These devices are to be used by a trained physician only. Cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriately sized cannula within the vessel for cardiopulmonary bypass. These products are intended for use up to 6 hours.

Device Description

The pediatric venous cannulae consist of a polyurethane wirewound body with a multi-port distal tip. All pediatric venous cannulae come with a non-vented 1/4-in connector. The one-piece nonphthalate PVC blunt and guidewire style introducers and included with these cannulae have an elongated taper for dilation over a longer distance.

The pediatric arterial cannulae consist of a polyurethane wirewound body and distal tip. All of the pediatric arterial cannulae come with a non-vented 1/4-in connector. The one-piece nonphthalate PVC blunt and guidewire introducers included with these cannulae have an elongated taper for dilation over a longer distance.

Sterile, nonpyrogenic disposable, single use only

AI/ML Overview

This document describes the FDA's 510(k) clearance for the Medtronic Bio-Medicus Pediatric Cannulae and Introducers. It focuses on the device's substantial equivalence to previously marketed predicate devices rather than a detailed study proving performance against defined acceptance criteria in the context of an AI/algorithm-based device. Therefore, a direct response to your detailed questions on AI study specifics (like sample size for test sets, expert ground truth, MRMC studies, etc.) cannot be fully provided from this document.

However, I can extract the information related to the device's acceptance criteria and the studies performed to demonstrate its performance where available in this regulatory document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test. Instead, it states that "Performance and biological tests confirm that the Medtronic Bio-Medicus Pediatric Arterial and Venous Cannulae product met pre-determined acceptance criteria." It also notes that the proposed device "performed as well or better than the legally marketed devices."

Test Performed	Reported Device Performance
Blood Trauma Testing	Passed (met pre-determined acceptance criteria)
Sterilization Testing	Passed (met pre-determined acceptance criteria)
Packaging Testing	Passed (met pre-determined acceptance criteria)
Pressure Drop Testing	Passed (met pre-determined acceptance criteria)
Cannula Shelf Life Testing	Passed (met pre-determined acceptance criteria)
Cannula and Introducer Performance Testing	Passed (met pre-determined acceptance criteria)
Cannula Testing	Passed (met pre-determined acceptance criteria)
Introducer Testing	Passed (met pre-determined acceptance criteria)
Securement Clip Testing	Passed (met pre-determined acceptance criteria)
Biocompatibility Testing	Passed (met pre-determined acceptance criteria and ISO 10993-1 standards)
	Substantially equivalent to predicate device

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

The document does not provide details on the specific sample sizes for each test set or the provenance of the data. It mentions "Pre-clinical bench testing" and "Animal testing."

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 not provided in this document, as it pertains to a physical medical device clearance, not an AI/algorithm-based diagnostic device.

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

This information is not applicable and not provided in this document.

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 not provided in this document.

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

This information is not applicable and not provided in this document.

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

For physical device testing, "ground truth" equates to established engineering and biological standards and expected performance parameters. The document states "Pre-clinical bench testing was used to verify the performance characteristics of this device. Animal testing was also completed to establish substantial equivalence with the predicate devices." Biocompatibility testing followed ISO 10993-1.

8. The sample size for the training set

This information is not applicable as it is not an AI/algorithm-based device.

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

This information is not applicable as it is not an AI/algorithm-based device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol resembles an abstract human figure embracing the world, representing the department's mission to protect and enhance the health and well-being of all Americans.

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

MAR 2 7 2015

Medtronic, Inc Bruce Backlund Principal Regulatory Affairs Specialist 8200 Coral St Ne Mounds View, Minnesota 55112

Re: K143083

Trade/Device Name: Bio-Medicus Pediatric Cannulae and Introducers Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: February 9, 2015 Received: February 11, 2015

Dear Mr. Backlund,

This letter corrects our substantially equivalent letter of March 25, 2015.

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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Page 2 - Bruce Backlund

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 (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" (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. Lillehammer

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) K143083

Device Name

Bio-Medicus Pediatric Cannulae and Introducers

Indications for Use (Describe)

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)

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."

