(95 days)
-
- Refractory ventricular failure.
- Cardiogenic shock. 2.
- Unstable refractory angina. 3.
- Impending infarction. 4.
- Mechanical complications due to acute myocardial infarction, i.e., ventricular septal defect, mitral regurgitation or papillary muscle rupture.
- Ischemia related intractable ventricular arrhythmias.
- Cardiac support for high risk general surgical patients and coronary angiography/angioplasty patients.
- Septic shock. 8.
- Weaning from cardiopulmonary bypass. 9.
- Intraoperative pulsatile flow generation. 10.
- Support for failed angioplasty and valvuloplasty. 11.
The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:
- · Refractory ventricular failure
- · Cardiogenic shock
- · Unstable refractory angina
- · Impending infarction
- Mechanical complications due to acute myocardial infarction .
- · Ischemic related intractable ventricular arrhythmias
- · Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients
- · Septic shock
- · Weaning from cardiopulmonary bypass
- · Interoperative pulsatile flow generation
- · Support for failed angioplasty and valvuloplasty
The provided 510(k) summary for the Datascope 8Fr. Polyimide Intra-Aortic Balloon Catheters does not contain acceptance criteria or a study proving the device meets specific acceptance criteria in the typical sense of a clinical trial with predefined endpoints and metrics.
This 510(k) submission is for a device seeking substantial equivalence to existing predicate devices. Therefore, the "acceptance criteria" are primarily established through demonstrating that the new device is as safe and effective as the predicate devices, and the "study" is a comparison of technological characteristics and in-vitro tests, not a clinical study.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: |
- Indications for Use (same as predicate)
- Safety (not adversely affected by material changes)
- Efficacy (not adversely affected by material changes) | Substantial Equivalence Claimed:
- Indications for use are identical to predicate devices.
- "The difference in material grade and chemical composition has been demonstrated not to affect safety or efficacy of the device."
- "The functionality and performance characteristics of the device are comparable to the currently marketed devices" (based on in-vitro tests). |
| Functional and Performance Characteristics comparable to marketed devices | "The results ofin-vitrotests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices." |
| Material Grade and Chemical Composition do not affect safety or efficacy | "The difference in material grade and chemical composition has been demonstrated not to affect safety or efficacy of the device." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. No human or animal test set was used for a clinical study. The evaluation was based on in-vitro testing and a review of technological characteristics against predicate devices.
- Data Provenance: Not applicable. The "data" primarily consists of technical specifications and in-vitro test results from Datascope Corp.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No ground truth was established by external experts for a clinical test set. The assessment was performed by the manufacturer, Datascope Corp., against their own in-vitro test results and comparison to predicate device specifications.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. There was no clinical 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
- MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not done. This device is an intra-aortic balloon catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable. This is a medical device, not a diagnostic algorithm. Performance was assessed through in-vitro tests and comparison to predicate devices, without human-in-the-loop considerations in the context of diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable in the traditional sense of a clinical study. The "ground truth" for this 510(k) submission is implicitly the established safety and efficacy profiles of the legally marketed predicate devices, against which the new device's technological characteristics and in-vitro performance are compared.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
§ 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.