(257 days)
The Guidant Bleedback Control Valve is intended for maintaining a seal around The Outdailt Dioodback Ochices with an outside diameter of less than 0.185" in the venous anatomy only, during interventional procedures.
The RAPIDO™ Cut-Away Bleedback Control Valve is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices such as balloon catheters, wires, and pacemaker and defibrillation leads. The RAPIDO™ Cut-Away Bleedback Control Valve has a single adjustable seal that provides control over fluid loss.
The Bleedback Control (BBC) seal is a diaphragm seal with a thin membrane across the inside diameter that forms around diagnostic/ interventional devices as they move into and out of the vasculature. This seal provides minimal fluid loss while not restricting device movement. The BBC seal is open when the cap is depressed, and closed with 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 seal can be locked open by rotating the cap an eighth clockwise turn when the cap is depressed. To release the lock the cap is rotated clockwise an eighth of a turn.
The acceptance criteria and study proving device performance are described as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meet established acceptance criteria | "The results of the verification testing demonstrate that the modified Bleedback Control I he received the established acceptance criteria..." |
| Perform in a manner equivalent to predicate device | "...and perform in a manner equivalent to the predicate device." |
| No new safety or effectiveness issues | "No new safety or effectiveness issues were raised during the testing program." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It generally refers to "verification testing."
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish ground truth for testing. The evaluation appears to be based on engineering performance testing against established criteria and comparison to a predicate device.
4. Adjudication Method for the Test Set
No adjudication method is described, as the evaluation is based on performance testing rather than human interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The device is a medical component, not an AI or imaging diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is a physical bleedback control valve, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device appears to be defined by engineering specifications and direct comparison to the performance of the predicate device (COPILOT™ Bleedback Control Valve). This is inferred from statements like "received the established acceptance criteria" and "perform in a manner equivalent to the predicate device."
8. Sample Size for the Training Set
Not applicable. This device is not an AI algorithm and does not involve a "training set."
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”