(94 days)
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 ventricular failure Cardiogenic shock Unstable refractory angina Impending infarction Mechanical complications due to acute myocardial infarction Ischemic related intractable ventricular arrhythmias Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients Septic shock Weaning from cardiopulmonary bypass Interoperative pulsatile flow generation Support for failed angioplasty and valvuloplasty
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 ventricular failure Cardiogenic shock Unstable refractory angina Impending infarction Mechanical complications due to acute myocardial infarction Ischemic related intractable ventricular arrhythmias Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients Septic shock Weaning from cardiopulmonary bypass Interoperative pulsatile flow generation Support for failed angioplasty and valvuloplasty
The provided 510(k) summary for the Datascope Percor STAT-DL® 9.5Fr. & 10.5 Fr. Intra-Aortic Balloon (IAB) does not contain specific acceptance criteria or a detailed study proving the device meets said criteria in the way typically expected for an AI/ML device.
This document describes a medical device from 1997, which predates the widespread use of AI/ML in medical devices and the regulatory frameworks associated with them. The criteria for demonstrating safety and effectiveness at that time were different.
Here's an analysis based on the provided text, highlighting the absence of the requested AI/ML specific information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria nor specific performance metrics in the way a modern AI/ML device submission would. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that it functions comparably to the predicates.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Functionality comparable to predicate devices | Functionality demonstrated to be comparable in in-vitro tests |
| Performance characteristics comparable to predicate devices | Performance characteristics demonstrated to be comparable in in-vitro tests |
| Safety not affected by material/chemical changes | Differences in material/chemical composition demonstrated not to affect safety |
| Efficacy not affected by material/chemical changes | Differences in material/chemical composition demonstrated not to affect efficacy |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. There was no "test set" in the context of an AI/ML model for this submission. The "tests" mentioned are in-vitro physical/mechanical tests.
- Data Provenance: Not applicable for an AI/ML test set. The in-vitro tests would have been conducted in a lab setting.
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. This device is not an AI/ML diagnostic or prognostic tool that relies on expert consensus for ground truth. Its safety and effectiveness are established through engineering design, material science, and mechanical testing, comparing it to existing, approved devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no expert adjudication process for this type of device submission.
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 is not an AI/ML device designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (an intra-aortic balloon), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this device, "ground truth" would relate to the physical and chemical properties of the device components and its functional operation when tested in vitro, compared against specifications or performance of predicate devices.
8. The sample size for the training set
Not applicable. There is no AI/ML model, and therefore no training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model, and therefore no training set or ground truth establishment for it.
Summary of the Study and Conclusion from the Document:
The "study" presented is a demonstration of substantial equivalence (through non-clinical tests) to legally marketed predicate devices.
- Non-Clinical Tests: In-vitro tests were conducted to demonstrate that the functionality and performance characteristics of the new device (Datascope Percor STAT-DL® 9.5Fr. & 10.5Fr. IAB) are comparable to the currently marketed predicate devices. The differences in material grade and chemical composition were analyzed and demonstrated not to affect safety or efficacy.
- Clinical Tests: The document explicitly states, "There has been no clinical evaluation of the new device in the U.S." This further emphasizes that the approval was based on non-clinical data and substantial equivalence.
- Conclusion: Based on the information from the in-vitro tests and comparison to predicate devices, Datascope's Percor STAT-DL® 9.5Fr. & 10.5Fr. IABs were considered substantially equivalent to Datascope's currently marketed IABs. This substantial equivalence is the "proof" that the device met the (implied) regulatory acceptance criteria for market clearance in 1997.
§ 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.