BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS

K980850 · C.R. Bard, Inc. · DSP · Jun 3, 1998 · Cardiovascular

Device Facts

• Record ID: K980850
• Device Name: BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS
• Applicant: C.R. Bard, Inc.
• Product Code: DSP · Cardiovascular
• Decision Date: Jun 3, 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 Associated mechanical complications of acute myocardial infarction Support and stabilization of high-risk patients undergoing general surgical procedures.

Device Story

Intra-aortic balloon (IAB) catheter system used for hemodynamic support. Device consists of 9Fr, 40cc balloon catheter, introducer tray, and accessories (dilators, guidewires, needle). Operated by clinicians in hospital settings. Functions as mechanical circulatory support; balloon inflates/deflates in aorta to augment cardiac output and reduce myocardial oxygen demand. Provides pulsatile flow and stabilization for patients in shock or undergoing high-risk procedures. Output is hemodynamic support; clinician monitors patient response via standard cardiovascular monitoring equipment. Benefits include improved perfusion and stabilization of hemodynamically unstable patients.

Clinical Evidence

Bench testing only. 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 testing was successfully completed.

Technological Characteristics

9Fr, 40cc intra-aortic balloon catheter. Materials include ABS tray with PETG lids, double-pouched in Tyvek/Mylar. Sterilization via 100% EtO. Mechanical device; no software or electronic components.

Indications for Use

Indicated for patients with refractory left ventricular failure, cardiogenic or septic shock, unstable refractory angina, impending infarction, ischemia-related ventricular arrhythmias, or mechanical complications of acute myocardial infarction. Also indicated for weaning from cardiopulmonary bypass, support during coronary angioplasty, intraoperative pulsatile flow generation, and support for high-risk patients undergoing general surgery. Contraindicated in patients with severe aortic regurgitation, dissecting aortic aneurysm, severe clotting disorders, or 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. 40cc ArmorGlide coated TaperSeal and RediGuard IAB catheters

Submission Summary (Full Text)

{0}------------------------------------------------

K980850

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

Registered Division

BARD

#### 510(k) SUMMARY FOR THE BARD 9Fr., 40cc. 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: February 12, 1998

#### B. Device Name

ﻟﻠﻌﺐ ﺍﻟﻤﺴﺘﺸﻔﻴﺔ ﺍﻟﻤﺴﺘﺸﺎﺑﻬﺎ ﺍﻟﻤﺴﺘﺸﺎﺑﻬﺎ ﺍﻟﻤﺴﺘﺸﺎﺑﻬﺎ ﺍﻟﻤﺴﺘﺸﺎﺑﻬﺎ ﺍﻟﻤﺴﺘﺸﺎﺑﻬﺎ ﺍﻟﻤﺴﺘﺸﺎﺑﻬﺎ ﺍﻟﻤﺴﺘﺸﺎﺑﻬﺎ ﺍﻟﻤﺴﺘﺸﺎﺑﻬﺎ ﺍﻟﻤﺴﺘﺸﺎﺑﻬﺎ ﺍﻟﻤﺴﺘﺸﺎﺑﻬﺎ ﺍﻟﻤﺴﺘﺸﺎﺑﻬﺎ ﺍﻟﻤﺴﺘﺸﺎﺑﻬﺎ ﺍﻟﻤﺴﺘﺸﺎﺑﻬﺎ ﺍﻟﻤﺴﺘﺸﺎﺑﻬﺎ ﺍﻟﻤﺴ

Bard" 9 Fr., 40cc. 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. 40cc 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. 40cc 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.

{1}------------------------------------------------

# 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.

| Table VI-I Comparison of General Characteristics | | |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| CHARACTERISTICS | New RediGuard/TaperSeal 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 |

# F. Technological Characteristics Summary

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

{2}------------------------------------------------

| Contraindications | -Severe aortic regurgitation<br>-Dissecting aortic aneurysm<br>-Severe clotting disorders<br>-Severe aorto-iliac disease<br>-Introduction of the LAB 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 | Same |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| | to percutaneous insertion. (TS only) | |
| 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.

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping profiles, representing the department's mission to protect the health of all Americans and provide essential human services.

JUN 3 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sandra L. Perreand Regulatory Affairs Manager Bard Cardiology-Cardiopulmonary GTC 25 Computer Drive Haverhill, MA 01832 Re : K980850

Bard® 9Fr., 40cc. TaperSeal® and RediGuard® Intra-Aortic Balloon (IAB) Modifications Regulatory Class: III (Three) Product Code: DSP Dated: March 3, 1998 Received: March 5, 1998

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 to 895. A substantially equivalent determination assumes compliance 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 Failure to comply with the GMP regulation may result in assumptions. requlatory 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.

{4}------------------------------------------------

#### 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 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. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Number (if known): K98850

Bard" 9Fr., 40cc. 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,

- Weaning Trom carelopon during coronary angioplasty,

-Intraoperative pulsatile flow generation,

- -Intraoperative pursative now generals, of acute myocardial infarction,
Associated mechanical complications of acute undersoing general
-Associated mechanical computeducils 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)

Bete R. Semperle
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number k980850

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use ・・.

(Optional Format 1-2-96)