(46 days)
The CARDIOSAVE Intra-Aortic Balloon Pump is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.
The CARDIOSAVE Intra-Aortic Balloon Pump (IABP) is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end-diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.
These beneficial effects are caused by the inflation and deflation of an intra-aortic balloon (IAB) in the patient's descending aorta. The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB inflation is initiated at the onset of diastole at the dicrotic notch and remains inflated through diastole. The IAB is then deflated at, or just prior to, the onset of systole and the balloon remains deflated throughout systole. Hence, the therapy is also referred to as counterpulsation. This is the same intended use as other IABPs.
The provided text describes a 510(k) premarket notification for a medical device called the CARDIOSAVE Intra-Aortic Balloon Pump (IABP). However, the application is specifically for a modification to the existing device: a new CARDIOSAVE Li-Ion battery transport and storage case.
Therefore, the acceptance criteria and study described are not for the entire IABP device, but rather for the safety and performance of this new battery case.
Here's an analysis based on the provided text, addressing your requested information points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Requirement) | Reported Device Performance (Compliance) |
|---|---|
| IEC 62133 Edition 2.0 2012-12: Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications. | The new CARDIOSAVE Li-Ion battery transport and storage case to be used for the CARDIOSAVE Li-Ion batteries for protective purposes when not installed in the IABP complies with IEC 62133 Edition 2.0 2012-12. The results of the tests conducted demonstrate this compliance. |
| (Implicit) Device functions as well as the predicate device (regarding the battery case). | The design verification and validation testing established that the CARDIOSAVE IABP with the new CARDIOSAVE Li-Ion battery transport and storage case performs as well as the predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify a numerical sample size (e.g., number of battery cases tested). It generally refers to "tests conducted."
- Data Provenance: The data was generated through "Performance testing" as part of Datascope Corp.'s development process. The country of origin is not explicitly stated. The nature of the testing (bench testing, design validation) makes it inherently prospective in relation to the design of the new case.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this submission. The "ground truth" for the battery case's performance is objective compliance with an international safety standard (IEC 62133) rather than subjective expert interpretation. The performance is assessed via engineering tests, not clinical or diagnostic evaluations requiring expert consensus.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for subjective assessments where there might be disagreement in interpretation (e.g., medical image reading). For objective engineering compliance testing, the results are typically pass/fail based on predefined criteria, not expert 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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or decision support tools that involve human interpretation. This submission is for a medical device accessory (battery case) and its compliance with safety standards.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical accessory (battery case), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the battery case's performance is objective compliance with regulatory and international safety standards, specifically IEC 62133 Edition 2.0 2012-12. This is not based on expert consensus, pathology, or outcomes data, but rather on engineering test results demonstrating adherence to the specifications of the standard.
8. The sample size for the training set
Not applicable. This submission is not for an AI model or a device that uses machine learning. Therefore, there is no "training set" in this context. The study performed involves testing physical hardware.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned or implied by the nature of the device modification.
§ 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.