(44 days)
CS300 Intra-Aortic Balloon Pump has the following indications for use: The balloon pump is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intraaortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The target populations are adult and pediatric. The balloon pump is intended for use in the health care facility setting. Datascope's Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter has 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 Datascope IABP System [Fiber Optic Pressure Sensor IAB Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] is used for intra-aortic balloon counterpulsation therapy in the aorta. The Datascope IABP System [Fiber Optic Pressure Sensor IAB Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] includes the following: - CS300 Intra-Aortic Balloon Pump - Fiber optic pressure Sensor IAB assembly - Revised packaging tray with cable retention feature
The provided text is a 510(k) summary for Datascope's IABP System, specifically the Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria, a dedicated clinical study proving device performance against those criteria, or the methodology typically associated with AI/ML device evaluations.
Therefore, I cannot fully complete the requested table and descriptions based only on the provided text for the following reasons:
- No explicit acceptance criteria: The document does not list quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision) as "acceptance criteria" for the device's function or a study comparing them. The evaluation is based on "substantial equivalence" to existing devices through non-clinical (in-vitro) testing.
- No "study" in the requested sense: There is no mention of a clinical trial designed to assess the new device against specific performance endpoints, particularly not one involving AI, human readers, or ground truth establishment.
- Absence of AI/ML specific information: The device is an Intra-Aortic Balloon Pump system, not a software-as-a-medical-device (SaMD) or an AI/ML diagnostic tool. Therefore, concepts like "test set," "training set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," and "type of ground truth" are not applicable in their typical sense to this submission.
However, I can extract the available information regarding how the device's performance was evaluated and the conclusions drawn:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functionality and performance comparable to currently marketed devices (Predicate 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." |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not applicable in the context of this 510(k) submission, which relies on in-vitro testing for substantial equivalence, not a clinical "test set" and ground truth as would be used for an AI/ML device. The document explicitly states: "There has been no clinical evaluation of the new device in the U.S."
- Data Provenance: Not applicable. The evaluation was in-vitro testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. This device is not an AI/ML diagnostic tool requiring expert review to establish ground truth for a test set.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No test set requiring expert adjudication was 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
- MRMC Study: No. This device is an IABP system, not an AI/ML image analysis or diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a mechanical/electronic medical system, not an algorithm. Its performance is inherent to its design and function, demonstrated through in-vitro tests and comparison to predicate devices, not through "standalone algorithm performance."
7. The type of ground truth used
- Type of Ground Truth: Not applicable in the sense of expert consensus, pathology, or outcomes data for diagnostic accuracy. The "ground truth" here is effectively the established performance characteristics of the predicate devices to which the new device was compared using in-vitro tests.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. This device does not involve a training set as it is not an AI/ML device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
Summary of the Study:
The study described is a non-clinical in-vitro testing program. The objective was to demonstrate substantial equivalence to predicate devices. The study concluded that "the functionality and performance characteristics of the device are comparable to the currently marketed devices" based on these in-vitro tests. No clinical trials or human subject studies were conducted for this 510(k) submission for the new device in the U.S.
§ 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.