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510(k) Summary of Safety and Effectiveness

Date Prepared:	October 23, 2014
Applicant:	Medtronic, Inc.Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428Establish Registration Number: 2184009
Contact Person:	Bruce BacklundPrincipal Regulatory Affairs SpecialistPhone: (763) 526-2357Fax: (763) 367-8361E-mail:bruce.j.backlund@medtronic.com
Trade Name:	Bio-Medicus™ Pediatric Cannulae and Introducers
Common Name:	Cardiopulmonary bypass vascular catheter, cannula, or tubing
Classification Name:	Catheter, Cannula and Tubing, Vascular, CardiopulmonaryBypass
Classification:	Class II, 21 CFR 870.4210
Product Code:	DWF
Name of Predicate Devices:	Bio-Medicus™ Cannula-Tubing(K872033)DLP Pediatric™ One-Piece Arterial Cannulae(K024069)

Device Description:

The pediatric arterial cannulae consist of a polyurethane wirewound body and distal tip. All of the pediatric arterial cannulae come with a non-vented 1/4-in connector. The one-piece non

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phthalate PVC blunt and guidewire introducers included with these cannulae have an elongated taper for dilation over a longer distance.

Sterile, nonpyrogenic disposable, single use only

Intended Use:

These devices are to be used by a trained physician only.

Cannulae are used to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriately sized cannula within the vessel for cardiopulmonary bypass. These products are intended for use up to 6 hours.

Contraindications:

Alone, the cannula and introducer are not medical treatment devices. The introducer is to be used only with the appropriately-sized Bio-Medicus™ cannula. These devices are not intended for use except as indicated above.

Comparison to Predicate Devices:

A comparison of the Medtronic Bio-Medicus Pediatric Arterial and Venous Cannulae to the predicate devices indicates the following similarities:

. Same intended use
. Same technological characteristics
Same operating principle .
. Similar design features, exceptions include improved transition between the introducer body and cannula tip to increase ease of cannula insertion, and an added radiopaque suture ring.
Similar materials, exceptions include the introducer material which has changed from ● Polyethylene to Polyvinyl Chloride (PVC), connector material from Polycarbonate to PVC and hemostasis cap material from Styrene to Silicone.
Same shelf life .

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Summary of Performance Data

Pre-clinical bench testing was used to verify the performance characteristics of this device. Animal testing was also completed to establish substantial equivalence with the predicate devices.

The following performance tests were conducted and passed:

Blood Trauma Testing
. Sterilization Testing
Packaging Testing ●
. Pressure Drop Testing
Cannula Shelf Life Testing ●
Cannula and Introducer Performance Testing .
Cannula Testing ●
Introducer Testing .
Securement Clip Testing with Cannula and Introducer ●
. Biocompatibility Testing (all blood contacting surfaces)
- Cytotoxicity l
- Sensitization -
- Intracutaneous Toxicity -
- Pyrogenicity -
- Genotoxicity -
- Hemocompibility -
- Subacute Toxicity -

Biocompatibility testing was performed in accordance with ISO 10993-1 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process. Performance and biological tests confirm that the Medtronic Bio-Medicus Pediatric Arterial and Venous Cannulae product met pre-determined acceptance criteria and is substantially equivalent to the predicate device.

Conclusion:

The primary predicate device, Bio-Medicus™ Cannula-Tubing was used to compare the fundamental technological characteristics of the proposed Bio-Medicus Pediatric Arterial and Venous Cannula and Introducer. When comparative testing was completed, the proposed Bio-Medicus Pediatric Cannulae and Introducer performed as well or better than the legally marketed devices.

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The data included in this submission is sufficient to provide reasonable assurance that the Bio-Medicus Pediatric Arterial and Venous Cannulae and Introducers are substantially equivalent to the legally marketed predicate Bio-Medicus Cannula-Tubing (K872033) 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).