(30 days)
The FIBEROPTIX IAB Catheter with the Intra-Aortic Balloon Pump as a control system is clinically indicated for use in any of the following conditions:
- Acute Coronary Syndrome
- Cardiac and Non-Cardiac Surgery
- Complications of Heart Failure
The FiberOptix® Intra-Aortic Balloon (IAB) Catheter consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning. A computerized control system, also known as Intra-Aortic Balloon Pump (IABP) is utilized to regulate the inflation and deflation of the balloon.
The FiberOptix® IAB Catheter consists of an inner lumen, an outer lumen, and an inflatable balloon. The outer lumen is comprised of an inflatable balloon connected to the distal tip of the catheter shaft and to the IAB catheter tip outer surface. The inner lumen is comprised of a luer adapter connected to the proximal end of the inner lumen and to the IAB catheter tip inner surface.
The FiberOptix® IAB Catheter has a fiber optic pressure sensor which acts as a pressure transducer embedded in the catheter tip.
The provided text is a 510(k) summary for the FiberOptix® Intra-Aortic Balloon Catheter Kit. It describes the device, its intended use, and claims substantial equivalence to a predicate device based on bench testing. However, it does not contain the detailed information necessary to answer all parts of your request, especially regarding a clinical study proving the device meets acceptance criteria, sample sizes for test/training sets, expert qualifications, or MRMC studies.
Here's an analysis of what information is available and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Specified acceptance criteria (not detailed) | Met the specified acceptance criteria and performed similar to the predicate device. |
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 for test set: Not specified.
- Data provenance: Not specified. The study described is "bench tests", implying laboratory testing rather than human subject 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)
- Number of experts: Not applicable. The study was bench testing of the device's physical performance, not an evaluation of diagnostic or clinical interpretation requiring expert consensus.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. This was bench testing, not a study involving human adjudication of clinical data.
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
- MRMC study: No, an MRMC study was not done. The document describes a medical device (an intra-aortic balloon catheter) and its physical performance, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This is for a medical device (catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Not explicitly stated as "ground truth" in the context of clinical data. For the bench tests, the "ground truth" would be the engineering specifications and performance standards for the device and its predicate, verified through physical measurements and observations during the tests.
8. The sample size for the training set
- Sample size for training set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described focuses on verifying the modified design's performance against the predicate.
9. How the ground truth for the training set was established
- How ground truth for training set was established: Not applicable, as there is no training set for this type of device and study.
Summary of the Study:
The study described is a series of bench tests (laboratory testing) to provide evidence that the modified FiberOptix® IAB Catheter is substantially equivalent to predicate devices. The technological differences relate to a modified fiber optic sensor configuration for improved robustness.
The specific tests performed were:
- Insertion, Durability Test & (FOS) Static Pressure Test
- Simulated Misuse Test & (FOS) Static Pressure Test
The reported conclusion is that "The results of the verification test met the specified acceptance criteria and performed similar to the predicate device." This demonstrates that the subject device is substantially equivalent based on its physical and functional performance characteristics.
The document does not provide information on clinical trials, human subject data, or AI algorithm performance, as it pertains to a mechanical medical device that is being cleared based on substantial equivalence to a predicate through bench testing.
§ 870.3535 Intra-aortic balloon and control system.
(a)
Identification. An intra-aortic balloon and control system is a prescription device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.(b)
Classification. (1) Class II (special controls) when the device is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure. The special controls for this device are:(i) Appropriate analysis and non-clinical testing must be conducted to validate electromagnetic compatibility and electrical safety of the device;
(ii) Software verification, validation, and hazard analysis must be performed;
(iii) The device must be demonstrated to be biocompatible;
(iv) Sterility and shelf-life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components;
(v) Non-clinical performance evaluation of the device must demonstrate mechanical integrity, durability, and reliability to support its intended purpose; and
(vi) Labeling must include a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(2) Class III (premarket approval) when the device is indicated for septic shock and pulsatile flow generation.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 31, 2014, for any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976. Any other intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.