(184 days)
The device is an Angiographic accessory intended for use as self-sealing Hemostatic luer activated valve for angiography and other high-pressure applications.
The H-Flow Valve developed by Elcam Medical ACAL can be connected, by a standard male luer-lock, to any standard Angiographic catheter. The device has a septum that prevents blood loss when nothing is connected to the female port of the device. Common guide-wires (in diameter of 0.014" to 0.038") can be introduced via the device (through the slit septum) without the need to open the valve and without bleeding due to the intra-catheter human arterial pressure. When connecting a standard male luer to the device's female port (for injection of contrast media or flushing with saline), the septum opens (with the aid of the actuator) to allow fluid flow. An accessory called 'Stylet' is added to the device and has two purposes: a) to make sure the slit is open prior to initial use. b) To aid with insertion of small and angled guide wires.
The provided text describes a 510(k) summary for the "H-Flow Valve" manufactured by Elcam Medical ACAL. While it states that "Performance tests related to functionality and biocompatibility of both new and predicate device were performed. Tests results showed that the product met all established acceptance criteria and therefore has equivalent performances capabilities and properties," it does not provide specific details on the acceptance criteria themselves, nor the specific results or methodology of the study.
Therefore, I cannot directly populate the requested table or answer most of the questions as the specific information is not present in the provided text.
Here's an attempt to answer based on the given information, highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| NOT SPECIFIED | "met all established acceptance criteria" |
| NOT SPECIFIED | "equivalent performances capabilities and properties" to the predicate device (Floswitch® HP) |
Notes:
- The document states that performance tests were conducted and the device met all established acceptance criteria. However, the specific criteria (e.g., maximum leakage rate, pressure resistance, flow rates, number of cycles) and the quantitative results achieved by the H-Flow Valve are not detailed.
- The comparison is against a predicate device, Floswitch® HP, implying that the acceptance criteria would be based on demonstrating equivalence or non-inferiority to the predicate's known performance.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests were performed to demonstrate substantial equivalence to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the provided document pertains to a medical device's performance testing for functional and biocompatibility characteristics, not a diagnostic algorithm or imaging study requiring expert ground truth for classification.
4. Adjudication method for the test set
This section is not applicable for the same reasons as point 3.
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
This section is not applicable as the document describes a physical medical device (valve), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable as the document describes a physical medical device (valve), not a software algorithm.
7. The type of ground truth used
For functional performance testing of a physical device, the "ground truth" would typically refer to objective measurements obtained through standardized testing methods, comparing the device's performance against predefined specifications or against the performance of a predicate device. The document mentions "functionality and biocompatibility tests" but does not detail the specific ground truth or reference standards used.
8. The sample size for the training set
This section is not applicable as the document describes a physical medical device (valve), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable as the document describes a physical medical device (valve), not a machine learning model.
§ 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).