(260 days)
Refractory left ventricular power failure. Cardiogenic shock unstable refractory angina. Mechanical complication due to acute myocardial infraction; i.e., ventricular sepial defect mitral requrgitation or papillary muscle rupture. Impending infraction, ischemia related intractable ventricular arrhythmias. Septic shock. Support for failed angioplasty and valvuloplasty. Cardiac support for high risk general surgical patients.
This device is identical in construction to the predicate 8 Fr-40cc NarrowFlex™ device IAB-04840 with the exception of the 30cc balloon and shorter overall length. The balloon volume and the overall length have been adapted from the 8 Fr-30cc IAB-04230 predicate.
The provided text describes the 510(k) summary for the Arrow 8 Fr.-30cc Narrowflex™ Intra-Aortic Balloon Catheter (K963920), which was submitted for market clearance in 1997. The submission is based on substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
Acceptance Criteria and Reported Device Performance
The submission relies on a comparison to predicate devices, asserting "substantial equivalence" rather than specific numerical performance targets for this device. The acceptance criterion is that the device demonstrates comparable performance to its predicate devices in specific nonclinical tests.
| Acceptance Criterion | Reported Device Performance (vs. Predicate) |
|---|---|
| Total cycle time | Comparable performance |
| Displaced volume | Comparable performance |
| First response | Comparable performance |
Note: The text explicitly states "comparable performance to the predicate devices" for these tests, without providing numerical values for either the predicate or the subject device.
Study Details
Based on the provided text, the study conducted was a nonclinical performance test battery comparing the subject device to its predicate devices.
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Sample size used for the test set and the data provenance:
- The sample size for the test set is not specified in the provided document.
- The data provenance is nonclinical test results, implying laboratory testing rather than human subject data. The country of origin is not specified but is presumably the USA, where Arrow International, Inc. is located. It is inherently prospective as it involves new testing for the device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a nonclinical performance test, not a study requiring expert human interpretation or establishment of ground truth against clinical endpoints.
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Adjudication method for the test set:
- Not applicable. This was a nonclinical performance test.
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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 MRMC study was done. This is a medical device (intra-aortic balloon catheter), not an AI-powered diagnostic or assistive technology involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the conventional sense. For these nonclinical performance tests, the "ground truth" would be the measured physical and mechanical properties of the device, compared against the measured physical and mechanical properties of the predicate devices. There is no biological "ground truth" like pathology or clinical outcomes.
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" as it is not an AI/machine learning product.
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How the ground truth for the training set was established:
- Not applicable. This device does not involve 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.