(75 days)
The Wingman Extendable Tip Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
The Wingman Extendable Tip Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral vasculature. The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.
The provided text describes the Wingman Extendable Tip Support Catheter and its substantial equivalence to predicate devices. However, it does not contain the specific information requested regarding acceptance criteria, device performance metrics, detailed study designs, or ground truth establishment relevant to AI/ML device evaluation.
Instead, the document focuses on the regulatory submission for a medical device (a catheter) and aims to demonstrate its substantial equivalence to existing legally marketed predicate devices, which is a different evaluation paradigm than that for AI/ML-driven diagnostic or assistive tools.
Therefore, most of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be extracted:
Acceptance Criteria and Device Performance for Wingman Extendable Tip Support Catheter
| Acceptance Criteria (Not explicitly stated as numerical targets) | Reported Device Performance (Summary) |
|---|---|
| Functional Equivalence to predicate devices | "All necessary verification and validation testing has been performed... to assure substantial equivalence to the predicate devices and demonstrate the device performs as intended." |
| Safety and Efficacy comparable to predicate devices | "Upon reviewing the safety and efficacy information... the Wingman Extendable Tip Support Catheter is determined by ReFlow Medical, to be substantially equivalent to existing legally marketed devices." |
| Physical and Technical Characteristics similar to predicates | "The Wingman Extendable Tip Support Catheter has similar physical and technical characteristics to the predicate devices." |
| Simulated Use Performance | "Comparative simulated use testing demonstrated that the Wingman Extendable Tip Support Catheter is substantially equivalent to the predicate devices." (No specific metrics or thresholds for "substantial equivalence" are provided here). |
Unavailable Information (Not present in the provided text):
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The text mentions "comparative simulated use testing" and "all necessary verification and validation testing" but does not specify sample sizes for these tests, nor the origin or nature (retrospective/prospective) of any data used.
- 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): This is not relevant to a medical device (catheter) substantial equivalence submission, which relies on engineering and performance testing rather than expert-labeled image data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device submission.
- 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 not an AI/ML diagnostic or assistive tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical catheter, "ground truth" would relate to its physical properties, mechanical performance, and safety in simulated use, not diagnostic outcomes based on expert consensus or pathology. The text implies performance against engineering specifications and comparison to predicate device performance.
- The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
§ 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).