(29 days)
The React™ 71 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
The React™ 71 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with various durable polymer outer layers. A lubricious, polytetrafluoroethylene liner and Engage™ inner layer is used to create a structure that has both proximal stiffness and distal flexibility. The React™ 71 Catheter is also designed with an encapsulated radiopaque distal platinumiridium marker band which is used for visualization under fluoroscopy. The React™ 71 Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. The proximal end of the React™ 71 Catheter is designed with a green thermoplastic elastomer strain relief and a clear hub. The distal end of the React™ 71 Catheter is coated with a Surmodics Serene™ Coating.
The provided text describes a 510(k) submission for the React™ 71 Catheter, focusing on demonstrating substantial equivalence to a predicate device after a change in device length. The information primarily covers non-clinical bench testing.
Here's an analysis of the provided information against your requested categories:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The length of the subject device shall be compatible with minimum length 136 cm guide catheter. | The subject device met the acceptance criteria. |
| The subject device should be able to navigate to the distal M1 segment of the MCA over a microcatheter. | The subject device met the acceptance criteria. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The text mentions "non-clinical bench testing was conducted," but does not provide details on the number of devices tested for each criterion.
- Data Provenance: Not specified. "Non-clinical bench testing" typically implies laboratory-based tests. The country of origin of the data is not mentioned. The data is prospective in the sense that new tests were conducted for this submission, but it's not clinical human data.
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)
This section is not applicable as the study described is non-clinical bench testing, not a study involving human or animal data requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable as the study described is non-clinical bench testing against predefined performance criteria, not a study involving subjective interpretations requiring adjudication.
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
No, an MRMC comparative effectiveness study was not done. This submission is for a percutaneous catheter, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This submission is for a physical medical device (catheter), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical bench tests, the "ground truth" is defined by the acceptance criteria established in the test methods, based on FDA Guidance 1757 and FDA Recognized Consensus Standards 5-125 & 5-129. These are objective engineering and performance standards, not clinical ground truths like pathology or expert consensus.
8. The sample size for the training set
This section is not applicable. This is a 510(k) submission for a physical medical device, not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the reasons stated in point 8.
§ 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).