(89 days)
Not Found
No
The summary describes a mechanical device (intra-aortic balloon catheter) and its intended use and physical characteristics. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The performance studies are non-clinical tests of the device's physical properties and function.
Yes
The device is described as an "intra-aortic balloon catheter" used for "temporary circulatory support" to lower cardiac workload by "systolic unloading" and "diastolic augmentation" in patients with various cardiac conditions. These actions directly treat physiological conditions.
No
The device is an intra-aortic balloon catheter primarily used for mechanical circulatory support, providing therapeutic benefits by lowering cardiac workload and improving perfusion, rather than diagnosing conditions.
No
The device description explicitly details physical components like a polyurethane blend balloon, nylon shaft, Nitinol/Stainless Steel central lumen, and guidewire, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as providing temporary circulatory support through mechanical displacement of blood in the aorta. This is a therapeutic intervention performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is an intra-aortic balloon catheter, designed to be inserted into the aorta. This is a medical device used for treatment, not for analyzing samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
The device is clearly a therapeutic medical device used to assist the heart's function.
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.
- 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.
Product codes (comma separated list FDA assigned to the subject device)
74 DSP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
aorta, common femoral artery
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:
- Sheathed Insertion Test: The force required to insert the SUB-9 designs (30 and 40 cc and Stainless Steel and Nitinol) was demonstrated to be substantially equivalent to the force required to insert the predicate NICATH™ and Sensation™ designs.
- Sheathless Insertion Test: 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.
- 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 30 cc and 40 cc SUB-9. 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. Since the SUB-9 performed faster on the BSC/CA 3001 it will perform faster on any IABP it is labeled for use on.
- Reliability/Integrity Test: 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. The maximum pumping rate limit post-reliability was found identical to the prereliability rate for the 40 cc SUB-9. Inflation and deflation times postreliability were also found comparable to pre-reliability times.
- Aneurization and Burst Pressure Test: The aneurization and burst pressure tests 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 the IABP's labeled for use on since the IABP's are unable to provide the volume required to aneurize the balloons then continue on to burst the balloons. The peak output pressures of all the IABP's indicated for use on is below the pressures required to aneurize and burst the balloons.
- Transmembrane Pressure and Volume Measurement Test: Since the balloons used on the SUB-9 are the same as the predicate Models 940 and 930 and 30 and 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.
- Trackability Test: The SUB-9 test samples (30 cc and 40 cc; Stainless Steel and Nitinol) were inserted over their guidewire, into position, and withdrawn to demonstrate that the catheters can perform with their insertion accessories. All the SUB-9, as well as predicate devices, were able to track their guidewire into position in the aorta without incident. There were no catheter kinks, no guidewire kinks, nor any problems encountered inserting or removing the catheters through their introducer.
- Kink Resistance Test: 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.
- Initial Performance, Insertion/Removal Integrity Test: All of the 30 cc and 40 cc SUB-9 Nitinol and Stainless Steel test samples opened as they should per the Directions for Use. The intearity of the SUB-9 design post insertion and removal was demonstrated.
No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K963187, K954431, K952221, K943919, K940298, K936232
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
K912113
510(k) SUMMARY
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 |
| ------------------- | --------------------------------------------------------------------------------------- |
|---|
Contact Person: Leo Basta Director, Regulatory Affairs and Clinical Research
Date of Preparation: 30 May 1997
B. DEVICE INFORMATION
Device Generic Name: Intra-Aortic Balloon Catheter
| Device Trade Name: | 30 cc SUB-9 Nitinol |
|---|---|
| 40 cc SUB-9 Nitinol | |
| 30 cc SUB-9 Stainless Steel | |
| 40 cc SUB-9 Stainless Steel |
Percutaneous Intra-Aortic Balloon Catheter Classification Name:
C. PREDICATE DEVICE INFORMATION:
The following devices are referenced in this premarket notification as predicate devices for the 30 cc and 40 cc SUB-9 Nitinol and Stainless Steel, 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.
