Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters

K981660 · C.R. Bard, Inc. · DSP · Oct 16, 1998 · Cardiovascular

Device Facts

• Record ID: K981660
• Device Name: Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters
• Applicant: C.R. Bard, Inc.
• Product Code: DSP · Cardiovascular
• Decision Date: Oct 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Refractory left ventricular failure Cardiogenic or Septic shock Unstable refractory angina Impending Infarction Ischemia-related ventricular arrhythmias Weaning from Cardiopulmonary bypass Support and stabilization during coronary angioplasty Intraoperative pulsatile flow generation Associated mechanical complications of acute myocardial infarction Support and stabilization of high-risk patients undergoing general surgical procedures.

Device Story

Dual-lumen coaxial intra-aortic balloon (IAB) catheter; 8Fr (40cc) or 7Fr (30cc) sizes. Central lumen facilitates guidewire introduction and pressure monitoring; outer lumen supports gas shuttle for balloon inflation/deflation. Radiopaque markers at distal tip and proximal balloon end. Supplied with balloon and insertion kits (introducer, dilator, guidewires, needle). Used in clinical settings (OR/ICU) by physicians for hemodynamic support. Device provides mechanical circulatory assistance via counterpulsation; output (pulsatile flow) helps stabilize patients in shock or undergoing high-risk procedures. Benefits include improved cardiac output and reduced myocardial oxygen demand.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with FDA General Program memorandum #G95-1 Attachment A. Performance testing conducted per FDA guidelines for IAB catheters. All testing successfully completed.

Technological Characteristics

Dual-lumen coaxial shaft design; 8Fr (40cc) or 7Fr (30cc) balloon. Radiopaque markers. Materials: ABS tray, PETG lids, Tyvek/Mylar pouch. Sterilization: 100% EtO. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients with refractory left ventricular failure, cardiogenic or septic shock, unstable refractory angina, impending infarction, ischemia-related ventricular arrhythmias, need for weaning from cardiopulmonary bypass, support during coronary angioplasty, intraoperative pulsatile flow generation, mechanical complications of acute myocardial infarction, and high-risk patients undergoing general surgery. Contraindicated in severe aortic regurgitation, dissecting aortic aneurysm, severe clotting disorders, and severe aorto-iliac disease.

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

• 9Fr. 30cc ArmorGlide coated TaperSeal and RediGuard IAB catheters
• DataScope IAB catheters for sheathless insertion

Submission Summary (Full Text)

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f 981660

OCT 16 1998

## VI. 510(k) SUMMARY FOR THE BARD 8Fr., 40cc. & 7Fr., 30cc SHEATHLESS INTRA-AORTIC BALLOON CATHETERS

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.

#### A. Submitter Information

Submitter's Name: Bard Cardiac Assist Global Technology Center, C.R. Bard Inc. Address: 12 Elizabeth Drive, Chelmsford, MA 01824 Phone #: [phone] Fax #: [phone] Sandra L. Perreand Contact Person: Bard Cardiology 25 Computer Drive Haverhill, MA 01832

Date of Preparation: May 4, 1998

#### B. Device Name

Trade Name: Bard 8 Fr., 40cc. & 7Fr., 30cc Intra Aortic Balloon Catheters Common/Usual Name: Intra aortic balloon catheters Classification Name: Intra-Aortic System, Balloon, Intra-Aortic and Control

#### C. Predicate Device

9Fr. 30cc ArmorGlide coated TaperSeal and RediGuard IAB catheters. DataScope IAB catheters for sheathless insertion

#### D. Device Description

The 8Fr. and 7Fr. IAB catheters consist of a dual lumen coaxial shaft design with either a 40cc (8Fr.) or 30cc (7Fr.) balloon attached to the distal end. The catheters all have a central lumen which serves as a guidewire introduction and pressure monitoring lumen. The central lumen also serves as the distal anchor for the balloon. The outer lumen terminates at the proximal end of the balloon. The area between the two lumens forms the gas shuttle area. Radiopaque

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markers are present at both the distal tip and proximal end of the balloon. Each IAB catheter is supplied with a balloon kit and an insertion kit. The balloon kit contains the balloon catheter, airway tubing, a male luer lock cap, a 3-way stopcock, a syringe, Kontron and/or DataScope adaptor, 6" pressure tubing with a stopcock, and 36" pressure tubing.

