(182 days)
The following are the indications for use for the System 96 Intra Aortic Balloon Pump:
- Refractory Ischemia
- Myocardial Infarction
- Preoperative Hemodynamic Stability
- Weaning from Cardio Pulmonary Bypass
- Refractory Ventricular Failure
- Cardiogenic Shock
- Unstable Refractory Angina
- Septic Shock
- Angioplasty Support
- Intraoperative Pulsatile Flow Generation
Any other uses are not recognized by Datascope Corporation as bonafide.
Datascope System 96 Intra-Aortic Balloon Pump (IABP)
This document is an FDA 510(k) clearance letter for the Datascope System 96 Intra-Aortic Balloon Pump (IABP). It states that the device is substantially equivalent to a predicate device and can be marketed.
However, the provided text DOES NOT contain the specific information required to answer your questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.
The document is a regulatory approval, not a scientific study report. It indicates that the device has met the FDA's requirements for substantial equivalence, but it does not detail the specific performance metrics or the studies used to demonstrate those metrics.
Therefore, I cannot populate the table or answer the specific questions based solely on the provided text. To get this information, you would need to access the actual 510(k) submission from Datascope Corporation (K965236) to the FDA, which would contain the technical data and performance studies.
{0}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Susan E. Mandy Manager Regulatory and Clinical Affairs Datascope Corporation JUL == 1 1097 580 Winters Avenue Paramus, New Jersey 07652 ----------
кае 5236 Re: Datascope System 96 Intra-Aortic Balloon Pump (IABP) Requlatory Class: III (Three) Product Code: DSP Dated: April 18, 1997 Received: April 21, 1997
Dear Ms. Mandy:
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 qeneral controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 requlation 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 regulations.
{1}------------------------------------------------
Page 2 - Ms. Susan E. Mandy
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 yourdesire specific advice for your device on our-labeling hand 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
{2}------------------------------------------------
Hic Balloon and 870, 3535 1112222 DSP TI K 4652363 510(k) Number (if known): Device Name: Datascope System 96 Intra Ac
Indications For Use:
The following are the indications for use for the System 96 Intra Aortic Balloon Pump:
- 0 Refractory Ischemia
- Myocardial Infarction 0
- Preoperative Hemodynamic Stability 0
- Weaning from Cardio Pulmonary Bypass 0
- Refractory Ventricular Failure 0
- Cardiogenic Shock 0
- 0 Unstable Refractory Angina
- Septic Shock 0
- Angioplasty Support 0
- Intraoperative Pulsatile Flow Generation 0
Any other uses are not recognized by Datascope Corporation as bonafide.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bera Campbele
ivision Sign-Off sion Sign Our, Respiratory, d Neurological Devices
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96
§ 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.