The device is a dual lumen percutaneously inserted Intra-Aortic IAB catheter, 8Fr. 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.
The catheter is available in an 8Fr. 30cc and 40cc sizes, and is identical in appearance and function to the predicate devices.

AI/ML Overview

This submission is a 510(k) premarket notification for the Arrow Ultra 8 Intra-Aortic Balloon Catheters (IAB) 8 Fr 30cc and 40cc Universal. As such, it is a notification claiming substantial equivalence to a predicate device, rather than a de novo submission or a PMA which would typically include detailed clinical study data with acceptance criteria for novel devices.

Therefore, the information you're requesting regarding acceptance criteria, specific study details (sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance), and training set information is not present in this 510(k) summary document.

Here's what can be extracted and inferred:

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

Acceptance Criteria	Reported Device Performance
Not explicit in document. The primary "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device.	"The results of the laboratory tests demonstrate that the device is substantially equivalent to the legally marketed predicate devices." (Implied to meet all relevant performance characteristics for an IAB catheter as demonstrated by the predicate.)

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

Not explicitly stated. The document mentions "laboratory tests" were performed, but no details about sample size (number of catheters tested, number of simulated cycles, etc.) or data provenance are provided. This is typical for a 510(k) where detailed test reports are submitted separately and referenced.

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)

Not applicable/Not stated. This type of information is typically relevant for studies involving diagnostic image interpretation or clinical outcomes adjudicated by specialists. Given that this is a balloon catheter, the "tests" would likely involve engineering performance (e.g., inflation/deflation times, material integrity, guidewire compatibility) rather than expert-adjudicated clinical data in the form you describe.

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

Not applicable/Not stated. See point 3.

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

No. This is a medical device (intra-aortic balloon catheter), not an AI diagnostic tool or software. Therefore, an MRMC study is 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 (expert consensus, pathology, outcomes data, etc)

Inferred: The "ground truth" for demonstrating substantial equivalence for this type of device would be established engineering and performance specifications, material standards, and clinical performance expectations for the predicate device. For example, balloon integrity might be tested against known pressure thresholds, or deployment characteristics against established clinical needs. However, the specific "type" is not detailed in terms of the categories you provided.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. See point 8.

Summary of what the document does provide:

Predicate Device: The new device is substantially equivalent to the current legally marketed Arrow 8Fr. 30cc and 40cc Universal Intra-Aortic Balloon Catheter Kits.
Technological Characteristics: States the device has "similar technological characteristics as its predicates."
Performance Claim: "The results of the laboratory tests demonstrate that the device is substantially equivalent to the legally marketed predicate devices."

In essence, this 510(k) relies on the established safety and effectiveness of its predicate device, and the "study" demonstrating this involves "laboratory tests" proving the new device's performance is comparable to the predicate. The details of these lab tests (specific protocols, sample sizes, methods of evaluation) are not included in this public summary but would have been part of the full 510(k) submission to the FDA.

Summary

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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: K000729

Trade/Device Name: Arrow Ultra 8 Intra-Aortic Balloon Catheters (IAB) 8 Fr 30cc and 40cc Universal Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-aortic balloon and control system Regulatory Class: Class II Product Code: DSP Dated: March 2, 2000 Received: March 6, 2000

Dear William Paquin:

This letter corrects our substantially equivalent letter of May 19, 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

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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/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) K000729

Device Name

Arrow Ultra 8 Intra-Aortic Balloon Catheters (IAB) 8 Fr 30cc and 40cc Universal

Indications for Use (Describe)

The Arrow Ultra 8 Intra-Aortic Balloon Catheters (IAB) 8 Fr 30cc and 40cc Universal 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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K000729

Image /page/3/Picture/1 description: The image shows the word "Teleflex" in a bold, sans-serif font. The word is all in uppercase letters, and there is a registered trademark symbol after the "x". The text is black and the background is white.

Arrow International, Inc.

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

www.teleflex.com

510(k) Summary K000729

Arrow Ultra 8 Intra-Aortic Balloon Catheters (IAB) 8FR 30CC and 40CC Universal

Date Prepared: March 2, 2000 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

Mike 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:	Arrow Ultra 8™ Intra-Aortic Balloon Catheter8Fr. 30cc and 40cc Universal
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 marketed Arrow 8Fr. 30cc and 40cc Universal Intra-Aortic Balloon Catheter Kits.

ய் Description of Device

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the heart, resulting in increased blood supply to the heart muscle and decreased work load for the left ventricle.

The catheter is available in an 8Fr. 30cc and 40cc sizes, and is identical in appearance and function to the predicate devices.

F. Intended Use

The Arrow Ultra 8 Intra-Aortic Balloon Catheter is indicated for use in any of the following conditions:

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

G. Technological Characteristics

The device has similar technological characteristics as its predicates.

The results of the laboratory tests demonstrate that the device is substantially equivalent to the legally marketed predicate devices.

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.