The Sarns™ High-Flow Aortic Arch Cannula is indicated for perfusion of the ascending aorta during cardiopulmonary bypass surgery for up to 6 hours of use.

Device Description

The design of the Sams™ High-Flow Aortic Arch Cannula allows patient blood to re-enter the body after the blood has routed through an extracorporeal circuit for blood oxygenation. The design of the cannula is simple in that it consists of a tubular conduit with a tip that can be positioned into the patient's anatomy (ascending aorta) to allow the blood to re-enter the vascular blood stream.

AI/ML Overview

The provided text describes a 510(k) submission for the Sarns™ High-Flow Aortic Arch Cannula, which is a modification of a previously cleared device. The submission asserts substantial equivalence to predicate devices and does not involve an AI device. Therefore, many of the requested details related to AI performance studies are not applicable.

Here's an attempt to extract relevant information and explain why other sections are not applicable:

Acceptance Criteria and Device Performance for Sarns™ High-Flow Aortic Arch Cannula (K133151)

This 510(k) submission is for a medical device (aortic cannula) and not an AI/ML-based diagnostic or therapeutic device. Therefore, many of the requested criteria related to AI performance, such as sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable.

The submission focuses on demonstrating substantial equivalence to existing predicate devices through bench testing and comparison of design, materials, and intended use.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table format for the modifications. Instead, it lists "Performance Evaluations" conducted to ensure the modified devices "continue to satisfy appropriate device performance specifications and to ensure that they satisfy customer needs." The implicit acceptance criterion is that the modified device performs comparably to the predicate device and retains its safety and effectiveness.

Performance Evaluation	Implicit Acceptance Criteria (based on "no appreciable differences" and "retained integrity")	Reported Device Performance
Force at break	Comparable to predicate device; sufficient strength for intended use.	Performance studies conducted; "no appreciable differences" reported between subject and predicate.
Liquid and air leak	Comparable to predicate device; no leaks.	Performance studies conducted; "no appreciable differences" reported between subject and predicate.
Ink adhesion	Comparable to predicate device; sufficient ink adhesion for labeling/markings.	Performance studies conducted; "no appreciable differences" reported between subject and predicate.
Hemolysis	Comparable to predicate device; acceptable levels of hemolysis.	Performance studies conducted; "no appreciable differences" reported between subject and predicate.
Torque	Comparable to predicate device; appropriate torque characteristics.	Performance studies conducted; "no appreciable differences" reported between subject and predicate.
Corrosion	Comparable to predicate device; no unacceptable corrosion.	Performance studies conducted; "no appreciable differences" reported between subject and predicate.
Pressure drop	Comparable to predicate device; acceptable pressure drop characteristics.	Performance studies conducted; "no appreciable differences" reported between subject and predicate.

Note: The document states that "Terumo Cardiovascular has conducted performance studies with the modified devices to ensure that they all continue to satisfy appropriate device performance specifications and to ensure that they satisfy customer needs. There are no appreciable differences between the subject devices and the predicate devices." This implies that the modified device met the performance standards established for the predicate device across these evaluations.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable in the context of an AI device. For this medical device, the "test set" would refer to the samples of the Sarns™ High-Flow Aortic Arch Cannula that underwent the bench performance evaluations. The document does not specify the exact number of cannulas tested for each evaluation. The provenance of the data is from Terumo Cardiovascular Systems Corporation's internal bench testing activities. These studies are prospective from the perspective of evaluating the modified device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. Ground truth for the performance evaluations of a physical medical device (like an aortic cannula) is established through laboratory measurements and engineering specifications, not expert interpretation of outputs.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically relevant for human interpretation or consensus in diagnostic or prognostic studies, not for the direct measurement of device performance characteristics.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI algorithms in diagnostic tasks, often comparing human readers with and without AI assistance. This submission pertains to a physical medical device.

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

Not applicable. This is not an AI algorithm. The performance evaluations listed ("force at break," "liquid and air leak," etc.) measure the physical properties and function of the device itself.

