The Affinity Pixie Cardiotomy/Venous Reservoir with Carmeda BioActive Surface or Balance Biosurface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass procedures requiring a blood flow rate up to 2.0 L/min.

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

Device Description

The Medtronic Affinity Pixie Cardiotomy Venous Reservoir (CVR) is a single use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the filtered venous blood. The reservoir can also be used for vacuum-assisted venous drainage.

The Affinity Pixie Cardiotomy Venous Reservoir is coated with either Carmeda BioActive Surface or Balance Biosurface. The device is single-use, nontoxic, nonpyrogenic, and supplied sterile for clinical use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Medtronic Affinity Pixie Cardiotomy Venous Reservoir:

This document is a 510(k) summary for a medical device (K141233), which primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than establishing de novo safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study" are interpreted within this regulatory context.

The device in question is the Medtronic Affinity Pixie® Cardiotomy Venous Reservoir with Carmeda® BioActive Surface or with Balance® Biosurface.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission, the "acceptance criteria" are generally framed as demonstrating equivalence to the predicate device in terms of design, materials, principles of operation, and performance. The "reported device performance" is the result of bench testing confirming these aspects.

Acceptance Criteria (Equivalence to Predicate K100645)	Reported Device Performance (Summary)
Intended Use: Same as predicate device.	Performance: The intended use is the same as the predicate device.
Design: Same as predicate device.	Performance: The design is the same as the predicate device.
Materials: Same as predicate device (with minor formulation change to protective port caps).	Performance: The materials of the Affinity Pixie CVR are the same with the exception of the protective port caps which have undergone a minor formulation change.
Principles of Operation and Technology: Same as predicate device.	Performance: The principles of operation are the same as the predicate device.
Performance (Bench Testing): Demonstrated equivalence for specified critical parameters.	Performance: The performance of the device is the same as the predicate device. Bench tests conducted for: Biocompatibility, Cap removal force, Cap particulate generation.

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

The document explicitly states that "Bench testing was used to verify the performance characteristics of this device. Clinical testing was not required to establish substantial equivalence."

Test Set Sample Size: Not specified in the provided document. For bench testing, typical sample sizes vary depending on the specific test and statistical requirements, but no numbers are given here.
Data Provenance: The data is from bench testing conducted by Medtronic, Inc. This is not human clinical data; it's laboratory/engineering data. It is prospective in the sense that the tests were conducted specifically for this 510(k) submission. No country of origin for the data (beyond the applicant being US-based) is specified, but it would have been generated in a controlled, manufacturing/testing facility.

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

Not applicable. Since clinical studies (which would typically involve expert reviewers to establish ground truth) were not required and not performed, there were no "experts" in this context establishing ground truth for a clinical test set. The "ground truth" for bench tests is based on engineering specifications, regulatory standards, and comparison to the predicate device's established performance.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like '2+1' or '3+1' are used for interpreting clinical data, particularly image-based studies, often involving multiple readers. Given that this submission relies on bench testing and not clinical trials, no such adjudication method was employed.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study involves multiple human readers evaluating cases, often with and without AI assistance, to assess the impact of the AI on reader performance. This type of study is specifically for evaluating the effectiveness of AI algorithms in a clinical setting. As this device is a physical medical device (Cardiotomy Venous Reservoir) and not an AI/software as a medical device (SaMD), and no clinical studies were performed, an MRMC study was not applicable and was not conducted.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No. This question is also specifically relevant for AI/SaMD devices. Since the device is a physical reservoir for cardiopulmonary bypass and not an AI algorithm, a "standalone algorithm performance" study is not applicable and was not performed. The performance evaluated was of the physical device itself in bench tests.

7. The Type of Ground Truth Used

The type of "ground truth" used for this 510(k) submission is primarily based on:

Engineering specifications and design requirements: For parameters like cap removal force, particulate generation, and biocompatibility.
Regulatory standards: Ensuring compliance with relevant industry and FDA standards for blood-contacting devices.
Predicate device performance: The critical "ground truth" for a 510(k) is the established, safe, and effective performance of the legally marketed predicate device (K100645). The new device's performance in bench tests must demonstrate it is "the same" or does not raise new questions of safety or effectiveness compared to this predicate.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." The concept of a training set is specific to machine learning.

