These cannulae are intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery.

Device Description

The ULTRAFLEX™ Venous Cannula is designed for use with cardiopulmonary bypass as a venous drainage cannula. The occluder with a malleable stylet aids in positioning and placement of the cannula. The device is available in 23 and 29 Fr. diameters. The device may also include Carmeda® coating.

AI/ML Overview

The provided document describes a 510(k) Premarket Notification for the ULTRAFLEX™ Venous Cannula, focusing on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria through extensive clinical studies. Therefore, much of the requested information regarding detailed acceptance criteria and specific study designs (like MRMC, standalone algorithm performance, expert qualifications for ground truth in AI studies, etc.) is not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to already legally marketed predicate devices. The performance criteria are therefore implicitly tied to the performance and safety profiles of those predicate devices.

Acceptance Criteria Category	Reported Device Performance (Summary)
Design Characteristics	Same or similar to predicate devices (VC2® Venous Cannula, Bio-Medicus® Femoral Cannula and Introducer)
Materials	Same as predicate devices (e.g., Bio-Medicus® Femoral Cannula and Introducer)
Indications for Use	Same as predicate devices (e.g., VC2® Venous Cannula: venous drainage during cardiopulmonary bypass)
Simulated Use Testing	Demonstrated performance characteristics of modifications
Functional Testing	Demonstrated performance characteristics of modifications
Visual Testing	Performed to establish performance characteristics
Dimensional Testing	Performed to establish performance characteristics
Carmeda® Coating Performance (if applicable)	Coverage, bio-activity, and functional testing performed

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

The document explicitly states that "In vitro visual, dimensional, simulated use and functional testing was used." This indicates that the testing was primarily bench testing or laboratory-based simulation, not human clinical trials.

Test Set Sample Size: Not specified in terms of number of human subjects or patient cases, as the testing was in vitro. The "sample size" would refer to the number of cannulas or components tested in the lab. This information is not provided.
Data Provenance: In vitro testing, likely conducted internally by Medtronic Perfusion Systems. No country of origin for patient data (as it's not a clinical study involving patients). The study is inherently prospective in the sense that the tests were designed and executed to evaluate the new device.

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

Not Applicable. This type of information is relevant for studies involving human interpretation (e.g., diagnostic imaging studies) where expert consensus is needed to establish ground truth for a test set. For in vitro engineering and performance testing, the "ground truth" is typically established by engineering specifications, validated test methods, and industry standards, executed by qualified engineers and technicians.

4. Adjudication Method

Not Applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies where multiple human readers or experts interpret data and their interpretations need to be reconciled to form a definitive ground truth. This was an in vitro engineering assessment.

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

No. An MRMC study involves human readers (e.g., radiologists, pathologists) interpreting cases with and without AI assistance to measure the effect size of AI on their performance. This is not mentioned or implied by the in vitro testing described.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This device is a physical medical device (cannula), not an AI algorithm. Therefore, "standalone" AI performance is not relevant.

7. The Type of Ground Truth Used

Engineering Specifications and Performance Standards. For this type of in vitro testing, the "ground truth" for evaluating the device's performance would be derived from:
- Predicate device characteristics: The new device must meet or be comparable to the established performance of its predicate devices.
- Manufacturing specifications: Internal design and quality control specifications for geometry, material properties, and functional parameters.
- Industry standards: Relevant ISO or ASTM standards for catheters and cannulae.
- Simulated use outcomes: Expected performance under simulated physiological conditions.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device that requires a "training set." The design and manufacturing processes are based on established engineering principles and prior device experience, not data-driven machine learning training.

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

Not Applicable. As there is no training set, this question is irrelevant.

Conclusion:

The submission for the ULTRAFLEX™ Venous Cannula is a 510(k) premarket notification that demonstrates substantial equivalence to predicate devices through in vitro visual, dimensional, simulated use, and functional testing. It does not involve human clinical trials or AI algorithm development, and therefore, many of the questions related to clinical study design, expert consensus, and AI performance are not applicable. The "acceptance criteria" are inherently tied to matching the safety and effectiveness profiles of the legally marketed predicate devices.

Summary

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j( 03) 827

JUL 2 2003

510(k) Summary

June 12, 2003 Date Prepared:

Submitter:

Medtronic Perfusion Systems 7611 Northland Boulevard

Brooklyn Park, MN 55428

Preeti Jain Contact Person: Senior Manager, Regulatory Affairs

Phone: (763) 391-9533 (763) 391-9100 Fax:

Device Name and Classification:

Trade Name:	ULTRAFLEX™ Venous Cannula23, 29 Fr.
Common Name:	Cardiopulmonary bypass vascular catheter, cannula ortubing
Classification:	Class II
Predicate Devices:	VC2® Venous CannulaK845045
	Bio-Medicus® Femoral Cannula and IntroducerK924642
	Extracorporeal Circuit with Bio-Active SurfaceK8918687

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Device Description:

Indication for Use

This product is intended for use with cardiopulmonary bypass as a venous drainage cannula.

Comparison to Predicate Devices

The predicate devices are cannulae with the same or similar design characteristics. The predicate cannulae VC2® Two Stage Venous Cannula has the same indications for use. The other predicate cannulae Bio-Medicus® Femoral Cannula and Introducer features the same material and similar introducer configuration and tip design to the ULTRAFLEX™.

Summary of Performance Data

In vitro visual, dimensional, simulated use and functional testing was used to establish the performance characteristic of the modifications of this device from previously marketed devices. In addition coverage, bio-activity and functional testing was performed on Carmeda® coated devices.

Conclusion

Medtronic Perfusion Systems has demonstrated that the ULTRAFLEX™ Venous Cannulae are substantially equivalent to the predicate devices based upon design, test results, and indications for use.

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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract caduceus, with three parallel lines that curve and flow into a serpentine shape at the bottom.

JUL 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Perfusion Systems c/o Mr. Preeti Jain 7611 Northland Drive N Minneapolis, MN 55428-1088

Re: K031827

ULTRAFLEXTM Venous Cannula Regulation Number: 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, ad Tubing Regulatory Class: Class II (two) Product Code: 74 DWF Dated: June 12, 2003 Received: June 13, 2003

Dear Mr Jain:

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. Preeti Jain

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. 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 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,

Quesada Vaz Sr

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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Page 1 of 1_

510(k) Number (if known): _______________

Device Name:

ULTRAFLEXTM Venous Cannula

Indications for Use:

These cannulae are intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Only

(Optional Format 3-10-98)

Alina D. Ag fr BPZ 7/1/03

510(k) Numbe

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).