The Medtronic DLP Arterial Cannulae with 3D Tip represent modified versions of existing Medtronic DLP Arterial Cannulae. The proposed change involves the incorporation of a baffled tip design into the 22 Fr. cannula. This baffled tip imparts a more diffuse pattern of blood flow exiting from the cannula tip than exists with the existing open tip cannula design.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (Medtronic DLP Arterial Cannulae with 3D Tip - 22 Fr.) and describes non-clinical performance data rather than a study with acceptance criteria and device performance in the context of human data or AI algorithms. As such, many of the requested categories are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility: In accordance with ISO 10993-1 for externally communicating devices in contact with circulating blood for <24 hours.	Material biocompatibility testing was conducted in accordance with ISO 10993-1.
Dynamic Hemolytic Properties: Rates of hemolysis comparable to competitive comparator models.	Rates of hemolysis observed for the modified device were comparable to those measured for comparator cannulae.

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

Sample Size: Not specified for biocompatibility testing; for hemolytic properties, "Short circuits containing 1000 ml of freshly collected, heparinized bovine blood" were constructed. The number of such circuits or repetitions is not specified.
Data Provenance: The hemolytic properties test used "freshly collected, heparinized bovine blood." This is an in vitro test, not human data. The country of origin for the data is not specified, but the test was likely conducted by Medtronic or a contracted lab.
Retrospective/Prospective: Prospective (experimental).

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

Not applicable. This was a non-clinical in vitro and material testing study, not requiring expert ground truth establishment in the traditional sense of clinical studies or AI algorithm evaluation.

4. Adjudication method for the test set

Not applicable. This was a non-clinical in vitro and material testing study.

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

Not applicable. This document describes a medical device, not an AI or imaging diagnostic tool, and therefore no MRMC study, human reader improvement, or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This document describes a physical medical device, not an algorithm.

7. The type of ground truth used

Biocompatibility: Compliance with ISO 10993-1 standard.
Dynamic Hemolytic Properties: Measurement of hemolysis rates in comparison to established performance of predicate/comparator devices. This is a scientific measurement rather than an expert consensus or pathology ground truth.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model, so there is no training set.

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

Not applicable. There is no training set for a physical medical device.

Summary

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KU13013

DEC 0 4 2001

Summary of Safety and Effectiveness Information

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DEC 0 4 2001

510(k) Summary [As Required by 21 CFR 807.92]

Submitter: Roger Brink Medtronic Cardiac Surgical Products 620 Watson SW Grand Rapids, MI 49504

Telephone:	(616) 643-7337
Fax:	(616) 643-1044

September 4, 2001 Date Summary Prepared:

Medtronic DLP Arterial Cannulae modified Trade Name of Device: with 3D Tip - 22 Fr.
Cardiovascular cannula Common Name of Device:
Classification Name of Device: "Cardiopulmonary bypass vascular cannula," Class II at 21 CFR 870.4210

Predicate Substantially Medtronic DLP Arterial Cannulae, Class II at Equivalent Devices: 21 CFR 870.4210, Curved Tip Models cleared under 510(k) Number K840002, and 24 Fr. 3D Tip Models cleared under 510(k) Number K000776.

The Medtronic DLP Arterial Cannulae with 3D Tip Description of Device: represent modified versions of existing Medtronic DLP Arterial Cannulae. The proposed change involves the incorporation of a baffled tip design into the 22 Fr. This baffled tip imparts a more diffuse cannula. pattern of blood flow exiting from the cannula tip than exists with the existing open tip cannula design.
Intended Use of Device: These cannulae are intended for the perfusion of the ascending aorta during short-term (6 hours or less) cardiopulmonary bypass.

Special 510(k) Notification	22 Fr. Arterial Cannulae with 3D Tip	Confidential
Medtronic, Inc.
Medtronic Cardiac Surgical Products	9/4/01	33

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Comparison to Existing Predicate Devices

The Medtronic DLP Arterial Cannulae with 3D Tip - 22 Fr. are substantially equivalent to existing Medtronic DLP Arterial Cannulae. The existing cannulae have been modified to include a baffled tip, which features side exit holes and scoop-shaped exit ports on the outside of the tip surface. The indications for use for both the existing and modified devices are identical, and the addition of a baffled tip feature does not represent a change to the fundamental scientific technology of the devices.

Summary of Non-Clinical Performance Data

Material biocompatibility testing was conducted in accordance with the ISO 10993-1 standard. Under this standard these cannulae are categorized as externally communicating devices in contact with circulating blood for a limited (<24 hour) contact duration.

An in vitro assessment of the dynamic hemolytic properties of the cannulae was also performed. Short circuits containing 1000 ml of freshly collected, heparinized bovine blood were constructed. The blood was circulated through test circuits which included the 22 Fr. 3D Tip model and competitive comparator models. Rates of hemolysis that were comparable to those measured for the comparator cannulae were observed for the modified device as well.

Conclusions of Non-Clinical Tests

The results of the non-clinical tests summarized above support an assertion that the Medtronic DLP Arterial Cannula 22 Fr. modified with a 3D Tip are as safe and effective as the existing Medtronic DLP Arterial Cannulae.

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Image /page/3/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 4 2001

Mr. Roger W. Brink Director RA/QA Medtronic Cardiac Surgical Products 620 Watson SW Grand Rapids, MI 49504-6393

Re: K013013

Trade Name: Medtronic DLP Arterial Cannulae with 3D Tip - 22 Fr Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiovascular Bypass Vascular Catheter Regulatory Class: II (two) Product Code: DWF Dated: September 4, 2001 Received: September 7, 2001

Dear Mr. Brink:

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. Roger W. Brink

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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). 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,

V. D. Teller

Bu Bram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Medtronic DLP Arterial Cannulae with 3D Tip – 22 Fr. Device Name:

Indications for Use:

These cannulae are intended for use in perfusion of the ascending These canndiao are internation for tess) cardiopulmonary bypass.

This Indication for Use is identical to the predicate device. Medtronic DLP Arterial Cannulae with 3D Tip - 24 Fr.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices

510(k) Number	K013015
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Prescription Use (Per 21 CFR 801.109	✓	OR	Over-The-Counter-Use
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Special 510(k) Notification	22 Fr. Arterial Cannulae with 3D Tip	Confidential
Medtronic, Inc.
Medtronic Cardiac Surgical Products	9/4/01	35

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).