The Medtronic tubing and accessories sets for extracorporeal membrane oxygenation (ECMO) with Balance biosurface are indicated for use in ECMO and extracorporeal life support (ECLS) procedures for adult patients with acute respiratory failure or acute cardiopulmonary failure when other available treatment options have failed, and when continued clinical deterioration is expected or the risk of death is imminent.

Device Description

The Medtronic Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface ("eSets") contain components used to prepare an extracorporeal circuit for extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) procedures. The Base eSet Model BB22LSB contains a preassembled drainage and return loop, tubing assemblies, and other components used to prepare a basic extracorporeal circuit. The Accessory eSet Model BB22LSA contains nonstandard components to supplement the basic extracorporeal circuit, as needed per case and hospital protocols. This product is nonpyrogenic, is intended for single use, and has been sterilized using ethylene oxide. Maximum transit temperature: 50°C (122°F). Standard storage conditions are sufficient to safeguard the device. Store the device in the original packaging at room temperature in a dry place.

AI/ML Overview

The provided text describes a medical device, "Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface" and its substantial equivalence submission to the FDA. The information focuses on regulatory compliance, device characteristics, and performance data from pre-clinical bench studies.

Based on the provided text, the device is a Class II medical device (Extracorporeal Circuit And Accessories For Long-Term Respiratory/Cardiopulmonary Failure). The device does not involve AI. Therefore, the questions related to AI-specific performance criteria, test sets, ground truth, experts, and human-in-the-loop performance are not applicable.

Here's the information that can be extracted:

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

The acceptance criteria are derived from the "Special Controls" identified in 21 CFR 870.4100, as outlined by the FDA Final Order 81 FR 7451, February 12, 2016. The reported device performance is a statement of compliance with these controls, supported by various bench studies.

Acceptance Criteria (Special Control)	Reported Device Performance
Technological Characteristics: The geometry and design parameters of the device are consistent with its intended use in extracorporeal support procedures, and the device is compatible with other devices and accessories in the extracorporeal circuit.	The device's technological characteristics are consistent with its intended use and compatible with other devices in the circuit.
Biocompatibility: The device is demonstrated to be biocompatible in accordance with ISO 10993-1:2018 and with FDA guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' (4 September 2020)."	Demonstrated to be biocompatible according to ISO 10993-1:2018 and FDA guidance.
Sterility and Shelf-life: Sterilization adoption evaluation and shelf-life testing demonstrate that the device maintains its sterility, integrity, durability, and reliability over the stated shelf life of the device.	Sterilization adoption and shelf-life testing confirm the device maintains sterility, integrity, durability, and reliability over its 2-year shelf life.
Non-clinical Performance: Substantial equivalence of the performance characteristics is demonstrated on bench, mechanical integrity, durability, and reliability testing. This includes demonstrating performance for the stated intended use and duration, including demonstrating that components maintain performance after exposure to maximum transit temperature. Compatibility with other devices and accessories, and resistance to kinking and compression that would obstruct fluid flow. Also includes evaluation of blood trauma and coating coverage.	Substantial equivalence of performance characteristics was demonstrated through pre-clinical bench testing including: 21-day simulated use durability testing, tensile strength after life conditioning, pressure test after life conditioning, functional testing, kink testing, blood trauma testing, and coating coverage.
Labeling: The Instructions for Use include a detailed summary of the non-clinical evaluations pertinent to use of the device in an extracorporeal circuit and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure.	Instructions for Use include detailed summaries of non-clinical evaluations, and adequate instructions for anticoagulation, circuit setup, performance characteristics, and maintenance.

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

The text mentions "pre-clinical bench studies" for performance testing. Specific sample sizes for each bench test are not provided. The testing is conducted by Medtronic, a US-based company, implying the studies were conducted internally or through contracted labs, but the specific country of origin for the data is not explicitly stated. The studies are described as "pre-clinical bench testing," which are inherently controlled laboratory experiments, not reflecting a "retrospective or prospective" study design in the clinical sense.

