(90 days)
Not Found
No
The summary describes a mechanical intra-aortic balloon pump and its physical characteristics and performance tests, with no mention of AI or ML.
Yes
The device is intended to provide temporary circulatory support and lower cardiac workload for patients with various cardiac conditions, which aligns with the definition of a therapeutic device.
No
The device is an intra-aortic balloon pump (IABC) designed for providing temporary circulatory support and lowering cardiac workload, not for diagnosing medical conditions.
No
The device description clearly details physical components like a balloon, shaft, and lumen, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that provides temporary circulatory support within the patient's body by mechanically displacing blood in the aorta. This is an in vivo (within a living organism) function, not an in vitro (outside the body, typically on biological samples) diagnostic test.
- Device Description: The description details a physical device (balloon catheter) designed for insertion into the circulatory system.
- Lack of Diagnostic Function: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical support.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The BSC/CA IABC's are indicated for use in patients with the following conditions:
- Refractory power failure.
- Cardiogenic shock.
- Unstable refractory angina.
- Hemodynamically 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 40 cc SUMO remains identical to that of the currently marketed IABC's. All of the devices are intended to provide temporary circulatory support of the left ventricle through 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 means :
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- Systolic unloading, as noted by a reduction in the patient's systolic pressure, which provides reduced myocardial oxygen consumption (MVO,).
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- Diastolic augmentation which provides an increase in the mean 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 onset of left ventricular ejection or systole, then rapidly deflates, reducing the aortic pressure, which in turn reduces the afterload.
Product codes
74 DSP
Device Description
The proposed 40 cc SUMO consists of a polyurethane blend symmetrical balloon at the distal end of a polyurethane-covered nylon shaft. The balloon is coated with a thin layer of silicone fluid. A Nitinol central lumen runs throughout the length of the catheter and terminates at the distal tip. This central lumen may be used to pass the device over a quidewire. The balloon is supplied prewrapped for insertion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Descending thoracic aorta
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests were performed:
- Sheathed Insertion Test: The force required to insert the 40 cc SUMO through its introducer, over its guidewire at 41.7 oz, was demonstrated to be substantially equivalent to the force required to insert the predicate 40 cc NICATH at 40.7 oz.
- Sheathless Insertion Test: The tightest restriction the 40 cc SUMO can pass through 100% of the time is 0.100 inch, which is substantially equivalent to the BSC/CA predicate devices at 0.095 inch, the 40 cc Datascope 9.5 F Percor-Stat at 0.100 inch, and the 40 cc 9 F Kontron/Arrow IAB at > 0.105 inch. All BSC/CA are well below the 0.118 inch dilator size provided for use with the sheathless introduction technique.
- Maximum Pumping Rate Limit Test: The maximum pumping rate limit, defined as the maximum pumping rate at which the balloon is able to inflate and deflate fully (greater than or equal to 90% of its nominal volume), was measured for the 40 cc SUMO on the BSC/CA 3001 IABP. The maximum pumping rate limit was 170 bpm which is substantially equivalent to the predicate 40 cc NICATH at 164 bpm and Model 940 at 140 bpm.
- Reliability/Integrity Test: The reliability of the 40 cc SUMO was compared to that of the predicate 40 cc NICATH by pumping test samples for a minimum of 3.6 million cycles. The 40 cc SUMO test samples were all able to cycle as reliably as the predicate 40 cc NICATH. Following reliability testing, the 40 cc SUMO test samples were subjected to a maximum pumping rate limit test on the BSC/CA 3001. The maximum pumping rate limit post-reliability was 166 bpm which compares well with the pre-reliability value of 170 bpm. Inflate and deflate times were also found comparable pre-reliability versus post-reliability testing. Dimensional inspection, visual inspection for signs of surface wear, and leak testing were performed. No changes in dimensions or signs of surface wear were noted. One test sample was damaged during removal from the maximum pumping rate limit test fixture and was found to leak during the leak testing; all other test samples passed the leak test.