1
K940298: Model 940 for use on BSC/CA 3001, Datascope Systems 90 and 97, Kontron KAAT and St. Jude/Aries 700.
K936232: Model 930 and 30 cc Sensation™ for use on BSC/CA 3001. Datascope Systems 90 and 97, Kontron KAAT and St. Jude/Aries 700.
FDA has concurred with the substantial equivalence of the above referenced premarket notifications. All of these devices are currently legally marketed.
PROPOSED DEVICE INFORMATION D.
This premarket notification proposes the following changes to the current legally marketed NICATH™, Sensation™ and Models 940 and 930:
- The catheter shaft outer diameter is 8.75 F for the proposed SUB-9 (30 cc and 40 cc volumes and Stainless Steel and Nitinol central lumens) as compared to 9 F for the predicate 30 cc and 40 cc NICATH™ and Models 940 and 930, and 9.5 F for the Sensation™,
The central lumen material of the proposed 30 cc and 40 cc SUB-9 2. Nitinol is the same as the predicate NICATH™, except that the central lumen is slightly smaller allowing a smaller folded balloon diameter.
The central lumen material of the proposed 30 cc and 40 cc SUB-9 အဲ Stainless Steel is the same as the predicate Sensation™, except that the central lumen is slightly smaller allowing a smaller folded balloon diameter.
- The smaller catheter shaft of the SUB-9 design (8.75 F vs. 9 F) allows the balloons to be folded to a smaller folded balloon diameter (0.121 inch vs. 0.129 inch) as compared to the predicate devices. This smaller folded balloon diameter allows the use of a 9 F introducer with the SUB-9 design as compared to a 10 F introducer for the predicate devices.
DEVICE DESCRIPTION ui
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.
ட் INDICATIONS FOR USE
The indications for use for the proposed SUB-9 IAB's is identical to that of the currently marketed predicate devices. The indications are as follows:
- · Refractory power failure.
- · Cardiogenic shock.
2
- · 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.
G. TECHNOLOGICAL CHARACTERISTICS
The 30 cc and 40 cc SUB-9 Stainless Steel and Nitinol design is identical to the predicate NICATHTM, uses the same balloons as the predicate NICATH™ and Models 940 and 930 and uses the same central lumen materials as the predicate NICATH™ and Sensation™. The slightly smaller catheter shaft of the SUB-9 design does not effect it's ability to perform equivalently to the predicate devices. Test data and information demonstrates that the use of the 30 cc and 40 cc SUB-9 Stainless Steel and Nitinol 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.
ાનં. NONCLINICAL TESTS
- Sheathed Insertion Test:
The force required to insert the SUB-9 designs (30 and 40 cc and Stainless Steel and Nitinol) was demonstrated to be substantially equivalent to the force required to insert the predicate NICATH™ and Sensation™ designs.
-
- Sheathless Insertion Test:
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.
- Sheathless Insertion Test:
3. 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 30 cc and 40 cc SUB-9. 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. Since the SUB-9 performed faster on the BSC/CA 3001 it will perform faster on any IABP it is labeled for use on.
3
-
- Reliability/Integrity Test:
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. The maximum pumping rate limit post-reliability was found identical to the prereliability rate for the 40 cc SUB-9. Inflation and deflation times postreliability were also found comparable to pre-reliability times.
- Reliability/Integrity Test:
-
- Aneurization and Burst Pressure Test:
The aneurization and burst pressure tests 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 the IABP's labeled for use on since the IABP's are unable to provide the volume required to aneurize the balloons then continue on to burst the balloons. The peak output pressures of all the IABP's indicated for use on is below the pressures required to aneurize and burst the balloons.
- Aneurization and Burst Pressure Test:
-
- Transmembrane Pressure and Volume Measurement Test:
Since the balloons used on the SUB-9 are the same as the predicate Models 940 and 930 and 30 and 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.
