Medtronic Tubing Packs are used in cardiopulmonary bypass for connecting the primary devices of the bypass circuit. The functionality and intended use of these devices are the same as those for the coated (Cortiva - Coated Tubing Packs(K891687), Trillium BioPassive Surface Coated Tubing Packs (K012538), and Balance BioSurface Coated Tubing Packs(K122811) and uncoated tubing, connectors, and accessories that are FDA cleared.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Tubing Pack" by Medtronic, Inc. This submission focuses on a packaging change and does not involve the development or evaluation of an AI/ML powered device. Therefore, many of the requested elements for describing the acceptance criteria and study proving an AI device meets them are not applicable to this document.

However, I can extract and present the information that is relevant to the device and its testing as described in the document, even though it's not specific to AI.

Here's a breakdown based on the information available:

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

The document does not explicitly state quantitative "acceptance criteria" in a table format with corresponding "reported device performance" in the context of an AI/ML model's output metrics (e.g., sensitivity, specificity, AUC). Instead, it discusses demonstrating equivalence to a predicate device through various tests, implying that the acceptance criterion is successful completion of these tests without adverse outcomes.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Process Characterization	Adequacy of new tray manufacturing process	Successfully characterized process
Shelf Life	Maintenance of product integrity and sterility over time	Successfully demonstrated shelf life
Process Validation	New tray manufacturing process consistency and reliability	Successfully validated process
Packaging Performance	Integrity of packaging against relevant standards	Successfully met packaging performance requirements
Sterilization	Achieved required sterility assurance level (SAL)	Successfully sterilized (Ethylene oxide sterilization methods unchanged)
Biocompatibility	No adverse biological reactions caused by the new material	Successfully passed biocompatibility testing

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

The document does not provide details on sample sizes for these tests, nor does it specify data provenance in terms of country of origin or retrospective/prospective nature. These kinds of details are typically provided for clinical studies involving patient data, not for engineering and material testing of packaging components.

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. The tests performed are engineering and material science evaluations, not clinical assessments requiring expert human interpretation of data for ground truth.

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

Not applicable. Adjudication methods are typically use for resolving discrepancies in expert interpretations in clinical studies.

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. This is not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for these tests would be established through scientific and engineering standards and validated test methods. For example:

Shelf Life: Stability of the product over time, measured through established degradation testing.
Sterilization: Achievement of a specified Sterility Assurance Level (SAL) confirmed by validated biological indicators and methods.
Biocompatibility: Absence of adverse biological reactions as per ISO 10993 standards and associated testing.
Packaging Performance: Adherence to ISO or ASTM packaging integrity test standards.

8. The sample size for the training set

Not applicable. There is no AI/ML model involved, and thus no training set.

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

Not applicable. There is no AI/ML model involved.

In summary, the provided document details a regulatory submission for a packaging change to a medical device. It thoroughly outlines the scope of the change (material, supplier, mold, and slight dimension changes to the tray) and the types of tests performed to ensure that these changes do not negatively impact the device's safety and effectiveness, and that it remains substantially equivalent to its predicate. However, it does not involve an AI/ML component and therefore lacks the information requested for AI device validation.

Summary

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

Public Health Service

Image /page/0/Picture/2 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 image of three faces in profile, stacked on top of each other.

June 2, 2017

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

Medtronic, Inc. Renee Cveykus Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112

Re: K171308

Trade/Device Name: Tubing Pack Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: May 2, 2017 Received: May 3, 2017

Dear Renee Cveykus:

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 of medical device

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

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/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 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,

Fernando
Aguel -S

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

Enclosure

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

Indications for Use

510(k) Number (if known)

K171308

Device Name Tubing Pack

Indications for Use (Describe)

This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) 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)

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:	May 2, 2017
Submitter's Name and Address:	Medtronic, Inc.Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428Establishment Registration Number: 2184009
Contact Person:	Renee L. CveykusPrincipal Regulatory Affairs SpecialistMedtronic Perfusion SystemsPhone: (763) 505-3059Fax: (763) 367-0401Email: renee.l.cveykus@medtronic.com
Alternate Contact:	Jake RoellerSr. Regulatory Affairs ManagerMedtronic Perfusion SystemsPhone: (763) 526-0404Fax: (763) 514-9521Email: jake.w.roeller@medtronic.com