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. This is a physical medical device clearance based on bench testing of its mechanical, material, and functional properties, not an AI or diagnostic device requiring expert interpretation of results to establish ground truth.

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

Not applicable, as this refers to expert adjudication in diagnostic studies, not bench testing of a physical device.

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. The device does not involve AI.

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

Not applicable. The device does not involve AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance evaluation, the "ground truth" is defined by established engineering and medical device standards (e.g., ISO 10993-1 for biocompatibility) and the device's design specifications for properties like durability, tensile strength, pressure resistance, kink resistance, blood trauma, and coating coverage. The "truth" is whether the device meets these pre-defined physical and functional requirements.

8. The sample size for the training set

Not applicable. The device does not involve AI, therefore there is no "training set."

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

Not applicable. The device does not involve AI.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

April 19, 2023

Medtronic Inc. Anna Wetherille Sr. Regulatory Affairs Specialist 8200 Coral Sea St. NE Mounds View, Minnesota 55112

Re: K223168

Trade/Device Name: Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface Regulation Number: 21 CFR 870.4100 Regulation Name: Extracorporeal Circuit And Accessories For Long-Term Respiratory/Cardiopulmonary Failure Regulatory Class: Class II Product Code: QWF Dated: March 15, 2023 Received: March 16, 2023

Dear Anna Wetherille:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Image /page/1/Picture/4 description: The image shows a signature block. The text reads "Sincerely, Kathleen M. Grunder -S". The text is in a simple sans-serif font and is left-aligned. The background is white.

for Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K223168

Device Name

Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface

Indications for Use (Describe)

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary of Safety and Effectiveness

Date Prepared: April 18, 2023
Applicant: Medtronic, Inc.Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428Establish Registration Number: 2184009
Contact Person: Anna WetherilleSenior Regulatory Affairs SpecialistPhone: (763) 514-9842Fax: (763) 367-8361E-mail: anna.wetherille@medtronic.comJuli Rubin (Alternate)Senior Regulatory Affairs Program ManagerPhone: (763) 526-2357Email: juli.c.rubin@medtronic.com
Trade Name: Tubing and Accessories Sets for Extracorporeal MembraneOxygenation (ECMO) Balance™ Biosurface
Common Name: Extracorporeal Life Support Circuit and Accessories
Classification Name: Extracorporeal circuit and accessories for long-termrespiratory/cardiopulmonary failure
Classification: Class II (with special controls)
Regulation Number: 21 CFR 870.4100
Product Code: QWF
Name of Predicate Device: FDA Final Order 81 FR 7451, February 12, 2016
Name of Reference Device: Tubing Pack (K171979)

{4}------------------------------------------------

Device Description:

The Base eSet Model BB22LSB contains a preassembled drainage and return loop, tubing assemblies, and other components used to prepare a basic extracorporeal circuit.

The Accessory eSet Model BB22LSA contains nonstandard components to supplement the basic extracorporeal circuit, as needed per case and hospital protocols.

This product is nonpyrogenic, is intended for single use, and has been sterilized using ethylene oxide. Maximum transit temperature: 50°C (122°F). Standard storage conditions are sufficient to safeguard the device. Store the device in the original packaging at room temperature in a dry place.

Bench studies were performed after device preconditioning including exposure (up to 21 days) to simulated in vivo use conditions to demonstrate safety and reliability.

Indication for Use:

The Medtronic tubing and accessories sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance biosurface are indicated for use in ECMO and extracorporeal life support (ECLS) procedures for adult patients with acute respiratory failure or acute cardiopulmonary failure, when other available treatment options have failed, and when continued clinical deterioration is expected or the risk of death is imminent.

Comparison to Predicate (Special Controls):

Substantial equivalence evaluation includes a comparison to requirements in the FDA Final Order 81 FR 7451, February 12, 2016, as well as a comparison to the Reference Device. Per FDA Final Order (81 FR 7451) membrane lung devices for long-term pulmonary support, a preamendment class III device, as extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure, were redesignated and reclassified to class II (special controls) in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.

