(236 days)
The DeRoyal Industries, Inc., Ultra High Pressure Injector Lines are indicated for use during coronary angiography procedures as a connecting line for the injection of radio-opaque dye or saline.
The DeRoyal Industries, Inc. Ultra High Pressure Injector Lines are comprised of PVC tubing ranging in length from 10" to 48". These devices have been tested to withstand up to 3 injections with a limiting pressure of 1200 psi.
Device DesignMaterials Used/Physical Properties: The DeRoyal Industries, Inc. Ultra High Pressure Injector Lines are made of PVC material commonly used in the industry for their purpose.
The provided text is a 510(k) summary for the DeRoyal Industries, Inc. Ultra High Pressure Injector Lines, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices and describes the device's technical specifications and intended use. It does not contain information about a study based on acceptance criteria, reader studies, ground truth establishment, or sample sizes related to clinical performance evaluations.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving device performance using the provided text. The document is a regulatory submission for premarket notification, not a report of a clinical performance study with the details you are asking for.
However, I can extract the acceptance criteria and stated performance as described in the document, which are related to the device's physical properties and intended function, not clinical study results.
Here's what can be extracted:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Withstand up to 3 injections | Device has been tested to withstand up to 3 injections |
| Limiting pressure of 1200 psi | Device has been tested to withstand a limiting pressure of 1200 psi |
The document does not provide the following information:
- Sample size used for the test set and the data provenance: There is no mention of a test set for clinical performance or any data provenance. The "testing" mentioned refers to engineering performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth assessment is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable as no clinical ground truth is established or used.
- The sample size for the training set: Not applicable as this is a physical medical device.
- How the ground truth for the training set was established: 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).