This device is intended for use during cardiopulmonary bypass surgery up to six hours or less, for the delivery of cardioplegia retrogradely through the coronary sinus.

Device Description

The cannulae consist of either a Polyvinyl Chloride (PVC) body or a silicone wirewound kink-resistant body with auto-inflate cuff. The cannula is used for direct cannulation within the coronary sinus to deliver cardioplegia solution during cardiopulmonary bypass surgery. The back of the cannula body terminates in a locking female luer. These cannulae utilize a guidewire or solid stylet to facilitate trans-atrial introduction. The cannulae are nonpyrogenic. single use, and sterile.

AI/ML Overview

The provided text describes a 510(k) summary for the DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff. This is a medical device submission, and the content primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance criteria through detailed studies involving human subjects or complex AI algorithms.

Therefore, many of the requested categories in your prompt, particularly those related to AI performance, sample sizes for training/test sets, ground truth establishment by experts, and MRMC studies, are not applicable to this type of device submission as described in the provided text. This submission focuses on engineering and functional testing for a physical medical device.

However, I can extract the relevant information concerning acceptance criteria and the engineering/functional study that proves the device meets those criteria from the provided text.

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

Acceptance Criteria (Implied)	Reported Device Performance
Design Verification Testing: - Pass kink test - Pass simulated use test - Pass bond joint tensile test - Pass leak testing of all bonded connections - Pass introducer twist test - Pass introducer tensile test	Summary of Design Verification Testing: The DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff product family added an additional French size option. Samples were subjected to a kink test, a simulated use test, functional tests of the cannula (bond joint tensile test and leak testing of all bonded connections), and functional tests of the introducer (twist test and tensile test). All samples passed the verification testing.
Performance Testing: - Acceptable retention within the coronary sinus (retention force testing)	Summary of Performance Testing: The DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff product family added an additional cuff style. Samples were subjected to retention force testing to ensure acceptable retention within the coronary sinus. All samples passed the verification testing.

Acceptance Criteria (Implied)

Reported Device Performance

Design Verification Testing: - Pass kink test - Pass simulated use test - Pass bond joint tensile test - Pass leak testing of all bonded connections - Pass introducer twist test - Pass introducer tensile test

Summary of Design Verification Testing: The DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff product family added an additional French size option. Samples were subjected to a kink test, a simulated use test, functional tests of the cannula (bond joint tensile test and leak testing of all bonded connections), and functional tests of the introducer (twist test and tensile test). All samples passed the verification testing.

Performance Testing: - Acceptable retention within the coronary sinus (retention force testing)

Summary of Performance Testing: The DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff product family added an additional cuff style. Samples were subjected to retention force testing to ensure acceptable retention within the coronary sinus. All samples passed the verification testing.

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

Sample Size: The document repeatedly states "All samples" passed the verification and performance testing but does not specify the numerical sample size used for each test.
Data Provenance: Not specified. This is a submission to the US FDA, so the testing was likely conducted in the US, but the document does not explicitly state the country. The data is prospective as it was performed specifically for this submission.

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. This is a physical medical device. The "ground truth" for these engineering and functional tests is defined by the objective performance standards of the tests themselves (e.g., a certain force before failure, absence of leaks, successful simulation). Expert opinion in the manner of medical image interpretation is not relevant for these types of tests.

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

Not Applicable. As per point 3, this is not a study requiring expert adjudication of results. The tests are objective and pass/fail is determined by predefined engineering specifications.

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 is a physical medical device (cannula), not an AI-powered diagnostic or assistive technology. No human reader studies or MRMC studies were performed or are relevant to this submission.

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

Not Applicable. This is a physical medical device. There is no algorithm or AI component involved.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" here is the engineering and functional specifications for the device's performance (e.g., pre-defined force limits for tensile tests, quantifiable leak rates, ability to withstand kinking). These are objective criteria established during the device design and manufacturing process.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

Not Applicable. As per point 8, there is no training set for this type of device.

Summary

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510(k) Summary

December 6, 2012 Date Prepared: Submitter:

Medtronic, Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establishment Registration Number: 2184009

Contact Person:

Chelsea L. Pioske Associate Regulatory Affairs Specialist Medtronic Perfusion Systems Phone: 763.514.9838 Fax: 763.367.8360 Email: chelsea.pioske@medtronic.com

Alternate Contact:

Susan Fidler Senior Regulatory Affairs Manager Medtronic Perfusion Systems Phone: 763.514.9839 Fax: 763.367.8360 Email: susan.c.fidler(@medtronic.com

Device Name and Classification

DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Trade Name: Cuff Common Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing 21 CFR 870.4210 Regulation Number: Product Code: DWF Product Class II Classification:

Predicate Devices

Retrograde Coronary Sinus Perfusion Cannula K901074 K030696 Retrograde Coronary Sinus Perfusion Cannula without Pressure Monitoring Lumen

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Device Description

Indications for Use

This device is intended for use during cardiopulmonary bypass surgery up to six hours or less, for the delivery of cardioplegia retrogradely through the coronary sinus.

Comparison to Predicate Devices

A comparison of the modified product to the currently marketed products (K901074 and K030696) indicates the following similarities:

Same intended use
트 Same technological characteristics
Same operating principle
Same design features
Same base materials
Same shelf life ■

Summary of Design Verification Testing

The DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff product family added an additional French size option, which was tested through the design verification process. The samples were subjected to a kink test, a simulated use test, functional tests of the cannula (bond joint tensile test and leak testing of all bonded connections), and functional tests of the introducer (twist test and tensile test). All samples passed the verification testing.

Summary of Performance Testing

The DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff product family added an additional cuff style, which was performance tested. The samples were subjected to retention force testing to ensure acceptable retention within the coronary sinus. All samples passed the verification testing.

Conclusion

Medtronic has demonstrated that the modifications made to the DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff product family described in this submission result in a substantially equivalent device the fundamental scientific principle, operating principle, design features and intended from the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of a human figure with three arms or lines extending from the body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

March 27, 2013

Medtronic, Inc. C/O Chelsea Pioske 8200 Coral Sea Street NE Mounds View, MN 55433

Re: K123762 Trade/Device Name: DLP Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula or tubing Regulatory Class: Class II Product Code: DWF Dated: March 7, 2013 Received: March 8, 2013

Dear Ms. Pioske:

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 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

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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.html 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 (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.htmfor 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Matthew G. Hillebrenner

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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Statement of Indications for Use

510(k) Number (if known): K123762

Device Name: DLP® Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff

Indications for Use:

This device is intended for use during cardiopulmonary bypass surgery up to six hours or less, for the delivery of cardioplegia retrogradely through the coronary sinus.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Matthew G. Hillebrenner

Page 1 of 1

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).