The EOPA 3D™ Cannulae have clear flexible, thin wall wire-wound PVC bodies with a tapered distal tip. The proximal end of the cannula includes a 3/8" (0.95 cm) vented or non-vented connector. The vented connector allows air to be vented from the cannula before connection to the perfusion line. The EOPA 3D™ Arterial Cannula tip has three integrated flutes which help diffuse and disperse blood flow. The cannula body has multiple depth markings, catalog code, and French size marked. Overall cannula length is 12.5" (31.8 cm). It will be available in 20 and 22 Fr sizes and either uncoated or with a Carmeda coating.

AI/ML Overview

The provided text describes a 510(k) summary for the EOPA 3D™ Arterial Cannula. It outlines the device, its indications for use, and a comparison to predicate devices. However, the document does NOT contain information about specific acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for a software or AI/ML device.

This submission is for a physical medical device (an arterial cannula), and the performance data described is "In vitro visual and functional testing" including "blood trauma testing." The criteria for substantial equivalence are based on "design, test results, and indications for use" compared to predicate devices.

Therefore, many of the requested fields are not applicable to this type of device submission as the prompt's questions are geared towards AI/ML device studies.

Here's an analysis based on the provided text, highlighting where information is unavailable or not applicable:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Visual equivalence to predicate	Met through in vitro visual testing
Functional equivalence to predicate	Met through in vitro functional testing
Blood trauma comparison to predicate	Met through in vitro blood trauma testing

Note: The document states "In vitro visual and functional testing was used to establish the performance characteristic of the changes from the predicate devices This includes visual, functional, and blood trauma testing." It doesn't provide specific numerical acceptance criteria or detailed results, but concludes that the device is "substantially equivalent."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the document.
Data Provenance: Not specified, but generally, in-vitro testing for physical devices like this is conducted in a controlled lab environment by the manufacturer. It's not "retrospective or prospective" data in the context of patient studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. "Ground truth" in the context of expert consensus is typically relevant for interpretative tasks, often in AI/ML or imaging. For a physical device's in-vitro testing, performance is measured against physical specifications or established benchmarks, not expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, not for physical device testing.

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 is not an AI/ML device or an imaging interpretation device.

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 (expert consensus, pathology, outcomes data, etc)

Type of "Ground Truth": The performance was assessed against established physical and functional parameters of the predicate device and engineering specifications. This is more akin to compliance with product design specifications and direct measurement (e.g., flow rates, material properties, visual inspection) rather than clinical ground truth from patients.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable. This is a physical device, not an AI/ML model that requires a training set and associated ground truth.

Summary

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K061254

510(k) Summary

Date Prepared:	May 3, 2006	JUN 2 3 2006
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: EOPA 3D™ Arterial Cannula Models 78220, 78222, 78320, 783222

Cardiopulmonary bypass vascular catheter, cannula or tubing

· .

Classification:

Predicate Devices: Select 3D Arterial Cannula K033416, K043179

Class II

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Device Description:

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 3D™ Arterial Cannulae with the same design characteristics. The modified devices use a straight body with the Select 3D Arterial Cannula diffuse flow tip.

Summary of Performance Data

In vitro visual and functional testing was used to establish the performance characteristic of the changes from the predicate devices This includes visual, functional, and blood trauma testing.

Conclusion

Medtronic Perfusion Systems has demonstrated that the modified EOPA 3D™ and Arterial Cannulae are substantially equivalent to the predicate devices based upon design, test results, and indications for use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2006

Medtronic Perfusion Systems Ronald W. Bennett Principal Regulatory Affairs Specialist 7611 Northland Drive N. Brooklyn Park, MN 55428

Re: K061254

Trade Name: EOPA 3D Arterial Cannula, Models 78220,78222,78320.78322 Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula or tubing Regulatory Class: II (two) Product Code: DWF Dated: May 3. 2006 Received: May 4, 2006

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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

vuna R. Vahner

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): K 06 (254

Device Name: EOPA 3D™ Arterial Cannula

Indications for Use:

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

Prescription Use X ______ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 - 1 - 1 - 1 -

una be line

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Kole) 254

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).