(177 days)
The Progreat is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities and all coronary vessels. The Progreat is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Progreat should not be used in cerebral vessels.
The Progreat catheter consists of metal coil reinforced multi-layer polymer tubing with a hydrophilic coating. The guidewire is comprised of an alloy core wire with radiopaque marker and hydrophilic coating. The subject 2.4 Fr Progreat catheter and 0.018" guidewire will be marketed as a combined unit and will be an extension of the existing Progreat product family. The design and technological characteristics of the subject 2.4 Fr Progreat with 0.018" guidewire are identical to the predicate 2.7 Fr Progreat with 0.021" guidewire.
The Progreat catheter is available with or without accessories. The accessories to the catheter are supplied in different configurations depending on the product code:
- The Guidewire has a super-elastic alloy core and is surface coated with a hydrophilic polymer.
- I The Inserter is used to assist the physician in the placement of the guidewire within the catheter.
- I The Catheter Mandrel (stylet) is used in the shaping of the catheter for procedures that require a catheter with a tip configuration other than straight.
- I The Syringe is used in the priming of the catheter.
- . The Wire Stopper can be clipped onto the guide wire to adjust the length of the guidewire that extends past the catheter tip.
- I The Catheter Stopper S can be clipped onto the catheter to adjust the insertion length of the catheter.
- . The Y-connector can be used to connect a power injector unit to the end of the catheter for infusion of contrast media.
The provided text is a 510(k) summary for the Progreat catheter, which is a medical device. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML-driven medical device.
Therefore, many of the requested criteria for AI/ML device studies (such as types of ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.
However, I can extract information related to the device's technical specifications and the non-clinical tests performed to assess its performance against predetermined criteria.
Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria
This 510(k) submission for the Progreat (2.4 Fr Catheter with 0.018" Guidewire) aims to demonstrate substantial equivalence to its predicate device (K033583, Terumo Progreat). The acceptance criteria for this submission are primarily focused on ensuring that the modified device maintains the safety and effectiveness of the predicate device and conforms to applicable external and internal standards. The study supporting this is a series of non-clinical performance tests.
1. Table of Acceptance Criteria and the Reported Device Performance
The document states that "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life." While the specific numerical acceptance criteria for each test are not explicitly detailed in this summary, the types of performance tests conducted serve as the basis for these criteria.
| Acceptance Criteria Category/Test Type | Reported Device Performance |
|---|---|
| Material/Surface Integrity | Met predetermined criteria |
| Radio-detectability | Met predetermined criteria |
| Mechanical Integrity: | |
| - Fracture test | Met predetermined criteria |
| - Flexing test | Met predetermined criteria |
| - Peak tensile force of guidewire | Met predetermined criteria |
| - Torque Strength | Met predetermined criteria |
| - Torqueability | Met predetermined criteria |
| - Tip Flexibility | Met predetermined criteria |
| - Bending strength | Met predetermined criteria |
| Functional Performance: | |
| - Sliding resistance | Met predetermined criteria |
| - Particulate evaluation | Met predetermined criteria |
| - Hermeticity test | Met predetermined criteria |
| - Shaping test | Met predetermined criteria |
| Dimensional Conformance | Met predetermined criteria |
| Biocompatibility | Deemed equivalent to predicate (materials, formulation, processing, sterilization, geometry are identical or not raising new concerns) |
| Sterilization | Deemed equivalent to predicate (identical method, not raising new concerns) |
| Shelf Life | 2 years (Identical to predicate) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific sample sizes for each non-clinical test conducted. It mentions that tests were performed on "non-aged and accelerated aged samples." The provenance of the data is from Terumo Corporation's Ashitaka Factory in Japan, where the device is manufactured and where these non-clinical tests were presumably conducted. This is retrospective in the sense that the testing was performed on manufactured devices to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the device is a physical medical instrument, not an AI/ML diagnostic tool requiring expert interpretation for ground truth. Performance was assessed against engineering specifications and industry standards.
4. Adjudication Method for the Test Set
This information is not applicable for a physical device's non-clinical performance testing. Adjudication methods like 2+1 or 3+1 typically apply to human interpretation of diagnostic images or data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted, and such a study is not applicable for this type of medical device (intravascular catheter). This type of study is relevant for evaluating the impact of AI assistance on human reader performance in diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
A standalone algorithm-only performance assessment was not conducted, as this device is a physical catheter and not an algorithm. This criterion is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests effectively refers to predetermined engineering specifications, design requirements, and relevant industry standards for intravascular catheters (e.g., ISO standards for medical devices, internal Terumo specifications). The tests confirm if the device meets these established benchmarks.
8. The Sample Size for the Training Set
This information is not applicable. The concept of a "training set" applies to machine learning models, not to the manufacturing and testing of a physical medical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
§ 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).