SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)

K965236 · Datascope Corp. · DSP · Jul 1, 1997 · Cardiovascular

Device Facts

• Record ID: K965236
• Device Name: SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)
• Applicant: Datascope Corp.
• Product Code: DSP · Cardiovascular
• Decision Date: Jul 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

System 96 Intra-Aortic Balloon Pump (IABP) provides temporary mechanical circulatory support. Device utilizes intra-aortic balloon catheter inserted into descending aorta; inflates/deflates balloon in synchronization with cardiac cycle to augment diastolic pressure and reduce left ventricular afterload. Operated by clinicians in clinical settings (OR, ICU). Input signals include ECG or arterial pressure waveforms to trigger balloon timing. Output consists of controlled pneumatic inflation/deflation of balloon. Enhances coronary perfusion and cardiac output; assists patients in cardiogenic shock or undergoing cardiac surgery. Physician monitors hemodynamic parameters to adjust therapy settings.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to existing legally marketed devices.

Technological Characteristics

Pneumatic control system for intra-aortic balloon catheter. Operates via synchronization with patient ECG or arterial pressure signals. Class III device. Intended for prescription use only.

Indications for Use

Indicated for patients requiring circulatory support due to refractory ischemia, myocardial infarction, refractory ventricular failure, cardiogenic shock, unstable refractory angina, or septic shock. Also indicated for preoperative hemodynamic stability, weaning from cardiopulmonary bypass, angioplasty support, and intraoperative pulsatile flow generation.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Susan E. Mandy
Manager
Regulatory and Clinical Affairs
Datascope Corporation
580 Winters Avenue
Paramus, New Jersey 07652

JUL 7 1997

Re: K96X5236
Datascope System 96 Intra-Aortic Balloon Pump (IABP)
Regulatory 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 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 Regulations, 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 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 regulations.

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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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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870.3535 Intra-aortic Balloon and Control System DSP III

510(k) Number (if known): K 965236

Device Name: Datascope System 96 Intra Aortic Balloon P

Indications For Use:

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K 965236

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)