- Trackability Test: 40 cc SUMO test samples were inserted over their guidewire, into position, and withdrawn as a set to demonstrate that the catheters can perform with their insertion accessories. All the 40 cc SUMO as well as the predicate devices were able to track their guidewire into place without incidence. There were no catheter kinks, no guidewire kinks, nor any problems encountered inserting or removing the catheters through their introducer.
- Aneurization and Burst Test: The aneurization and burst pressures of the 40 cc SUMO were found substantially equivalent to the predicate devices. The 40 cc SUMO mean aneurization pressure of 8.0 psi which compares well with the mean aneurization pressure of 8.3 psi for the predicate 40 cc Sensation. Results indicate that the 40 cc SUMO burst pressure of 6.3 psi compares favorably with the predicate 40 cc NICATH with a mean burst pressure of 6.1 psi.
- Transmembrane Pressure and Volume Measurement: The volume of the 40 cc SUMO at a transmembrane pressure of 50 mmHg was found to be 41.7 cc which meets the acceptance criteria of 40 cc +/-5%, as did the predicate devices. At a 40 cc displacement, the 40 cc SUMO transmembrane pressure on average will be 27 mmHg which meets the acceptance criteria of
§ 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.
0
510(k) SUMMA
Pursuant to Section 513(i)(3)(A) of the Federal Food, Drug and Cosmetic Act, Boston Scientific Corporation/Cardiac Assist (BSC/CA) is required to submit within this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." BSC/CA chooses to submit a summary of information regarding safety and effectiveness.
GENERAL INFORMATION A.
Submitter's Name: Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
Leo Basta Contact Person: Director, Regulatory Affairs and Clinical Research
Date of Preparation: 05 May 1997
B. DEVICE INFORMATION
Device Generic Name: Intra-Aortic Balloon Catheter
Device Trade Name: 40 cc SUMO
Classification Name: Percutaneous Intra-Aortic Balloon Catheter
். PREDICATE DEVICE INFORMATION
The following devices are referenced in this premarket notification as predicate devices for the 40 cc SUMO, subject of this submission:
K963187: Modified Labeling of BSC/CA IAB's.
K954431: Modified Model 940 and Model 930 for use on BSC/CA 3001. Datascope Systems 90 and 97, St. Jude/Aries 700, Kontron KAAT and Bard H-8000.
K952221: 30 and 40 cc Sensation™, Model 940 and Model 930 for use on Bard H-8000.
K943919: 40 cc Sensation™ for use on Datascope System 97 and St. Jude/Aries 700.
K940298: Model 940 for use on BSC/CA 3001. Datascope Systems 90 and 97, Kontron KAAT and St. Jude/Aries 700.
1
FDA has concurred with the substantial equivalence of the above referenced premarket notifications. All of these devices are currently legally marketed.
D. PROPOSED DEVICE INFORMATION
This premarket notification proposes the following changes to the current legally marketed 40 cc NICATH™:
- The balloon bladder inflation diameter change from 15 mm to 17 mm and length change from 27.5 cm to 22.0 cm. The diameter and length of the proposed balloon is the same as the predicate 40 cc Sensation™
E. DEVICE DESCRIPTION
The proposed 40 cc SUMO consists of a polyurethane blend symmetrical balloon at the distal end of a polyurethane-covered nylon shaft. The balloon is coated with a thin layer of silicone fluid. A Nitinol central lumen runs throughout the length of the catheter and terminates at the distal tip. This central lumen may be used to pass the device over a quidewire. The balloon is supplied prewrapped for insertion.
ட் INDICATIONS FOR USE
The indications for use for the 40 cc SUMO is identical to that of the currently marketed predicate devices. The indications are as follows:
- · Refractory power failure.
- · Cardiogenic shock.
- · Unstable refractory angina.
- · Impending or extending myocardial infarction (MI).
- Hemodynamically significant mechanical complications secondary to acute MI:
- · Ventricular septal defect.
- · Mitral valve requraitation.