The insertion kit contains a 6" percutaneous introducer, an introducer dilator, a vessel dilator, two 150cm floppy J guidewires (0.025") and an 18 gauge angiography needle.

#### E. Intended Use

The device indications for use are as follows: Refractory left ventricular failure Cardiogenic or Septic shock Unstable refractory angina Impending Infarction Ischemia-related ventricular arrhythmias Weaning from Cardiopulmonary bypass Support and stabilization during coronary angioplasty Intraoperative pulsatile flow generation Associated mechanical complications of acute myocardial infarction Support and stabilization of high-risk patients undergoing general surgical procedures.

#### F. Technological Characteristics Summary

For a comparison of the two device's general characteristics see Table VI-I below.

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| CHARACTERISTICS | New 8Fr. & 7Fr. IAB | Current RediGuard/TaperSeal<br>IAB |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Indications For Use<br>(from the device's IFU) | The device indications for use are<br>as follows:<br>-Refractory left ventricular failure<br>-Cardiogenic or Septic shock<br>-Unstable refractory angina<br>-Impending Infarction<br>-Ischemia-related ventricular<br>arrhythmias<br>-Weaning from Cardiopulmonary<br>bypass<br>-Support and stabilization during<br>coronary angioplasty<br>-Intraoperative pulsatile flow<br>generation<br>-Associate to mechanical<br>complications of acute myocardial<br>infarction<br>-Support and stabilization of<br>high-risk patients undergoing<br>general surgical procedures. | Same |
| Contraindications | -Severe aortic regurgitation<br>-Dissecting aortic aneurysm<br>-Severe clotting disorders<br>-Severe aorto-iliac disease<br>-Introduction of the IAB without<br>the use of an introducer sheath is<br>not recommended in patients with<br>severe obesity, scarring of the<br>groin, or other contra-indications<br>to percutaneous insertion. | Same |
| Packaging | ABS tray w/PETG lids. Double<br>pouched in Tyvek/Mylar pouch | Same |
| Sterilization | 100% EtO | Same |

# Table VI-I Comparison of General Characteristics

#### G. Performance Data

The Bard 8Fr. & 7Fr. IAB catheters were subjected to biocompatibility testing as outlined in FDA's May 1, 1995 General Program memorandum- #G95-1 Attachment A, and to the FDA's current guidelines on IAB testing. All testing was successfully completed.

Bard" SFr., 40cc & 7Fr., 30cc. Shouthless Intra-Aortic Balloon Catheters 510(K)

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OCT 16 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sandra L. Perreand Regulatory Affairs Manager Bard Cardiopulmonary & Cardiac Assist Bard Vascular Systems Division C.R. Bard, Inc. 25 Computer Drive Haverhill, MA 01832

Re : K981660 Bard® 8Fr., 40cc and 7Fr., 30cc Sheathless Intra-Aortic Balloons (IAB) III (Three) Requlatory Class: Product Code: DSP Dated: August 18, 1998 August 20, 1998 Received:

Dear Ms. Perreand:

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 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). 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 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 regulations 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 requirements, as set forth in the Quality System Requlation (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 obliqation 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 requlations.

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### Page 2 - Ms. Sandra L. Perreand

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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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.qov/cdrh/dsma/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

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Page____of____

510(k) Number (if known): 长981660

Bard" 8Fr., 40cc & 7Fr., 30cc Sheathless Intra-Aortic Balloon Catheters Device Name:

-Refractory left ventricular failure, Indication for Use: -Cardiogenic or septic shock, -Unstable refractory angina, -Impending infarction, -Ischemia related ventricular arrhythmias, -Weaning from cardiopulmonary bypass, -Support and stabilization during coronary angioplasty, -Intraoperative pulsatile flow generation, -Associated mechanical complications of acute myocardial infarction, -Support and stabilization of high-risk patients undergoing general surgical procedures.

(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,<br>and Neurological Devices | |
| K(k) Number | K981660 |
| Prescription Use <span style="text-decoration: underline;">✓</span><br>(Per 21 CFR 801.109) | OR Over-The-Counter Use ____<br>(Optional Format 1-2-96) |