(129 days)
for use during coronary angiography procedures as a connecting line for the injection of radiopaque dye, saline or other diagnostic fluids.
The Disposable High Pressure Injection Lines with and without Rotating Adapters are a combination of connectors and tubing bonded together for injection of radiopaque dye, saline, or other diagnostic fluids during a coronary angiography procedure. The device is designed, like other legally marketed devices, for one end to connect to the fluid source (such as an angiographic syringe) and the other end to connect to the catheter. The contrast, saline, or other diagnostic fluid is then injected from the syringe, through the high pressure line, into the catheter. The materials and properties of the device are tabled in Item 6, below.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
This document is a 510(k) premarket notification for a medical device (Disposable High Pressure Injection Lines with and without Rotating Adapters). The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to conduct a comprehensive study on a new or innovative technology. Therefore, many of the typical acceptance criteria and study characteristics you'd expect for AI/software-as-a-medical-device (SaMD) are not applicable here.
Device: Coeur Medical, a division of Coeur, Inc. Disposable High Pressure Injection Lines with and without Rotating Adapters
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Functional Performance) | Reported Device Performance |
|---|---|
| Pressure Rating | 500 to 1200 psi |
| Pressure Test at "worst case" (1200psi) | Acceptable performance |
| Sterility Assurance Level (SAL) | 10⁻⁶ |
Note: The document states that the primary difference is the manufacturer assembling components and sterilizing the devices, and that the proposed devices will offer a "more flexible device that meets the needs of the high pressure market." However, quantitative metrics for "flexibility" or how it "meets the needs" beyond the pressure rating are not provided as acceptance criteria or performance metrics directly in this summary.
2. Sample size used for the test set and data provenance
- Sample Size: Not explicitly stated as a number of units. The document mentions "pressure testing was conducted at 1200psi to verify acceptable performance of the 'worst case' challenge," implying at least one or more units were tested.
- Data Provenance: Not applicable. These are nonclinical (bench) tests for a physical medical device, not data from patients or medical imaging.
3. Number of experts used to establish the ground truth for the test set and their qualifications
- Not applicable. This relates to nonclinical physical testing, not expert-based ground truth for diagnostic accuracy.
4. Adjudication method for the test set
- Not applicable. This relates to nonclinical physical testing, not expert review or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done
- No. This is a 510(k) premarket notification for a physical medical device, not an AI/SaMD product. MRMC studies are not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Bench test results/Engineering specifications: The "ground truth" for the device's performance is against its own design specifications and functional requirements (e.g., ability to withstand 1200psi without failure, achieving a specific SAL).
8. The sample size for the training set
- Not applicable. There is no "training set" for this physical device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" for this physical device.
Summary of the Study:
The "study" described in the 510(k) summary is based on nonclinical tests to verify the functional performance of the Disposable High Pressure Injection Lines.
- Nonclinical Tests Submitted: "Verification of functional performance has been performed."
- Pressure Testing: Conducted at 1200psi to verify acceptable performance, as this is the greatest pressure for which the device is developed ("worst case" challenge).
- Sterilization Cycle Verification: The Coeur sterilization cycle is stated to be able to sterilize the proposed device with an SAL of 10⁻⁶, based on a comparison to products tested for inclusion in the Coeur cycle. This implies a validation of the sterilization process itself.
- Clinical Tests Submitted: "NA" (None)
- Conclusions: The testing verifies that the proposed devices are suitable for their intended use. The primary basis for substantial equivalence is that the device has similar technological characteristics (materials, intended use, sterilization method, components, pressure rating) to legally marketed predicate devices, and the nonclinical testing demonstrates equivalent performance where 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).