(89 days)
The BSC/CA IABC's are indicated for use in patients with the following conditions: Refractory power failure. Cardiogenic shock. Unstable refractory angina. Histodynamically significant mechanical complications secondary to acute MI: Ventricular septal defect. Mitral valve regurgitation. Papillary muscle rupture. Cardiac support for high risk general surgical and coronary angiography/ angioplasty patients. Septic shock. The intended use of the 30 cc and 40 cc SUB-9 remain identical to that of the currently marketed IABC's. All of the devices are intended to provide temporary circulatory ntireded that 3. The or in athrough controlled mechanical displacement of a volume of blood in the aorta. The mechanical action of the IAB catheter therapy lowers the cardiac workload by two reans : Systolic unloading, as noted by a reduction in the patient's systolic pressure, l . which provides reduced myocardial oxygen consumptions (MVO,). Diastolic augmentation which provides an increase in the mean ann aortic pressure and leads to an improvement in systemic and coronary arterial perfusion. Balloon pump therapy is achieved by inserting an intra-aortic balloon catheter into the descending thoracic aorta via the common femoral artery. Balloon inflation is timed to occur during diastole, beginning with the aortic valve closure. The balloon remains inflated until the onser of left ventricular ejection or systole, then rapidly deflates, reducing the aortic pressure, which in turn reduces the afterload.
The proposed 30 cc and 40 cc SUB-9 Stainless Steel and Nitinol consists of a polyurethane blend symmetrical balloon at the distal end of a polyurethane-covered nylon shaft. The balloons are coated with a thin layer of silicone fluid. A Nitinol central lumen runs throughout the length of the 30 cc and 40 cc SUB-9 Nitinol catheters and terminates at the distal tip. A Stainless Steel central lumen runs throughout the length of the 30 cc and 40 cc SUB-9 Stainless Steel catheters and terminates at the distal Each central lumen may be used to pass the devices over their tip. guidewire. The balloon is supplied prewrapped for insertion utilizing either a hemostasis sheath (provided in each IAB insertion kit) or sheathless.
The provided 510(k) summary for the Boston Scientific Corporation/Cardiac Assist (BSC/CA) SUB-9 Intra-Aortic Balloon Catheter describes the device and its substantial equivalence to predicate devices. However, this document does not contain the detailed acceptance criteria, specific device performance metrics, or a formal study report with the requested sample sizes, ground truth establishment, or multi-reader multi-case study information that would typically be found in a comprehensive clinical or non-clinical study report.
The document focuses on demonstrating substantial equivalence through a series of non-clinical tests comparing the new SUB-9 device to its predicate devices. The "acceptance criteria" in this context are implicitly that the SUB-9 design performs substantially equivalently to, or better than, the predicate devices in various mechanical and functional aspects.
Here's an attempt to extract and infer the information based on the provided text, with clear indications where information is not available in the document:
Acceptance Criteria and Device Performance for K912113 SUB-9 Intra-Aortic Balloon Catheter
This 510(k) summary focuses on demonstrating substantial equivalence of the SUB-9 Intra-Aortic Balloon Catheter to its predicate devices through non-clinical testing. The "acceptance criteria" are implicitly met when the SUB-9 device performs comparably to, or better than, the predicate devices in the described tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Implicit Acceptance Criteria | Reported Device Performance and Remarks |
|---|---|---|
| 1. Sheathed Insertion Test | Force required for insertion is substantially equivalent to predicate devices. | The force required to insert the SUB-9 designs (30 and 40 cc, Stainless Steel and Nitinol) was demonstrated to be substantially equivalent to the force required to insert the predicate NICATH™ and Sensation™ designs. |
| 2. Sheathless Insertion Test | Ability to pass through restrictions comparable to, or better than, predicate devices. | The tightest restriction that the SUB-9 design can pass through was found to be smaller than that required for the predicate BSC/CA IAB's, the Datascope 40 cc 9.5 F Percor-Stat, and the Kontron/Arrow 40 cc 9 F IAB. (SUB-9 performed better) |
| 3. Maximum Pumping Rate Limit Test | Maximum pumping rate at which the balloon fully inflates/deflates is comparable to, or better than, predicate devices. | The maximum achievable pumping rate limits for the SUB-9 designs were found to be higher than that for the predicate NICATH™ and Models 940 and 930 on the BSC/CA 3001. It is inferred that SUB-9 will perform faster on any IABP it is labeled for use on. (SUB-9 performed better). |
