The tubing consists of biocompatible polyvinyl chloride tubing in various lengths. This tubing will be used in the extracorporeal circuit during cardiopulmonary bypass to interconnect the catheters and cannula with an oxygenator and other accessory bypass equipment. The connectors consist of molded fittings for use in interconnecting tubing, cannula and/or other extracorporeal devices. Tubing and connectors are coated with Trillium™ Biopassive Surface (a polyment containing non-leaching heparin).

AI/ML Overview

The provided text describes a 510(k) submission for "Tubing and Connectors with Trillium™ Biopassive Surface." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria in the way a new drug or novel medical device might.

Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert involvement, etc.) is not applicable or available within this document, as the submission relies on demonstrating comparable technological characteristics and safety/effectiveness data through bench testing, not clinical performance studies with defined endpoints against acceptance criteria.

However, I can extract the relevant information regarding the types of testing performed to demonstrate that the device does not raise new safety or effectiveness questions compared to its predicate:

1. Table of "Acceptance Criteria" and Reported Device Performance:

Since this is a 510(k) for a modified device (coating) and relies on substantial equivalence to a predicate, there aren't explicit, quantified "acceptance criteria" in the traditional sense that would be seen in a clinical trial. Instead, the "performance data" demonstrates that the new device's characteristics do not significantly affect safety and effectiveness when compared to the predicate. The "reported device performance" is essentially that the device performed comparably to the predicate in these tests.

Characteristic Tested (Proxy for Acceptance Criteria)	Device Performance (Reported Outcome)
Coating Characteristics
Coating Leaching	Demonstrated safety and effectiveness comparable to predicate.
Physical/Performance Characteristics
Spallation	Demonstrated safety and effectiveness comparable to predicate.
Pressure Decay/Pressure Integrity	Demonstrated safety and effectiveness comparable to predicate.
Kink Resistance	Demonstrated safety and effectiveness comparable to predicate.
Blood Trauma	Demonstrated safety and effectiveness comparable to predicate.
Pull Strength	Demonstrated safety and effectiveness comparable to predicate.
Biocompatibility	Demonstrated safety and effectiveness comparable to predicate.

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

Sample Size: Not specified in the document. The testing described is bench testing (in vitro), not human or animal studies with a "test set" in the clinical trial sense.
Data Provenance: The data provenance is from in vitro bench testing. The country of origin of this data is not specified, but it would have been generated by Medtronic Perfusion Systems or a contracted lab. The testing is prospective in the sense that it was conducted specifically for this 510(k) submission to evaluate the modified device.

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

Not Applicable: This type of testing (bench testing for material properties and performance) does not typically involve human experts establishing "ground truth" in the way a clinical image analysis study would. The "ground truth" is established by the standardized methods for measuring coating leaching, pressure integrity, etc., and comparison against the predicate device.

4. Adjudication Method for the Test Set:

Not Applicable: Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in clinical data interpretation. Bench tests rely on objective measurements and established protocols.

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

No: No MRMC study was performed. This device is tubing and connectors for cardiopulmonary bypass, not an imaging or diagnostic device that would involve human readers.

6. Standalone Performance (Algorithm Only):

Not Applicable: This is a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used:

For the bench testing, the "ground truth" is based on objective measurements of physical and chemical properties (e.g., coating leaching, pressure decay, pull strength) as defined by established test methods and comparison to the performance characteristics of the legally marketed predicate devices.

8. Sample Size for the Training Set:

Not Applicable: This device is not an AI/ML algorithm that requires a "training set." The materials and manufacturing processes are evaluated through standard engineering and biocompatibility testing.

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

Not Applicable: As there is no training set.