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

Not applicable. As there is no AI/ML component, there is no training set and thus no ground truth established for it.

Summary

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K141233

()

JUN 1 2 2014

510(k) Summary
Date Prepared:	May 9, 2014
Submitter:	Medtronic, Inc.Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428Establish Registration Number: 2184009
Contact Person:	Jessica SixberryPrinciple Regulatory Affairs SpecialistPhone: (763) 514-9849Fax: (763) 367-8360Email: jessica.m.sixberry@medtronic.com

Device Name and Classification:

Trade Name:	Affinity Pixie® Cardiotomy Venous Reservoir with Carmeda®BioActive Surface or with Balance® Biosurface
Common Name:	Cardiotomy Venous Reservoir
Classification Name:	Blood Reservoir, cardiopulmonary bypass
Classification Panel:	Cardiovascular
Regulation Number:	21 CFR 870.4400, 21 CFR 870.4270, 21 CFR 870.4230
Product Code:	DTN, JOD, DTP
Classification:	Class II

Predicate Devices

Medtronic Affinity Pixie® Cardiotomy Venous Reservoir with Carmeda® BioActive Surface or with Balance® Biosurface (K100645)

Device Description

Models	Description
BBP241	Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir BalanceBiosurface

Alleviating Pain · Restoring Health · Extending Life

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Models	Description
CBP241	Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir CarmedaBioActive Surface

Indications for Use

Comparison to Predicate Devices

The Affinity Pixie CVR has the same intended use, design and materials, and principles of operation and technology when compared to the predicate Affinity Pixie CVR.

Intended Use: The intended use is the same as the predicate device. .
Design: The design is the same as the predicate device. .
Materials: The materials of the Affinity Pixie CVR are the same with the exception . of the protective port caps which have undergone a minor formulation change.
Principles of Operation and Technology: The principles of operation are the same as ● the predicate device.
Performance: The performance of the device is the same as the predicate device. .

Summary of Performance Data

Bench testing was used to verify the performance characteristics of this device. Clinical testing was not required to establish substantial equivalence.

The following performance tests were conducted:

. Biocompatibility
Cap removal force .
Cap particulate generation .

Conclusion

Medtronic has demonstrated that the Affinity Pixie CVR is 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 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 graphic of what appears to be an abstract caduceus or a symbol representing health and human services.

Public Health Service

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

June 12, 2014

Medtronic, Inc. Ms. Jessica Sixberry Principal Regulatory Affairs Specialist 7611 Northland Dr. Minneapolis, MN 55428

Re: K141233

Trade/Device Name: Affinity Pixie Oxygenation System with Carmeda BioActive Surface or Balance BioSurface Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary bypass blood reservoir Regulatory Class: Class II Product Code: DTN, JOD, DTP Dated: May 9, 2014 Received: May 13, 2014

Dear Ms. Sixberry:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

.. .

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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

MDA

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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510(k) Number (if known): K141233

Device Name: Affinity Pixie Oxygenator System with Carmeda Bioactive Surface or with Balance Biosurface

Indications for Use:

ModelBBP241:

The Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Carmeda BioActive Surface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass procedures requiring a blood flow rate up to 2.0 L/min.

The Affinity Pixie Hollow Fiber Oxygenator is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

The Affinity Pixie Cardiotomy/Venous Reservoir 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.

See next page for Model CBP241.

Prescription Use X OR Over-The-Counter Use

Per 21 CFR 801.109

(PLEASEDONOTWRITEBELOWTHISLINE-CONTINUEONANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

MDA

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Model CBP241:

The Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface are indicated for use for neonate, infant, and small pediatric patients undergoing cardiopulmonary bypass procedures requiring a blood flow rate up to 2.0 L/min.

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.