The Affinity Fusion Cardiotomy/Venous Reservoir with Baiance Biosurface is intended to be used in an extractivered perfusion circuit to collect venous and canioned blood during routine cardiopulmonary procedures up to 6 hours in duntion. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.

The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open head surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

Device Description

The Affinity Fusion® Cardiotomy/Venous Reservoir (CVR) with Balance® Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.

The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement. The inside of the jar is coated with Balance Biosurface to reduce platelet activation and preserve platelet function.

This product is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The Affinity Fusion Cardiotomy/Venous Reservoir is sterilized by ethylene oxide.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria (Implied by "Pass" result)	Reported Device Performance
Blood Damage Testing	Meet specified thresholds for blood damage	Pass
Defoaming	Effectively remove foam	Pass
Filtration Efficiency	Meet specified filtration standards	Pass
Cardiotomy Gaseous Microemboli	Remain below critical levels of microemboli	Pass
Dynamic Holdup	Maintain holdup within acceptable limits	Pass
Prime Breakthrough	Prevent prime breakthrough	Pass
Static Holdup	Maintain static holdup within acceptable limits	Pass
Volume Marking Accuracy	Accurate volume markings	Pass
Reservoir Capacity	Meet specified capacity	Pass
Particulate Count	Remain below specified particulate levels	Pass
Cytotoxicity	Non-cytotoxic	Pass
Hemocompatibility	Hemocompatible	Pass

Explanation of Acceptance Criteria:

The document states that the device demonstrated "substantially equivalent" performance to the predicate device and that all tests "Passed." While the specific numerical acceptance criteria values are not explicitly detailed in this summary, the implication of the "Pass" result is that the device met pre-defined, acceptable thresholds for each performance metric, consistent with the predicate device and relevant special controls guidance.

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

The document does not specify the exact sample sizes used for each individual test. It states that "The following verification and validation testing has demonstrated that substantially equivalent to the predicate device."

Data Provenance: The studies were conducted by Medtronic, Inc. as part of a 510(k) submission. The data is retrospective in the sense that it's being submitted for regulatory approval, but the studies themselves would have been prospective tests undertaken by the manufacturer during product development and validation. No country of origin for data collection is specified, but the applicant is Medtronic, Inc., a US-based company, and the submission is to the FDA.

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

This information is not applicable and not provided. The device is a medical device (cardiotomy/venous reservoir), not an AI/software device that requires expert-established ground truth for its performance metrics (like diagnostic accuracy). The tests conducted are engineering and biocompatibility evaluations.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of data where consensus among experts is needed to establish ground truth for algorithm comparison. The studies for this device are laboratory/benchtop performance and biocompatibility tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a physical medical device, and its performance is evaluated through engineering and biocompatibility tests, not human interpretation tasks.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable and not provided. This device is a physical product (a reservoir), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is based on:

Pre-defined performance specifications and industry standards: For tests like Blood Damage Testing, Defoaming, Filtration Efficiency, Gaseous Microemboli, Dynamic Holdup, Prime Breakthrough, Static Holdup, Volume Marking Accuracy, Reservoir Capacity, and Particulate Count. These would be established through engineering requirements, regulatory guidance (Special Controls Guidance Document), and comparison to the predicate device.
Biocompatibility standards: For Cytotoxicity and Hemocompatibility, the ground truth is established by the criteria defined in ISO 10993-1.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical medical product, not a machine learning model. Therefore, there is no "training set."

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

This information is not applicable and not provided for the same reason as point 8.

