(87 days)
The 8Fr. Narrowflex Universal Intra-Aortic Balloon Catheter is clinically indicated for the following conditions:
a. Acute Coronary Syndrome
b. Cardiac and Non-Cardiac Surgery
c. Complications of Heart Failure
The device is a dual lumen percutaneously inserted Intra-Aortic IAB catheter, 8 Fr. in size, with two independent non-communicating lumens. The outer lumen is comprised of an inflatable bladder connected to the catheter distal tip and to the IAB 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 tip inner surface. The IAB inner lumen is used for placement of the device with a guidewire and the outer lumen is used to shuttle helium gas to and from the inflatable bladder. The IAB is timed to inflate in the aorta during the diastolic relaxation of the heart and deflate during the systolic contraction of the heart, resulting in increased blood supply to the heart muscle and decreased work load for the left ventricle.
The provided text describes a 510(k) premarket notification for a medical device, the 8Fr. NarrowFlex Universal Intra-Aortic Balloon Catheter. The document assesses the substantial equivalence of the new device to a predicate device. However, it does not contain information about specific acceptance criteria, comprehensive study designs, or detailed performance data as would be typically found in a clinical trial report or a more extensive validation study summary.
Therefore, many of the requested items (sample size, data provenance, expert qualifications, adjudication method, MRMC study, effect size, standalone performance, ground truth details, training set information) cannot be extracted from this document because they are not present.
Below is a summary of the available information, noting where requested details are absent.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Technological Equivalence (Implied): The device should have the same technological characteristics as the predicate. | The device has the "same exact technological characteristics as the predicate." |
| IAB Performance (Implied): Inflate/deflate characteristics, total cycle time, and volume at all rates should be comparable to the predicate. | "IAB performance comparisons, Inflate/deflate, total cycle time and volume (all rates)" were conducted. Results "demonstrate that the device is substantially equivalent to the legally marked predicate device." |
| Nitinol Inner Lumen Stiffness and Buckling Point (Implied): Stiffness and buckling point should be comparable to the predicate. | "Nitinol inner lumen stiffness and buckling point - Stiffness bend test and buckling point comparison test results" were conducted. Results "demonstrate that the device is substantially equivalent to the legally marked predicate device." |
Note on Acceptance Criteria: The document implies acceptance criteria by stating that the new device has the “same exact technological characteristics as the predicate” and that test results “demonstrate that the device is substantially equivalent.” Specific numerical thresholds or acceptance ranges are not provided.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document only mentions "tests" were conducted but does not provide details on the number of devices or data points included in these tests (e.g., number of balloons tested, number of inflate/deflate cycles).
- Data Provenance: Not specified. These appear to be laboratory performance tests, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The "ground truth" in this context refers to laboratory performance metrics against a predicate device, not clinical diagnoses requiring expert consensus.
4. Adjudication method for the test set
- Not Applicable. As the tests are performance comparisons against a predicate, there is no expert adjudication process described.
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. This document pertains to an intra-aortic balloon catheter, a physical medical device. It does not describe an AI-powered diagnostic tool, therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- The "ground truth" in this context is the performance characteristics of the legally marketed predicate device. The new device's performance was compared against these established characteristics through laboratory testing.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is a physical medical device, not an algorithm that requires a training set.
§ 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.