Medtronic uncoated Tubing and Connector Components are intended for use in the extracorporeal circuit during cardiopulmonary bypass surgery. These components are primarily used to interconnect the primary devices of the bypass circuit. The lumen of the uncoated Tubing and Connector Components consist of smooth blood-contacting surfaces which provide a continuous pathway for the flow of blood and/or other fluids during cardiopulmonary bypass surgical procedures. The uncoated Tubing Components are comprised of polyvinyl chloride (PVC) and the uncoated Connector Components are comprised of polycarbonate and Plastisol. The uncoated Connectors are provided in Y-type, straight, and reducer configurations with ½ inch to ½ inch connection sites.

AI/ML Overview

This document is a 510(k) summary for the Medtronic Uncoated Tubing and Connector Components. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or a specific level of performance through extensive clinical studies like those typically associated with AI/ML devices or novel therapies.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert involvement, and ground truth is generally not applicable in the context of this 510(k) submission for a non-active medical device like tubing and connectors. The approval is based on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through performance and biological testing.

However, I can extract the relevant information that is present in the document.

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

The document states: "Performance and biological tests confirm that the uncoated Tubing and Connector Components met pre-determined acceptance criteria". However, the specific quantitative acceptance criteria and the detailed reported performance values for each test are not provided in this 510(k) summary. The summary only lists the types of performance tests conducted.

Test Type	Acceptance Criteria (Not Detailed)	Reported Performance (Not Detailed)
Shelf life	Met pre-determined criteria	Met pre-determined criteria
Pressure Integrity	Met pre-determined criteria	Met pre-determined criteria
Kink Resistance	Met pre-determined criteria	Met pre-determined criteria
Pressure Decay	Met pre-determined criteria	Met pre-determined criteria
Spallation	Met pre-determined criteria	Met pre-determined criteria
Pull Force	Met pre-determined criteria	Met pre-determined criteria
Method of sterilization and sterility assurance level	Met pre-determined criteria	Met pre-determined criteria
Blood Trauma	Met pre-determined criteria	Met pre-determined criteria
Biocompatibility	Met pre-determined criteria (EN ISO 10993-1:2009)	Met pre-determined criteria

2. Sample sizes used for the test set and the data provenance

The document does not specify sample sizes for any of the performance or biological tests. All testing is implied to be prospective and conducted by Medtronic, likely in a lab setting, given the nature of the device (tubing and connectors). There is no mention of country of origin for data as it's not a clinical data study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. The device is an inert medical component. "Ground truth" in the context of clinical outcomes or expert consensus for AI/ML devices is not relevant here. Performance is evaluated against engineering specifications and biological safety standards.

4. Adjudication method for the test set

This is not applicable. There is no "adjudication" in the sense of resolving discrepancies in expert opinions for a diagnostic task. Performance is measured against physical and chemical standards.

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

This is not applicable. This device is not an AI-powered diagnostic tool, nor does it have human "readers" in the context of image interpretation.

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

This is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

"Ground truth" for this type of device refers to objectively measurable physical, chemical, and biological properties. This includes:

Engineering specifications: For properties like pressure integrity, kink resistance, pull force, and pressure decay.
Material standards: For aspects like spallation.
Sterilization standards: For sterility assurance level.
Biocompatibility standards: Specifically EN ISO 10993-1:2009 for biological evaluation.
Chemical analysis/testing: For blood trauma (e.g., hemolysis).

8. The sample size for the training set

This is not applicable. This is not an AI/ML device that requires a "training set."

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

This is not applicable. As above, there is no training set. The "ground truth" for the device's characteristics is established through recognized industry standards, test methods, and scientific principles applied during the performance and biological testing.

Summary

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

July 15, 2015

Medtronic, Inc. Jacqueline A. Hauge Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112

Re: K151523

Trade/Device Name: Uncoated Tubing and Connector Components Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II Product Code: DWF, DTL Dated: June 18, 2015 Received: June 22, 2015

Dear Jacqueline Hauge:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/ResourcesforYou/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.

M.A. Hillebrand

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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Indications for Use

510(k) Number (if known) K151523

Device Name

Uncoated Tubing and Connector Components

Indications for Use (Describe)

This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures.

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)

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510(k) Summary

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Date Prepared:	June 4, 2015
Submitter:	Medtronic, Inc.Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428Establishment Registration Number: 2184009
Contact Person:	Jacqueline A. HaugeSenior Regulatory Affairs SpecialistMedtronic Perfusion SystemsPhone: 763.514.9967Fax: 763.367.8360Email: jacqueline.a.hauge@medtronic.com
Alternate Contact:	Susan FidlerSenior Regulatory Affairs ManagerMedtronic Perfusion SystemsPhone: 763.514.9839Fax: 763.367.8360Email: susan.c.fidler@medtronic.com

Device Name and Classification

Trade Name :	Uncoated Tubing and Connector Components
Regulation Name :	Cardiopulmonary bypass vascular catheter, cannula, or tubing
Regulation Number:	21 CFR 870.4210
Product Code:	DWF, DTL
Regulatory Class :	Class II
510(k) Review Panel:	Cardiovascular

Predicate Devices

K113845	Tubing, Connectors and Accessories with Balance Biosurface
K122811	Connector Components with Balance Biosurface

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De vice Description

Indications for Use

This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgical procedures.

Comparison to Predicate

When compared to the predicate devices, the uncoated Tubing and Connector Components have the same:

Base materials

Packaging materials and configurations

Intended Use
Technological characteristics ●
Operating principle - - -●
Design features ●
Performance ●

Summary of Performance and Biological Testing

Medtronic conducted the following performance testing for the uncoated Tubing and Connector Components:

Shelf life

. Pressure Integrity Kink Resistance
Pressure Decay ●

Spallation

●

Pull Force
Method of sterilization and sterility assurance level
Blood Trauma ●
Additionally, biocompatibility testing was performed in accordance with EN ISO 10993-1:2009 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process.

Performance and biological tests confirm that the uncoated Tubing and Connector Components met pre-determined acceptance criteria and are substantially equivalent to the predicate device.

Conclusion

●

Medtronic has demonstrated that uncoated Tubing and Connector Components for use in extracorporeal cardiopulmonary bypass perfusion systems (tubing sets/packs) are substantially equivalent to the predicate devices based upon design, test results, and indications for use. The fundamental scientific principle, labeling and intended use are unchanged from the predicate devices.

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).