Summary

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510(k) Summary of Safety and Effectiveness

Date Prepared: October 25, 2013 Applicant: Medtronic, Inc. OCT 2 8 2013 Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establish Registration Number: 2184009 Contact Person: Julia A. Nelson Principal Regulatory Affairs Specialist Phone: (763) 514-9844 (763) 367-8361 Fax: E-mail:julia.a.nelson@medtronic.com Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Trade Name: Biosurface Common Name: Cardiotomy Venous Reservoir Classification Name: Cardiopulmonary bypass blood reservoir Classification: Class II, 21 870.4400 Product Code: DTN Name of Predicate Device: Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface (K122914) Reference Device: Affinity® NT Cardiotomy/Venous Reservoir with Filter Model 540 (K936003)

K132972

Device Description:

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This product is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The Affinity Fusion Cardiotomy/Venous Reservoir is sterilized by ethylene oxide.

Intended Use:

The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.

Contraindications:

Do not use this device for any purpose other than indicated.

Do not use if air leaks are observed during priming and/or operation; this may result in air embolism to the patient and/or fluid loss.

The Affinity Fusion Cardiotomy/Venous Reservoir is contraindicated for use in postoperative chest drainage and autotransfusion procedures when:

There is an air leak in the lung or gross perforations to the chest wall exist. .
o Pericardial, mediastinal, pulmonary or systemic infection or malignancy is present.
Gross contamination or a lymphatic failure is present or suspected. .
Suctioned blood is obtained from a site where a topical hemostatic agent has been used. o
The chest is open and vacuum is applied. ●
. Protamine has been administered prior to the reservoir being removed from the bypass circuit.
o The patient is returned to surgery for any reason.
o Vented chest tubes not incorporating vent flow regulation, such as a stopcock, are used. Caution: An assessment should be made of the quality and suitability of the blood that has been collected before re-infusion begins.

Comparison to Predicate Devices:

A comparison of the Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface to the predicate device (the Affinity Fusion Cardiotomy/Venous Reservoir with Balance® Biosurface) indicates the following similarities:

. Intended Use: The intended use is the same as predicate and reference devices.
Design: The basic design is the same as the predicate. Minor enhancements were made . to the cardiotomy filtration, and a valve protector was added.

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Materials: The materials are the same as the predicate, with the exception of the . cardiotomy filtration media, which is the same as the reference device.
Principles of Operation and Technology: The principles of operation are the same as the . predicate device.
Performance: The performance is substantially equivalent to the predicate and/or . reference device.

Summary of Performance Data

The following verification and validation testing has demonstrated that substantially equivalent to the predicate device.

	Test Performed	Result
Testing per Special ControlsGuidance Document	Blood Damage Testing	Pass
	Defoaming	Pass
	Filtration Efficiency	Pass
Additional Testing	Cardiotomy Gaseous Microemboli	Pass
	Dynamic Holdup	Pass
	Prime Breakthrough	Pass
	Static Holdup	Pass
	Volume Marking Accuracy	Pass
	Reservoir Capacity	Pass
	Particulate Count	Pass

A complete biocompatibility assessment was conducted based on ISO 10993-1. The following biocompatibility testing was performed related to new material and design change to the subject device.

Test Performed	Result
Cytotoxicity	Pass
Hemocompatibility	Pass

Clinical testing was not required to establish substantial equivalence with the predicate devices.

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® Cardiotomy/Venous Reservoir with Balance® Biosurface is substantially equivalent to the legally marketed predicate device, the Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface (K122914).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird-like figure with three curved lines representing wings or feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

October 28, 2013

Medtronic, Inc. Julia Nelson Principal Regulatory Affairs Specialist Medtronic CardioVascular 8200 Coral Street NE Mailstop MVS83 Mounds View, MN 55112

K132972 Re:

Trade/Device Name: Affinity Fusion® Cardiotomy/Venous Reservoir (CVR) with Balance® Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II Product Code: DTN Dated: September 19, 2013 Received: September 23, 2013

Dear Ms. Nelson:

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 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

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Page 2 - Julia Nelson

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Resourcesfor You/Industry/default.htm.

Sincerelv vours.

M. Azbillieman

for

for
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132972

Device Name

Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

[X] Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

M.A. Zilliox

FORM FDA 3881 (9/13)

Regulation Number and Section

§ 870.4400 Cardiopulmonary bypass blood reservoir.

(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.