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 Description

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).

AI/ML Overview

This FDA 510(k) premarket notification describes the Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System. However, it does not contain the detailed study information required to fully answer your request regarding acceptance criteria and device performance.

The document primarily focuses on establishing "substantial equivalence" to predicate devices, which is a regulatory pathway that often relies on demonstrating that a new device is as safe and effective as an already legally marketed device, rather than requiring extensive de novo clinical trials or detailed performance studies with acceptance criteria.

Here's what information can be extracted and what is missing based on your request:

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

Missing. The document states, "The results of the laboratory tests demonstrate that the device is substantially equivalent," but it does not provide a table of specific acceptance criteria or the quantitative reported performance of the device against those criteria (e.g., accuracy, precision, bias of the fiber optic sensor pressure readings).

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

Missing. No information on the sample size of any test sets, the type of study (retrospective or prospective), or the data provenance is provided. The evaluation seems to be based on "laboratory tests" rather than clinical or extensive animal studies detailed in this summary.

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)

Missing. There is no mention of experts or ground truth establishment for a test set.

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

Missing. No information on adjudication methods is present.

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

Not Applicable / Missing. This device is an IAB catheter with a fiber optic pressure sensor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or AI assistance effect size is not relevant to this specific device.

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

Partially Applicable / Missing Details. The device's primary function is to measure arterial pressure via a fiber optic sensor. The description implies it acts as a standalone measurement system, outputting pressure via a digital or analog signal to a patient monitoring system or IABP. However, the document does not contain details of specific standalone performance studies (e.g., detailed accuracy studies comparing its readings to a gold standard, independent of an IABP or human interpretation). It only states "laboratory tests" were performed.

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

Missing. The document does not specify the ground truth used for validating the "laboratory tests." For a pressure sensor, a typical ground truth would involve comparison to a highly accurate calibrated reference pressure transducer.

8. The sample size for the training set

Not Applicable / Missing. This device does not appear to involve a machine learning algorithm that would require a "training set" in the conventional sense. If there were any statistical models involved in the sensor's calibration or processing, details are not provided.

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

Not Applicable / Missing. See point 8.

Summary of available information:

Device Name: Arrow Intra-Aortic Balloon (IAB) Catheter With A Fiber Optic Sensor And A Measurement System
Intended Use: Clinically indicated for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, and Complications of Heart Failure.
Technological Characteristics: The device provides an alternative means for obtaining arterial pressure readings directly from the tip of an IAB catheter using a fiber optic sensor. It is described as "technologically equivalent" to previously cleared pressure sensors and the Camino Ventrix Subdural Tunneling Pressure Monitoring Kit (K982702) for its fiber optic aspect.
Testing: "Laboratory tests" were performed, and the results "demonstrate that the device is substantially equivalent." No details of these tests, specific acceptance criteria, or quantitative results are provided in this summary.
Regulatory Pathway: 510(k) "Substantial Equivalence" to predicate devices.

To obtain the detailed information requested, one would typically need to review the full 510(k) submission and supporting documentation, which is generally much more extensive than this summary letter.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

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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:

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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: 617-387-2157

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 (978)250-5100 Fax (978)250-5105

B. Company Contact

Michael Malis Director RAIQA Arrow International, Inc. 16 Elizabeth Drive, Chelmsford, MA 01824 Phone (978)250-5100 Fax (978)250-5105

C. Device Name

Trade Name:	Arrow Intra-Aortic Balloon (IAB) Catheter with A Fiber Optic Sensorand A Measurement System
Common Name:	Intra-Aortic Balloon (IAB) with a Fiber Optic Sensor and MeasurementSystem
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.

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

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.

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.