ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840

K021462 · Arrow Intl., Inc. · DSP · Jun 6, 2002 · Cardiovascular

Device Facts

• Record ID: K021462
• Device Name: ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840
• Applicant: Arrow Intl., Inc.
• Product Code: DSP · Cardiovascular
• Decision Date: Jun 6, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arrow Intra-Aortic Balloon (IAB) Catheter With a Fiber Optic Sensor and a Measurement System is clinically indicated for the following conditions: - a. Acute Coronary Syndrome - b. Cardiac and Non-Cardiac Surgery - c. Complications of Heart Failure

Device Story

Device provides cardiac assist therapy via intra-aortic balloon (IAB) catheter. Modification integrates fiber optic pressure sensor at catheter tip to measure arterial pressure directly in aorta, replacing external fluid-filled column/transducer systems. Sensor transmits light through optical fiber to external measurement system; system converts optical signal to digital/analog arterial pressure output. Output connects to patient monitoring systems or Intra-Aortic Balloon Pumps (IABP). Used in clinical settings (e.g., OR, ICU) by physicians/nurses. Fiber optic technology provides immunity to electrical noise/interference. Benefits include direct, real-time arterial pressure monitoring without fluid-column lag or electrical interference.

Clinical Evidence

Bench testing only. Laboratory tests demonstrated the device's performance and substantial equivalence to predicate devices.

Technological Characteristics

Intra-aortic balloon catheter with integrated fiber optic pressure sensor at the tip. Uses optical transmission via flexible fiber to an external measurement system. Provides digital or analog pressure output. Immune to electrical noise/interference. Replaces fluid-filled column/electronic transducer monitoring.

Indications for Use

Indicated for patients with acute coronary syndrome, those undergoing cardiac or non-cardiac surgery, and 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, 30cc Arrow Ultra 8 (K000729)
• IAB 8Fr, 40cc Arrow Ultra 8 (K000729)
• IAB 8Fr, 30cc Arrow NarrowFlex Universal (K963920)
• IAB 8Fr, 40cc Arrow NarrowFlex Universal (K993966)
• IAB 8Fr, 40cc RediGuard Arrow ArmorGlide (K981660)

Reference Devices

• Camino Ventrix Subdural Tunneling Pressure Monitoring Kit (K982702)

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 or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is presented in black and white.

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

June 16, 2016

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

Re: K021462

Trade/Device Name: Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-aortic balloon and control system Regulatory Class: Class II Product Code: DSP Dated: May 1, 2002 Received: May 7, 2002

Dear William Paquin:

This letter corrects our substantially equivalent letter of June 6, 2002.

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, listing 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

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# Page 2 - William Paquin

or any Federal statutes and regulations administered by other Federal agencies. You must 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/MedicalDeyices/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/ResourcesforYou/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) K021462

Device Name

Arrow Intra-Aortic Balloon (IAB) Catheter With A Fiber Optic Sensor And A Measurement System

Indications for Use (Describe)

The Arrow Intra-Aortic Balloon (IAB) Catheter With a Fiber Optic Sensor and a Measurement System 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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K021462

Image /page/3/Picture/1 description: The image shows the word "Teleflex" in a stylized, bold, sans-serif font. The letters are black, and there is a registered trademark symbol to the right of the "x". The word appears to be a logo or brand name.

#### Arrow International, Inc

9 Plymouth Street Everett. MA 02149 USA 617-389-6400 Phone: Fax: [phone]

www.teleflex.com

## 510(k) Summary K021462

Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System

Date Summary Updated: July 28, 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 RAIQA Arrow International, Inc. 16 Elizabeth Drive, Chelmsford, MA 01824 Phone [phone] Fax [phone]

#### C. Device Name

| Trade Name: | Arrow Intra-Aortic Balloon (IAB) Catheter with A Fiber Optic Sensor<br>and A Measurement System |
|----------------------|-------------------------------------------------------------------------------------------------|
| Common Name: | Intra-Aortic Balloon (IAB) with a Fiber Optic Sensor and Measurement<br>System |
| Classification Name: | Balloon, Intra-Aortic and Control System |

#### 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 |
|---------|------------------------------------------|
| K000729 | IAB 8Fr, 30cc Arrow Ultra 8 |
| K000729 | IAB 8Fr, 40cc Arrow Ultra 8 |
| K963920 | IAB 8Fr, 30cc Arrow NarrowFlex Universal |
| K993966 | IAB 8Fr, 40cc Arrow NarrowFlex Universal |
| K981660 | IAB 8Fr, 40cc RediGuard Arrow ArmorGlide |

The fiber optic sensor and measurement system is technologically equivalent to the following device:

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Image /page/4/Picture/0 description: The image shows the word "Teleflex" in a stylized, bold, sans-serif font. The "T" in "Teleflex" is unique, with a horizontal bar extending to the left. A circled "R" trademark symbol appears to the right of the "x" in "Teleflex", indicating that the name is a registered trademark.

1. Camino Ventrix Subdural Tunneling Pressure Monitoring Kit from Camino NeuroCare, 5955 Pacific Center Blvd., San Diego, California 92121, Premarket Notification K982702.

#### E. Description of Device

IAB's are designed to provide cardiac assist therapy. In cardiac assist therapy a standard electronic pressure transducer can be connected externally to the central lumen of an IAB as a means of monitoring arterial pressure.

The purpose of the IAB device modification is to provide an alternative means for obtaining arterial pressure readings directly from the tip of an IAB catheter, as opposed to a standard electronic pressure transducer that is connected externally to the central lumen of an IAB.

A pressure sensor is attached to a flexible optical fiber in the IAB catheter. The sensor is positioned within the tip of the IAB catheter and the fiber runs the length of the inner lumen, exiting at the trifurcation and attaches to an optical connector. The sensor in the IAB catheter optically transmits light to a sensor measurement system. The sensor measurement system displays and outputs an arterial pressure.

Because the fiber optic sensor is positioned directly in the aorta, an arterial pressure can be directly obtained as opposed to obtaining arterial pressure readings through the end of a fluid-filled column and transducer. Additionally the fiber optical not electrical, therefore, the pressure signal is immune to any electrical noiselinterference that can affect a standard electronic pressure transducer. The fiber optic measurement system outputs the pressure via a digital or analog signal. The output signal can be input into a patient monitoring system or Intra-Aortic Balloon Pump (IABP).

#### F. Indications for Use

The Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System is clinically indicated for the following conditions:

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

#### G. Technological Characteristics

The device has similar technological characteristics as previously cleared pressure sensors.

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