(37 days)
The Heartrail™ III Guiding Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the radial artery.
The Heartrail III Guiding Catheter is a three-layer construction comprised of a stainless steel mesh sandwiched between a layer of polytetrafluoroethylene and a layer of polyester elastomer. The polyester elastomer contains tungsten for visibility and contrast under fluoroscopy in the distal portion of the catheter. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tip is a flexible, supple polyester elastomer containing tungsten. This tip is permanently welded to the catheter shaft. Depending on the product code, the tip is either straight or curved into a specific shape.
The provided text is for a 510(k) premarket notification for a medical device called the "Heartrail™ III Guiding Catheter." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a traditional study with acceptance criteria and performance metrics in the way a new, novel device might.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, training set sample size, detailed ground truth establishment) are not applicable in this context because the manufacturer is not conducting a de novo clinical trial or an AI/software performance study.
Here's how to interpret the provided information in the context of your request:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
For a 510(k) submission, "acceptance criteria" are implicitly met by demonstrating that the new device is "substantially equivalent" to predicate devices across several key attributes. The "reported device performance" is then framed in relation to these predicates, primarily through bench testing.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance (as stated in submission) |
|---|---|
| Intended Use Equivalence: The device's intended clinical application must be the same as the predicate. | The Heartrail™ III Guiding Catheter is intended for cardiac and vascular procedures to deliver radiopaque media, guide wires, catheters, and therapeutic agents. This is stated to be substantially equivalent to the predicate devices. |
| Technological Characteristics Equivalence: Design, materials, and principle of operation should be similar, and any differences should not raise new questions of safety or effectiveness. | The Heartrail™ III Guiding Catheter utilizes a three-layer construction (stainless steel mesh, PTFE, polyester elastomer with tungsten), a "soft-tip", and similar materials to the predicate devices (Radifocus® Optitorque™ Angiographic Catheter K082736 and Boston Scientific Mach 1 Catheter K981788). Differences in materials are explicitly stated not to raise new issues of safety and effectiveness. The principle of operation is manual, similar to predicates. |
| Performance Equivalence: The device must perform as safely and effectively as the predicate, typically demonstrated through non-clinical testing. | Bench Testing: "The performance of the Heartrail III Guiding Catheter is substantially equivalent to the performance of the predicate devices. The equivalence was shown through bench testing." Specific quantitative results for individual performance parameters (e.g., maximum injection pressure, catheter length, available sizes) are listed: |
- Available Sizes: 6 Fr.
- Catheter Length: 100 cm
- Maximum Injection Pressure: 700 psi.
These specifications implicitly meet the performance of equivalent predicate devices.
Biocompatibility: Materials are biocompatible, tested according to ISO-10993, for limited contact (
§ 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).