional medical device submission, not specifically for software or an AI-powered device. Therefore, the "acceptance criteria" and "study" described are primarily focused on demonstrating substantial equivalence to an existing predicate device rather than achieving specific quantitative performance metrics through extensive clinical trials as one might expect for a novel AI diagnostic tool.
The core of the study is the comparison of the Y-Click Connector's features, intended use, and principle of operation with the predicate device. The "acceptance criteria" are implicitly met by demonstrating that the device does not raise new questions of safety and effectiveness compared to the predicate.
Given the nature of the device (a Y-connector hemostatic valve), the performance evaluation would primarily involve bench testing and possibly animal or in-vitro studies to confirm functional aspects, rather than human-centric clinical trials with ground truth experts.
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Table of Acceptance Criteria and Reported Device Performance:
Criterion Type Acceptance Criteria Reported Device Performance Substantial Equivalence The device has the same intended use and the same principle of operation as the predicate device (EasyPass™ US Y-Connector Haemostatic Valve from Millimed A/S, K042060), and does not raise new questions of safety or effectiveness. The Y-Click Connector has the same intended use and the same principle of operation as the EasyPass™ of Millimed A/S (K042060). "The evaluation of the Y-Click Connector does not raise any additional concerns regarding safety and effectiveness." (Conclusion in document) Intended Use Intended to maintain hemostasis during introduction, use, and withdrawal of diagnostic and interventional devices used in angioplasty procedures; compatible with 9 Fr or smaller guide catheters and 0.014" - 0.038" diameter guide wires. "The Y-Click Connector is a Y-connector Hemostatic Valve, which is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices used in angioplasty procedures such as; guide catheters, guide wires, balloons and stents. It is compatible with 9 Fr or smaller guide catheters and 0.014" - 0.038" diameter guide wires." (Indications for Use) Functionality - Prevent blood loss through a septum.
- Allow introduction of common guide-wires (0.014" to 0.038") through the slit septum without bleeding.
- Septum can be opened to semi-unsealed and full-unsealed positions.
- Allow injection of contrast media, saline flush, and blood pressure monitoring through the Y side arm. | The device description outlines these functionalities: "The device has a septum that prevents blood loss. Common guide-wires (in diameter of 0.014" to 0.038") can be introduced via the device (through the slit septum) without bleeding..." "The septum can be opened to an unsealed position... The Y-Click can also be opened to a semi unsealed position." "The injection of contrast media, saline flush and blood pressure monitoring can be performed through the Y side arm." |
| Mechanical Design | Connectable by a standard male luer-lock to any standard Angiographic catheter, up to 9 Fr guiding catheters. | "...can be connected, by a standard male luer-lock, to any standard Angiographic catheter, up to 9 Fr guiding catheters." |
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Sample sizes used for the test set and the data provenance:
- Not applicable / Not specified in this 510(k) summary. This type of device clearance typically relies on bench testing, comparison to the predicate, and adherence to relevant standards, not a "test set" in the context of AI or diagnostic accuracy studies. No specific sample sizes for a "test set" are mentioned in the provided document.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified in this 510(k) summary. The clearance process described here does not involve establishing ground truth for a diagnostic test set by human experts. The "ground truth" for this device's safety and effectiveness is established by its similarity to a legally marketed predicate device and conformance to generally accepted engineering and medical device principles.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no "test set" or diagnostic reading adjudication method described in this submission.
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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. An MRMC study is not relevant for this type of medical device (a hemostatic connector). This device does not involve human readers interpreting images or data, nor does it incorporate AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical connector, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The concept of "ground truth" in this context is primarily related to the device's functional performance, material biocompatibility, and sterilization effectiveness (which would be assessed via standard laboratory testing, not human expert consensus for a diagnostic task). The primary "ground truth" for regulatory clearance is that the device is substantially equivalent to a legally marketed predicate, meaning it performs as intended and is as safe and effective as the predicate.
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The sample size for the training set:
- Not applicable / Not specified. This device does not employ machine learning or AI, and therefore does not have a "training set."
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How the ground truth for the training set was established:
- Not applicable. No training set exists for this mechanical device.
In summary, the provided 510(k) summary is for a physical medical accessory (a connector), not a diagnostic or AI-powered device. Therefore, the criteria and study details are focused on technical specifications, intended use, and comparison to a predicate device, rather than the types of performance metrics and ground truth establishment typically associated with AI/SaMD products.
§ 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.