(90 days)
Not Found
No
The summary describes a mechanical intra-aortic balloon pump and does not mention any AI or ML components in its operation or design.
Yes
The device is indicated for use in patients with various medical conditions (e.g., refractory power failure, cardiogenic shock, myocardial infarction) and is intended to provide temporary circulatory support, lower cardiac workload, and improve systemic and coronary arterial perfusion. These actions directly address a disease or condition, which is the definition of a therapeutic device.
No
This device is designed to provide temporary circulatory support by mechanically displacing blood in the aorta, reducing cardiac workload, and improving perfusion. Its function is therapeutic, not diagnostic.
No
The device description clearly outlines physical components like a balloon, shaft, lumen, guidewire, and introducer, indicating it is a hardware device, not software-only.
Based on the provided text, 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 by mechanically displacing blood in the aorta. This is a direct intervention on the patient's circulatory system, not a test performed on a sample taken from the body.
- Device Description: The device is described as an intra-aortic balloon catheter, designed for insertion into the descending thoracic aorta. This is a physical device used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
The device is a therapeutic device used to assist the heart's function in patients with various cardiac conditions.
N/A
Intended Use / Indications for Use
The BSC/CA INBC's are indicated for use in patients with the following conditions:
- 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 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 Grande. " 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:
- Systolic unloading, as noted by a reduction in the patient's systolic pressure, which provides reduced myocardial oxygen consumption (MVO,).
- 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 and 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 (comma separated list FDA assigned to the subject device)
74 DSP
Device Description
The proposed 40 cc Grande™ 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 polvurethane 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 guidewire. The balloon is supplied prewrapped for insertion and supplied with a 0.025 inch extra stiff quidewire and 10 F introducer.
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)
1. Initial Performance Testing: test samples were tested on the BSC/CA 3001 IABP. All the proposed 40 cc Grande™ IAB's opened (unwrapped) per the Directions for Use and QA final acceptance criteria. Demonstration that the proposed 40 cc Grande™ can be inserted and removed from it's introducer twice, inserted into another introducer and passed the unwrapping test demonstrates the integrity of the device post insertion and removal.
2. Sheathed Insertion Test: The force required to insert the 40 cc Grande™ through it's introducer, over it's guidewire at 34.8 oz was demonstrated to be substantially equivalent to the force required to insert the predicate Model 940 at 30.1 OZ.
3. Sheathless Insertion Test: The tightest restriction that the 40 cc Grande™ can pass through 100% of the time is 0.100 inch which is substantially equivalent to the predicate 40 cc Grande NT™ at 0.100 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. This restriction is well below the 0.118 inch dilator size provided for use with the sheathless introduction technique.
4. 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 Grande™ on the BSC/CA 3001 IABP. The maximum pumping rate limit was 175 bpm which is substantially equivalent to the predicate 40 cc Grande NTM at 170 bpm and greater than the Model 940 at 140 bpm. The proposed 40 cc Grande™ combined inflation/deflation time of 245 msec compares favorably with the combined inflation/deflation times of the predicate Model 940 at 275 msec and 40 cc Grande NTTM at 264 msec.
5. Reliability and Integrity Test: The reliability of the 40 cc Grande™ was compared to that of the predicate 40 cc Grande NTTM and Model 940 by pumping test samples for a minimum of 3.6 million cycles. The 40 cc Grande™ test samples were all able to cycle as reliably as the predicate devices. Dimensional inspection, visual inspection for signs of surface wear, and leak testing were performed following reliability testing. No changes in dimensions, signs of surface wear or leaks were noted. Following reliability testing, dimensional and visual inspections and leak testing, the 40 cc Grande™ test samples were subjected to a maximum pumping rate limit test on the BSC/CA 3001. The maximum pumping rate limit post-reliability was 176 bpm which compares well with the prereliability value of 175 bpm. Inflate and deflate times were also found comparable post-reliability versus pre-reliability testing.
6. Trackability Test: 40 cc Grande™ 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 Grande™ as well as the predicate devices were able to track their guidewire into place without. There were no catheter kinks, no guidewire kinks, nor any incident problems encountered inserting or removing the catheters through their introducer.
7. Transmembrane Pressure and Volume Measurement Test: The volume of the 40 cc Grande™ at a transmembrane pressure of 50 mmHq was found to be 41.6 cc which meets the acceptance criteria of 40 cc +/- 5% and is substantially equivalent to the predicate 40 cc Grande NT™ at 41.7 cc. At a 40 cc displacement, the 40 cc Grande™ transmembrane pressure on average will be 21.5 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
897424
1998
Image /page/0/Figure/1 description: The image shows a rectangular box with the text "510(k) SUMMARY" inside. The text is in bold and capital letters. Below the box, there is the text "FEB | O", which appears to be a date.
Pursuant to Section 513(i)(3)(A) of the Federal Food, Drug and Cosmetic Act, 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
Contact Person: Leo Basta Director, Requlatory Affairs and Clinical Research
Preparation Date: 11 November 1997
B. DEVICE INFORMATION
Intra-Aortic Balloon Catheter Device Generic Name:
40 cc Grande™ Device Trade Name:
Percutaneous Intra-Aortic Balloon Catheter Classification Name:
PREDICATE DEVICE INFORMATION ்.
