INTRA-AORTIC BALLOON (IAB)

K040801 · Arrow Intl., Inc. · DSP · May 6, 2004 · Cardiovascular

Device Facts

• Record ID: K040801
• Device Name: INTRA-AORTIC BALLOON (IAB)
• Applicant: Arrow Intl., Inc.
• Product Code: DSP · Cardiovascular
• Decision Date: May 6, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intra-Aortic Balloon catheter is indicated for use in any of the following conditions: a. Acute Coronary Syndrome b. Cardiac and Non-Cardiac Surgery c. Complications of Heart Failure

Device Story

Intra-Aortic Balloon (IAB) provides cardiac assist therapy via percutaneous insertion. Device features dual-lumen catheter: inner lumen for guidewire placement; outer lumen for helium gas shuttle to/from inflatable bladder at distal tip. IAB inflates in aorta during diastolic relaxation and deflates during systolic contraction; increases blood supply to heart muscle; decreases left ventricular workload. Used in clinical settings by healthcare providers to support patients with acute coronary syndrome, surgical complications, or heart failure.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dual-lumen percutaneous catheter; inflatable bladder; helium gas inflation/deflation mechanism; luer adapter; guidewire compatible.

Indications for Use

Indicated for patients with Acute Coronary Syndrome, those undergoing cardiac or non-cardiac surgery, or patients experiencing complications of heart failure.

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

• IAB 8Fr, 30/40cc and, 10 Fr, 50cc with Peel-Away Hemostasis (K970689)
• IAB 8Fr, 30cc Arrow NarrowFlex Universal (K963920)
• IAB 8Fr, 40cc Arrow NarrowFlex Universal (K993966)
• IAB 8Fr, 30/40cc Arrow Ultra Series (K000729)
• IAB 8Fr, 30/40cc Arrow Ultra Series with Light Wave Sensor (K021462)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 15, 2016

Arrow International, Inc. c/o Mr. William Paquin Quality Assurance/Regulatory Affairs Manager 9 Plymouth Street Everett, MA 02149

Re: K040801

Trade/Device Name: Intra-Aortic Balloon Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-aortic balloon and control system Regulatory Class: Class II Product Code: DSP Dated: March 25, 2004 Received: April 6, 2004

Dear William Paquin:

This letter corrects our substantially equivalent letter of May 6, 2004.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - William Paquin

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Eric E. Richardson -S

For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K040801

Device Name Intra-Aortic Balloon (IAB)

Indications for Use (Describe)

The Intra-Aortic Balloon (IAB) is clinically indicated for the following conditions:

- a. Acute Coronary Syndrome
b. Cardiac and Non-Cardiac Surgery

c. Complications of Heart Failure

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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K040801

Image /page/3/Picture/1 description: The image shows the word "Teleflex" in a bold, sans-serif font. The letters are closely spaced together, and the word appears to be slightly italicized. There is a registered trademark symbol to the right of the word.

#### Arrow International, Inc

9 Plymouth Street Everett. MA 02149 USA Phone: [phone] Fax [phone]

www.teleflex.com

# 510(k) Summary K040801

Intra-Aortic Balloon (IAB)

Date Prepared: March 25, 2004 Date Summary Updated: July 10, 2015

- A. Submitter's Name: Arrow International, Inc. 9 Plymouth Street, Everett, MA 02149
Updated Correspondent Address: Fusun Tufan Senior Regulatory Affairs Manager Arrow International, Inc. 16 Elizabeth Drive, Chelmsford, MA 01824 Phone [phone] Fax [phone]

### B. Company Contact

Michael Malis Director RA/QA Arrow International, Inc. 16 Elizabeth Drive. Chelmsford, MA 01824 Phone [phone] Fax [phone]

### C. Device Name

Trade Name: Intra-Aortic Balloon (IAB) Common Name: Intra-Aortic Balloon Catheter Classification Name: Balloon, Intra-Aortic

## D. Predicate Devices

The following table contains the predicate devices which Arrow claims substantial equivalence. Table 1: Predicate Devices

| 510(k) | Intra-Aortic Balloon Description | Catalog |
|---------|-------------------------------------------------------------|-----------------------------|
| K970689 | IAB 8Fr, 30/40cc and, 10 Fr, 50cc with Peel-Away Hemostasis | IAB-042XX-U |
| K963920 | IAB 8Fr, 30cc Arrow NarrowFlex Universal | IAB-04830-U |
| K993966 | IAB 8Fr, 40cc Arrow NarrowFlex Universal | IAB-04840-U |
| K000729 | IAB 8Fr, 30/40cc Arrow Ultra Series | IAB-058XX-U /<br>IAB-68XX-U |
| K021462 | IAB 8Fr, 30/40cc Arrow Ultra Series with Light Wave Sensor | IAB-058XX-LWS |

#### E. Description of Device

IAB's are designed to provide cardiac assist therapy. The devices are dual lumen percutaneously inserted

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Image /page/4/Picture/0 description: The image shows the word "Teleflex" in a stylized font. The letters are all in lowercase, except for the first letter, which is uppercase. The word is in black and the background is white. There is a registered trademark symbol after the word.

Intra-Aortic IAB catheters, with two independent non-communicating lumen is comprised of an inflatable bladder connected to the catheter distal tip and to the IAB tip outer surface. The inner lumen is comprised of a luer adapter connected to the proximal end of the inner lumen and to the IAB tip inner surface. The IAB inner lumen is used for placement of the device with a guidewire and the outer lumen is used to shuttle helium gas to and from the inflatable bladder. IABs are timed to inflate within the aota during the diastolic relaxation of the heart and deflate during the systolic contraction of the heart, resulting in increased blood supply to the heart muscle and decreased work load for the left ventricle.

#### F. Intended Use

The Intra-Aortic Balloon catheter is indicated for use in any of the following conditions:

- a. Acute Coronary Syndrome
- Cardiac and Non-Cardiac Surgery b.
- Complications of Heart Failure C.

## G. Technological Characteristics

The results of the laboratory tests demonstrate that the device is substantially equivalent.