(105 days)
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and intended to improve cardiovascular functioning during the following situations:
- . Unstable refractory angina
- Impending infarction .
- Post Infarction Angina or Threatening Extension of Myocardial . Infarction
- Refractory ventricular failure .
- Mechanical complications because of myocardial infarction
- Cardiogenic shock .
- Support and stabilization of high risk patients undergoing . diagnostic and non-surgical procedures
- Ischemic related intractable ventricular arrhythmias .
- Septic shock .
- Interoperative pulsatile flow generation .
- Weaning from cardiopulmonary bypass .
- Cardiac support for high risk surgical patients and coronary . angiography and angioplasty patients
- Prophylactic support in preparation for cardiac surgery .
- Post-surgical myocardial dysfunction .
- . Cardiac Contusion
- . Mechanical bridge to other assist devices
- . Cardiac support following correction of anatomical defects
- Support for failed angioplasty and valvuloplasty .
The SupraCor Balloon Catheter is a 40cc symmetrical polyurethane balloon attached to an 8 Fr dual lumen catheter, designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloon, and the inner lumen is used for a guidewire and blood pressure measurement.
The balloon inflation and deflation cycle is synchronized (using a commercially available control console) with the ECG or arterial pressure to provide counterpulsation synchronized with the heartbeat. It is intended to increase coronary perfusion, decrease the workload of the left ventricle and allow healing of the myocardium.
The provided text describes a 510(k) premarket notification for the SupraCor Balloon Catheter. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria and performance metrics against ground truth in the way a diagnostic AI device would.
Therefore, many of the requested points, such as sample sizes for test sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types for training/test sets, are not applicable to this type of device and submission.
Here's an attempt to answer the questions based on the provided text, highlighting the non-applicability of certain points:
Acceptance Criteria and Device Performance for SupraCor Balloon Catheter
This submission demonstrates substantial equivalence to predicate devices, focusing on technological characteristics and pre-clinical test results, rather than clinical performance against specific acceptance criteria in the manner of a diagnostic device. The "acceptance criteria" here implicitly refer to meeting the substantial equivalence requirements by demonstrating similar design, materials, and performance to the predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Predicate Equivalence) | Reported Device Performance (SupraCor IAB) |
|---|---|---|
| Duration of Use | Temporary use: Approx. ≤ 30 days (matching predicates) | Temporary use: Approx. ≤ 30 days |
| Balloon Size | 40 cc (matching predicates) | 40 cc |
| Balloon Shape | Symmetric (matching predicates) | Symmetric |
| Balloon Material | Polyether urethane (matching predicates) | Polyether urethane |
| Balloon Length | Approximately 10.25 - 10.4 inches (matching predicates) | 10.25 inches |
| Catheter Type | Dual Lumen (matching predicates) | Dual Lumen |
| Outer Wall Material | Polyether urethane (matching predicates) | Polyether urethane |
| Outer Wall Circumference | 8 F (matching predicates) | 8 F |
| Introducer Size | 8 F (matching predicates) | 8 F |
| Sterilization | EtO (matching predicates) | EtO |
| Inner Packaging | Tray in Tyvek/Mylar Pouch (matching predicates) | Tray in Tyvek/Mylar Pouch |
| Outer Packaging | Tyvek Mylar Pouch (matching predicates) | Tyvek Mylar Pouch |
| Pre-clinical Testing | Performance and reliability equivalent to predicate devices, in accordance with FDA guidance (12/8/1993 draft). Biocompatibility and sterility compliance with requirements for device classification. | Demonstrated equivalence to 2 predicate devices, compliant with biocompatibility and sterility requirements. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This submission relies on substantial equivalence through comparison of technical characteristics and pre-clinical laboratory testing, not a clinical test set with human subjects or a dataset for an algorithm.
- Data Provenance: Not applicable in the context of a "test set" for performance metrics. The data comes from pre-clinical laboratory testing of the device itself and comparison to specifications of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "test set" with ground truth established by experts in the context of this 510(k) submission for a physical medical device. Substantial equivalence is determined by regulatory review based on comparison of technical specifications and pre-clinical test results.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. There is no "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
- Not applicable. This is a physical medical device (intra-aortic balloon catheter), not an AI device or a diagnostic tool involving 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, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the common sense of clinical ground truth. The "ground truth" for this submission are the established specifications and performance characteristics of the legally marketed predicate devices, against which the new device's engineering specifications and pre-clinical test results are compared to establish substantial equivalence.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, this is a physical medical device.
§ 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.