DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM

K063525 · Datascope Corp. · DSP · Jan 5, 2007 · Cardiovascular

Device Facts

• Record ID: K063525
• Device Name: DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM
• Applicant: Datascope Corp.
• Product Code: DSP · Cardiovascular
• Decision Date: Jan 5, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

CS300 Intra-Aortic Balloon Pump has the following 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. Datascope's Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter has the following indications for use: Refractory unstable angina; Impending infarction; Acute MI; Refractory ventricular failure; Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture); Cardiogenic shock; Support for diagnostic, percutaneous revascularization, and interventional procedures; Ischemia related intractable ventricular arrhythmias; Septic shock; Intraoperative pulsatile flow generation; Weaning from bypass; Cardiac support for non-cardiac surgery; Prophylactic support in preparation for cardiac surgery; Post surgical myocardial dysfunction/low cardiac output syndrome; Myocardial contusion; Mechanical bridge to other assist devices; Cardiac support following correction of anatomical defects.

Device Story

System comprises CS300 IABP control unit and fiber optic pressure sensor IAB catheter. Catheter placed in descending aorta; pump inflates/deflates balloon in synchrony with patient ECG or arterial pressure waveform. Principle of operation: counterpulsation to provide temporary left ventricular support. Used in healthcare facilities by clinicians. Output: hemodynamic support via balloon inflation/deflation. Benefits: improved cardiac output, reduced myocardial oxygen demand, hemodynamic stabilization. Modifications include revised packaging tray with cable retention.

Clinical Evidence

No clinical evaluation performed in the U.S. Substantial equivalence supported by in-vitro bench testing demonstrating comparable functionality and performance to currently marketed devices.

Technological Characteristics

System includes CS300 electromechanical pump and fiber optic pressure sensor IAB catheter. Features fiber optic sensing technology for pressure monitoring. Includes revised packaging with cable retention. Operates via ECG or arterial pressure waveform synchronization.

Indications for Use

Indicated for adult and pediatric patients requiring temporary left ventricular support via counterpulsation. Used for conditions including refractory unstable angina, acute MI, cardiogenic shock, ventricular failure, complications of MI, septic shock, and cardiac support during/after surgery or interventional procedures.

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

• Datascope's Linear 7.5Fr. IAB (K041281)
• Datascope's CS100 IAB Pump (K031636)
• Datascope's 8Fr. IAB (K031569)
• Datascope's Fidelity 8Fr. IAB (K013326)
• Arrow AutoCAT Intra-Aortic Balloon Pump (IABP) Series (K060309)
• Arrow International's Intra-Aortic Balloon Catheter (K040801)
• Arrow International's IAB Fiber Optic Sensor (FOS)/FOS Measurement System (K021462)
• Arrow International (C.R. Bard, Inc.) 8Fr 40 cc and 7Fr. 30 cc Sheathless Intra-Aortic Balloon (IAB) (K981660)

Submission Summary (Full Text)

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063525

# Attachment D

JAN -5 2007

### 510(k) SUMMARY FOR DATASCOPE'S IABP SYSTEM FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON (IAB) CATHETER and CS300 INTRA-AORTIC BALLOON PUMP (IABP) CONTROL SYSTEM

(Prepared in accordance with 21 CFR Part 807.92)

#### A. GENERAL INFORMATION

| Submitter: | Datascope Corp.<br>Cardiac Assist Division |
|-----------------|-----------------------------------------------------------------------|
| Address: | 15 Law Drive<br>Fairfield, NJ 07004 |
| Contact Person: | Nancy Cohen<br>Manager Regulatory Affairs and Product<br>Surveillance |
| Phone: | 973/244-6104 |
| Fax: | 973/244-6243 |
| Email: | [e-mail] |
| Date: | November 21, 2006 |

#### B. DEVICE INFORMATION

| Generic Name: | Intra-Aortic Balloon (IAB) Catheter and<br>Control System |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Datascope's IABP System [Fiber Optic<br>Pressure Sensor Intra-Aortic Balloon (IAB)<br>Catheter and CS300 Intra-Aortic Balloon<br>Pump (IABP) Control System] |
| Classification Name: | Intra-Aortic Balloon (IAB) Catheter and<br>Control System is classified under 21CFR<br>870.3535 |

#### C. PREDICATE DEVICE INFORMATION

Datascope's IABP System [Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] is substantially equivalent to the following marketed devices:

- K041281 Datascope's Linear 7.5Fr. IAB, Substantially . Equivalent 6/07/04
- Datascope's CS100 IAB Pump, Substantially K031636 -. Equivalent 8/11/03
- K031569 Datascope's 8Fr. IAB. Substantially Equivalent . 6/10/03

