Fiberoptix IAB

K190117 · Arrow International, Inc. · DSP · Jun 13, 2019 · Cardiovascular

Device Facts

• Record ID: K190117
• Device Name: Fiberoptix IAB
• Applicant: Arrow International, Inc.
• Product Code: DSP · Cardiovascular
• Decision Date: Jun 13, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FIBEROPTIX® IAB with the Intra-Aortic Balloon Pump as a control system is indicated for use in any of the following conditions: 1. Acute Coronary Syndrome 2. Cardiac and Non-Cardiac Surgery 3. Complications of Heart Failure

Device Story

FIBEROPTIX IAB is an intra-aortic balloon catheter designed to improve cardiovascular function; functions as part of an intra-aortic balloon pump (IABP) control system. Device consists of an inflatable balloon, inner lumen, and outer lumen; features an integrated fiber optic pressure sensor at the catheter tip acting as a pressure transducer. Used in clinical settings (e.g., surgery, critical care) by healthcare professionals to regulate balloon inflation/deflation cycles. The fiber optic sensor provides real-time pressure data to the IABP control system, which manages hemodynamic support. The device assists in stabilizing patients with acute coronary syndrome, surgical complications, or heart failure by augmenting cardiac output and reducing myocardial oxygen demand.

Clinical Evidence

Bench testing only. Verification tests included balloon volume, aneurysm, durability, catheter insertion, bond tensile testing (per ISO 10555-1), and sheath/dilator testing (per ISO 11070). All results met specified acceptance criteria.

Technological Characteristics

Intra-aortic balloon catheter with integrated fiber optic pressure sensor. Features inner/outer lumens and inflatable balloon. Design verification performed per ISO 10555-1 (catheter/bond tensile) and ISO 11070 (sheath/dilator).

Indications for Use

Indicated for patients with acute coronary syndrome, those undergoing cardiac or non-cardiac surgery, or those experiencing complications of heart failure requiring intra-aortic balloon pump support.

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

• Arrow Intra-Aortic Balloon Fiber Optic Sensor/ Fiber Optic Measurement System (K021462)

Reference Devices

• Arrow RediGuard® 9 Fr. 50cc Universal Intra-Aortic Balloon Catheter (K010330)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 13, 2019

Arrow International, Inc. Niyati Boghani Regulatory Affairs Specialist 16 Elizabeth Drive Chelmsford, Massachusetts 01824

Re: K190117

Trade/Device Name: Fiberoptix IAB Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon And Control System Regulatory Class: Class II Product Code: DSP Dated: April 16, 2019 Received: April 17, 2019

### Dear Niyati Boghani:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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

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

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known)

#### K190117

Device Name FIBEROPTIX® IAB

Indications for Use (Describe)

FIBEROPTIX® IAB with the Intra-Aortic Balloon Pump as a control system is indicated for use in any of the following conditions:

1. Acute Coronary Syndrome

2. Cardiac and Non-Cardiac Surgery

3. Complications of Heart Failure

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

## 2. 510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared: June 11, 2019

| Submitter | Arrow International, Inc. (Subsidiary of Teleflex, Inc.)<br>16 Elizabeth Drive<br>Chelmsford, MA 01824<br>Establishment Registration: 3010532612<br><br>Arrow International, Inc. (Subsidiary of Teleflex, Inc.)<br>Reading, PA 19605<br>Owner/ Operator: 2518433 | |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Company<br>Contact | Deb Fleetham<br>Manager, Regulatory Affairs<br>Arrow International, Inc.<br>16 Elizabeth Drive<br>Chelmsford, MA 01824<br>[e-mail]<br>Phone: [phone]<br>Fax: [phone] | |
| Trade Name | Proprietary Name:<br>Common Name:<br>Product Code:<br>Classification Name:<br>Regulation No.:<br>Regulatory Class: | FIBEROPTIX® IAB<br>Intra-Aortic Balloon Catheter (IAB)<br>DSP<br>Intra-aortic balloon and control system<br>21 CFR 870.3535<br>Class II |
| Legally<br>Marketed<br>Predicate<br>Device | K021462 Arrow Intra-Aortic Balloon Fiber Optic Sensor/ Fiber Optic Measurement System (Arrow International, Inc.- Cleared June 6, 2002) | |
| Reference<br>Device | K010330 Arrow RediGuard® 9 Fr. 50cc Universal Intra-Aortic Balloon Catheter (Arrow International, Inc.- Cleared March 2, 2001) | |

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

- Device The FIBEROPTIX IAB consists of an inflatable balloon, which is placed in the Description aorta to improve cardiovascular functioning. A computerized control system, also known as the Intra-Aortic Balloon Pump (IABP) is utilized to requlate the inflation and deflation of the balloon.
The FIBEROPTIX IAB consists of an inner lumen, an outer lumen, and an inflatable balloon. The outer lumen is comprised of an inflatable balloon connected to the distal tip of the catheter shaft and to the IAB catheter 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 catheter tip inner surface.

The FIBEROPTIX IAB has a fiber optic pressure sensor which acts as a pressure transducer embedded in the catheter tip.

Indications for The FIBEROPTIX IAB with the Intra-Aortic Balloon Pump as a control system Use is indicated for use in any of the following conditions:

- 1. Acute Coronary Syndrome
- 2. Cardiac and Non-Cardiac Surgery
- 3. Complications of Heart Failure

Technological The subject FIBEROPTIX IAB is similar in design and identical in indications Characteristics for use to the predicate, Arrow Intra-Aortic Balloon Fiber Optic Sensor / Fiber Comparison Optic Measurement System Catheter. Compared to the predicate device, the FIBEROPTIX IAB has an increased balloon size/volume, and the size of the supplied insertion sheath and dilator was increased to accommodate the larger balloon.

> The technological differences between the subject and the predicate devices have been evaluated through bench tests to provide evidence that the FIBEROPTIX IAB is substantially equivalent to the predicate device. The device design has been verified through the following tests:

- · Balloon Volume Test
- Aneurysm Test
- · Durability Test
- · Catheter Insertion Test
- · Catheter Tip to Balloon Bond Tensile per ISO 10555-1
- · Outer Lumen to Balloon Bond Tensile per ISO 10555-1
- · Catheter Rate Limit Test
- · Sheath and Dilator Surface Visual Inspection per ISO 11070
- · Sheath and Dilator Tensile Testing per ISO 11070
- Sheath and Dilator Dimensional Analysis

The results of the verification tests met the specified acceptance criteria and performed similar to the predicate device. The testing demonstrates that the catheter is substantially equivalent to the predicate device.

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

### Substantial Equivalence Conclusion

The subject FIBEROPTIX IAB Catheter is substantially equivalent to the specified predicate device based on comparison of the device functionality, technological characteristics, and indications for use. The device modifications and results of design verification tests do not raise new or different questions of safety or effectiveness. The subject device is substantially equivalent to the predicate device.