The Select 3D™ and Select CAP™ Arterial Cannulae both have clear flexible, thin w.ill wire-wound PVC bodies with angled, beveled tips. The proximal end of each 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 indicate direction of the cannula tip during cannulation. Overall cannula length is 11.5" (29.2 cm). It is available in 22 and 24 Fr sizes.

The Select CAP™ Arterial Cannula tips have an integrated pressure monitoring port. The pressure monitoring port on the tip of the cannulae provides the real time capability of accurately measuring central arterial pressure within the aorta. Overall cannula length is 12" (30.5 cm). It is available in 18, 20, 22, and 24 Fr. sizes.

The devices may include a Carmeda® BioActive Surface.

AI/ML Overview

This submission describes device modifications, specifically adding a Carmeda® BioActive Surface coating to existing Select 3D™ and Select CAP™ Arterial Cannulae. Therefore, the "study" is focused on demonstrating that the coated devices maintain the performance characteristics of the uncoated predicate devices and that the coating itself is safe and effective.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance (Summary)
Functional Performance	Performance characteristics of the materials (after Carmeda® coating) were established through in vitro visual and functional testing.
Coating Integrity/Coverage	Coverage, bioactivity, and leach testing were performed on Carmeda® coated devices. (Specific quantitative acceptance criteria are not provided in the document).
Substantial Equivalence	Demonstrated through design, test results, and indications for use, confirming equivalence to predicate devices.

Missing Information: The document does not explicitly present a table of quantitative acceptance criteria (e.g., minimum flow rates, burst pressures, specific leach limits) that were met. Instead, it refers to "functional testing," "coverage, bioactivity, and leach testing" as having been performed and the results supporting substantial equivalence.

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

Sample Size for Test Set: Not explicitly stated. The description mentions "in vitro visual and functional testing" and "coverage, bioactivity, and leach testing" performed on "Carmeda® coated devices," implying a sample of such devices, but the exact number is not provided.
Data Provenance: The testing was "in vitro," meaning laboratory-based testing. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of human subjects.

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

This is not applicable as the study did not involve human subjects or expert assessment for ground truth establishment. The testing described is entirely in vitro (laboratory-based chemical and physical performance testing).

4. Adjudication Method for the Test Set:

This is not applicable as the study did not involve human subjects, diagnostic assessments, or a need for adjudication among experts.

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:

This is not applicable. This submission is for a medical device (arterial cannulae), not an AI/imaging diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is relevant.

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

This is not applicable as this is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on:

In vitro measurements and observations: This includes visual inspections, functional tests (e.g., flow characteristics, mechanical integrity), and chemical analyses (e.g., coverage, bioactivity, leach testing) conducted in a laboratory setting.
Comparison to predicate devices: The "ground truth" for performance is effectively defined by the established performance characteristics of the prior, uncoated, predicate devices, which the new coated devices must match or exceed.

8. The Sample Size for the Training Set:

This is not applicable as this is not an AI/algorithm-based device, so there is no "training set."

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

This is not applicable as this is not an AI/algorithm-based device, so there is no "training set" or ground truth establishment for it.

Summary

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NOV = 5 2003

K033416
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510(k) Summary

Date Prepared:	October 24, 2003
Submitter:	Medtronic Perfusion Systems7611 Northland BoulevardBrooklyn Park, MN 55428
Contact Person:	Ronald W. BennettPrincipal Regulatory Affairs Specialist
	Phone: (763)-391-9086Fax: (763) 391-9603

Device Name and Classification:

Trade Name:	Select 3D™ Arterial Cannula22, 24 Fr. with Carmeda® BioActive SurfaceSelect CAP™ Arterial Cannula18, 20, 22, 24 Fr. with Carmeda® BioActive Surface
-------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------

Common Name:	Cardiopulmonary bypass vascular catheter, cannula ortubing
Classification:	Class II
	Predicate Devices:Arterial CannulaK840002, K000776, K013013, K010737
	Extracorporeal Circuit with BioActive Surface

Extracorporeal Cir
K891687

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Device Description:

The devices may include a Carmeda® BioActive Surface.

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 and Select CAP™ Arterial Cannulae with the same design characteristics. The predicate cannulae were uncoated. The predicate cannulae have the same indications for use, with the addition of the clarification "(6 hours or less)" for the Select CAPTM.

Summary of Performance Data

In vitro visual and functional testing was used to establish the performance characteristic of the materials of these devices after Carmeda® coating. In addition coverage, bioactivity, and leach testing was performed on Carmeda® coated devices.

Conclusion

Medtronic Perfusion Systems has demonstrated that the modified Select 3D™ and Select CAP™ Arterial 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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes.

Public Health Service

NOV - 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Perfusion Systems c/o Mr. Ronald W. Bennett Director, Regulatory/Clinical Affairs 7611 Northland Drive N Brooklyn Park, MN 55428-1088

Re: K033416

Select 3D™ Arterial Cannula and Select CAP™ Arterial Cannula with Carmeda® BioActive Surface Regulation Number: 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: Class II (two) Product Code: 74 DWF Dated: October 24, 2003 Received: October 27, 2003

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

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): KD3341 b

Device Name:

Select 3D™ Arterial Cannula and Select CAP™ Arterial Cannula with Carmeda® BioActive Surface

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Q. M. C.

of Cardiovascular Devices

510(k) Number K033416

(Optional Format 3-10-98)

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).