CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX

K031636 · Datascope Corp. · DSP · Aug 11, 2003 · Cardiovascular

Device Facts

• Record ID: K031636
• Device Name: CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
• Applicant: Datascope Corp.
• Product Code: DSP · Cardiovascular
• Decision Date: Aug 11, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The balloon pump is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle. The target populations are adult and pediatric. The balloon pump is intended for use in the health care facility setting.

Device Story

CS100 Intra-Aortic Balloon Pump (IABP) is a cardiac assist device providing temporary left ventricular support via counterpulsation. Device inputs include ECG or arterial pressure waveforms; system processes these signals to trigger inflation/deflation of an intra-aortic balloon placed in the descending aorta. Operation modes include auto, semi-auto, and manual. Used in OR, cath lab, critical care, and transport by medical staff. Auto mode minimizes operator intervention; semi-auto/manual modes provide flexibility for complex cases. Output is mechanical balloon inflation/deflation synchronized with cardiac cycle, increasing coronary perfusion and reducing left ventricular work. Benefits include hemodynamic support for patients with cardiac compromise.

Clinical Evidence

Bench testing only. Validation included requirements specification review, hardware and software testing, code design/reviews, environmental testing, safety testing, performance testing, and hardware/software validation of the auto operation mode.

Technological Characteristics

Electromechanical system; intra-aortic balloon control; ECG/arterial pressure waveform sensing; three operation modes (auto, semi-auto, manual); improved ergonomic design and user interface compared to predicate; software-controlled synchronization.

Indications for Use

Indicated for adult and pediatric patients requiring temporary left ventricular support via counterpulsation in healthcare facility settings.

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.

Predicate Devices

• System 96 Intra-Aortic Balloon Pump (K965236)
• Arrow AutoCAT Intra-Aortic Balloon Pump (K983866)

Submission Summary (Full Text)

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K031636

## AUG 1 1 2003 510(k) Summary of Safety and Effectiveness

| Date: | May 21, 2003 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Patient Monitoring Division<br>Datascope Corp. |
| Contact Person: | Susan E. Mandy<br>Director, Clinical & Regulatory Affairs<br>Patient Monitoring Division<br>Datascope Corp.<br>Telephone: [phone]<br>Fax:[phone] |
| | Device trade name: CS100 Intra-Aortic Balloon Pump |
| | Common/usual name: Intra-aortic balloon and control system |
| Classification name:<br>21 CFR 870.3535 | Intra-aortic balloon and control system |
| Predicate Devices: | K965236 System 96 Intra-Aortic Balloon Pump<br>K983866 Arrow AutoCAT Intra-Aortic Balloon Pump |
| Device Description: | The CS100 Intra-Aortic Balloon Pump ( IABP) is a cardiac assist device.<br>It supports the heart's left ventricle by increasing coronary perfusion and<br>reducing left ventricular work. The CS100 is equipped with the flexibility<br>to aid medical staff in supporting a broad range of patients. It is also<br>designed to work in conditions which are unique to the operating room,<br>catheterization laboratory, critical care unit and transport. The CS100<br>IABP has three operation modes; auto, semi auto and manual. The auto<br>operation mode provides simplicity and minimizes operator intervention.<br>The semi-auto and manual operation modes provide operators with<br>flexibility for difficult clinical cases. |
| Intended Use: | The balloon pump is an electromechanical system used to inflate and<br>deflate intra-aortic balloons. It provides temporary support to the left<br>ventricle via the principle of counterpulsation. The intra-aortic balloon is<br>placed in the descending aorta, just distal to the left subclavian artery.<br>Once the balloon is positioned, the pump is adjusted to trigger in<br>synchrony with the ECG or arterial pressure waveform to ensure that<br>inflation and deflation occur at the appropriate points during the cardiac<br>cycle. The target populations are adult and pediatric. The balloon pump is<br>intended for use in the health care facility setting. |
| Technology: | The CS100 Intra-Aortic Balloon Pump ( IABP) is substantially equivalent<br>to the Datascope Corp. System 96 IABP, with the exception of the auto<br>operational mode which is equivalent to the auto operation mode of the<br>Arrow International AutoCAT IABP, which is manufactured by Belmont<br>Instrument Corporation. The CS100 has the same principles of operation<br>as the S96 IABP and the Arrow International AutoCAT IABP. The CS100<br>IABP is differentiated from the S96 IABP by its automated operation<br>option. The CS100 IABP also features improved ergonomics and a more<br>intuitive user interface than the System 96 IABP. |
| Test Summary | The CS100 Intra-Aortic Balloon Pump complies with the voluntary<br>standards identified in section six of this submission. Datascope's<br>product development process required that the following activities be<br>completed during the development of the CS100 Intra-Aortic Balloon<br>Pump.<br>• Requirements specification review<br>• Hardware and software testing<br>• Code design and code reviews<br>• Environmental testing<br>• Safety testing<br>• Performance testing<br>• Hardware and Software validation<br>• Auto Operation Mode |
| Conclusion | The results of all measurements demonstrated that the CS 100 Intra-Aortic<br>Balloon Pump is as safe, as effective and performs as well as the predicate<br>devices. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping human profiles facing to the right.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 2003 SEP

Datascope Corp. Patient Monitoring Division c/o Ms. Susan E. Mandy Director, Clinical and Regulatory Affairs 800 MacArthur Blvd. Mahwan, N.J. 07430

Re: K031636

CS100 Intra-Aortic Balloon Pump Regulation Number: 21 CFR 870.3535 Regulation Name: Balloon, Intra-Aortic and Control System Regulatory Class: Class III (three) Product Code: DSP Dated: May 23, 2003 Received: May 27, 2003

Dear Ms. Mandy:

This letter corrects our substantially equivalent letter of August 11, 2003 regarding the incorrect address.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent [(for the indications for use stated in the enclosure)] to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Susan E. Mandy

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 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 Part 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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Roy D. Zutler, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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## INDICATION FOR USE

The balloon pump is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle.

The target populations are adult and pediatric. The balloon pump is intended for use in the health care facility setting.

N. De Gortu

n Sian-Off n of Cardiovascular ices 510(k) Numbe

Prescription Use Only

25