Arrow FiberOptix Intra-Aortic Balloon Catheter Kit

K200634 · Arrow International, Inc. · DSP · Apr 9, 2020 · Cardiovascular

Device Facts

• Record ID: K200634
• Device Name: Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
• Applicant: Arrow International, Inc.
• Product Code: DSP · Cardiovascular
• Decision Date: Apr 9, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3535
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FiberOptix® IAB Catheter is utilized for intra-aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Device Story

FiberOptix IAB Catheter consists of inflatable balloon, inner/outer lumens, and embedded fiber optic pressure sensor at distal tip. Used with Intra-Aortic Balloon Pump (IABP) control system. Device placed in aorta; IABP regulates inflation/deflation cycles. Inflation during diastole increases myocardial blood supply; deflation during systole reduces left ventricular workload. Used in clinical settings (e.g., OR, ICU) by trained healthcare providers. Fiber optic sensor provides real-time pressure monitoring to guide pump timing. Modified sensor configuration improves mechanical robustness compared to predicate. Benefits include improved cardiovascular function via counterpulsation therapy.

Clinical Evidence

Bench testing only. Verification testing included insertion, durability, and static pressure tests, including simulated misuse scenarios. Results met all acceptance criteria and demonstrated performance equivalent to the predicate device.

Technological Characteristics

Catheter includes inflatable balloon, inner/outer lumens, and embedded fiber optic pressure sensor. Operates via connection to external IABP control system. Modified design features fiber optic sensor configuration along distal length for increased robustness. Sterilization and specific material standards not disclosed.

Indications for Use

Indicated for patients with Acute Coronary Syndrome, those undergoing Cardiac or Non-Cardiac Surgery, or those 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

• Arrow FiberOptix IAB (K190117)
• FiberOptix® IAB Catheter (K021462)

Submission Summary (Full Text)

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April 9, 2020

Arrow International Inc. Apurva Gokhale Senior Regulatory Affairs Specialist 16 Elizabeth Drive Chelmsford, Massachusetts 01824

Re: K200634

Trade/Device Name: FiberOptix Intra-Aortic Balloon Catheter Kit Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon And Control System Regulatory Class: Class II Product Code: DSP Dated: March 6, 2020 Received: March 10, 2020

Dear Apurva Gokhale:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,

for 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

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# Indications for Use

510(k) Number (if known) K200634

#### Device Name

FiberOptix® Intra-Aortic Balloon Catheter Kit

Indications for Use (Describe)

The FIBEROPTIX IAB Catheter with the Intra-Aortic Balloon Pump as a control system is clinically 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)| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 2. 510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared: 6 March 2020

| Submitter | Arrow International, Inc. (Subsidiary of Teleflex, Inc.)<br>16 Elizabeth Drive<br>Chelmsford, MA 01824<br>Establishment Registration: 3010532612 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| | Arrow International, Inc. (Subsidiary of Teleflex, Inc.)<br>Reading, PA 19605<br>Owner/ Operator: 2518433 |
| Company Contact | Apurva N. Gokhale<br>Sr. Regulatory Affairs Specialist<br>Arrow International, Inc.<br>16 Elizabeth Drive<br>Chelmsford, MA 01824 |

[e-mail]

| Regulatory Information | |
|------------------------|--------------------------------------------------|
| Proprietary Name: | FiberOptix® Intra-Aortic Balloon Catheter Kit |
| Common Name: | System, Balloon, Intra-Aortic and Control System |
| Product Code: | DSP |
| Regulation #: | 870.3535 |
| Description: | Intra-aortic balloon & control system |
| Regulatory Class: | Class II |

Phone: [phone] extension 722202

- Leqally Marketed ● K190117 Arrow FiberOptix IAB (Arrow International, Inc. - Cleared June 13, Predicate Device 2019)- Primary Predicate
The FiberOptix® Intra-Aortic Balloon (IAB) Catheter consists of an inflatable balloon, Device Description which is placed in the aorta to improve cardiovascular functioning. A computerized control system, also known as Intra-Aortic Balloon Pump (IABP) is utilized to regulate the inflation and deflation of the balloon.

> The FiberOptix® IAB Catheter 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 Catheter has a fiber optic pressure sensor which acts as a pressure transducer embedded in the catheter tip.

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The FiberOptix® IAB Catheter is utilized for intra-aortic balloon counterpulsation Intended Use therapy in the aorta, whereby balloon inflation, during diastole and deflation during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

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

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

The subject FiberOptix® IAB catheter is similar in design and identical in Technological indications for use to the predicate devices. Arrow Intra-Aortic Balloon Fiber Optic Characteristics Comparison Sensor/ Fiber Optic Measurement System and Arrow FiberOptix IAB Catheter. Compared to the predicate devices, the subject FiberOptix® IAB has a modified configuration of the fiber optic sensor along the distal length of the IAB catheter to improve its robustness.

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

- Insertion, Durability Test & (FOS) Static Pressure Test ●
- . Simulated Misuse Test & (FOS) Static Pressure Test

The results of the verification test met the specified acceptance criteria and performed similar to the predicate device. The testing demonstrates that the subject FiberOptix® IAB catheter is substantially equivalent to the predicate device.

The subject FiberOptix® IAB Catheter is substantially equivalent to the Substantial specified predicate device, FiberOptix® IAB Catheter (K021462 and K190117) Equivalence Conclusion based on a comparison of the device functionality, materials, 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; therefore, the subject device is substantially equivalent to the predicate device.