The following devices are referenced in this premarket notification as predicate devices for the 40 cc Grande™, subject of this submission:
K971673: 40 cc SUMO for use on BSC/CA 3001, Datascope Systems 90 and 97. Kontron KAAT, St. Jude/Aries 700 and Bard H-8000.
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, Kontron KAAT, St. Jude/Aries 700 and Bard H-8000.
K952221: 30 cc and 40 cc Sensation™, Model 940 and Model 930 for use on Bard H-8000.
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 determination of the All of these devices are above referenced premarket notifications. currently legally marketed.
PROPOSED DEVICE INFORMATION D.
This premarket notification proposes the following changes to the current legally marketed 40 cc Grande NTTM:
- The proposed 40 cc Grande™ has a polyurethane central lumen. The polvurethane central lumen design is similar to that of the predicate Model 940 with a smaller ID and OD.
DEVICE DESCRIPTION പ്
The proposed 40 cc Grande™ consists of a polyurethane blend symmetrical balloon at the distal end of a polyurethane-covered nylon The balloon is coated with a thin layer of silicone fluid. shaft. A polvurethane 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 guidewire. The balloon is supplied prewrapped for insertion and supplied with a 0.025 inch extra stiff quidewire and 10 F introducer.
F. INDICATIONS FOR USE
The indications for use for the 40 cc Grande™ 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 regurgitation.
- · Papillary muscle rupture.
- · Angiography/Angioplasty patients.
- · Septal shock.
C. TECHNOLOGICAL CHARACTERISTICS
The 40 cc Grande™ is Identical to the predicate 40 cc Grande NTTM except for the central lumen which is made of polyurethane (same as predicate Model 940 with smaller ID and OD). Test data and information demonstrates that the use of the 40 cc Grande™ is substantially equivalent to 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
H. NONCLINICAL TESTS
1. Initial Performance Testing:
To demonstrate the unwrapping and integrity of the 40 cc Grande™ post insertion and removal, test samples were tested on the BSC/CA 3001 IABP. All the proposed 40 cc Grande™ IAB's opened (unwrapped) per the Directions for Use and QA final acceptance criteria. Demonstration that the proposed 40 cc Grande™ can be inserted and removed from it's introducer twice, inserted into another introducer and passed the unwrapping test demonstrates the integrity of the device post insertion and removal.
2. Sheathed Insertion Test:
The force required to insert the 40 cc Grande™ through it's introducer, over it's guidewire at 34.8 oz was demonstrated to be substantially equivalent to the force required to insert the predicate Model 940 at 30.1 OZ.
-
- Sheathless Insertion Test:
The tightest restriction that the 40 cc Grande™ can pass through 100% of the time is 0.100 inch which is substantially equivalent to the predicate 40 cc Grande NT™ at 0.100 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. This restriction is well below the 0.118 inch dilator size provided for use with the sheathless introduction technique.
- Sheathless Insertion Test:
-
- 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 Grande™ on the BSC/CA 3001 IABP. The maximum pumping rate limit was 175 bpm which is substantially equivalent to the predicate 40 cc Grande NTM at 170 bpm and greater than the Model 940 at 140 bpm.
- Maximum Pumping Rate Limit Test:
The proposed 40 cc Grande™ combined inflation/deflation time of 245 msec compares favorably with the combined inflation/deflation times of the predicate Model 940 at 275 msec and 40 cc Grande NTTM at 264 msec.
-
- Reliability and Integrity Test:
The reliability of the 40 cc Grande™ was compared to that of the predicate 40 cc Grande NTTM and Model 940 by pumping test samples for a minimum of 3.6 million cycles. The 40 cc Grande™ test samples were all able to cycle as reliably as the predicate devices.
- Reliability and Integrity Test:
Dimensional inspection, visual inspection for signs of surface wear, and leak testing were performed following reliability testing. No changes in dimensions, signs of surface wear or leaks were noted.
3
Following reliability testing, dimensional and visual inspections and leak testing, the 40 cc Grande™ test samples were subjected to a maximum pumping rate limit test on the BSC/CA 3001. The maximum pumping rate limit post-reliability was 176 bpm which compares well with the prereliability value of 175 bpm. Inflate and deflate times were also found comparable post-reliability versus pre-reliability testing.
6. Trackability Test:
40 cc Grande™ 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 Grande™ as well as the predicate devices were able to track their guidewire into place without There were no catheter kinks, no guidewire kinks, nor any incident. problems encountered inserting or removing the catheters through their introducer.
7. Transmembrane Pressure and Volume Measurement Test:
The volume of the 40 cc Grande™ at a transmembrane pressure of 50 mmHq was found to be 41.6 cc which meets the acceptance criteria of 40 cc +/- 5% and is substantially equivalent to the predicate 40 cc Grande NT™ at 41.7 cc.
At a 40 cc displacement, the 40 cc Grande™ transmembrane pressure on average will be 21.5 mmHg which meets the acceptance criteria of