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- K013326 Datascope's Fidelity 8Fr. IAB, Substantially . Equivalent 11/02/01
- Arrow AutoCAT Intra-Aortic Balloon Pump . K060309 -(IABP) Series, Substantially Equivalent 4/06/06
- K040801 Arrow International's Intra-Aortic Balloon . Catheter, Substantially Equivalent 5/06/04
- . K021462 - Arrow International's IAB Fiber Optic Sensor (FOS)/FOS Measurement System, Substantially Equivalent 6/06/02
- Arrow International (C.R. Bard, Inc.) 8Fr 40 cc . K981660 and 7Fr. 30 cc Sheathless Intra-Aortic Balloon (IAB)

### D. DEVICE DESCRIPTION/INTENDED USE DEVICE DESCRIPTION

The Datascope IABP System [Fiber Optic Pressure Sensor IAB Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] is used for intra-aortic balloon counterpulsation therapy in the aorta.

### INTENDED USE

CS300 Intra-Aortic Balloon Pump has the following 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 intraaortic 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.

Datascope's Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter has the following indications for use:

- Refractory unstable angina .
- . Impending infarction
- . Acute MI
- Refractory ventricular failure .
- . Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture)
- . Cardiogenic shock

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- Support for diagnostic, percutaneous revascularization, and . interventional procedures
- Ischemia related intractable ventricular arrhythmias .
- Septic shock .
- Intraoperative pulsatile flow generation .
- . Weaning from bypass
- Cardiac support for non-cardiac surgery .
- Prophylactic support in preparation for cardiac surgery .
- . Post surgical myocardial dysfunction/low cardiac output syndrome
- . Myocardial contusion
- Mechanical bridge to other assist devices .
- Cardiac support following correction of anatomical defects .

#### E. TECHNOLOGICAL CHARACTERISTICS

The Datascope IABP System [Fiber Optic Pressure Sensor IAB Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] includes the following:

- . CS300 Intra-Aortic Balloon Pump
- Fiber optic pressure Sensor IAB assembly .
- . Revised packaging tray with cable retention feature

These modifications to the Datascope IAB System [Fiber Optic Pressure Sensor IAB Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] have been demonstrated not to affect safety or effectiveness of the device.

#### F. NON-CLINICAL TESTS

The results of in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed devices.

#### G. CLINICAL TESTS

There has been no clinical evaluation of the new device in the U.S.

#### H. CONCLUSIONS

Based on the information presented in this 510(k) premarket notification, Datascope's IABP System [Fiber Optic Pressure Sensor IAB Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] is considered substantially equivalent to Datascope's currently marketed IAB Catheters and Control Systems.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's commitment to health, well-being, and human services. The eagle is positioned in the center of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN -5 2007

Datascope Corp. c/o Ms. Nancy Cohen Manager Regulatory Affairs and Product Surveillance 15 Law Drive Fairfield, NJ 07004

K063525 Re:

> Datascope's IABP System [Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter and CS300 Intra-Aortic Balloon Pump (IABP) Control System] Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-aortic Balloon and Control System Regulatory Class: III Product Code: DSP Dated: December 15, 2006 Received: December 18, 2006

Dear Ms. Cohen:

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 application (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 such 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. Nancy Cohen

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 begin 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Blymmuta for

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

Enclosure

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### · Attachment B

## Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Datascope's IABP System Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Device Name: Catheter & CS300 Intra-Aortic Balloon Pump (IABP) Control System)

Indications For Use:

CS300 Intra-Aortic Balloon Pump has the following indications for use:

The balloon pump is an electromechanical system used to inflate and deflate intra-aortic It provides temporary support to the left ventricle via the principle of balloons. 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.

B. Asmmento

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K063525

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# Attachment B

## Indications for Use

Koc 35 25 510(k) Number (if known):

Datascope's IABP System Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Device Name: Catheter & CS300 Intra-Aortic Balloon Pump (IABP) Control System

Indications For Use:

Datascope's Fiber Optic Pressure Sensor Intra-Aortic Balloon (IAB) Catheter has the following indications for use:

- Refractory unstable angina .
- . Impending infarction
- . Acute Mi
- Refractory ventricular failure .
- Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture) .
- . Cardiogenic shock
- Support for diagnostic, percutaneous revascularization, and interventional procedures .
- Ischemia related intractable ventricular arrhythmias .
- . Septic shock
- Intraoperative pulsatile flow generation .
- . Weaning from bypass
- . Cardiac support for non-cardiac surgery
- . Prophylactic support in preparation for cardiac surgery
- Post surgical myocardial dysfunction/low cardiac output syndrome .
- Myocardial contusion .
- Mechanical bridge to other assist devices .
- Cardiac support following correction of anatomical defects .

Blummo

on Sign-Off lon of Cardiovascular Devices

Prescription Use x

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)