This cannula is intended for short term use (six hours or less) in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solutions. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.

Device Description

The Pediatric Aortic Root Cannula (18 Gauge) is a device with a flange and two side holes. The tip is attached to a flexible tapered tube that terminates in a female luer fitting. A stainless steel 18 gauge introducer with needle tip and locking male luer fitting is supplied inside the cannula.

AI/ML Overview

This document describes the premarket notification for a Pediatric Aortic Root Cannula (18 Gauge). The submission aims to demonstrate substantial equivalence to predicate devices, not primarily to prove specific acceptance criteria through a clinical study or AI performance. Therefore, many of the requested elements for an AI/clinical study are not directly applicable or available in this type of regulatory submission.

However, I can extract the information relevant to the device's performance assessment as presented in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Dimensional properties	Meet design specifications	All testing passed.
Functional properties	Operate as intended	All testing passed.
Biocompatibility	Meet established standards	Evaluated.
Sterilization	Effective sterilization	Evaluated.
Packaging integrity	Maintain sterility and protection	Evaluated.
Accelerated Aging (Dimensional)	Maintain dimensions after aging	All testing passed.
Accelerated Aging (Functional)	Maintain function after aging	All testing passed.

Note: The document doesn't explicitly list numerical acceptance criteria. The statement "All testing passed" implies that the device met internal, established criteria for successful performance in each category, which are typically defined by the manufacturer based on regulatory standards and predicate device performance.

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

The document states "In vitro dimensional and functional testing was used" and "Accelerated aged dimensional and functional testing was also performed."

Sample Size: Not specified. The document does not provide the number of devices or units tested for the in vitro or accelerated aging tests.
Data Provenance: Not specified, but implied to be from internal lab testing conducted by Medtronic Perfusion Systems (manufacturer). It is retrospective in the sense that the testing was completed before the 510(k) submission. No country of origin for the data is mentioned, but the manufacturer is based in the USA.

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

Not Applicable. This type of 510(k) submission for a physical medical device (cannula) does not involve establishing ground truth by human experts in the manner of an AI or diagnostic imaging study. Performance is assessed through direct physical and functional testing against engineering specifications and industry standards.

4. Adjudication Method for the Test Set

Not Applicable. As per point 3, there's no "ground truth" adjudicated by experts in this context. Testing results ("All testing passed") are likely determined by comparing measurements and observations against pre-defined engineering tolerances and performance requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not Applicable. This is a physical medical device, not an AI or diagnostic imaging device that involves human readers interpreting results.

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

Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance is based on its ability to meet predefined dimensional tolerances, material properties, functional requirements (e.g., flow rates, leak resistance, introducer needle functionality), biocompatibility standards (e.g., ISO 10993), sterilization efficacy, and packaging integrity. These are established through internal design specifications and compliance with relevant industry and regulatory standards.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI. Design and manufacturing are based on established engineering principles and prior device experience, not algorithmic training.

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

Not Applicable. There is no "training set" or "ground truth" in the AI sense for this device. The design and validation are based on engineering specifications and empirical testing.

Summary

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MAR 1 9 2004

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510(k) Summary

Date Prepared:	March 2, 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:	Pediatric Aortic Root Cannula(18 Gauge)
Common Name:	Cardiopulmonary bypass vascular catheter, cannula ortubing
Classification:	Class II
	Predicate Devices:

Predicate Devices:
Aortic Root Cannulae K790565, K810548, K831591

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Device Description:

Dorice Decliption. a flange and two side holes. The tip is attached to a flexible tapered tube that terminates in a female luer fitting. A stainless steel 18 gauge introducer with needle tip and locking male luer fitting is supplied inside the cannula.

Indication for Use

This cannula is intended for short term use (six hours or less) in conjunction with I mo cannala is may bypass surgery for delivering cardioplegia solutions. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.

Comparison to Predicate Device

The predicate devices are Aortic Root Cannulae with the same design characteristics and indications for use. The predicate cannulae had similar design and materials. The new cannula varies from the predicates in tip length and color, in having a ribbed body, in overall length and in featuring an over-molded ABS introducer needle sheath.

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 were evaluated. Accelerated aged dimensional and functional testing was also performed. All testing passed.

Conclusion

Medtronic Perfusion Systems has demonstrated that the modified Pediatric Aortic Root Cannula (18 Gauge) is substantially equivalent to the predicate devices based upon design, test results, and indications for use.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.

MAR 1 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Perfusion Systems c/o Mr. Ronald W. Bennett Principal Regulatory Affairs Specialist 7611 Northland Drive N Minneapolis, MN 55428-1088

Re: K040173

Pediatric Aortic Root Cannula (18 Gauge) Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula or Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: March 3, 2004 Received: March 4, 2004

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/dsmamain.html

Sincerely yours,

Ashley B. Beam

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): K040173 Device Name: Pediatric Aortic Root Cannula

Indications for Use:

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ashley B. Baan

510(k) Number K040173 (SM. K)

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).