The recirculation line consists of a 0.6 cm (1/4 in) flexible line with Y connector and female luer ports. The recirculation line provides a path from the recirculation port of the Affinity Fusion® Oxygenator with Integrated Arterial Filter to the venous reservoir. It is configured for maximum flexibility to facilitate ease of circuit set up and priming.

AI/ML Overview

The provided text describes the 510(k) submission for the Medtronic Affinity Fusion® Recirculation Line. This device is a cardiopulmonary bypass tubing component, and its approval was based on demonstrating substantial equivalence to a predicate device, not on meeting specific quantitative acceptance criteria derived from a clinical study.

Therefore, many of the typical elements requested in the prompt, such as acceptance criteria tables with performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable to this type of submission. This is a pre-clinical bench testing submission for a physical medical device, not a software-driven diagnostic or AI device.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Functional Requirements)	Reported Device Performance (Summary of Performance Data)
Maintain integrity of connections.	Integrity Testing (Passed)
Withstand internal pressure without bursting.	Burst Testing (Passed)
Withstand pull forces on dust caps.	Dust Cap Pull-Off Testing (Passed)
Withstand pull forces on tubing connections.	Tube Pull-Off Testing (Passed)

Note: The specific quantitative acceptance criteria or detailed performance results (e.g., burst pressure in psi, pull-off force in Newtons) are not disclosed in this summary. The summary only states that these tests were conducted and the device's performance was verified.

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

Sample Size: Not specified in the summary. Performance tests typically involve a statistically relevant number of samples, but the exact count is not provided.
Data Provenance: Pre-clinical bench testing. The country of origin of the data is implicitly the United States, given Medtronic's location and the FDA submission. The data is prospective in the sense that the device was manufactured and then subjected to these tests as part of the approval process.

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

Not Applicable. For mechanical/physical performance tests, "ground truth" is established by direct measurement and observation against engineering specifications, not by expert consensus in a clinical context. The "experts" involved would be engineers and technicians conducting the bench tests and interpreting the results according to validated test methods.

4. Adjudication Method for the Test Set:

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for interpreting subjective clinical data (e.g., imaging reads). For bench testing, results are typically objective measurements or pass/fail criteria against engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a physical medical device, not an AI or imaging-based diagnostic device. Therefore, MRMC studies are not relevant.

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

No. This is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used:

Engineering Specifications/Validated Test Methods. The "ground truth" for these tests refers to established engineering requirements and validated test protocols for integrity, bursting, and pull-off strength.

8. The Sample Size for the Training Set:

Not Applicable. This device did not involve a "training set" in the context of machine learning or algorithms. Its design and manufacturing process would involve internal development and testing, but not a dataset for training.

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

Not Applicable. See point 8.

Summary

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K122913

510(k) Summary of Safety and Effectiveness

Date Prepared:	September 17, 2012
Applicant:	Medtronic, Inc.
	Medtronic Perfusion Systems
	7611 Northland Drive
	Brooklyn Park, MN 55428
	Establishment Registration No. 2184009
Contact Person:	Mary Donlin
	Senior Regulatory Affairs Specialist
	Phone: (763) 526-9172
	Fax: (763) 367-8147
	E-mail:mary.e.donlin@medtronic.com
Trade Name:	Affinity Fusion® Recirculation Line
Common Name:	Cardiopulmonary bypass tubing
Classification Name:	Cardiopulmonary bypass vascular catheter, cannula, or tubing
Classification:	Class II, 21 CFR 870.4350
Product Code:	DWF
Name of Predicate Device:	Tubing, Connectors and Accessories with Balance® Biosurface (K113845)

Device Description:

Intended Use:

The Affinity Fusion Recirculation Line is intended for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.

Contraindications:

None.

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Comparison to the Predicate Device:

A comparison of Affinity Fusion® Recirculation Line to the predicate device indicates the following similarities:

Same intended use .
Same technological characteristics .
Same operating principle .
Same design features .
Same materials .
Same shelf life. .

Summary of Performance Data

Pre-clinical bench testing was used to verify the performance characteristics of this device. Clinical testing was not required to establish substantial equivalence with the predicate devices.

The following performance tests were conducted:

Integrity Testing .
Burst Testing .
Dust Cap Pull-Off Testing �
Tube Pull-Off Testing .

Conclusion:

The data included in this submission is sufficient to provide reasonable assurance of the safety and effectiveness of the device and the Affinity Fusion® Recirculation Line is substantially equivalent to the legally marketed predicate device, Tubing, Connectors and Accessories with Balance® Biosurface (KI13845).

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird symbol, with three wing-like shapes extending upwards and a curved body below.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 19 2012

Medtronic, Inc. c/o Ms. Mary Donlin Senior Regulatory Affairs Specialist 7611 Northland Drive Brooklyn Park, MN 55428

Re: K122913

Affinity Fusion® Recirculation Line Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: September 19, 2012 Received: September 21, 2012

Dear Ms. Donlin:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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Page 2 - Ms. Mary Donlin

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

A. Killer

Caram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4.0 Indications for Use Statement

510(k) Number (if known): _ K1229 l 3

Device Name:

Affinity Fusion® Recirculation Line

Indications for Use:

The recirculation line is indicated for use in connecting tubing and/ or devices during cardiopulmonary bypass procedures up to 6 hours in duration.

Prescription Use × (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 if NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.S. Wheeler

(Division Sign-Off) (Division Sign-off)
Division of Cardiovascular Devices

510(k) Number_K122913

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).