- Transmembrane Pressure and Volume Measurement Test:
-
- Trackability Test:
The SUB-9 test samples (30 cc and 40 cc; Stainless Steel and Nitinol) were inserted over their guidewire, into position, and withdrawn to demonstrate that the catheters can perform with their insertion accessories. All the SUB-9, as well as predicate devices, were able to track their guidewire into position in the aorta without incident. There were no catheter kinks, no guidewire kinks, nor any problems encountered inserting or removing the catheters through their introducer.
- Trackability Test:
-
- Kink Resistance Test:
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.
- Kink Resistance Test:
-
- Initial Performance, Insertion/Removal Integrity Test:
All of the 30 cc and 40 cc SUB-9 Nitinol and Stainless Steel test samples opened as they should per the Directions for Use. The intearity of the SUB-9 design post insertion and removal was demonstrated.
- Initial Performance, Insertion/Removal Integrity Test:
Additional nonclinical tests performed for previous premarket notifications and submitted as reference information within this submission include abrasion testing and biocompatibility testing.
4
CLINICAL TESTS 1.
testing was performed by Boston Scientific No clinical Corporation/Cardiac Assist in support of this premarket notification.
STERILIZATION AND PACKAGING J.
There are no changes to the packaging and sterilization of the SUB-9 IAB's as compared to the predicate devices. The catheters are placed in a plastic tray and sealed into a Tyvek/Mylar pouches and sterilized using 100% Ethylene Oxide gas. Ethylene oxide gas residuals and bacterial endotoxin levels are monitored for compliance with maximum release limits.
POTENTIAL COMPLICATIONS K.
Potential complications associated with the use of intra-aortic balloon catheters, in general, appear in the device Directions for Use and are reproduced below:
- · Leg ischemia.
- Femoral, aortic or illiac dissection.
- · Arterial injury.
- · Renal artery occlusion.
- · Arterial rupture.
- · Arterial perforation.
- · Hypotension.
- · Distal embolization.
- Death.
- · Vascular thrombosis.
- · Short-term hemodynamic deterioration.
- · Hemorrhage.
- · Arteriovenous fistula formation.
ட் CONCLUSIONS
Based on the functional and performance data and information submitted in this premarket notification, Boston Scientific Corporation/Cardiac Assist believes that the 30 cc and 40 cc SUB-9 Nitinol and Stainless Steel are substantially equivalent to the predicate devices, NICATHTM, Sensation™ and Models 940 and 930 for use on the BSC/CA 3001, Datascope Systems 90 and 97. St. Jude/Aries 700, Kontron KAAT and Bard H-8000.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Leo Basta Director, Regulatory Affairs and Clinical Research Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts__01760-1537.____________________________________________________________________________________________________________________________________________
Re: K972113 Cardiac Assist Sub-9 Intra-Aortic Balloon Catheters Requlatory Class: III (Three) Product Code: 74 DSP Dated: June 3, 1997 Received: June 5, 1997
Dear Mr. Basta:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requiation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
SEP - 2 1997
6
Page 2 - Mr. Leo Basta
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
FROM : CSA
Page 1 of
K972113 510(k) Number lif known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
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.
-
- Histodynamically significant mechanical complications secondary to acute MI:
-
- Ventricular septal defect.
-
- Mitral valve regurgitation.
-
- Papillary muscle rupture.
-
- Histodynamically significant mechanical complications secondary to acute MI:
-
- 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,).
IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
Concurrance of CDRH, Office of Device Evaluation (ODE)
Thum Mye kn. BLL
(Division Sign Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K97211
Prescription Use (Per 21 CFR 801.109)
OR over-
Over-The-Counter Usa__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
8
K972113 510(k) Number:
Page 2 of 2
30 cc and 40 cc SUB-9 Device Name:
Indications for Use (continued):
-
- 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.
- Diastolic augmentation which provides an increase in the mean ann aortic pressure and leads to an improvement in systemic and coronary arterial perfusion.