| 4. Reliability/Integrity Test | Reliability and integrity comparable to predicate devices (ability to cycle at least 3.6 million cycles). | The reliability of the SUB-9 was found comparable to all BSC/CA predicate devices, all of which were able to cycle for at least 3.6 million cycles. Maximum pumping rate limit post-reliability was identical to pre-reliability rate for 40cc SUB-9. Inflation and deflation times post-reliability were comparable to pre-reliability times. |
| 5. Aneurization and Burst Pressure Test | Aneurization and burst pressures are substantially equivalent to predicate devices, and external IABP output pressures are below these limits. | Demonstrated substantially equivalent aneurization and burst pressures as compared to the predicate devices. The SUB-9 balloons will not aneurize or burst when used on labeled IABP's, as IABP's cannot provide the volume/pressure required. Peak output pressures of all indicated IABP's are below the pressures required to aneurize and burst the balloons. |
| 6. Transmembrane Pressure and Volume Measurement Test | Transmembrane pressure at a given inflated volume is substantially equivalent to predicate devices. | Since the balloons on SUB-9 are the same as predicate Models 940 and 930 and 30/40 cc NICATH™, they will have the same transmembrane pressure at the same inflated volume. The volume of the 30 and 40 cc SUB-9 were found substantially equivalent to the predicate Models 940 and 930, demonstrating equal transmembrane pressures. |
| 7. Trackability Test | Ability to track over guidewire into position in aorta without incident. | All SUB-9 test samples (30 cc and 40 cc; Stainless Steel and Nitinol) were able to track their guidewire into position in the aorta without incident. No catheter kinks, guidewire kinks, or problems inserting/removing were encountered. |
| 8. Kink Resistance Test | Mean kink radius substantially equivalent to predicate devices. | The mean kink radius of the SUB-9 Stainless Steel and Nitinol were demonstrated to be substantially equivalent to the predicate NICATH™, Sensation™, and Models 940 and 930. |
| 9. Initial Performance, Insertion/Removal Integrity Test | Proper opening per Directions for Use, and integrity maintained post-insertion/removal. | All 30 cc and 40 cc SUB-9 Nitinol and Stainless Steel test samples opened as they should per the Directions for Use. The integrity of the SUB-9 design post insertion and removal was demonstrated. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document repeatedly refers to "the SUB-9 designs (30 and 40 cc and Stainless Steel and Nitinol)" or "SUB-9 test samples (30 cc and 40 cc; Stainless Steel and Nitinol)". However, specific numerical sample sizes (e.g., "n=X devices were tested for each configuration") are not provided.
- Data Provenance: All tests described are "Nonclinical Tests" performed by Boston Scientific Corporation/Cardiac Assist. The origin of the data is internal laboratory testing and physical characterization. The document states, "No clinical testing was performed by Boston Scientific Corporation/Cardiac Assist in support of this premarket notification." Therefore, the data is retrospective non-clinical bench testing data, not from human subjects, and there is no country of origin for human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. The "ground truth" in this context refers to the physical and functional characteristics of the devices (e.g., force required for insertion, pumping rate, burst pressure). These are objective measurements determined by laboratory equipment and procedures, not by expert interpretation. Therefore, experts were not used to establish a ground truth in the sense of clinical interpretations.
4. Adjudication Method for the Test Set
- Not applicable. As the ground truth is based on objective physical measurements, there is no need for expert adjudication. The tests likely follow validated laboratory protocols.
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 done. This device is an Intra-Aortic Balloon Catheter, which is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance in interpretation. The document explicitly states: "No clinical testing was performed by Boston Scientific Corporation/Cardiac Assist in support of this premarket notification."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical tests is established by objective physical measurements and engineering specifications. For example, burst pressure is measured until the balloon bursts, pumping rate until full inflation/deflation cannot be achieved, and insertion force is quantified using mechanical testing equipment. Comparison is made against the performance of legally marketed predicate devices, which serve as the reference standard for "substantially equivalent" performance.
8. The Sample Size for the Training Set
- Not applicable. Since this is a hardware device and not an AI or machine learning model, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.
§ 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.