Medtronic Tubing Packs are used in cardiopulmonary bypass procedures for connecting the primary devices of the bypass circuit. 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. This submission is to add additional tubing and connectors for use in Tubing Pack and is changing as part of continual process improvement efforts. The component additions include tubing and connectors that may be coated or uncoated. The coating types include: Cortiva, Trillium and Balance and these three types of coatings are identical to the cleared existing components for Tubing Packs (K891687, K012538 and K122811). The components being added do not have any changes in materials, technology or labeling than previously cleared components for Tubing Packs. These additional components are representative of currently cleared components and do not add any additional risk to patients therefore, Medtronic believes these components may be added to the Tubing Packs. All packaging components remain unchanged (peel pouches, ties, bands, trays, lids and shipper). There is no change to the sterile barrier, sterilization and test methods used for these components.

AI/ML Overview

This looks like information for a regulatory submission for a medical device. Based on the provided text, here's a breakdown of the acceptance criteria and the study conducted to prove the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Requirements)	Reported Device Performance
Pressure Integrity	Met (Verification testing demonstrated)
Pressure Decay	Met (Verification testing demonstrated)
Spallation (Tubing)	Met (Verification testing demonstrated)
Kink Resistance (Tubing)	Met (Verification testing demonstrated)
Pull Force	Met (Verification testing demonstrated)
Tubing Life	Met (Verification testing demonstrated)
Biocompatibility	Met (Verification testing demonstrated)
Mechanical Requirements	Met (Rationalization documentation completed)
Coating Requirements	Met (Rationalization documentation completed)
Design Verification for Non-stacked conditioning and Pressure Integrity	Met (Rationalization documentation completed)

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the test set in quantitative terms (e.g., number of units tested). Instead, it mentions that "worse case testing for tubing and connectors" was performed and "verification results were leveraged based on most challenging components." This suggests that a subset of components representing the most challenging scenarios was selected for testing.

The data provenance is from Medtronic, Inc.'s internal testing. It is prospective in the sense that the testing was conducted specifically for this submission to verify the performance of the added components. The country of origin of the data is implicitly the United States, as Medtronic is based there and submitting to the FDA.

3. Number of Experts and Qualifications for Ground Truth

This device (Medtronic Tubing Pack) is a Class II medical device, specifically "Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing." The "ground truth" in this context refers to established engineering and biocompatibility standards and performance requirements for such medical components, rather than clinical interpretation by medical experts (like radiologists for imaging devices).

The document does not mention the use of experts to establish a "ground truth" for a test set in the way one would for an AI-powered diagnostic device. The "ground truth" for this device's performance is derived from established industry standards, internal product specifications, and regulatory requirements that define acceptable limits for pressure integrity, biocompatibility, etc. The document refers to "product specification" and "rationalization documentation" as the basis for evaluation.

4. Adjudication Method

An adjudication method (like 2+1, 3+1) is typically used in clinical studies where there's a need to resolve discrepancies in expert opinions on imaging or clinical assessments. For this type of device (tubing and connectors), the "adjudication" is based on objective measurement against predefined specifications and standards. There is no mention of human adjudication in the traditional sense for reconciling expert interpretations for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are relevant for devices that involve human interpretation, particularly in diagnostic imaging, to assess improvements in reader performance with AI assistance. This device is a passive component for cardiopulmonary bypass and does not involve human interpretation in a diagnostic capacity or AI assistance.

6. Standalone Performance Study

The studies described are essentially standalone performance studies for the device components. The verification and validation testing assesses the "algorithm only" (if one considers the manufacturing process and design as the "algorithm" for a physical device) against predetermined performance specifications. The tests for pressure integrity, spallation, kink resistance, pull force, tubing life, and biocompatibility are all evaluations of the device's inherent performance characteristics without human interaction being part of the primary performance metric.

7. Type of Ground Truth Used

The ground truth used is primarily engineering specifications, material science standards, and biocompatibility standards, as outlined in the "product specification" and various "rationalization documentation" (e.g., Mechanical Requirements, Coating Requirements, Biocompatibility per product specifications). Essentially, the "ground truth" is established industry and regulatory benchmarks for the safety and efficacy of cardiopulmonary bypass components.

