The Select 3D™ Arterial Cannulae both have clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector with a peel cap. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The Select 3D™ Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation. Overall cannula length is 11.5" (29.2 cm). The new sizes are 18 and 20 Fr. The Cannulae are available uncoated or with a Carmeda® Coating.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic Select 3D™ Arterial Cannula. It describes a medical device, its intended use, and a comparison to predicate devices, along with a summary of performance data.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Dimensional Testing	All testing passed.
Functional Testing	All testing passed.
Biocompatibility	Not affected by the changes in the device.
Sterilization	Not affected by the changes in the device.
Packaging	Not affected by the changes in the device.
Accelerated Aged Dimensional Testing	Performed as well as flow and hemolysis characterization. All testing passed.
Accelerated Aged Functional Testing	Performed as well as flow and hemolysis characterization. All testing passed.
Flow Characterization	Performed. All testing passed.
Hemolysis Characterization	Performed. All testing passed.
Carmeda® Coating Ability	Tested. All testing passed.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size for the "in vitro dimensional and functional testing," "accelerated aged dimensional and functional testing," "flow and hemolysis characterization," or the "Carmeda® Coating ability" tests. It only states that these tests were performed and "All testing passed."
Data Provenance: The studies were in vitro (laboratory-based) tests. The country of origin for the data is not explicitly stated but implies the studies were conducted by Medtronic Perfusion Systems in the USA, as they are the submitter located in Minnesota. The studies were prospective as they were conducted to validate the new device sizes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" for this device validation is based on engineering specifications, material properties, and performance standards for in vitro testing, not expert interpretation of medical images or clinical outcomes. The tests evaluate physical and functional characteristics against predetermined engineering benchmarks.

4. Adjudication Method for the Test Set

This is not applicable as the validation did not involve subjective interpretation or a need for reconciliation of expert opinions. The tests were objective measurements against predefined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The submission is for a medical device (cannula) and focuses on its physical and functional performance, not on diagnostic accuracy requiring human reader judgment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical medical cannula, not an algorithm or AI system. The validation focuses on the device's intrinsic physical properties and performance in an in vitro setting.

7. The Type of Ground Truth Used

The "ground truth" for this device validation involved engineering specifications, material specifications, and established performance benchmarks for flow characteristics, hemolysis, dimensional accuracy, and durability (accelerated aging). It is based on objective, measurable physical and functional properties, rather than pathology, outcomes data, or expert consensus in a medical diagnostic context.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical product, not an AI or machine learning model that requires a training set. The "training" in this context refers to the manufacturing and design processes, which are guided by established engineering principles and prior device knowledge, rather than a data-driven training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as point 8. The "ground truth" is inherent in the established engineering and design principles, and the performance of the predicate devices. The new cannulae were developed based on the known successful design and performance of the predicate devices, simply differing in diameter.

Summary

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FEB - 8 2005

510(k) Summary

Date Prepared:	November 12, 2004
Submitter:	Medtronic Perfusion Systems7611 Northland BoulevardBrooklyn Park, MN 55428
Contact Person:	Ronald W. BennettPrincipal Regulatory Affairs SpecialistPhone: (763)-391-9086Fax: (763) 391-9603

Device Name and Classification:

Trade Name:	Select 3DTM Arterial Cannula
Common Name:	Cardiopulmonary bypass vascular catheter, cannula ortubing
Classification:	Class II

Predicate Devices: Select 3D™ Arterial Cannula 22 Fr. K013013, K033416

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Device Description:

The Select 3D™ Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body features a tip orientation line indicating direction of the cannula tip during cannulation. Overall cannula length is 11.5" (29.2 cm). The new sizes are 18 and 20 Fr. The Cannulae are available uncoated or with a Carmeda® Coating.

Indication for Use

These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

Comparison to Predicate Device

The predicate devices are Select 3DTM Arterial Cannulae with the same design characteristics and indications for use. The predicate cannulae had identical design characteristics and materials. The new cannulae differ only in diameter from the predicates.

Summary of Performance Data

In vitro dimensional and functional testing was used to establish the performance characteristic of the new device. The biocompatibility, sterilization, and packaging are not affected by the changes in the device. Accelerated aged dimensional and functional testing was performed as well as flow and hemolysis characterization. The ability to adequately Carmeda® Coat the devices was also tested. All testing passed.

Conclusion

Medtronic Perfusion Systems has demonstrated that the modified Select 3D™ Cannulae (18 and 20 Fr.) are substantially equivalent to the predicate devices based upon design. test results, and indications for use.

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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 an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 8 2005

Medtronic Perfusion Systems c/o Mr. Ronald W. Bennett Principal Regulatory Affairs Specialist 7611 Northland Boulevard Brookyn Park, MN 55428

Re: K043179

Select 3D™ Arterial Cannula, 18 and 20 Fr. Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: January 6, 2005 Received: January 11, 2005

Dear Mr. Bennett:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Ronald W. Bennett

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dilina R. Vechner

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): K043179

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dina R. Lochner
(Division Sign-Off)

Division of Cardiovascular Devices

Number K043179

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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).