IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U

K970689 · Arrow Intl., Inc. · DSP · Jun 4, 1998 · Cardiovascular

Device Facts

• Record ID: K970689
• Device Name: IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U
• Applicant: Arrow Intl., Inc.
• Product Code: DSP · Cardiovascular
• Decision Date: Jun 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Refractory left ventricular power failure. Cardiogenic shock, unstable refractory angina. Mechanical complication due to acute myocardial infarction; i.e., ventricular septal defect, mitral regurgitation or papillary muscle rupture. Impending infraction, ischemia related intractable ventricular arrhythmias. Septic shock. Support for failed angioplasty and valvuloplasty. Cardiac support for high risk general surgical patients.

Device Story

Arrow Intra-Aortic Balloon (IAB) catheters modified with integrated peel-away hemostasis device; enables universal application for either sheathless insertion or standard sheath insertion; peel-away component discarded if sheathless technique used. Device provides mechanical circulatory support in clinical settings for patients with acute cardiac failure or high-risk surgical needs. Physician-operated; provides hemodynamic support to improve cardiac output and reduce myocardial oxygen demand; benefits patient by stabilizing hemodynamics during critical cardiac events.

Clinical Evidence

Bench testing only; no clinical data provided. Nonclinical performance test results demonstrated comparable performance to predicate sheathless devices.

Technological Characteristics

Intra-aortic balloon catheter with integrated peel-away hemostasis mechanism. Designed for universal use (sheathless or standard sheath). Class III device.

Indications for Use

Indicated for patients experiencing refractory left ventricular power failure, cardiogenic shock, unstable refractory angina, mechanical complications of acute myocardial infarction (ventricular septal defect, mitral regurgitation, papillary muscle rupture), impending infarction, ischemia-related intractable ventricular arrhythmias, septic shock, support for failed angioplasty/valvuloplasty, and cardiac support for high-risk general surgical patients.

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.

Submission Summary (Full Text)

{0}

K970689

JUN 4 1998

## SECTION 2 - 510(k) SUMMARY and CERTIFICATION

### 510(k) SUMMARY

The addition of a new peel-away hemostasis device to four existing Arrow IABs makes them now "universal" IABs, in that they can be used as is for sheathless insertion techniques, or can be used with current standard sheaths if the sheathless feature is not desired, by peeling it away and discarding it.

The four new "Universal" products are therefore substantially equivalent to eight current Arrow IAB products.

The device new "Universal" are indicated for the following conditions:

- Refractory left ventricular power failure.
- Cardiogenic shock unstable refractory angina.
- Mechanical complication due to acute myocardial infraction; i.e., ventricular septal defect mitral regurgitation or papillary muscle rupture.
- Impending infraction, ischemia related intractable ventricular arrhythmias.
- Septic shock.
- Support for failed angioplasty and valvuloplasty.
- Cardiac support for high risk general surgical patients.

The devices have comparable technological characteristics to the predicate devices.

The nonclinical performance test results included in the submission show comparable performance to the predicate sheathless devices.

### CERTIFICATION

Since this is a class III device, the required class III Special Certification is appended as Attachment 1.

{1}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
JUN 4 1998
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

Mr. Robert A. Szurgot
Project Engineer
Arrow International
Research/Engineering
3000 Bernville Road
Reading, Pennsylvania 19605

Re: K970689
Arrow Intra-Aortic Balloon Catheter with Peel-Away Hemostasis Device (IAB-04840-U; IAB-04250-U; IAB-04240-U; IAB-04230-U)
Regulatory Class: III (Three)
Product Code: 74 DSP
Dated: June 6, 1997
Received: June 11, 1997

Dear Mr. Szurgot:

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 Regulations, 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 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.

{2}

Page 2 - Mr. Robert A. Szurgot

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

Enclosure

{3}

870.3535 - DSP III - Intra-Aortic Balloon and Control System

510(k) Number (if known): K970689

Device Name: Arrow Intra-Aortic Balloon Catheter with Peel-Away Hemostasis Device
IAB-04840-U
IAB-04240-U
IAB-04230-U

Indications For Use:

Refractory left ventricular power failure. Cardiogenic shock, unstable refractory angina. Mechanical complication due to acute myocardial infarction; i.e., ventricular septal defect, mitral regurgitation or papillary muscle rupture. Impending infraction, ischemia related intractable ventricular arrhythmias. Septic shock. Support for failed angioplasty and valvuloplasty. Cardiac support for high risk general surgical patients.

(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, and Neurological Devices
510(k) Number K970689

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)