Proprietary Name:

Models	Description
See Appendix 2	Tubing Pack

Device Name and Classification:

Trade Name:	Tubing Pack
Common Name:	Catheter, cannula and tubing, vascular, cardiopulmonary bypass
Classification Name:	Cardiopulmonary bypass vascular catheter, cannula, or tubing.
Classification Panel:	Cardiovascular
Regulation Number:	21 CFR 870.4210
Product Code:	DWF
Classification:	Class II

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

Predicate Device:

K151523 Uncoated Tubing and Connector Components

Device Description

Indications for Use

There is no change to the intended use of the devices/components. The current Indications for Use statement for these devices is listed below:

The Medtronic Tubing Pack is indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.

●

Comparison to Predicate Devices

When compared to the predicate devices, the Tubing Packs have the same:

o Intended Use
Performance ●
Technological characteristics ●
Base materials

Method of sterilization and sterility assurance level

Operating principle ●
Design features ●
Shelf life ●

Packaging Change - New Trays

Medtronic Tubing Packs consist of coated and uncoated tubing, connectors and various medical devices that are pre-assembled into user-specified extracorporeal cardiopulmonary bypass perfusion circuits. Tubing Packs are intended for use within the extracorporeal blood pathway during cardiopulmonary bypass surgical procedures. Medtronic Tubing Packs are currently packaged into qualified clear tray and sterile packaging systems. The packaging trays for the Tubing Pack is changing as part of continual process improvement efforts. The trays are available in three sizes and include the Universal tray, the MIDI Deep tray and MIDI Low tray, for the remainder of this submission they will be referred to as tray(s) and includes all three models. The tray size for a particular tubing pack is based upon the pack contents (size and volume of the pack components). The tray modification includes material, supplier, mold and slight dimension changes. All other packaging components remain unchanged (peel pouches, ties, bands and shipper). There is no change to the sterilization and test methods

1 Brand Name Change from Carmeda to Cortiva.

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

used for the new trays (Sterilization, Biocompatibility, Stability and Performance testing). The packaging tray changes are summarized in Tables 1.

Feature		Current:	Future:	Model Number	Change
Tray
Dimension	Universal	27.75Lx23.79Wx21.77H	27.78Lx23.79Wx21.72H	999505-04 oldM057602T001 new	Yes
	MIDI Deep	29.92Lx16.02Wx8.21H	29.83Lx 15.73W x 8.33H	999505-02 oldM972494A001 new	Yes
	MIDI Low	29.92Lx16.02Wx6.36H	29.75Lx 15.68W x 6.37H	999505-03 oldM972495A001 new	Yes
Supplier		Nelipak	C&J Tech	N/A	Yes
Technology (Mold)		Thermoformed Molded	Injection Molded	N/A	Yes
Material		ResinEastman SpectarPETG 14471Copolyester	ResinResireneCET® 265Styrene MethylMethacrylate AcrylicCopolymer	N/A	Yes
Additional Packaging Components
Lid		Tyvek 1073B coatedwith Oliver TolasTPT-0260	Tyvek 1073B coatedwith Oliver TolasTPT-0260	See Appendix 2	No
Peel Pouches		Tyvek 1073B / 48 GAPET, 28 LBS LDPE (RLE-005)	Tyvek 1073B / 48 GAPET, 28 LBS LDPE (RLE-005)	See Appendix 2	No
Straps, velcros, and tiebands, foam,etc		Various	Various	See Appendix 2	No
Shipper Box		Various	Various	See Appendix 2	No
Sterilization		Ethylene oxidesterilization	Ethylene oxidesterilization	N/A	No
Testing		Biocompatibility,Stability andPerformance	Biocompatibility,Stability andPerformance	N/A	No

Table 1: Package Component Details

Summary of Performance and Biological Testing

Medtronic conducted the following packaging system retesting for new tray:

Process Characterization
Shelf Life
Process Validation
●
Packaging Performance
Sterilization
Biocompatibility

Conclusion

Medtronic has demonstrated that the Tubing Pack with the new tray used in extracorporeal cardiopulmonary bypass perfusion systems is substantially equivalent to the predicate device based upon design, test results, and indications for use. The fundamental scientific principle, labeling and the intended use are unchanged because of this device modification.

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).