The Intra-Aortic Balloon (IAB) 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. The devices are dual lumen percutaneously inserted Intra-Aortic IAB catheters, with two independent non-communicating 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. IABs are timed to inflate within the aota 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

This appears to be a 510(k) summary for an Intra-Aortic Balloon (IAB) device. The document does not describe a study involving an AI component or a specific algorithm. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is common for medical device clearances that are not novel AI/ML devices.

Therefore, most of the requested information about acceptance criteria, study design, and AI performance metrics is not applicable to this document. The document primarily focuses on the device description, indications for use, and a list of predicate devices used to establish substantial equivalence.

Here's an attempt to answer the questions based on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" given the nature of the document:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics in the manner typically seen for AI/ML performance. The document implies the acceptance criterion is "substantial equivalence" to predicate devices based on technological characteristics and intended use.
- Reported Device Performance: The document states, "The results of the laboratory tests demonstrate that the device is substantially equivalent." No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are provided, as this is not a study reporting on diagnostic or predictive output.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. The document refers to "laboratory tests" but does not detail the sample size or provenance of data used in those tests, as it's a submission for an IAB device, not an AI study.
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 provided. Ground truth establishment by experts is not relevant in this context, as it's about the physical and functional characteristics of an IAB device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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 is not an AI/ML device, and no MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm with standalone performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For a substantial equivalence claim for an IAB, ground truth would relate to its physical and functional specifications meeting design requirements and performance similar to predicate devices, rather than a diagnostic 'truth'.
The sample size for the training set
- Not applicable/Not provided. There is no AI training set for this device.
How the ground truth for the training set was established
- Not applicable/Not provided.

Summary

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

June 15, 2016

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

Re: K040801

Trade/Device Name: Intra-Aortic Balloon Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-aortic balloon and control system Regulatory Class: Class II Product Code: DSP Dated: March 25, 2004 Received: April 6, 2004

Dear William Paquin:

This letter corrects our substantially equivalent letter of May 6, 2004.

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. Iisting 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/Resourcesfor You/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) K040801

Device Name Intra-Aortic Balloon (IAB)

Indications for Use (Describe)

The Intra-Aortic Balloon (IAB) 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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K040801

Image /page/3/Picture/1 description: The image shows the word "Teleflex" in a bold, sans-serif font. The letters are closely spaced together, and the word appears to be slightly italicized. There is a registered trademark symbol to the right of the word.

Arrow International, Inc

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

www.teleflex.com

510(k) Summary K040801

Intra-Aortic Balloon (IAB)

Date Prepared: March 25, 2004 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: Intra-Aortic Balloon (IAB) Common Name: Intra-Aortic Balloon Catheter Classification Name: Balloon, Intra-Aortic

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	Catalog
K970689	IAB 8Fr, 30/40cc and, 10 Fr, 50cc with Peel-Away Hemostasis	IAB-042XX-U
K963920	IAB 8Fr, 30cc Arrow NarrowFlex Universal	IAB-04830-U
K993966	IAB 8Fr, 40cc Arrow NarrowFlex Universal	IAB-04840-U
K000729	IAB 8Fr, 30/40cc Arrow Ultra Series	IAB-058XX-U /IAB-68XX-U
K021462	IAB 8Fr, 30/40cc Arrow Ultra Series with Light Wave Sensor	IAB-058XX-LWS

E. Description of Device

IAB's are designed to provide cardiac assist therapy. The devices are dual lumen percutaneously inserted

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Image /page/4/Picture/0 description: The image shows the word "Teleflex" in a stylized font. The letters are all in lowercase, except for the first letter, which is uppercase. The word is in black and the background is white. There is a registered trademark symbol after the word.

Intra-Aortic IAB catheters, with two independent non-communicating 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. IABs are timed to inflate within the aota 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.

F. Intended Use

The 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 C.

G. Technological Characteristics

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.