SUPRACOR BALLOON CATHETER

K062582 · Abiomed, Inc. · DSP · Dec 14, 2006 · Cardiovascular

Device Facts

• Record ID: K062582
• Device Name: SUPRACOR BALLOON CATHETER
• Applicant: Abiomed, Inc.
• Product Code: DSP · Cardiovascular
• Decision Date: Dec 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and intended to improve cardiovascular functioning during the following situations: - Unstable refractory angina - Impending infarction - Post Infarction Angina or Threatening Extension of Myocardial Infarction - Refractory ventricular failure - Mechanical complications because of myocardial infarction - Cardiogenic shock - Support and stabilization of high risk patients undergoing diagnostic and non-surgical procedures - Ischemic related intractable ventricular arrhythmias - Septic shock - Interoperative pulsatile flow generation - Weaning from cardiopulmonary bypass - Cardiac support for high risk surgical patients and coronary angiography and angioplasty patients - Prophylactic support in preparation for cardiac surgery - Post-surgical myocardial dysfunction - Cardiac Contusion - Mechanical bridge to other assist devices - Cardiac support following correction of anatomical defects - Support for failed angioplasty and valvuloplasty

Device Story

SupraCor Balloon Catheter is 40cc symmetrical polyetherurethane balloon on 8 Fr dual-lumen catheter; provides counterpulsation cardiac assist. Outer lumen facilitates helium-based inflation/deflation; inner lumen enables guidewire passage and blood pressure measurement. Used in clinical settings (e.g., OR, ICU) by physicians; requires external commercially available control console for synchronization with patient ECG or arterial pressure. Device inflates/deflates in sync with heartbeat to increase coronary perfusion and decrease left ventricular workload; promotes myocardial healing. Benefits include hemodynamic stabilization and cardiac support for high-risk patients.

Clinical Evidence

Bench testing only. Laboratory performance and reliability testing conducted in accordance with FDA guidance for Intra-Aortic Balloon Catheters. Biocompatibility and sterility testing confirmed compliance with device classification requirements.

Technological Characteristics

40cc symmetrical balloon; polyetherurethane construction; 8 Fr dual-lumen catheter; EtO sterilization; temporary use (≤ 30 days). Operates via external pneumatic control console using helium for inflation/deflation.

Indications for Use

Indicated for patients requiring cardiovascular support due to unstable angina, myocardial infarction, ventricular failure, cardiogenic or septic shock, or during high-risk surgical/diagnostic procedures, cardiopulmonary bypass weaning, or cardiac surgery preparation.

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 Fidelity IAB catheter (K980385)
• Arrow Ultra 8 IAB catheter (K000729)

Submission Summary (Full Text)

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DEC 1 4 2006

#### Section 5.0- 510(k) Summary (Prepared in accordance with 21 CFR Part 807.92)

#### a. Submitted

| Applicant Name: | ABIOMED, Inc.<br>22 Cherry Hill Drive, Danvers, MA 01923 |
|-----------------------|----------------------------------------------------------|
| Contact Person: | Robert T.V. Kung, Ph.D. |
| Date Summary | August 30, 2006 |
| Prepared: | |
| b. Device information | |
| Trade Name: | SupraCor Balloon Catheter |
| Common Name: | Intra-Aortic Balloon Catheter and insertion kit |
| Classification Name: | Intra-aortic Balloon (classified under CFR870.3535) |
| Product Code: | 74DSP |

#### c. Legally Marketed Predicate Devices

Datascope Fidelity IAB catheter (K 980385), 8 F, 40 cc Intra-Aortic Balloon catheter

Arrow Ultra 8 IAB catheter (K000729), 8 F, 40 cc Intra-Aortic Balloon catheter

#### d. Device Description:

The SupraCor Balloon Catheter is a 40cc symmetrical polyurethane balloon attached to an 8 Fr dual lumen catheter, designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloon, and the inner lumen is used for a guidewire and blood pressure measurement.

The balloon inflation and deflation cycle is synchronized (using a commercially available control console) with the ECG or arterial pressure to provide counterpulsation synchronized with the heartbeat. It is intended to increase coronary perfusion, decrease the workload of the left ventricle and allow healing of the myocardium.

#### e. Intended Use:

The SupraCor Balloon Catheter is placed in the descending aorta just below the subclavian artery and intended to improve cardiovascular functioning during the following situations:

- Unstable refractory angina .
- . Impending infarction
- Post Infarction Angina or Threatening Extension of . Myocardial Infarction
- . Refractory ventricular failure
- . Mechanical complications because of myocardial infarction
- Cardiogenic shock .

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- . Support and stabilization of high risk patients undergoing diagnostic and non-surgical procedures
- . Ischemic related intractable ventricular arrhythmias
- . Septic shock
- Interoperative pulsatile flow generation .
- . Weaning from cardiopulmonary bypass
- Cardiac support for high risk surgical patients and coronary . angiography and angioplasty patients
- . Prophylactic support in preparation for cardiac surgery
- Post-surgical myocardial dysfunction .
- Cardiac Contusion .
- Mechanical bridge to other assist devices .
- Cardiac support following correction of anatomical defects .
- Support for failed angioplasty and valvuloplasty .

