The 8Fr. Narrowflex Universal Intra-Aortic Balloon Catheter is clinically indicated for the following conditions:
a. Acute Coronary Syndrome
b. Cardiac and Non-Cardiac Surgery
c. Complications of Heart Failure

Device Description

The device is a dual lumen percutaneously inserted Intra-Aortic IAB catheter, 8 Fr. in size, with two independent non-communicating lumens. The outer lumen is comprised of an inflatable bladder connected to the catheter distal tip and to the IAB 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 tip inner surface. The IAB inner lumen is used for placement of the device with a guidewire and the outer lumen is used to shuttle helium gas to and from the inflatable bladder. The IAB is timed to inflate in the aorta during the diastolic relaxation of the heart and deflate during the systolic contraction of the heart, resulting in increased blood supply to the heart muscle and decreased work load for the left ventricle.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the 8Fr. NarrowFlex Universal Intra-Aortic Balloon Catheter. The document assesses the substantial equivalence of the new device to a predicate device. However, it does not contain information about specific acceptance criteria, comprehensive study designs, or detailed performance data as would be typically found in a clinical trial report or a more extensive validation study summary.

Therefore, many of the requested items (sample size, data provenance, expert qualifications, adjudication method, MRMC study, effect size, standalone performance, ground truth details, training set information) cannot be extracted from this document because they are not present.

Below is a summary of the available information, noting where requested details are absent.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Technological Equivalence (Implied): The device should have the same technological characteristics as the predicate.	The device has the "same exact technological characteristics as the predicate."
IAB Performance (Implied): Inflate/deflate characteristics, total cycle time, and volume at all rates should be comparable to the predicate.	"IAB performance comparisons, Inflate/deflate, total cycle time and volume (all rates)" were conducted. Results "demonstrate that the device is substantially equivalent to the legally marked predicate device."
Nitinol Inner Lumen Stiffness and Buckling Point (Implied): Stiffness and buckling point should be comparable to the predicate.	"Nitinol inner lumen stiffness and buckling point - Stiffness bend test and buckling point comparison test results" were conducted. Results "demonstrate that the device is substantially equivalent to the legally marked predicate device."

Note on Acceptance Criteria: The document implies acceptance criteria by stating that the new device has the “same exact technological characteristics as the predicate” and that test results “demonstrate that the device is substantially equivalent.” Specific numerical thresholds or acceptance ranges are not provided.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document only mentions "tests" were conducted but does not provide details on the number of devices or data points included in these tests (e.g., number of balloons tested, number of inflate/deflate cycles).
Data Provenance: Not specified. These appear to be laboratory performance tests, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. The "ground truth" in this context refers to laboratory performance metrics against a predicate device, not clinical diagnoses requiring expert consensus.

4. Adjudication method for the test set

Not Applicable. As the tests are performance comparisons against a predicate, there is no expert adjudication process described.

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. This document pertains to an intra-aortic balloon catheter, a physical medical device. It does not describe an AI-powered diagnostic tool, therefore, MRMC studies and AI assistance are not relevant.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is the performance characteristics of the legally marketed predicate device. The new device's performance was compared against these established characteristics through laboratory testing.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an algorithm that requires a training set.

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

Not Applicable. This is a physical medical device, not an algorithm that requires a training set.

Summary

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

June 14, 2016

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

Re: K993966

Trade/Device Name: 8Fr. NarrowFlex Universal Intra-Aortic Balloon Catheter Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-aortic balloon and control system Regulatory Class: Class II Product Code: DSP Dated: January 14, 2000 Received: January 19, 2000

Dear William Paquin:

This letter corrects our substantially equivalent letter of February 18, 2000.

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 or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - William Paquin

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/MedicalDevices/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) K993966

Device Name

8Fr. Narrowflex Universal Intra-Aortic Balloon Catheter

Indications for Use (Describe)

The 8Fr. Narrowflex Universal Intra-Aortic Balloon Catheter 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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K993966

Image /page/3/Picture/1 description: The image shows the word "Teleflex" in a bold, sans-serif font. The letters are black, and the background is white. There is a registered trademark symbol after the word "Teleflex". The word appears to be a company logo.

510(k) Summary K993966

8Fr. NarrowFlex Universal Intra-Aortic Balloon Catheter

Date Prepared: November 3, 1999 Date Summary Updated: July 10, 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 RA/QA Arrow International, Inc. 16 Elizabeth Drive, Chelmsford, MA 01824 Phone (978)250-5100 Fax (978)250-5105

C. Device Name

Trade Name: 8Fr. NarrowFlex Universal Intra-Aortic Balloon Catheter Common Name: Intra-aortic balloon catheter Classification Name: Balloon, Intra-Aortic and Control System

D. Predicate Devices

The device is substantially equivalent to the current legally Arrow 8Fr. NarrowFlex Universal Intra-Aortic Balloon Catheter Kit.

Description of Device E.

The catheter is available in two sizes, 30cc and is identical in appearance and function to

Arrow International, Inc.

9 Plymouth Street Everett. MA 02149 USA Phone: 617-389-6400 617-387-2157 Fax:

www.teleflex.com

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Teleflex®

the predicate devices.

F. Intended Use

The 8Fr. NarrowFlex Universal Intra-Aortic Balloon Catheter is indicated for use in any of the following conditions:

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

G. Technological Characteristics

The device has the same exact technological characteristics as the predicate.

The tests in the submission include:

IAB performance comparisons, Inflate/deflate, total cycle time and volume (all rates). .
. Nitinol inner lumen stiffness and buckling point - Stiffness bend test and buckling point comparison test results.

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