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. The Bio-Medicus™ cannula (18-cm [7.09-in] tip length models) may be used in either the femoral position as an arterial delivery cannula or in the jugular position as venous return cannula. This product is intended for use up to 6 hours.

Device Description

The Bio-Medicus™ Adult Cannulae and Introducer is intended 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 appropriate sized cannula within the vessel for cardiopulmonary bypass.

The Bio-Medicus™ Adult Cannulae and Introducer set consists of adult arterial and venous cannulae and introducer. This submission will focus on the adult venous cannulae only. The adult venous cannulae are all supplied sterile, and non-pyrogenic and are for single use only.

The adult venous cannula consists of:

o Polyurethane cannula with stainless steel wire-wound multi-port body
- o Non-vented 3/8-in connector
- The overall length of the cannulae is 25.6-in and 30-in o
Insertion marks that aid in positioning the cannula ●
o Repositionable suture ring that is radiopaque

The one-piece non-phthalate PVC introducers included with these cannulae have an elongated taper for dilation over a longer distance.

The Bio-Medicus™ Adult Cannulae and Introducer package contains a securement clip which can be used near the insertion site for securement of the cannula body which aides in securement as well as an aide for physician organization. The large venous models (23-25 Fr) also contain a 3/8-in x ½-in tubing adapter with an attached length of 3/8-in tubing to allow connection to a ½in cardio pulmonary bypass circuit.

This new Bio-Medicus™ Adult Cannulae and Introducer set consists of increased number of drainage side holes along the insertable length and the increase of depth markings from every 10cm to every 5cm to further aid in positioning of the cannula. The change is taking place on the 15 French (F) through 25 F adult venous Bio-Medicus cannulae.

AI/ML Overview

The provided FDA 510(k) summary (K180453) describes a device, the Bio-Medicus™ Adult Cannulae and Introducer. However, it does not contain information related to a study that establishes acceptance criteria for performance metrics typically associated with AI/ML-driven devices, such as sensitivity, specificity, or reader improvement.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench) testing. The acceptance criteria and performance data are related to the physical and functional aspects of the cannulae, not diagnostic accuracy or AI performance.

Therefore, many of the requested details (sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types, training set sample size, and ground truth for training set) are not applicable to this submission as it is not for an AI/ML medical device.

Here's the information that can be extracted from the document:

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

Test	Acceptance Criteria (Implied)	Reported Device Performance
Blood Trauma Testing	Demonstrate acceptable blood compatibility/minimal trauma	Verified (implied to meet acceptable standards)
Bioburden Testing	Meet sterility requirements for medical devices	Verified (implied to meet acceptable standards)
Pressure Drop Testing	Ensure efficient fluid flow through the cannulae	Verified (implied to meet efficient flow standards)
Cannula Testing - Kink During Perfusion	Maintain patency during use (no kinking under normal perfusion conditions)	Verified (implied to maintain patency)
Depth Marking Presence	Markings are present and aid in positioning as intended	Verified (implied that markings are present and functional)

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

This information is not provided in the document as the studies are non-clinical bench tests. The concept of a "test set" in the context of clinical data or AI/ML performance is not applicable here.

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 as the studies are non-clinical bench tests, and ground truth in the context of expert diagnosis is not relevant.

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

This information is not applicable as the studies are non-clinical 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

This information is not applicable. This is not an AI/ML device, and no MRMC study was conducted.

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

This information is not applicable. This is not an AI/ML device.

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

This information is not applicable. For bench testing, the "ground truth" refers to engineering specifications and performance standards against which the device is tested.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device, and therefore no training set was used.

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

This information is not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 22, 2018

Medtronic Inc Huda Yusuf Sr. Regulatory Affairs Specialist 8200 Coral Street NE Mounds View, Minnesota 55112

Re: K180453

Trade/Device Name: Bio-Medicus Adult Cannulae and Introducer Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: February 16, 2018 Received: February 20, 2018

Dear Huda Yusuf:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nicole G. Ibrahim -S

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)

K180453

Device Name Bio-Medicus Adult Cannulae and Introducer

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary of Safety and Effectiveness

Date Prepared	February 16, 2018
Applicant	Medtronic, Inc.Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428Establishment Registration No. 2184009
Contact Person	Ms. Huda Yusuf, M.Sc., RACSr. Regulatory Affairs SpecialistPhone: (763) 514-9805Fax: (763) 367-8147Email: huda.yusuf@medtronic.com
	Mike Green, MBARegulatory Affairs ManagerPhone: (763) 514-9774Fax: (763) 367-8147Email: mike.green@medtronic.com
Trade Name	Bio-Medicus™ Adult Cannulae and Introducer
Common Name	Cardiopulmonary bypass vascular catheter, cannula,or tubing
Classification Name	Catheter, Cannula and Tubing, Vascular,Cardiopulmonary Bypass
Classification	Class II, 21 CFR 870.4210
Product Code	DWF
Name of Predicate Device	Bio-Medicus™ Adult Cannulae and Introducer(K142673)

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Device Description

The adult venous cannula consists of:

o Polyurethane cannula with stainless steel wire-wound multi-port body
- o Non-vented 3/8-in connector
- The overall length of the cannulae is 25.6-in and 30-in o
Insertion marks that aid in positioning the cannula ●
o Repositionable suture ring that is radiopaque

The one-piece non-phthalate PVC introducers included with these cannulae have an elongated taper for dilation over a longer distance.

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. The Bio-Medicus™ cannula (18-cm [7.09-in] tip length models) may be used in either the femoral position as an arterial delivery cannula or in the jugular position as venous return cannula. This product is intended for use up to 6 hours.

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Contraindications

Alone, the cannula and introducer are not medical treatment devices. The cannula introducer is only to be used with the appropriately-sized Bio-Medicus cannula. These devices are not intended for use, except as indicated above. Do not use if the patient has severe peripheral atherosclerosis or severe arterial dissection.

Comparison to Predicate Devices

A comparison of the Medtronic Bio-Medicus™ Adult Cannulae and Introducer to the predicate device indicates the subject devices are substantially equivalent with the following similarities:

Same intended use
Same technological characteristics
Same operating principle
Same design features ●
- except for increased number of drainage side holes along the insertable length | and
- । the increase of depth markings from every 10cm to every 5cm to further aid in positioning of the cannula
- the addition of a single marking which is 5cm from the proximal set of holes | to further aid the positioning of the cannula
Same device and packaging materials ●
Same sterilization requirements
Same shelf life

Summary of Performance Data

Bench testing was used to verify the performance characteristics of these devices. Clinical testing was not required to establish substantial equivalence.

The following tests were conducted:

Blood Trauma Testing ●
Bioburden Testing
Pressure Drop Testing ●
Cannula Testing-Kink During Perfusion ●
Depth Marking Presence ●

Conclusion

In conclusion, the information included in this submission demonstrates that the Bio-Medious™ Adult Cannulae and Introducer, with the changes made to them, are substantially equivalent to the legally marketed predicate devices.

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).