8. Sample Size for the Training Set

This document does not mention a "training set" as this is not an AI/machine learning device. The "training" for a physical medical device typically refers to the design, manufacturing process, and quality control procedures, which are developed and refined over time based on engineering principles and previous device iterations. There isn't a "training data" set in the context of an algorithm.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" in the AI/machine learning sense, there is no ground truth established for it. The development and refinement of the device's design and manufacturing processes (analogous to "training" for a physical product) would be based on:

Engineering design principles
Material science knowledge
Previous iterations of similar devices (predicates)
User feedback
Regulatory requirements and standards for medical devices.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 27, 2017

Medtronic, Inc. Renee Cveykus Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE (MVS83) Mounds View, Minnesota 55112

Re: K171979

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: October 18, 2017 Received: October 19, 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-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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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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 (DICE) 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 (DICE) 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,

Nicole G. Ibrahim -S

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)

K171979

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)

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510(k) Summary

Date Prepared:	June 29, 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 3	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

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Predicate Device:

K171308 Tubing Pack

Device Description

Medtronic Tubing Packs are used in cardiopulmonary bypass procedures for connecting the primary devices of the bypass circuit. The functionality and intended use of these devices are the same as those for the listed in the Table 2-1.

510(k)Number	Date ofClearance	Device
K800178	02/21/1980	Uncoated Tubing Packs
K883956	10/28/1988	Biomedicus Tubing Packs
K924529	06/23/1993	Signature Tubing Packs
K891687	05/31/1989	Carmeda Coated Tubing Packs
K012538	23/08/2001	Trillium Coated Tubing Packs
K113845	01/25/2012	Tubing, Connectors, and Accessories with Balance™ Biosurface
K122811	10/12/2012	Balance Coated Connector Components
K151523	07/16/2015	Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass
K171308	06/02/2017	Tubing Pack – New Packaging Trays

Table 2-1: Tubing Packs Cleared

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 device, the Tubing Packs have the same:

Intended Use
Performance ●
Technological characteristics ●
Base materials ●
Operating principle
Method of sterilization and sterility assurance level .
Design features
Shelf life

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Coatings
Biocompatibility

Addition of Components (Tubing and Connectors)

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. This submission is to add additional tubing and connectors for use in Tubing Pack and is changing as part of continual process improvement efforts. The component additions include tubing and connectors that may be coated or uncoated. The coating types include: Cortiva, Trillium and Balance and these three types of coatings are identical to the cleared existing components for Tubing Packs (K891687, K012538 and K122811). The components being added do not have any changes in materials, technology or labeling than previously cleared components for Tubing Packs. These additional components are representative of currently cleared components and do not add any additional risk to patients therefore, Medtronic believes these components may be added to the Tubing Packs. All packaging components remain unchanged (peel pouches, ties, bands, trays, lids and shipper). There is no change to the sterile barrier, sterilization and test methods used for these components. The type of components being added are outlined in Table 2-2.

Component	Quantity	Uncoated	Coated
			Cortiva	Trillium	Balance
Connectors	121	39Type: Cap, luer, stopcock, monitoring line, connectors	28	24	30
Tubing	86	35Size: .085x.062x, .107x.040x, 1/2X1/8, 1/2x3/32x, 1/4X1/16, 3/16x1/16, and5/16x3/32x	0	23	28
Total	207

Table 2-2: Types of Components being Added

A detailed list of the new components can be found within Appendix 2.

Summary of Performance and Biological Testing

Verification and validation testing demonstrated that the tubing and connectors are substantially equivalent to the predicate. Medtronic conducted the following testing for the tubing and connector components:

. Pressure Integrity
Pressure Decay

●

Spallation (Tubing) ●
Kink Resistance (Tubing) ●
- ●
  - Tubing Life Biocompatibility ●

Pull Force

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The testing completed was a representative of worse case testing for tubing and connectors and the verification results were leveraged based on most challenging components. Each of the components in scope of this submission were reviewed against the product specification and the following rationalization documentation was completed:

. Mechanical Requirements (10561942DOC)
Coating Requirements (10552508DOC) ●
. Design Verification for Non-stacked conditioning and Pressure Integrity (10571289DOC)
Biocompatibility per product specifications (10560838DOC) ●

Based on this evaluation Medtronic considers these tubing and connectors are substantially equivalent to the predicate.

Conclusion

Medtronic has demonstrated that the Tubing Pack with the additional components used in extracorporeal cardiopulmonary bypass perfusion systems is substantially equivalent to the predicate device based upon design, testing, 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).