The One Piece Pediatric Arterial Cannula Models 77006 and 77106 are 6 Fr., flexible, thin-walled cannula with wire wound bodies and a 9" overall length. They have a beveled tip that is made as part of the PVC body. There are depth markings located at 1 cm increments. A tip orientation line indicates the direction of the bevel for location once the cannula is inside the body. The proximal end of the cannula terminates in a 1/4" barbed connector that can be either vented or non-vented. The model 77006 is vented and the model 77106 is non-vented. The proximal end connector on these models is also molded as part of the body.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Medtronic Perfusion Systems "One Piece Pediatric Arterial Cannula Models 77006 and 77106":

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance	Study Type
Visual Inspection	Absence of defects	"found acceptable"	In vitro
Dimensional Testing	Correct dimensions of cannula and markings	"found acceptable"	In vitro
Leak Testing	No water or air leakage	"found acceptable"	In vitro
Bend Tests	Acceptable flexibility/durability under various bends	"found acceptable"	In vitro
Functional Testing	Acceptable performance in simulated use	"found acceptable"	In vitro
Substantial Equivalence	Demonstrates equivalence to predicate devices based on design, test results, and indications for use.	"demonstrated that the Arterial One Piece Pediatric Cannula Models 77006 and 77106 are substantially equivalent to predicate devices based upon design, test results, and indications for use."	Substantial equivalence comparison

Study Details

Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text only mentions "various bend tests" and general "in vitro visual, dimensional, simulated use and functional testing."
- Data Provenance: The "Summary of Performance Data" describes "in vitro" testing. This implies the data was generated in a lab setting, likely without direct human patient involvement or geographical origin listed. It does not indicate retrospective or prospective data from a clinical setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The study involved in vitro testing of the device's physical and functional properties, not a diagnostic or AI-based assessment requiring expert ground truth establishment.
Adjudication method for the test set:
- Not applicable. As noted above, this was an in vitro engineering performance study, not a clinical study or AI performance evaluation requiring adjudication of interpretations. The "acceptance" was likely based on pre-defined engineering specifications and test protocols.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical cannulae, not an AI-powered diagnostic tool requiring human reader comparisons.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical product, not an algorithm.
The type of ground truth used:
- The "ground truth" for this study was established by engineering specifications, design requirements, and pre-defined test protocols for the physical and functional characteristics of the cannulae. The "accepted" results indicate that the device met these engineering specifications.
The sample size for the training set:
- Not applicable. This device is a physical medical product, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable. As above, there was no AI model or training set.

Summary

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K∅24∅69

JAN 0 8 2003

510(k) Summary

Date Prepared:	December 6, 2002
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:	One Piece Pediatric Arterial CannulaModels 77006 and 77106
Common Name:	Cardiopulmonary bypass vascular catheter, cannula ortubing
Classification:	Class II
Predicate Devices:	K840001Arterial Cannula7000 Series8, 10, 12, 14, 16, 18, 20, 22, 24, 26 Fr.Pediatric and Adult Sizes

Device Description:

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Indication for Use

These cannulae are intended for use in perfusion of the ascending aorta during cardiopulmonary bypass, up to six hours or less.

Comparison to Predicate Device

The predicate devices are cannulae with a thin walled tip attached to a flexible PVC body and having both 1/4 " and 3/8" connectors. There was an indexing line for determining tip orientation when the cannula is in the aorta. There was a molded plastic vent plug to allow venting before connection to the perfusion line. The overall length of the cannula was 7". The predicate devices had the same indication for use.

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. Visual inspection for defects, dimensional testing of the cannula and markings, water and air leak testing, and various bend tests were performed and the results found acceptable.

Conclusion

Medtronic Perfusion Systems has demonstrated that the Arterial One Piece Pediatric Cannula Models 77006 and 77106 are substantially equivalent to 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 is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with three overlapping profiles, suggesting a sense of community or interconnectedness.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 8 2003

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

Re: K024069

Trade Name: One Piece Pediatric Arterial Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular cannula Regulatory Class: Class II (two) Product Code: DWF Dated: December 6, 2002 Received: December 10, 2002

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 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 vours.

K. Oa. Till

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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K024069

Page 1 of 1_

510(k) Number (if known):

One Piece Pediatric Arterial Cannula Device Name:

Models 77006 and 77106

Indications for Use:

These cannulae are intended for use in perfusion of the ascending aorta during cardiopulmonary bypass, up to six hours or less.

(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)

V. Oettel

iovascular Devices

510(k) Number K024069

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).