# f. Technological Characteristics and Comparison to Predicate Device(s):

The SupraCor Balloon Catheter is of similar design and made of materials commonly used in other marketed balloon catheters. The insertion kit contains instruments commonly provided for insertion of an IAB.

Table 1 provides a comparison of the SupraCor Balloon Catheter with predicate balloon catheters, the Datascope 40cc Fidelity and Arrow 40cc Ultra 8. This table illustrates the equivalency of the SupraCor Balloon Catheter with the predicates.

| Feature | SupraCor IAB | Fidelity IAB | Ultra 8 IAB |
|-----------------------------|----------------------------------------|----------------------------------------|----------------------------------------|
| 510(k) approval | This<br>Submission | K980385 | K000729 |
| Duration of Use | Temporary<br>use: Approx. ≤<br>30 days | Temporary<br>use: Approx. ≤<br>30 days | Temporary<br>use: Approx. ≤<br>30 days |
| Balloon:<br>Size | 40 cc | 40 cc | 40 cc |
| Shape | Symmetric | Symmetric | Symmetric |
| Material | Polyether<br>urethane | Polyether<br>urethane | Polyether<br>urethane |
| Length (in) | 10.25 | 10.4 | 10.25 |
| Catheter:<br>Type | Dual Lumen | Dual Lumen | Dual Lumen |
| Outer wall material | Polyether<br>urethane | Polyether<br>urethane | Polyether<br>urethane |
| Outer wall<br>circumference | 8 F | 8 F | 8 F |
| Introducer Size | 8 F | 8 F | 8 F |

Table 1- Comparison Table for SupraCor Balloon Catheter

ABIOMED Confidential

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| Sterilization | EtO | EtO | EtO |
|-----------------|---------------------------------|---------------------------------|---------------------------------|
| Inner Packaging | Tray in<br>Tyvek/Mylar<br>Pouch | Tray in<br>Tyvek/Mylar<br>Pouch | Tray in<br>Tyvek/Mylar<br>Pouch |
| Outer Packaging | Tyvek Mylar<br>Pouch | Tyvek Mylar<br>Pouch | Tyvek Mylar<br>Pouch |

## g. Pre-clinical Test Results:

Three different types of pre-clinical testing were completed for the SupraCor Balloon Catheter: laboratory, biocompatibility and sterility tests. The laboratory tests demonstrated equivalence to the 2 predicate devices, and included performance and reliability testing in accordance with FDA's recommendations, as provided in the Guidance for the Preparation and Contents of Applications to the Food and Drug Administration for Determining the Equivalence of Intra-Aortic Balloon Catheters and Consoles under the 510(k) Regulations (12/8/1993 draft). The biocompatibility and sterility testing showed that the SupraCor Balloon Catheter complies with the requirements for this device classification. The pre-clinical test results demonstrate that the SupraCor Balloon Catheter is safe and effective.

### h. Conclusion:

Based on the information presented in this 510(k) premarket notification, the SupraCor Balloon Catheter is considered substantially equivalent to the currently marketed predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, and is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2006

Robert T.V. Kung, Ph.D. Chief Scientific Officer Abiomed, Inc. 22 Cherry Hill Drive Danvers, MA 01923

Re: K062582

Abiomed SupraCor Balloon Catheter Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon and Control System Regulatory Class: Class III Product Code: DSP Dated: November 28, 2006 Received: November 29, 2006

Dear Dr. Kung:

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 devira 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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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/industry/support/index.html.

Sincerely yours,

suina R. Vochues

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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SupraCor Balloon Catheter - K062582 Response to FDA letter of November 9, 2006: received November 15, 2006

Indications for Use

| 510(k) Number (if known): | K062582 |
|---------------------------|---------------------------|
| Device Name: | SupraCor Balloon Catheter |

Indications for Use:

The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and intended to improve cardiovascular functioning during the following situations:

- . Unstable refractory angina
- Impending infarction .
- Post Infarction Angina or Threatening Extension of Myocardial . Infarction
- Refractory ventricular failure .
- Mechanical complications because of myocardial infarction �
- Cardiogenic shock .
- Support and stabilization of high risk patients undergoing . diagnostic and non-surgical procedures
- Ischemic related intractable ventricular arrhythmias .
- Septic shock .
- Interoperative pulsatile flow generation .
- Weaning from cardiopulmonary bypass .
- Cardiac support for high risk surgical patients and coronary . angiography and angioplasty patients
- Prophylactic support in preparation for cardiac surgery .
- Post-surgical myocardial dysfunction .
- . Cardiac Contusion
- . Mechanical bridge to other assist devices
- . Cardiac support following correction of anatomical defects
- Support for failed angioplasty and valvuloplasty .

| Prescription Use _ X<br>(Part 21 CFR 801 Subpart D) | |
|-----------------------------------------------------|--|
|-----------------------------------------------------|--|

AND/OR

| Over-The-Counter Use<br>(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) Page 1 of 2

R. Vochner
(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_K662582

ABIOMED Confidential