The MiAR™ cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia up to 6 hours. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct visualization techniques.

Device Description

MiARTM Cannulae are single-use, sterile, nonpyrogenic devices designed to deliver cardioplegia through the aorta in an antegrade manner, for periods up to six hours during cardiopulmonary bypass surgery. These devices are available in models that feature two tip sizes and the Flow-Guard™ feature to maintain hemostasis during removal of the introducer needle from the cannula. The increased overall length of these cannulae relative to standard models, make them easier to use when minimally invasive surgical approaches are utilized (i.e., mini-sternotomy and right thoracotomy).

AI/ML Overview

The provided document is a 510(k) summary for the Medtronic MiAR™ Aortic Root Cannula with Flow-Guard™. This is a medical device, and the document focuses on demonstrating substantial equivalence to predicate devices rather than proving a specific diagnostic or therapeutic performance based on complex acceptance criteria and clinical trials, which would be typical for an AI/ML powered device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or extractable from this type of regulatory submission.

However, I can extract the general acceptance criteria used for this device, which are based on engineering performance characteristics.

Here's a summary of the requested information based on the provided text, indicating where information is not applicable (N/A) due to the nature of the device and submission:

Acceptance Criteria and Device Performance for Medtronic MiAR™ Aortic Root Cannula with Flow-Guard™

The Medtronic MiAR™ Aortic Root Cannula with Flow-Guard™ is a Class II medical device intended for use during cardiopulmonary bypass. The regulatory submission focused on demonstrating substantial equivalence to predicate devices (Medtronic DLP Aortic Root Cannula K790565 and Medtronic Pediatric Aortic Root Cannula K040173) through bench testing. Clinical testing was not required to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Characteristic)	Reported Device Performance
Flow Rate Versus Pressure Drop	Met - Bench testing conducted. (Implicitly, performance was comparable to predicate devices or within acceptable engineering limits as no new issues of safety/effectiveness were raised).
Distal Tip Visibility Under Fluoroscopic Visualization	Met - Bench testing conducted. (Implicitly, performance was comparable to predicate devices or within acceptable engineering limits).
Structural Integrity (bonded joints)	Met - Bench testing conducted. (Implicitly, performance was comparable to predicate devices or within acceptable engineering limits).
Technological Characteristics	Same as predicate devices.
Operating Principle	Same as predicate devices.
Design Features (excluding length)	Same as predicate devices (only longer length).
Flow-Guard™ Introducer	Same as predicate devices.
Connectors	Same as predicate devices.
Materials	Same as predicate devices.
Shelf Life	Same as predicate devices.

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

Sample Size for Test Set: Not specified. The document states "Bench testing was used," implying a series of laboratory tests. Specific sample sizes for each bench test are not provided in this 510(k) summary.
Data Provenance: Bench test data. Not applicable for country of origin or retrospective/prospective as it relates to clinical data.

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

Not Applicable. Ground truth, in the context of expert consensus for diagnostic accuracy, is not relevant for this device's performance assessment. Performance was established via engineering bench tests.

4. Adjudication method for the test set

Not Applicable. Adjudication methods are typically for subjective assessments or discrepancy resolution in clinical studies, not for objective engineering bench tests.

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 not an AI/ML powered device, and no MRMC study was conducted.

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

Engineering Standards and Specifications. The "ground truth" for this device's performance would be the pre-defined engineering specifications, material properties, and functional requirements, against which the bench test results were compared.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI/ML model, so there is no "training set."

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

Not Applicable. As there is no training set for an AI/ML model, this question is not applicable.

Summary

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510(k) Summary

MiAR™ Aortic Root Cannula with Flow-Guard™ Traditional 510/k

Date Prepared:	January 28, 2010	MAY 10 2010
Submitter:	Medtronic 7611 Northland Drive Minneapolis, MN 55428 Establish Registration Number: 2184009
Contact Person:	Caralee Walton Senior Regulatory Affairs Specialist Phone: (763) 514-9851 Fax: (763) 367-8360 Email: caralee.a.walton@medtronic.com

Device Name and Classification

Trade Name:	MiART™ (Minimally Invasive) Aortic Root Cannula with Flow-Guard™
Common Name:	Cardiopulmonary bypass vascular catheter, cannula, or tubing
Regulation Number:	21 CFR 870.4210
Product Code:	DWF
Classification:	Class II

Predicate Devices

Medtronic DLP Aortic Root Cannula (K790565) Medtronic Pediatric Aortic Root Cannula (K040173)

Device Description

Indications for Use

The MiAR™ cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia for up to 6 hours. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct visualization techniques.

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Comparison to Predicate Devices

A comparison of the modified product and the currently marketed Aortic Root Cannula indicates the following similarities to the device which received 510(k) clearance:

. Same technological characteristics
Same operating principle .
Same design features, only longer length .
. Same Flow-Guard™ introducer
Same connectors .
Same materials ●

Same shelf life .

Summary of Performance Data

Bench testing was used to establish the performance characteristics of the modifications of this device from previously marketed Medtronic cannula devices. Clinical testing was not required to establish substantial equivalence. The following performance tests were conducted:

. Flow Rate Versus Pressure Drop
. Distal tip visibility Under Fluoroscopic Visualization
Structural Integrity (bonded joints) .

Conclusion

Medtronic has demonstrated that the MiAR™ Cannulae are substantially equivalent to the predicate device based upon design and test results. Any noted differences do not raise new issues of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAY 1 0 2010

Medtronic, Inc. c/o Ms. Caralee A. Walton Senior Regulatory Affairs Specialist 710 Medtronic Parkway NE Minneapolis, MN 55432

Re: K100274

MiAR™ (Minimally Invasive) Aortic Root Cannula with Flow-Guard™ Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: II Product Code: DWF Dated: May 3, 2010 Received: May 4, 2010

Dear Ms. Walton:

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.

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 - Ms. Caralee A. Walton

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.him 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,

R. Richmen

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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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MiAR™ Aortic Root Cannula with Flow-Guard™ Traditional 510(k)

Indications for Use

510(k) Number (if known): _ K100274

Device Name: MiAR™ Aortic Root Cannula with Flow-Guard™

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dina R. Viinik

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K\00274

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).