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

Bio-Medicus Cannula Kits contains the necessary components to achieve insertion of a Bio-Medicus cannula and introducer. The included items are: Adult Cannula and Introducer (in various sizes), a Seldinger needle, a guidewire, a scalpel blade, stepped dilators, and or a catheter tip syringe.

The Bio-Medicus Cannula Kit is intended to be 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 appropriate sized cannula within the vessel for cardiopulmonary bypass.

The Bio-Medicus Cannula Kit set consists of adult arterial and venous cannulae and introducer:

All kits are provided sterile and nonpyrogenic, disposable, and for single use only and comprised of:

Adult Arterial and Venous Cannulae (in numerous sizes)
Seldinger Needle
Scalpel Blade
Catheter Tipped Syringe
Appropriately Sized Dilators and Guidewires

This submission will focus on the adult venous cannulae only and there are no other changes to the remaining kit components. The adult venous cannulae are all supplied sterile, and nonpyrogenic and are for single use only.

The adult venous cannula consists of:

Polyurethane cannula with stainless steel wire-wound multi-port body
- Non-vented 3/8-in connector
- The overall length of the cannulae is 25.6-in and 30-in
Insertion marks that aid in positioning the cannula
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 adult venous cannula 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 ½-in cardio pulmonary bypass circuit.

This new adult venous cannulae consists of increased number of drainage side holes along the insertable length and the increase of depth markings from 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 cannulae.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Bio-Medicus Adult Cannula Kit. It details the device's indications for use, contraindications, and comparisons to a predicate device. However, the document does not contain acceptance criteria for device performance nor does it describe a study proving the device meets specific performance criteria in terms of effectiveness or clinical outcomes.

Instead, the submission focuses on demonstrating substantial equivalence to a previously marketed predicate device (Medtronic Bio-Medicus Adult Cannula Kit, K153598). This substantial equivalence is primarily established through comparisons of intended use, technological characteristics, operating principles, design features (with minor noted changes), materials, sterilization, and shelf life.

The "Summary of Performance Data" section mentions bench testing as the method used to verify performance characteristics, but it does not provide quantitative acceptance criteria or detailed results of these tests beyond listing the types of tests performed.

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided document. I can, however, extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as quantitative performance metrics for clinical efficacy. The primary "acceptance criterion" in a 510(k) for substantial equivalence is that the device is as safe and effective as a predicate device.
Reported Device Performance: The document states that the device is "substantially equivalent" to the predicate device. The specific performance characteristics verified through bench testing are listed, but no quantitative results or acceptance criteria for these tests are provided.

Acceptance Criteria (Stated or Implied for Substantial Equivalence to Predicate)	Reported Device Performance (as per document)
Performance characteristics as verified by bench testing (Blood Trauma, Bioburden, Pressure Drop, Cannula Kink during Perfusion, Depth Marking Presence)	"Bench testing was used to verify the performance characteristics of these devices." (No specific quantitative performance data or acceptance criteria for these tests are provided in the document.)
Safe and effective as the predicate device	The device is declared "substantially equivalent to the legally marketed predicate devices."

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

Sample Size: Not specified. The document mentions "bench testing" but does not provide details on the number of units tested.
Data Provenance: Not applicable in the context of clinical data. It involves bench testing of the device itself.

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

Not applicable. This information is relevant for studies involving human interpretation or clinical data with expert-adjudicated ground truth. The provided document details bench testing, which does not involve experts establishing ground truth in this manner.

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

Not applicable. As above, this is relevant for studies involving human interpretation.

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 a medical device (cannula kit), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant.

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:

For the bench tests, the "ground truth" would be established by the specifications and measurable physical/chemical properties of the device and its interaction with test media (e.g., blood for trauma testing, fluid for pressure drop). It's based on engineering and material science principles rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

Not applicable. This pertains to machine learning algorithms, which are not the subject of this 510(k) submission.

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

Not applicable. As above, this pertains to machine learning algorithms.

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: K180456

Trade/Device Name: Bio-Medicus Adult Cannula Kit 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) K180456

Device Name

Bio-Medicus Adult Cannula Kit

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)

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FORM FDA 3881 (7/17)

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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.comMike Green, MBARegulatory Affairs ManagerPhone: (763) 514-9774Fax: (763) 367-8147Email: mike.green@medtronic.com
Trade Name	Bio-Medicus Adult Cannula Kit
Common Name	Cardiopulmonary bypass vascular catheter, cannulaor tubing
Classification Name	Catheter, Cannula and Tubing, Vascular,Cardiopulmonary Bypass
Classification	Class II, 21 CFR 870.4210
Product Code	DWF
Name of Predicate Device	Medtronic Bio-Medicus Adult Cannula Kit(K153598)

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Device Description

The Bio-Medicus Cannula Kit set consists of adult arterial and venous cannulae and introducer:

All kits are provided sterile and nonpyrogenic, disposable, and for single use only and comprised of:

Adult Arterial and Venous Cannulae (in numerous sizes)
Seldinger Needle
Scalpel Blade
Catheter Tipped Syringe ●
Appropriately Sized Dilators and Guidewires ●

The adult venous cannula consists of:

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 ●
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.

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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.

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 Kit to the predicate device indicates the subject devices are substantially equivalent with the following similarities:

Same intended use
o 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

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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-Medicus Adult Cannula Kits, 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).