BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS

K973962 · C.R. Bard, Inc. · DSP · Feb 19, 1998 · Cardiovascular

Device Facts

• Record ID: K973962
• Device Name: BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS
• Applicant: C.R. Bard, Inc.
• Product Code: DSP · Cardiovascular
• Decision Date: Feb 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

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 Intraoperative pulsative now generals of acute myocardial infarction Associated mechanical computations of actions in action in the many of any ical procedures.

Device Story

Intra-aortic balloon (IAB) catheter system used for hemodynamic support. Device consists of 9Fr, 30cc balloon catheter, introducer tray, and accessories (dilators, guidewires, needle). Operated by clinicians in clinical settings. Functions by inflating/deflating balloon in aorta to provide pulsatile flow, reduce left ventricular workload, and improve coronary perfusion. Output is mechanical circulatory support. Benefits include stabilization of hemodynamics in shock or high-risk surgical states. Device is provided sterile for single use.

Clinical Evidence

No clinical data. Biocompatibility testing was performed in accordance with FDA's May 1, 1995 General Program memorandum #G95-1 Attachment A and current FDA guidelines for IAB testing. All bench testing was successfully completed.

Technological Characteristics

9Fr, 30cc intra-aortic balloon catheter. Materials include ABS tray with PETG lids, double-pouched in Tyvek/Mylar. Sterilization via 100% EtO. Mechanical operation via external control console (not described).

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, or 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

Submission Summary (Full Text)

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MANSOOR

Bard Vascular Systems Division C.R. Bard, Inc. 25 Computer Drive Haverhill, MA 01832 508-373-1000

FEB 1 9 1998

#### 510(k) SUMMARY FOR THE BARD 9Fr., 30cc. REDIGUARD VI. AND TAPERSEAL BALLOONS

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] Contact Person: Sandra L. Perreand Bard Cardiology 25 Computer Drive Haverhill. MA 01832

Date of Preparation: October 13, 1998

#### B. Device Name

Bard" 9 Fr., 30cc. RediGuard" and TaperSeal" Intra Aortic Balloon Trade Name: Catheters

Common/Usual Name: intra aortic balloon catheters Intra-Aortic System, Balloon, Intra-Aortic and Control Classification Name:

### C. Predicate Device

9Fr. 30cc ArmorGlide coated TaperSeal and RediGuard IAB catheters.

### D. Device Description

Each Intra Aortic Balloon catheter comes with a catheter tray and an introducer tray. The catheter tray contains: a 9Fr. 30cc IAB catheter, airway tubing w/female luer fitting, 6" pressure tubing with stopcock, a 3 way stopcock, a 60cc syringe, an optional Datascope or Arrow adaptor, 36" pressure tubing, and a male luer lock cap. The accessory tray contains; a percutaneous tearaway introducer, 8" or 11" introducer dilators, 18 gauge angiography needle, and two 150cm floppy J guidewires.

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## 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 Intraoperative pulsative now generals of acute myocardial infarction Associated mechanical computations of actions in action in the many of any ical procedures.

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

| CHARACTERISTICS | New RediGuard/TaperSeal IAB | Current RediGuard/TaperSeal IAB |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Indications For Use<br>(from the device's IFU) | The device indications for use are as follows:<br>-Refractory left ventricular failure<br>-Cardiogenic or Septic shock<br>-Unstable refractory angina<br>-Impending Infarction<br>-Ischemia-related ventricular arrhythmias<br>-Weaning from Cardiopulmonary bypass<br>-Support and stabilization during coronary angioplasty<br>-Intraoperative pulsatile flow generation<br>-Associate to mechanical complications of acute myocardial infarction<br>-Support and stabilization of high-risk patients undergoing general surgical procedures. | Same |

# Table VI-I Comparison of General Characteristics

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| 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. (TS only) | 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 RediGuard and TaperSeal 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.

-

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Image /page/3/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 1998

Ms. Sandra L. Perreand Requlatory Affairs Manager Bard Vascular Systems Division C.R. Bard, Inc. 25 Computer Drive Haverhill, MA 01832

Re: K973962 Bard® 9FR., 30cc. RediGuard® and TaperSeal® Intra-Aortic Balloon Catheters with Mobay Balloons Regulatory Class: III (Three) Product Code: DSP Dated: October 13, 1997 October 16, 1997 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 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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, 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. 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 requlation (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. Callehan

Thomas J. Callaha n, 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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Bard" 9Fr., 30cc. TaperSeal" and RediGuard" Intra-Aortic Balloons Device Name:

Indication for 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | <img alt="Signature" src="signature.png"/> |
|-------------------------------------------------------------------|--------------------------------------------|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K973962 |

OR
Over-The-Counter UsePrescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96) ---