(82 days)
The indications for use for the Cardiac Assist IAB's are identical to that of the currently marketed devices. The indications are as follows:
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- Refractory power failure.
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- Cardiogenic shock.
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- Unstable refractory angina.
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- Impending or extending myocardial infarction (MI).
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- Hemodynamically significant mechanical complications secondary to acute MI:
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- Ventricular septal defect.
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- Mitral valve regurgitation.
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- Papillary muscle rupture.
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- Hemodynamically significant mechanical complications secondary to acute MI:
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- Angiography/angioplasty patients.
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- Septal shock.
The Models 940 and 930, 30 cc and 40 cc Sensation™ and NICATH™ 40 cc and 30 cc IAB's consist of a polyurethane blend balloon at the distal end of a polyurethane-covered nylon shaft. The balloons are coated with a thin layer of Medical Grade silicone fluid. A central lumen runs throughout the length of the catheters and terminates at the distal tip. This central lumen may be used to pass the device over a guidewire. The balloon is supplied pre-wrapped for insertion.
The manufacturer, Boston Scientific Corporation / Cardiac Assist (BSC/CA), is seeking to label its Intra-Aortic Balloon Catheters (IABs) – Models 940 and 930, 30 cc and 40 cc Sensation™, and NICATH™ 40 cc and 30 cc – for an optional sheathless method of insertion. The claim is that these devices are substantially equivalent to existing predicate devices (Datascope 9.5 F 40 cc PERCOR STAT-DL and Kontron 9 F 40 cc IAB for Sheathless Insertion, and for some tests, Arrow 9 F 40 cc).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Performed | Predicate Device Performance / Reference | BSC/CA Device Performance | Outcome |
|---|---|---|---|
| Insertion Test | |||
| (Ability to be inserted through a restriction without damage) | Datascope and Arrow IABs required larger openings to pass without failure. | Able to be inserted through a tighter restriction without failure compared to predicate devices. | Meets / Exceeds |
| Kink Resistance Test | |||
| (Smallest bend radius without failure) | Datascope mean: 0.24 inch | ||
| Arrow mean: 0.23 inch | Mean radius ranged from 0.124 to 0.54 inch. | Substantially Equivalent | |
| Trackability Test | |||
| (Ability to track guidewire into position and be removed without damage) | Datascope and Arrow IABs were able to track their guidewire into proper position without incident. | All Cardiac Assist IABs were able to track their guidewire into proper position and were removed without incident. No kinks in catheter or guidewire. | Substantially Equivalent |
| Dimensional Comparison | |||
| (Difference between folded balloon diameter and catheter shaft diameter) | Datascope: 0.009 inch | ||
| Arrow: 0.029 inch | Ranged from 0.009 to 0.015 inch. | Substantially Equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not specify the sample size (number of devices tested) for the nonclinical tests (Insertion, Kink Resistance, Trackability, Dimensional Comparison). The data provenance is nonclinical (laboratory bench testing) conducted by Boston Scientific Corporation / Cardiac Assist. No country of origin is specified for the data, but it can be assumed to be from the manufacturer's testing facilities. The data is prospective as it was generated specifically to support this premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The ground truth for the nonclinical tests was established by direct measurement and observation of device performance under controlled laboratory conditions, not by expert consensus or interpretation.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically used for clinical studies involving human interpretation or subjective assessments. The nonclinical tests described involve objective measurements of physical device characteristics and performance.
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 MRMC study was conducted. This device is a medical device (Intra-Aortic Balloon Catheter) and not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical instrument, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant.
7. The Type of Ground Truth Used
The ground truth for the nonclinical tests was based on objective measurements and direct observation of physical and mechanical performance under controlled laboratory conditions. For example, in the insertion test, the "ground truth" was whether the device could pass through a restriction without damage, measured mechanically. In the kink resistance test, it was the smallest radius without failure, measured directly.
8. The Sample Size for the Training Set
This information is not applicable. This is a traditional medical device, not an AI/ML-based device that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for this 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.