(25 days)
Datascope's 7.5Fr. Intra-Aortic Balloon Catheters and Accessories are used for intra-aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle. This is the same intended use as previously cleared for all other Datascope Intra-Aortic Balloon Catheters.
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 unstable angina .
- Impending infarction .
- . Acute MI
- Refractory ventricular failure .
- Complications of acute MI (i.e. Acute MR or VSD, or papillary . muscle rupture)
- Cardiogenic shock .
- Support for diagnostic, percutaneous revascularization, and . interventional procedures.
- Ischemia related intractable ventricular arrhythmias .
- Septic shock .
- Intraoperative pulsatile flow generation .
- . Weaning from bypass
- Cardiac support for non-cardiac surgery .
- Prophylactic support in preparation for cardiac surgery .
- Post surgical myocardial dysfunction/low cardiac output syndrome .
- Myocardial contusion
- Mechanical bridge to other assist devices .
- Cardiac support following correction of anatomical defects .
Datascope's 7.5Fr. Intra-aortic Balloon Catheters and Accessories are used for intra-aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle. The intra-aortic balloon is placed in the descending aorta just below the subclavian artery. The modification to the Datascope predicate 8Fr. IAB is dimensional only. The dimension of the co-extruded polyurethane blend catheter will be changed from 8Fr. to 7.5Fr. and the polyimide inner lumen dimension will be changed from .030" to .027". To accommodate the smaller 7.5Fr. IAB catheter, Datascope's predicate 8Fr. Reinforced Catheter Introducer has been modified from 8Fr. to 7.5Fr., and the Stepped Dilator from 5-8Fr. to 4-7.5Fr. Modifications to the 8Fr. Reinforced Catheter Introducer Set also include a change in the material of the sheath hub and internal tubing, color code the introducer hub and dilator to industry standard (orange for 7Fr.), change the hub cap design from round to square, change dilator/sheath interface from a snap-fit to a lock-fit design, and add an alternate source contract manufacturer.
The provided document is a 510(k) summary for Datascope's 7.5Fr. IAB and Accessories, submitted to the FDA. It's a premarket notification for a medical device seeking substantial equivalence to already marketed devices. This type of document describes the device, its intended use, and how it is demonstrated to be substantially equivalent to predicates, often through non-clinical testing. It does not contain acceptance criteria or a study proving that a device meets acceptance criteria in the format typically used for performance studies of AI/ML or diagnostic devices.
The document claims substantial equivalence based on:
- Identical intended use as previously cleared Datascope Intra-Aortic Balloon Catheters.
- Dimensional modifications only (8Fr to 7.5Fr for the IAB, and related changes to introducer and dilator).
- Material changes in the introducer set are to previously FDA cleared materials.
- Non-clinical (in-vitro) tests demonstrating comparable functionality and performance to currently marketed devices.
Therefore, many of the requested items (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of submission, as it focuses on demonstrating substantial equivalence through non-clinical data and minor dimensional/material changes, rather than a clinical performance study with specific acceptance criteria that would typically be associated with AI/ML or diagnostic device evaluations.
Here's an attempt to answer the questions based only on the provided document:
-
A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in a table format. Instead, it states that "The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices" (Page 2, Section F). This qualitative statement of comparability to predicate devices serves as the performance "acceptance" for this type of submission.Acceptance Criteria (Implied) Reported Device Performance Functionality and performance comparable to currently marketed devices (predicate: K031569, K013326, K002365) In-vitro tests demonstrated comparable functionality and performance characteristics to currently marketed devices. Safety and efficacy unaffected by modifications Modifications (dimensional and material) have been demonstrated not to affect safety or efficacy. -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "There has been no clinical evaluation of the new device in the U.S." (Page 2, Section G). The testing mentioned is "in-vitro tests" (Page 2, Section F). Therefore, there is no clinical test set, human data, or associated provenance. In-vitro testing typically uses bench models or simulated environments, not patient data. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical test set or human-derived ground truth was established as per the document. The evaluation was based on in-vitro (bench/laboratory) testing. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set was used requiring adjudication. -
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
Not applicable. This is a traditional medical device (intra-aortic balloon catheter), not an AI/ML device, and no MRMC study was conducted or mentioned. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a traditional medical device, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For in-vitro testing of a physical device like an IAB, "ground truth" would typically refer to established engineering specifications, physical measurements, or industry standards, rather than clinical ground truth forms like pathology or expert consensus. The document implies compliance with these engineering/performance standards through its claim of "comparable functionality and performance characteristics." -
The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set. -
How the ground truth for the training set was established
Not applicable. As above, no training set was used.
§ 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.