This cannula is intended for use in conjunction with cardiopulmonary bypass surgery for up to 6 hours. When properly placed, it can be used to deliver blood (or fluids) to the proximal end of a vein graft.

Device Description

The cannula has a graduated, soft silicone, rubber tip to accommodate vessels of various sizes. The attached 50.8 cm (20 in) flexible tube has a clamp to stop flow through the cannula. Model 10011 has an additional clamp on the antegrade outlet line to stop the flow of fluid into the antegrade cannula. The antegrade cannula connector is a male luer adapter. The cardioplegia inlet fitting is a female luer port. Sterile, nonpyrogenic, single use.

AI/ML Overview

The provided text is a 510(k) Pre-Market Notification for the DLP® Vein Graft Cannula. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a comprehensive clinical or standalone study with detailed performance metrics.

Therefore, the document does not contain the information required to answer most of your questions, as it is structured differently from what would be presented for a study proving device acceptance criteria in the manner you've outlined.

However, I can extract the limited "performance data" presented and explain why other requested information is not available in this document.

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

The document does not explicitly state acceptance criteria in the format of specific thresholds for the performance metrics tested. Instead, it reports "Pass" for the conducted tests, implying that the device met an unstated internal acceptance criterion.

Test Conducted	Reported Device Performance
For Model 10010 (Bonding to male luer)
Air Flow Test	Pass
Leak Test	Pass
Bond Strength Test	Pass
For Model 10010 (Y-Connector changed to in-house manufacturing)
Air flow test	Pass

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

This information is not available in the provided document. The 510(k) summary only lists the type of tests performed and the results ("Pass") but does not detail the methodology, sample sizes, or data provenance.

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)

This information is not applicable and therefore not available. The "ground truth" concept is typically relevant for studies involving subjective interpretation (e.g., image analysis, clinical diagnosis), where expert consensus or pathology is used to validate an AI algorithm's output. The tests described here are engineering/performance verification tests for a physical medical device (cannula), not an AI or diagnostic tool.

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

This information is not applicable and therefore not available for the same reasons as point 3. Adjudication methods are relevant for resolving discrepancies in expert interpretations, which is not the nature of the tests performed on this device.

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

This information is not applicable and therefore not available. An MRMC study is relevant for evaluating the impact of an AI system on human diagnosticians' performance. The DLP® Vein Graft Cannula is a physical medical device used in surgery, not an AI or diagnostic tool that would involve human "readers."

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

This information is not applicable and therefore not available. The concept of "standalone performance" refers to the performance of an algorithm without human intervention. This device is a physical surgical cannula and does not involve an algorithm.

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

This information is not applicable in the context of the device's performance tests. The "ground truth" in this context would be the objective physical properties and functional performance of the cannula as measured against engineering specifications (e.g., bond strength exceeding a certain threshold, no leaks under pressure). The document doesn't detail these specific underlying ground truths or specifications.

8. The sample size for the training set

This information is not applicable and therefore not available. "Training set" refers to data used to train an AI algorithm. The DLP® Vein Graft Cannula is a physical medical device and does not involve an AI algorithm or a training set.

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

This information is not applicable and therefore not available for the same reasons as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.

Public Health Service

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

January 7, 2015

Medtronic, Inc. Kevin Lam Senior Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, MN 55428

Re: K143107

Trade/Device Name: DLP Vein Graft Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II Product Code: DWF Dated: December 4, 2014 Received: December 8, 2014

Dear Mr. Lam,

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (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.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,

M.A. Hilleman

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Device Name

DLP® Vein Graft Cannula

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

� 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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) Summary

Date Prepared:	December 4, 2014
Applicant:	Medtronic, Inc.Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428Establishment Registration Number: 2184009
Contact Person:	Kevin T. LamSenior Regulatory Affairs SpecialistMedtronic, Inc.Phone: (763) 526-2360Fax: (763) 367-8360Email: kevin.t.lam@medtronic.com
	Alternate Contacts:Susan C. FidlerSenior Regulatory Affairs ManagerMedtronic, Inc.Phone: (763) 514-9839Fax: (763) 367-8360Email: susan.c.fidler@medtronic.com
Device Name and ClassificationTrade Name:	DLP® Vein Graft Cannula

Common Name:

Product Code:

Regulation Number:

Product Classification:

Models: 10010 and 10011

Cardiopulmonary bypass vascular catheter, cannula, or tubing

DWF

21 CFR 870.4210

Class II

Classification:

Predicate Device

DLP® Vein Graft Cannula K791832

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Indications for Use

Device Description

Comparison to Predicate Devices

Same intended use
Same technological characteristics
. Same operating principle
. Same design features
Same base materials Acrylic, Polypropylene, Polyvinyl chloride (PVC), Silicone ●
Same shelf life ●

Summary of Performance Data

Testing has demonstrated that the DLP® Vein Graft Cannula is substantially equivalent to the predicate.

The following performance tests were conducted:

Change	Verification/Validation	Results
For Model 10010Bonding to male luer	Air Flow TestLeak TestBond Strength Test	PassPassPass
For Model 10010Y-Connector changed to in-house manufacturing	Air flow test	Pass

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Conclusion

Medtronic has demonstrated that the modifications made to the DLP® Vein Graft Cannulae products described in this submission resulted in a substantially equivalent device because the fundamental scientific principle, operating principle, design features, and intended use are unchanged from the predicate device.

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).