- · Papillary muscle rupture.
- · Angiography/Angioplasty patients.
- · Septal shock.
G. TECHNOLOGICAL CHARACTERISTICS
The 40 cc SUMO is identical to the predicate 40 cc NICATH™ except for the inflated balloon diameter and balloon length (which are the same as the predicate 40 cc Sensation™). Test data and information demonstrates that the use of the 40 cc SUMO is substantially equivalent is the performance of the predicate devices on the BSC/CA 3001, Datascope Systems 90 and 97, St. Jude/Aries 700, Kontron KAAT and Bard H-8000 IABP's.
2
NONCLINICAL TESTS H.
1. Sheathed Insertion Test:
The force required to insert the 40 cc SUMO through it's introducer, over it's quidewire at 41.7 oz, was demonstrated to be substantially equivalent to the force required to insert the predicate 40 cc NICATH™ at 40.7 oz.
2. Sheathless Insertion Test:
The tightest restriction that the 40 cc SUMO can pass through 100% of the time is 0.100 inch which is substantially equivalent to the BSC/CA predicate devices at 0.095 inch, the 40 cc Datascope 9.5 F Percor-Stat at 0.100 inch, and the 40 cc 9 F Kontron/Arrow IAB at > 0.105 inch. All BSC/CA are well below the 0.118 inch dilator size provided for use with the sheathless introduction technique.
- Maximum Pumping Rate Limit Test:
The maximum pumping rate limit, defined as the maximum pumping rate at which the balloon is able to inflate and deflate fully (greater than or equal to 90% of it's nominal volume), was measured for the 40 cc SUMO on the BSC/CA 3001 IABP. The maximum pumping rate limit was 170 bpm which is substantially equivalent to the predicate 40 cc NICATH™ at 164 bpm and Model 940 at 140 bpm.
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- Reliability/Integrity Test:
Allen
- Reliability/Integrity Test:
The reliability of the 40 cc SUMO was compared to that of the predicate 40 cc NICATH™ by pumping test samples for a minimum of 3.6 million cycles. The 40 cc SUMO test samples were all able to cycle as reliably as the predicate 40 cc NICATH™
Following reliability testing, the 40 cc SUMO test samples were subjected to a maximum pumping rate limit test on the BSC/CA 3001. The maximum pumping rate limit post-reliability was 166 bpm which compares well with the pre-reliability value of 170 bpm. Inflate and deflate times were also found comparable pre-reliability versus post-reliability testing.
Dimensional inspection, visual inspection for signs of surface wear, and leak testing were performed. No changes in dimensions or signs of surface wear were noted. One test sample was damaged during removal from the maximum pumping rate limit test fixture and was found to leak during the leak testing; all other test samples passed the leak test.
-
- Trackability Test:
40 cc SUMO test samples were inserted over their quidewire, into position, and withdrawn as a set to demonstrate that the catheters can perform with their insertion accessories. All the 40 cc SUMO as well as the predicate devices were able to track their guidewire into place without incidence. There were no catheter kinks, no guidewire kinks, nor any problems encountered inserting or removing the catheters through their introducer.
- Trackability Test:
3
- Aneurization and Burst Test:
The aneurization and burst pressures of the 40 cc SUMO were found substantially equivalent to the predicate devices. The 40 cc SUMO mean aneurization pressure of 8.0 psi which compares well with the mean aneurization pressure of 8.3 psi for the predicate 40 cc Sensation™. Results indicate that the 40 cc SUMO burst pressure of 6.3 psi compares favorably with the predicate 40 cc NICATH™ with a mean burst pressure of 6.1 psi.
- Transmembrane Pressure and Volume Measurement:
The volume of the 40 cc SUMO at a transmembrane pressure of 50 mmHq was found to be 41.7 cc which meets the acceptance criteria of 40 cc +/-5%, as did the predicate devices.
At a 40 cc displacement, the 40 cc SUMO transmembrane pressure on average will be 27 mmHg which meets the acceptance criteria of