The Medtronic Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface device meets all special controls identified in 21 CFR 870.4100, as follows:

Technological Characteristics: The geometry and design parameters of the subject ● device are consistent with the device's intended use in extracorporeal support procedures, and the device is compatible with the other devices and accessories in the extracorporeal circuit.
Biocompatibility: The subject device is demonstrated to be biocompatible in ● accordance with ISO 10993-1:2018 and with FDA guidance document Use of

{5}------------------------------------------------

International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (4 September 2020).

Sterility and Shelf-life: Sterilization adoption evaluation and shelf-life testing ● demonstrate that the subject device maintains its sterility, integrity, durability, and reliability over the stated shelf life of the device.
Non-clinical Performance: Substantial equivalence of the performance characteristics ● is demonstrated on bench, mechanical integrity, durability, and reliability testing.
Labeling: The Instructions for Use include a detailed summary of the non-clinical ● evaluations pertinent to use of the device in an extracorporeal circuit and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure.

Comparison to Reference Device:

A comparison of the Medtronic Tubing and Accessories Sets for ECMO with Balance™ Biosurface to the reference device indicates the following similarities:

Similar intended use, the only exception is the extended duration of extracorporeal support.
Same technological characteristics ●
Same operating principle
Same design features ●
Similar materials, the only exception is the new TOTM plasticizer used for the ● prolonged use components
Same shelf life, the subject device has a 2-year shelf life

Summary of Performance Data

In vivo pre-clinical and clinical studies involving patients or animals were not necessary to demonstrate the safety and performance of the subject device. Pre-clinical bench testing was used to verify the performance characteristics of this device.

The following preclinical bench studies were conducted:

21-day Simulated use durability testing ●
Tensile strength after life conditioning (long term use)
Pressure test after life conditioning (long term use) ●
Functional testing
Kink testing ●
Blood trauma testing ●
Coating coverage ●

{6}------------------------------------------------

Conclusion:

The data included in this submission are sufficient to demonstrate that the Medtronic Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface meets the special controls in FDA's Final Order (81 FR 7451, Redesignation as Extracorporeal Circuit and Accessories For Long- term Respiratory/cardiopulmonary Failure (ECMO), February 12, 2016), to connect perfusion devices and circulate blood as part of an extracorporeal circuit for use in Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS) procedures.

Regulation Number and Section

§ 870.4100 Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.

(a)
Identification. An extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary support (>6 hours) is a system of devices and accessories that provides assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The main devices and accessories of the system include, but are not limited to, the console (hardware), software, and disposables, including, but not limited to, an oxygenator, blood pump, heat exchanger, cannulae, tubing, filters, and other accessories (e.g., monitors, detectors, sensors, connectors).(b)
Classification —Class II (special controls). The special controls for this device are:(1) The technological characteristics of the device must ensure that the geometry and design parameters are consistent with the intended use, and that the devices and accessories in the circuit are compatible;
(2) The devices and accessories in the circuit must be demonstrated to be biocompatible;
(3) Sterility and shelf-life testing must demonstrate the sterility of any patient-contacting devices and accessories in the circuit and the shelf life of these devices and accessories;
(4) Non-clinical performance evaluation of the devices and accessories in the circuit must demonstrate substantial equivalence of the performance characteristics on the bench, mechanical integrity, electromagnetic compatibility (where applicable), software, durability, and reliability;
(5) In vivo evaluation of the devices and accessories in the circuit must demonstrate their performance over the intended duration of use, including a detailed summary of the clinical evaluation pertinent to the use of the devices and accessories to demonstrate their effectiveness if a specific indication (patient population and/or condition) is identified; and
(6) Labeling must include a detailed summary of the non-clinical and in vivo evaluations pertinent to use of the devices and accessories in the circuit and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure.