The FIBEROPTIX IAB consists of an inflatable balloon, which is placed in the 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.

AI/ML Overview

The provided text describes the 510(k) submission for the FIBEROPTIX IAB, focusing on its substantial equivalence to a predicate device. The information details various tests performed to demonstrate this equivalence.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The provided text lists several design verification tests performed. While it explicitly states that the results "met the specified acceptance criteria and performed similar to the predicate device," it does not provide a specific table detailing the acceptance criteria values for each test or the exact performance metrics observed.

Acceptance Criteria (Not Explicitly Stated - Inferred)	Reported Device Performance
Pass/Meet specified criteria for:	Met specified acceptance criteria
- Balloon Volume Test	Performed similar to the predicate device
- Aneurysm Test	Met specified acceptance criteria
- Durability Test	Performed similar to the predicate device
- Catheter Insertion Test	Met specified acceptance criteria
- Catheter Tip to Balloon Bond Tensile per ISO 10555-1	Performed similar to the predicate device
- Outer Lumen to Balloon Bond Tensile per ISO 10555-1	Met specified acceptance criteria
- Catheter Rate Limit Test	Performed similar to the predicate device
- Sheath and Dilator Surface Visual Inspection per ISO 11070	Met specified acceptance criteria
- Sheath and Dilator Tensile Testing per ISO 11070	Performed similar to the predicate device
- Sheath and Dilator Dimensional Analysis	Met specified acceptance criteria

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text mentions "bench tests" for design verification. However, it does not specify the sample size used for any of these tests. It also does not provide any information regarding data provenance (e.g., country of origin, retrospective or prospective nature), as these are bench tests and not human clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is usually relevant for studies involving subjective human interpretation (e.g., image analysis). For the described bench tests, no experts were used to establish ground truth in this manner. The ground truth for these engineering tests would be established by objective measurements against predefined engineering specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. Since the described tests are bench tests, no such adjudication method was applicable or employed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The provided information focuses on the substantial equivalence of an intra-aortic balloon catheter, a physical medical device, through a series of engineering bench tests. It does not describe an AI-powered device or an MRMC comparative effectiveness study involving human readers or AI assistance. Therefore, there is no mention of effect size for human readers with or without AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Similar to the point above, the FIBEROPTIX IAB is a physical medical device, not an algorithm. Therefore, a standalone algorithm-only performance study was not conducted or is not applicable in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the bench tests described, the ground truth would be established by engineering specifications and objective measurements. For example:

Dimensional Analysis: Ground truth is the specified dimensions (e.g., diameter, length).
Tensile Testing: Ground truth is the specified material strength or bond strength.
Volume Test: Ground truth is the specified balloon inflation volume.

There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for these specific tests.

8. The sample size for the training set

The provided text only discusses pre-market submission via a 510(k) pathway, focusing on substantial equivalence to a predicate device through bench testing. It does not mention any training set size, as it does not describe the development or evaluation of a machine learning or AI algorithm.

9. How the ground truth for the training set was established

As there is no mention of a training set (because it's not an AI/ML device), this information is not applicable and therefore not provided in the text.

Summary

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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

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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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:

Acute Coronary Syndrome
Cardiac and Non-Cardiac Surgery
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)

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2. 510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared: June 11, 2019

Submitter	Arrow International, Inc. (Subsidiary of Teleflex, Inc.)16 Elizabeth DriveChelmsford, MA 01824Establishment Registration: 3010532612Arrow International, Inc. (Subsidiary of Teleflex, Inc.)Reading, PA 19605Owner/ Operator: 2518433
CompanyContact	Deb FleethamManager, Regulatory AffairsArrow International, Inc.16 Elizabeth DriveChelmsford, MA 01824deb.fleetham@teleflex.comPhone: (612) 403-3806Fax: (763) 656-4253
Trade Name	Proprietary Name:Common Name:Product Code:Classification Name:Regulation No.:Regulatory Class:	FIBEROPTIX® IABIntra-Aortic Balloon Catheter (IAB)DSPIntra-aortic balloon and control system21 CFR 870.3535Class II
LegallyMarketedPredicateDevice	K021462 Arrow Intra-Aortic Balloon Fiber Optic Sensor/ Fiber Optic Measurement System (Arrow International, Inc.- Cleared June 6, 2002)
ReferenceDevice	K010330 Arrow RediGuard® 9 Fr. 50cc Universal Intra-Aortic Balloon Catheter (Arrow International, Inc.- Cleared March 2, 2001)

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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
1. Cardiac and Non-Cardiac Surgery
1. 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.

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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.

Regulation Number and Section

§ 870.3535 Intra-aortic balloon and control system.

(a)
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.(b)
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.