(21 days)
Datascope's CA 40 8Fr. Intra-Aortic Balloon Catheters have the following indications for use:
- Refractory unstable angina
- Impending infarction
- Acute MI
- Refractory ventricular failure
- Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture)
- Cardiogenic shock
- Support for diagnostic, percutaneous revascularization, and interventional procedures.
- Ischemia related intractable ventricular arrhythmias
- Septic shock
- Intraoperative pulsatile flow generation
- Weaning from bypass
- Cardiac support for non-cardiac surgery
- Prophylactic support in preparation for cardiac surgery
- Post surgical myocardial dysfunction/low cardiac output syndrome
- Myocardial contusion
- Mechanical bridge to other assist devices
- Cardiac support following correction of anatomical defects
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:
- Refractory unstable angina .
- Impending infarction .
- Acute MI .
- Refractory ventricular failure ●
- Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture) .
- Cardiogenic shock ●
- Support for diagnostic, percutaneous revascularization, and interventional . procedures.
- Ischemia related intractable ventricular arrhythmias ●
- Septic shock .
- Intraoperative pulsatile flow generation ●
- Weaning from bypass ●
- Cardiac support for non-cardiac surgery ●
- Prophylactic support in preparation for cardiac surgery .
- Post surgical myocardial dysfunction/low cardiac output syndrome ●
- Myocardial contusion ●
- Mechanical bridge to other assist devices ●
- Cardiac support following correction of anatomical defects .
Modifications to Datascope's predicate 8 Fr. IAB catheters include a material modification of Datascope's currently marketed balloon membrane to enable the balloon to be manufactured using different molding process. The catheter tip material is that of a previously FDA cleared IAB tip material and the catheter's tip dimension has been tapered.
Here's an analysis of the provided text regarding the acceptance criteria and study for Datascope's CA 40 8Fr. Intra-Aortic Balloon Catheters:
Acceptance Criteria and Reported Device Performance
The provided document describes a 510(k) premarket notification for a Class III medical device. In the context of 510(k) submissions, the primary "acceptance criterion" is Substantial Equivalence to a predicate device. This means demonstrating that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.
The document does not explicitly list quantitative acceptance criteria for specific performance metrics in the way one might see for a diagnostic AI algorithm (e.g., sensitivity, specificity thresholds). Instead, the acceptance is based on demonstrating that modifications do not negatively impact safety or efficacy, and the device performs comparably to its predicates.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The device is considered substantially equivalent to Datascope's currently marketed IABs (K013326 and K003598). |
| Functionality and Performance Comparable to Marketed Devices | "The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices." |
| No adverse effect on Safety or Efficacy due to modifications | "These modifications to the 8Fr. IAB catheters have been demonstrated not to affect safety or efficacy of the device." Modifications include a material change to the balloon membrane for a different molding process, a previously cleared catheter tip material, and a tapered tip dimension. |
| Intended Use Matches Predicate Devices | Datascope's CA 40 8Fr. IAB Catheters are substantially equivalent to the predicate devices with regard to intended use, covering a range of cardiovascular conditions and support scenarios. |
Study Details
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No clinical test set was used. The document explicitly states: "There have been no clinical evaluations of the new device."
- The evaluation was based on in-vitro tests to demonstrate comparable functionality and performance. The sample size for these in-vitro tests is not specified.
- The data provenance is not applicable as it was an in-vitro study, 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 (e.g. radiologist with 10 years of experience)
- Not applicable. Since no clinical test set was used and the evaluation was based on in-vitro performance, there was no ground truth requiring expert establishment in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical test set requiring adjudication.
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. This is a medical device (Intra-Aortic Balloon Catheter), not an AI diagnostic or assistance system that involves human readers interpreting data. Therefore, an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an invasive medical catheter, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the in-vitro tests: The "ground truth" would be established by engineering specifications, established physical and mechanical properties, and functional benchmarks derived from the performance of the predicate devices. The document implies performance was compared against these established standards of the predicate devices.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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.