(115 days)
The Ultra IABP is placed in the descending aorta just below the subclavian artery. and is intended to improve cardiovascular function during the following situations: refractory unstable angina, impending infarction, post-infarction angina, refractory feft ventricular failure, complications of acute MI (i.e., acute MR or VSD or papillary muscle rapture), cardiogenic shock, support for diagnostic perculaneous revascularization and interventional procedures, ischemic related intractable ventricular arrhythmias, septic shock, interoperative pulsatile flow generation, weaning from cardiopulmonary bypass, cardiac support for non-cardiac surgery, prophylactic support in preparation for cardiac surgery, post-surgical myocardial dysfunction/low cardiac output syndrome, cardiac contusion, mechanical bridge to other assist devices and cardiac support following correction of anatomical defects.
The Insightra Ultra IABP Catheter Kit is a 7 French catheter available with either a 40, 35, 30, 25, or 20 cc balloon. The catheter has two lumens and is designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloon. The inner lumen is used for a guidewire and blood pressure measurement. It is packaged as a convenience kit with accessories (one-way valve, 50 cc syringe, guide wires, introducer needle, dilator, pressure tubing, Datascope & Arrow adaptors).
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 hearbeat. It is intended to increase coronary perfusion, decrease the workload of the left ventricle and allow healing of the myocardium.
The provided text describes the Insightra Ultra IABP Catheter Kit, a medical device for cardiac assist therapy. However, the documentation focuses primarily on demonstrating substantial equivalence to predicate devices through design and material comparison, and pre-clinical testing for safety and basic functionality. It does not include the details of a study that would typically be associated with AI/ML-based device performance evaluation, such as specific acceptance criteria for diagnostic accuracy, sample sizes for test/training sets in an AI context, expert ground truth establishment, or multi-reader multi-case studies.
Therefore, the response below will reflect the information that is available in the provided text, and explicitly state what information is not present given the nature of the device and the submission.
Acceptance Criteria and Study Details for the Insightra Ultra IABP Catheter Kit (K082746)
Based on the provided 510(k) summary, the device is an Intra-Aortic Balloon Pump (IABP) Catheter, a physical medical device designed to provide mechanical left heart assist. The assessment of its performance and acceptance criteria is centered on its physical and biological properties and its functional equivalence to existing, legally marketed predicate devices, rather than on the performance of a diagnostic algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is demonstrated through pre-clinical in vitro tests and biocompatibility testing. The specific quantitative acceptance criteria are not detailed in the summary document but are stated to have been "pre-determined." The performance is reported as meeting these criteria.
| Acceptance Criteria Category | Specific Acceptance Criteria (as reported or inferred) | Reported Device Performance |
|---|---|---|
| In Vitro Performance | Pre-determined acceptance criteria based on clinical demands (e.g., proper inflation/deflation, lumen patency, mechanical integrity under simulated physiological conditions). Specific quantitative criteria are not disclosed in this summary. | "The in vitro tests showed that the device meets pre-determined acceptance criteria that were based on the clinical demands the device will be subjected to." |
| Biocompatibility | Compliance with requirements for Class III devices intended for blood-contacting applications (e.g., cytotoxicity, sensitization, irritation, acute systemic toxicity, hemolysis, thrombogenicity, material-mediated pyrogenicity, complement activation, etc. as per ISO 10993 standards). | "The biocompatibility testing demonstrated that the Ultra IABP Catheter Kits comply with the requirements for this device classification." |
| Functional Equivalence | Demonstrating similar design, materials, and intended use to existing predicate devices (Abiomed SupraCor Balloon Catheter (K062582) and Datascope 7.5Fr IAB Catheter and Accessories (K041281)). | A comparison table (Table 1) is provided, highlighting design, dimensions, and material similarities with predicate devices. |
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a distinct "test set" sample size in the context of diagnostic accuracy, as this is a physical medical device. For the "in vitro" and "biocompatibility" tests, the sample size would refer to the number of catheters tested. This information is not provided in the summary.
- Data Provenance: The tests are described as "in vitro" and "biocompatibility" tests. This indicates laboratory-based testing, likely conducted within the manufacturer's facilities or by contracted testing laboratories. Information regarding country of origin of data or whether it's retrospective/prospective is not applicable in the same way it would be for clinical data or AI model evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This information is not applicable to this type of device and submission. The ground truth for device performance in this context would be objective physical and biological measurements against pre-defined engineering and safety standards, not expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
- This information is not applicable. Adjudication methods like "2+1" or "3+1" are used for resolving discrepancies in expert interpretations of medical data, which is not relevant to the physical and biological testing described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the function of the Insightra Ultra IABP Catheter Kit.
6. Standalone (Algorithm Only) Performance Study
- No standalone algorithm performance study was done. This device is a physical catheter, not an AI/ML algorithm.
7. Type of Ground Truth Used
- The ground truth used for assessing this device's performance is based on engineering specifications, established industry standards for material properties and device functionality (e.g., inflation/deflation characteristics, pressure handling), and regulatory requirements for biocompatibility (e.g., ISO 10993 standards). It is not based on expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.
8. Sample Size for the Training Set
- This information is not applicable as this is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as this is not an AI/ML device requiring 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.