(152 days)
The Twin-Pass catheter is intended to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic agents.
The Twin-Pass Torque is a dual lumen catheter consisting of an over-the-wire (OTW) lumen that runs the full length of the catheter, exiting just proximal to the distal tip, and a rapid exchange (RX) delivery lumen on the distal segment. The two exit ports are each marked by a radiopaque platinum-iridium marker band and the device shaft has two positioning marks located at 95cm (single mark) and 105cm (double marks) from the distal tip, which are not visible under fluoroscopy.
This document is a 510(k) premarket notification for the "Twin-Pass Torque" catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a clinical study with acceptance criteria for device performance based on patient outcomes or diagnostic accuracy. Therefore, information regarding reader studies, ground truth establishment, or multi-reader multi-case analyses is not applicable.
Here's an breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted to establish substantial equivalence. For each test, the document states that "The results of the verification tests met the specified acceptance criteria." However, the specific numerical acceptance criteria or detailed numerical performance results are not provided in this summary.
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| Met specified acceptance criteria | Passed Kink resistance |
| Met specified acceptance criteria | Passed Guidewire insertion |
| Met specified acceptance criteria | Passed Tip flexibility |
| Met specified acceptance criteria | Passed Distal shaft flexibility |
| Met specified acceptance criteria | Passed Proximal shaft support |
| Met specified acceptance criteria | Passed Coating lubricity/Durability |
| Met specified acceptance criteria | Passed Radiopacity |
| Met specified acceptance criteria | Passed Guidewire deflection |
| Met specified acceptance criteria | Passed Distal tip length |
| Met specified acceptance criteria | Passed Torque control |
| Met specified acceptance criteria | Passed Torque transmission |
| Met specified acceptance criteria | Passed Tensile strength |
| Met specified acceptance criteria | Passed Torque strength |
| Met specified acceptance criteria | Passed Torque robustness |
| Met specified acceptance criteria | Passed Hub luer tests (air leak, burst, compatibility) |
| Met specified acceptance criteria | Passed Hydrophilic coating particulate |
| Met specified acceptance criteria | Passed Package integrity |
| Met specified acceptance criteria (ISO 10993-1) | Passed Cytotoxicity |
| Met specified acceptance criteria (ISO 10993-1) | Passed Sensitization |
| Met specified acceptance criteria (ISO 10993-1) | Passed Irritation |
| Met specified acceptance criteria (ISO 10993-1) | Passed Systemic toxicity |
| Met specified acceptance criteria (ISO 10993-1) | Passed Pyrogenicity |
| Met specified acceptance criteria (ISO 10993-1) | Passed Hemocompatibility |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes performance tests (bench testing), not a clinical trial with a "test set" in the context of patient data. The sample sizes for these engineering and biocompatibility tests are not specified in this summary. The data provenance is also not specified, but given it's bench testing, it would originate from the manufacturer's testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a study assessing diagnostic accuracy or human interpretation. It's about mechanical and biological performance of a medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 document does not describe a MRMC study or an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document is for a physical medical device (catheter), not an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the performance tests, the "ground truth" would be the engineering and physical standards and specifications established for the device's functional characteristics (e.g., kink resistance, tensile strength) and the biological response standards for biocompatibility (e.g., ISO 10993-1).
8. The sample size for the training set
Not applicable. There is no software or algorithm involved that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).