(69 days)
The COPILOT™ Bleedback Control Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic/interventional devices.
The COPILOT™ Bleedback Control Valve is indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter
The COPILOT™ Bleedback Control Valve has a 0.096" (2.44 mm) inside diameter. This device has two seals that operate independently: the clamp seal and the bleedback control (BBC) seal. The clamp seal can be opened or closed by rotating the cap. Closing of the clamp seal allows for pressure injections up to 400 psi and also secures the diagnostic/interventional device in position within the vasculature. The BBC seal is a diaphragm seal that forms around diagnostic/ interventional devices as they move into and out of the vasculature. This seal provides minimal fluid loss without restricting device movement. The BBC seal is open when the cap is pressed down, and closed when the cap is released. An open BBC seal allows air and fluid to be purged and allows the advancement/ withdrawal of diagnostic/ interventional devices.
The provided document, K991102, is a 510(k) summary for the COPILOT™ Bleedback Control Valve. This document describes the device, its intended use, and its substantial equivalence to a predicate device. It also briefly mentions performance data.
However, the provided text does not contain acceptance criteria or detailed study information that would allow for a comprehensive answer to the requested questions. The "Performance data" section explicitly states: "The safety and effectiveness of the Guidant COPILOT™ Bleedback Control Valve have been demonstrated through data collected from nonclinical bench tests and analyses." This indicates that performance testing was done, but the details of these tests, including specific acceptance criteria and detailed results, are not included in this summary.
Therefore, I cannot provide the requested table or answer most of the questions based on the provided input.
Here's what I can extract and state based on the limited information:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: The document only generally states that "safety and effectiveness... have been demonstrated through data collected from nonclinical bench tests and analyses." No specific performance metrics or values are provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified.
- Data Provenance: "nonclinical bench tests and analyses" – Implies laboratory/bench testing, not patient data. Country of origin not specified. Retrospective/prospective is not applicable as it's non-clinical.
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 device is a mechanical hemostatic valve. "Ground truth" in the context of expert judgment (like for image interpretation) is not relevant for this type of device's performance evaluation. The "bench tests and analyses" would likely rely on physical measurements and engineering standards rather than expert consensus on diagnostic interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are typically used in clinical studies or studies involving expert interpretation of data/images. This is a mechanical device evaluated via bench tests.
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 study is not relevant for this type of medical device (a hemostatic valve). This type of study is used for diagnostic devices, particularly those involving human interpretation of imaging.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical device, not an algorithm. Standalone performance for an algorithm is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For bench tests, "ground truth" would be established by validated measurement techniques, engineering specifications, and possibly comparison against industry standards or the predicate device's known performance. The document doesn't specify the exact metrics, but they would likely relate to seal integrity, pressure resistance, flow rates, and ease of device movement.
8. The sample size for the training set:
- Not Applicable. This is a mechanical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As above, this is a mechanical device and not an AI/ML algorithm.
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.