7. The Type of Ground Truth Used

For the performance evaluations, the "ground truth" would be the engineered specifications and performance characteristics of the predicate device, against which the modified device's performance was compared. This is based on engineering specifications and direct physical measurements rather than expert consensus, pathology, or outcomes data in the typical sense of AI/clinical studies.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this type of medical device submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Terumo Cardiovascular Systems. The logo consists of a circle with a T inside of it, followed by the word "TERUMO" in bold, sans-serif font. Below the word "TERUMO" is the phrase "Cardiovascular Systems" in a smaller, sans-serif font. The logo is black and white.

ﺔ ﺍﻟﺘﻲ

FEB - 3 2014

K133151

SECTION 5-510(K) SUMMARY Sarns™ High-Flow Aortic Arch Cannula

Date Prepared:

September 2013

Sponsor Information: Owner/Applicant/Submitter:

Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, Michigan 48103 Phone: 1-800-262-3304 Fax: 410-398-6079 Registration No. 1828100

Contact Person:

Garry A. Courtney, MBA, RAC Corporate Director, Regulatory Affairs 125 Blue Ball Road Elkton, MD 21921 Phone: 1-800-262-3304 ext. 7486 Fax: 410-398-6079 Email: garry.courtney@terumomedical.com

Device Names/Classifications:

Device Trade Name:	Sarns™ High-Flow Aortic Arch Cannula
Device Common Name:	Aortic cannula for cardiopulmonary bypass
Classification Name:	Cardiopulmonary bypass vascular catheter, cannula, tubing
Regulation Number:	21 CFR 807.4210
Classification:	Class II
Product Code:	DWF

Predicate Devices:

Sarns™ High Flow Aortic Arch Cannula, K770429 .
Sarns™ X-coated Aortic Cannula, K083301 .

Purpose of Submission:

Terumo Cardiovascular Systems is submitting this Premarket Notification due to cumulative changes that have been made since the time that the original submissions were cleared by FDA. Although none of the individual changes were determined to be significant, Terumo Cardiovascular Systems Corporation believes it is appropriate to submit a 510(k) that represents the devices in their current design state.

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Image /page/1/Picture/0 description: The image shows the Terumo Cardiovascular Systems logo. The logo consists of a circle with a T inside of it, followed by the word "TERUMO" in bold, sans-serif font. Below the word "TERUMO" is the phrase "Cardiovascular Systems" in a smaller, sans-serif font.

Intended Use/Indications for Use:

The Sarns™ High-Flow Aortic Arch Cannula is indicated for perfusion of the ascending aorta during cardiopulmonary bypass surgery for up to 6 hours of use.

Principles of Operation and Technology:

The subject devices are modifications of the predicate devices, and these modifications do not impact the technology of the predicate devices, the principles of operation and do not raise different or new questions of safety and effectiveness from the predicates. The Sarns™ High-Flow Aortic Arch Cannula provides a conduit for the flow of patient blood within the extracorporeal circuit during cardiopulmonary bypass surgery. Typically, blood is gravity drained from the body into a blood reservoir. From the reservoir, blood then is propelled through the balance of the extracorporeal circuit via a roller pump or centrifugal pump. The Sams™ High-Flow Aortic Arch Cannula is a component within the circuit that tunnels patient blood back into the body.

Design and Materials:

The materials of construction for the Sarns™ High-Flow Aortic Arch Cannula can include polyvinylchloride, PMEA polymer, polyethylene, acrylonitrile butadiene styrene and stainless steel.

Performance Evaluations:

Clinical studies involving patients are not necessary to demonstrate the safety and effectiveness of the subject devices. Performance assessments for safety and effectiveness were accomplished through bench studies that included the following evaluations:

force at break
liquid and air leak .
ink adhesion .
hemolysis .
torque .
corrosion .
pressure drop .

Substantial Equivalence Comparison:

The information presented in this section depicts a comparison between the subject device, the modified Sarns™ High-Flow Aortic Arch Cannula and the predicate device, the unmodified Sarns™ High-Flow Aortic Arch Cannula.