Summary

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AUG 2 3 2001

Summary of Safety and Effectiveness

Company and Contact Person

Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Tel: 763-391-9183 Fax: 763-391-9603

Marie Holm, Associate Product Regulations Manager, Regulatory Affairs

Device Name

Tubing and Connectors with Trillium™ Biopassive Surface

Name of Predicated or Legally Marketed Device

Intersept Blood Tubing Packs (K800178) mensept Drood Tubing Packs (115001773)
Affinity Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760)

Description of Device

The tubing consists of biocompatible polyvinyl chloride tubing in various lengths (see Appendix I). This tubing will be used in the extracorporeal circuit during I cardiopulmonary bypass to interconnect the catheters and cannula with an oxygenator and other accessory bypass equipment.

The connectors consist of molded fittings for use in interconnecting tubing, cannula and/or other extracorporeal devices (see Appendix I).

Tubing and connectors are coated with Trillium™ Biopassive Surface (a polyment containing non-leaching heparin).

Statement of Intended Use

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

Statement of Intended Use of Predicate Device

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

Special 510(k) NotificationMedtronic, Inc.	Tubing and Connectors with Trillium™Biopassive Surface	Confidential
Medtronic Perfusion Systems	Appendix III	17

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Statement of Technological Characteristics and Comparison

Information regarding technological characteristics comparison is provided in the following section, "Determination of Substantial Equivalence".

Determination of Substantial Equivalence

This "SPECIAL 510(k)" is being submitted for a modification to various Medtronic tubing and connectors. The modification to the current tubing and connectors is to coat the blood contact surfaces with Trillium™

The Medtronic Tubing and Connectors with Trillium™ Biopassive Surface are being compared to the following marketed devices:

Tubing and connectors described in (K800178) Affinity Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760)

The tubing and connectors with Trillium™ Biopassive Surface have the same indications statement and intended uses as the:

Tubing and connectors described in (K800178)

The tubing and connectors with Trillium™ Biopassive Surface have no "new technological characteristics (e.g., materials and manufacturing processes)" from the currently marketed tubing and connectors.

The technological characteristic of the Trillium™ Biopassive Surface is used in other cardiopulmonary devices currently in commercial distribution as follows:

Affinity Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760)

This technological characteristic "could affect the safety and effectiveness of the device". However, these "new technological characteristics do not raise new types of safety or effectiveness questions". In addition, "there are acceptable scientific methods which exist for assessing effects of these new technological characteristics".

"Performance data to assess the effects of these new technological characteristics" has been performed. These "performance data demonstrate" that the tubing and connectors with Trillium™ Biopassive Surface are substantially equivalent to other marketed tubing and connectors.

The biocompatibility and in vitro bench testing demonstrated that when compared to the predicate devices, the tubing and connectors with Trillium™ Biopassive Surface does not significantly affect safety and effectiveness and are substantially equivalent to other

Special 510(k) Notification	Tubing and Connectors with Trillium™	Confidential
Medtronic, Inc.	Biopassive Surface
Medtronic Perfusion Systems	Appendix III	18

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commercially distributed cardioplegia delivery system. The in vitro bench testing included analysis of:

Coating Characteristics:

Coating Leaching

Physical/Performance Characteristics:

Spallation Pressure Decay/Pressure Integrity Kink Resistance Blood Trauma Pull Strength

Special 510(k) Notification	Tubing and Connectors with Trillium™	Confidential
Medtronic, Inc.	Biopassive Surface
Medtronic Perfusion Systems	Appendix III	19

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

AUG 2 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marie Holm Associate Product Regulations Manager Medtronic, Inc. 7611 Northland Drive Minneapolis, MN 55428

K012538 Re:

Tubing and Connectors with Trillium™ Biopassive Surface Regulation Number: 870.4210 Regulatory Class: II (two) Product Code: DWF Dated: August 6, 2001 Received: August 7, 2001

Dear Ms. Holm:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Marie Holm

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

James E. Dillard III Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number if known: KO12538___________________________________________________________________________________________________________________________________________

Device Name: Medtronic Tubing and Connectors with Trillium™ Biopassive Surface

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012338

Prescription Use _

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Per 21 CFR 801.109

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).