8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S

K963865 · Arrow Intl., Inc. · DSP · Sep 16, 1997 · Cardiovascular

Device Facts

• Record ID: K963865
• Device Name: 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S
• Applicant: Arrow Intl., Inc.
• Product Code: DSP · Cardiovascular
• Decision Date: Sep 16, 1997
• 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 8 Fr-30cc NarrowFlex™ Sheathless Intra-Aortic Balloon Catheter provides temporary mechanical circulatory support. Device consists of balloon catheter inserted into aorta to assist cardiac function via counterpulsation. Operates by inflating/deflating balloon in synchronization with cardiac cycle to reduce left ventricular workload and improve coronary perfusion. Used in clinical settings (e.g., OR, ICU) by trained physicians. Output is hemodynamic support; assists in stabilizing patients in cardiogenic shock or undergoing high-risk procedures. Benefits include improved cardiac output and reduced myocardial oxygen demand.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through nonclinical testing of insertion characteristics (distal tip flexibility, deflection, column strength) and performance parameters (total cycle time, displaced volume, first response) compared to predicate devices.

Technological Characteristics

Intra-aortic balloon catheter; 8 Fr diameter; 30cc balloon volume. Features Nitinol inner lumen and kink-resistant outer lumen. Designed for sheathless insertion. Mechanical device; no software or electronic components.

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, or requiring support for failed angioplasty/valvuloplasty or high-risk general surgery.

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

• 8 Fr-40cc Sheathless NarrowFlex™ (K961358)
• 8 Fr-30cc Sheathless (K961358)

Submission Summary (Full Text)

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K 76 3865

510(k) SUMMARY - K963865

SEP 16 1997

The device is substantially equivalent to the following legally marketed Arrow intra-aortic balloon devices:

1. 8 Fr-40cc Sheathless NarrowFlex™, with Nitinol inner lumen and kink resistant outer lumen, product no. IAB-04840S, premarket notification K961358.
2. 8 Fr-30cc, Sheathless, with stainless steel inner lumen and plastic outer lumen, product no. IAB-04230S, premarket notification K961358.

This device is identical in construction to the predicate sheathless 8 Fr-40cc NarrowFlex™ device IAB-04840S with the exception of the 30cc balloon and shorter overall length. The balloon volume and the overall length have been adapted from the 8 Fr-30cc Sheathless IAB-04230S predicate.

The device is indicated for the following conditions:

Refractory left ventricular power failure. Cardiogenic shock unstable refractory angina. Mechanical complication due to acute myocardial infarction; i.e., ventricular sepial 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 device has comparable technological characteristics to the predicate devices.

The nonclinical test results included in the submission showing comparable performance to the predicate devices are as follows:

Insertion characteristics
- Distal tip flexibility
- Deflection
- Column strength

Performance Test
- Total cycle time
- Displaced volume
- First response

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

Mr. Thomas D. Nickel
Vice President, Regulatory Affairs
and Quality Assurance
Arrow International
2400 Bernville Road
Reading, Pennsylvania 19605

SEP 16 1997

Re: K963865
Arrow 8Fr - 30cc Narrowflex™ Sheathless
Intra-Aortic Balloon Catheter
Regulatory Class: III (Three)
Product Code: 74 DSP
Dated: July 18, 1997
Received: July 21, 1997

Dear Mr. Nickel:

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.

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Page 2 - Mr. Thomas D. Nickel

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

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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870.3535 - DSP III - Intra-aortic Balloon's Control System

510(k) Number (if known): K963865

Device Name: Arrow 8 Fr. 30cc NarrowFlex™ Sheathless Intra-Aor Balloon Catheter

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 K963865

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)