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Image /page/2/Picture/0 description: The image shows the logo for Terumo Cardiovascular Systems. The logo consists of a circle with the letter 'T' inside, followed by the word 'TERUMO' in bold, sans-serif font. Below the word 'TERUMO' is the text 'Cardiovascular Systems' in a smaller, sans-serif font.

Comparison of Intended Use:

The modified Sarns™ High-Flow Aortic Arch Cannula and the predicate Sarns™ High-Flow Aortic Arch Cannula have the exact same intended use statements:

The modified and the unmodified Sarns™ High-Flow Aortic Arch Cannulae are each indicated for perfusion of the ascending aorta during cardiopulmonary bypass surgery for up to 6 hours of use.

Duration of Use:

The modified Sarns™ High-Flow Aortic Arch Cannula and the predicate Sarns™ High-Flow Aortic Arch Cannula can both be used in procedures lasting up to 6 hours in duration.

Comparison of Labeling: .

The labeling that will be used for the modified device is similar to the labeling used with the predicate device, although some labeling is revised to provide greater clarity for the user. The revised instructions labeling accurately presents the directions that are necessary for the end-user to employ the device in a safe and effective manner. Terumo submits that the labeling complies with applicable regulations in those regions where the device is to be distributed.

Comparison of Operation and Technology:

The modified Sarns™ High-Flow Aortic Arch Cannula and the predicate Sams™ High-Flow Aortic Arch Cannula utilize the exact same technologies and principles of operation. The technology of the modified Cannula is not impacted by the modifications made to the subject device.

Comparison of Design:

With respect to the design of the modified Sarns™ High-Flow Aortic Arch Cannula, there have been no significant design changes implemented. Terumo has made non-significant changes since the original submission of these devices - each of which has been determined to maintain the integrity of the product without adversely impacting safety and/or performance.

Comparison of Materials:

The materials of construction used in the modified Sarns™ High-Flow Aortic Arch Cannula are the same generic materials that are used in the predicate device with the addition of an luer cap made of ABS plastic. Both the modified Sarns™ High-Flow Aortic Arch Cannula and the predicate cannula have been demonstrated to meet biocompatibility requirements.

Comparison of Performance:

Terumo Cardiovascular has conducted performance studies with the modified devices to ensure that they all continue to satisfy appropriate device performance specifications and to ensure that they satisfy customer needs. There are no appreciable differences between the subject devices and the predicate devices.

Conclusion:

The information and data included in the 510(k) notice demonstrate the Sams™ High-Flow Aortic Arch Cannula is substantially equivalent to the predicate devices for perfusion of the ascending aorta during cardiopulmonary bypass for up to 6 hours of use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

February 3, 2014

Terumo Cardiovascular Systems Corporation . Garry Courtney, MBA, RAC 6200 Jackson Road Ann Arbor, MI 48103

Re: K133151

Trade/Device Name: Sarns™ High-Flow Aortic Arch Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiovascular (74) Regulatory Class: II Product Code: DWF Dated: September 27, 2013 Received: October 17, 2013

Dear Mr. Courtney:

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 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.

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Page 2 - Mr. Garry Courtney

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance 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.

M. A. Holliem

for Bram Zuckerman, MD Director, Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for Terumo Cardiovascular Systems. The logo consists of a circle with the letter T inside, followed by the word "TERUMO" in bold, sans-serif font. Below the word "TERUMO" is the phrase "Cardiovascular Systems" in a smaller, regular font. The logo is simple and professional, and it is likely used to represent the company on its products and marketing materials.

SECTION 4 - INDICATION FOR USE Sarns™ High-Flow Extended Aortic Arch Cannula

510(k) Number (if known):

K133151 Unknown at time of submission

Device Name:

Sarns™ High-Flow Aortic Arch Cannula

Indications for Use:

Device Intended Use - The device is indicated for perfusion of the ascending aorta during cardiopulmonary bypass surgery for up to six hours of use.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. Z. Hillerman

Regulation Number and Section

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).