(29 days)
The PROGREAT Catheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels in the lower and upper extremities and all coronary vessels. The PROGREAT Catheter is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Catheter should not be used in cerebral vessels.
The PROGREAT catheter is available with or without the following accessories: guide wire, inserter, mandrel (stylet), syringe, wire stopper, and Y-connector. The catheter consists of metal coil reinforced multi-layer polymer tubing. The coil is embedded in the catheter wall the entire length of the catheter. This increases the flexibility, kink resistance, and pressure resistance of the catheter. The inner layer of the catheter is made of PTFE (polytetrafluoroethylene) to ensure smooth movement of devices such as the guide wire. The outer surface of the catheter is coated with a hydrophilic polymer which becomes lubricious when wet with saline solution or blood.
The provided text describes a 510(k) premarket notification for the PROGREAT Catheter, asserting its substantial equivalence to a predicate device, the GT LEGGIERO (K981359). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance tests conducted to demonstrate this substantial equivalence.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table labeled "acceptance criteria." Instead, it lists "verification tests" performed to demonstrate substantial equivalence to the predicate device. For each test, it implicitly states that the performance was satisfactory to deem the device substantially equivalent, meaning it met an internal standard set by the manufacturer to compare to the predicate.
| Verification Test (Acceptance Criteria) | Reported Device Performance |
|---|---|
| Ease of removal from holder | Met (No new issues of safety and effectiveness raised) |
| Frictional resistance of catheter and guide wire | Met (No new issues of safety and effectiveness raised) |
| Joint strength of hub on catheter and guide wire | Met (No new issues of safety and effectiveness raised) |
| Pressure resistance of catheter | Met (No new issues of safety and effectiveness raised) |
| Kink resistance | Met (No new issues of safety and effectiveness raised) |
In addition to these performance tests, the device also met biological and sterilization acceptance criteria:
| Acceptance Criteria | Reported Performance |
|---|---|
| Biocompatibility (for blood contacting materials) | Blood contacting materials tested in accordance with FDA G95-1; results demonstrate biocompatibility. |
| Sterilization | Validated in accordance with AAMI/ANSI/ISO 11135 to a SAL of 10⁻⁶; ETO residuals within limits. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the specified verification tests (e.g., Ease of removal, Frictional resistance, etc.). These are likely internal engineering tests, and the exact number of units tested is not typically disclosed in the public summary. The data provenance is internal to the manufacturer, Terumo Medical Corporation, for the "modified device (PROGREAT catheter)." These would be prospective tests performed during the development and verification phase of the PROGREAT catheter.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this 510(k) submission. The "ground truth" for the performance tests mentioned (e.g., frictional resistance, kink resistance) would be the physical properties and performance characteristics of the predicate device (GT LEGGIERO K981359) and established engineering standards. There is no mention of human expert consensus being used to establish the "ground truth" for these physical device performance characteristics.
4. Adjudication Method for the Test Set
Not applicable. The verification tests are objective physical and mechanical tests, not subjective evaluations requiring adjudication by experts.
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
Not applicable. This device is a physical medical device (angiographic catheter), not an AI imaging or diagnostic algorithm. Therefore, an MRMC study related to AI assistance for human readers is not relevant.
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
The "ground truth" for demonstrating substantial equivalence for the PROGREAT Catheter primarily relied on:
- Predicate Device Performance: The established performance characteristics of the GT LEGGIERO (K981359) served as the benchmark for comparison.
- Engineering Standards: Standardized tests for mechanical properties (e.g., pressure resistance, kink resistance, joint strength) and material properties were used.
- Regulatory Standards: Biocompatibility was assessed against FDA General Program Memorandum #G95-1 (ISO-10993), and sterilization against AAMI/ANSI/ISO 11135.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no training set for this type of device submission.
§ 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).