(117 days)
The Occlusion Balloon Catheter is indicated for temporary occlusion of large vessels, including the superior vena cava, in applications including perioperative occlusion and emergency control of hemorrhage.
The Occlusion Balloon Catheter is a multi-lumen catheter which has a compliant polyurethane balloon with a maximum diameter of 32mm at 60cc inflation volume. The balloon has a nominal length of 80mm. The device is constructed with a blended PEBA shaft and is available in two models; one model is compatible with 8Fr (or larger) introducer sheaths and one model is compatible with 10Fr (or larger) introducer sheaths. Both models provide the same balloon performance with respect to sizing and occlusion. The two models are intended for individual physician preference for patient-specific sheath selection. The device has an effective length of 90cm and is compatible with 0.035" diameter guidewires. Three (3) platinum-iridium radiopaque marker bands are placed on the shaft to facilitate balloon placement in the anatomy prior to inflation. The proximal end of the catheter has an integral PEBA bifurcation manifold with female luer ports to allow communication with the balloon inflation lumen and guidewire lumen. A PVC extension tube (with stopcock) is connected to the balloon inflation port to facilitate handling. The device is a single use, sterile device.
The provided text describes a 510(k) premarket notification for an Occlusion Balloon Catheter. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria and reporting its performance.
Therefore, many of the requested items (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable and cannot be extracted from this document because the submission method relies on demonstrating equivalence through non-clinical testing and comparison to predicate devices, not through a clinical trial with specific performance metrics against acceptance criteria.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The document does not provide specific quantitative acceptance criteria or reported performance metrics against such criteria in the context of a clinical study. It lists a series of non-clinical tests performed to ensure the device meets established performance criteria and will perform as intended for substantial equivalence.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided for clinically relevant performance metrics. Non-clinical tests were performed to ensure substantial equivalence and intended performance. | Not provided for clinically relevant performance metrics. The non-clinical tests included items like visual/dimensional inspections, vessel occlusion, balloon fatigue, kink resistance, burst/leak volume, tensile strength, torque strength, and shelf life. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No clinical test set or data provenance is detailed, as clinical evaluation was not required. The tests performed were non-clinical (mechanical, performance, biocompatibility).
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. No ground truth for a test set was established using experts, as no clinical study requiring such ground truth was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method for a test set is mentioned, as no clinical study requiring this was conducted.
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. No MRMC study was done, nor does the device involve AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical medical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth of this nature was used, as clinical studies involving such data were not performed. The "ground truth" for this submission was based on successful completion of non-clinical performance and mechanical tests to demonstrate substantial equivalence to the predicate device.
8. The sample size for the training set
- Not Applicable. No training set is mentioned, as this is a medical device submission based on substantial equivalence and non-clinical testing, not a machine learning model.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth for it was established.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).