(140 days)
FIBEROPTIX® IAB with the Intra-Aortic Balloon Pump as a control system is indicated for use in any of the following conditions:
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Acute Coronary Syndrome
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Cardiac and Non-Cardiac Surgery
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Complications of Heart Failure
The FIBEROPTIX IAB consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning. A computerized control system, also known as the Intra-Aortic Balloon Pump (IABP) is utilized to requlate the inflation and deflation of the balloon.
The FIBEROPTIX IAB 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 has a fiber optic pressure sensor which acts as a pressure transducer embedded in the catheter tip.
The provided text describes the 510(k) submission for the FIBEROPTIX IAB, focusing on its substantial equivalence to a predicate device. The information details various tests performed to demonstrate this equivalence.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided text lists several design verification tests performed. While it explicitly states that the results "met the specified acceptance criteria and performed similar to the predicate device," it does not provide a specific table detailing the acceptance criteria values for each test or the exact performance metrics observed.
| Acceptance Criteria (Not Explicitly Stated - Inferred) | Reported Device Performance |
|---|---|
| Pass/Meet specified criteria for: | Met specified acceptance criteria |
| - Balloon Volume Test | Performed similar to the predicate device |
| - Aneurysm Test | Met specified acceptance criteria |
| - Durability Test | Performed similar to the predicate device |
| - Catheter Insertion Test | Met specified acceptance criteria |
| - Catheter Tip to Balloon Bond Tensile per ISO 10555-1 | Performed similar to the predicate device |
| - Outer Lumen to Balloon Bond Tensile per ISO 10555-1 | Met specified acceptance criteria |
| - Catheter Rate Limit Test | Performed similar to the predicate device |
| - Sheath and Dilator Surface Visual Inspection per ISO 11070 | Met specified acceptance criteria |
| - Sheath and Dilator Tensile Testing per ISO 11070 | Performed similar to the predicate device |
| - Sheath and Dilator Dimensional Analysis | Met specified 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)
The text mentions "bench tests" for design verification. However, it does not specify the sample size used for any of these tests. It also does not provide any information regarding data provenance (e.g., country of origin, retrospective or prospective nature), as these are bench tests and not human clinical studies.
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 type of information is usually relevant for studies involving subjective human interpretation (e.g., image analysis). For the described bench tests, no experts were used to establish ground truth in this manner. The ground truth for these engineering tests would be established by objective measurements against predefined engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. Since the described tests are bench tests, no such adjudication method was applicable or employed.
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
The provided information focuses on the substantial equivalence of an intra-aortic balloon catheter, a physical medical device, through a series of engineering bench tests. It does not describe an AI-powered device or an MRMC comparative effectiveness study involving human readers or AI assistance. Therefore, there is no mention of effect size for human readers with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Similar to the point above, the FIBEROPTIX IAB is a physical medical device, not an algorithm. Therefore, a standalone algorithm-only performance study was not conducted or is not applicable in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench tests described, the ground truth would be established by engineering specifications and objective measurements. For example:
- Dimensional Analysis: Ground truth is the specified dimensions (e.g., diameter, length).
- Tensile Testing: Ground truth is the specified material strength or bond strength.
- Volume Test: Ground truth is the specified balloon inflation volume.
There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for these specific tests.
8. The sample size for the training set
The provided text only discusses pre-market submission via a 510(k) pathway, focusing on substantial equivalence to a predicate device through bench testing. It does not mention any training set size, as it does not describe the development or evaluation of a machine learning or AI algorithm.
9. How the ground truth for the training set was established
As there is no mention of a training set (because it's not an AI/ML device), this information is not applicable and therefore not provided in the text.
§ 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.