The BioTrend oxygen saturation and hematocrit system measures percent The Blor rond oxygen saturation in the extracorporeal circuit. The extracorporeal circuit is used for, but is not limited to, cardiopulmonary bypass, closed chest support and limb perfusion.

Device Description

The Trillium™ Tri-optic Measurement Cell is a single-use insert designed to be used in the BioTrend Qxygen Saturation and Hematocrit System (K954501). The BioTrend Oxygen Saturation and Hematocrit System measures oxygen saturation and hematocrit by using dual wavelength photometric techniques. The Tri-optic Measurement Cell is an in-line, full flow, sterile and non-pyrogenic fluid path disposable device. The device accommodates the transmission of the light-emitting signal into the blood path and collection of the backscattered light signal.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the Trillium™ Tri-optic Measurement Cell. This particular submission is a "SPECIAL 510(k)," meaning it's for a modification to an already legally marketed device. The modification involves coating the blood contact surfaces with Trillium™. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report with specific performance metrics.

Therefore, much of the requested information (like a table of acceptance criteria, specific device performance, sample sizes for test/training sets with provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) is not explicitly available in the provided text.

However, based on what is available, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a quantitative table of acceptance criteria or specific reported device performance metrics in numerical form. Instead, it states that the device was evaluated for its Coating Characteristics, Physical Characteristics, and Performance Characteristics during "in vitro bench testing." The conclusion drawn from these tests is:

Acceptance Criteria Category	Reported Device Performance (Qualitative)
Biocompatibility	Demonstrated that it "does not significantly affect safety and effectiveness" compared to predicate devices.
Coating Characteristics	Evaluated (details not provided).
Physical Characteristics	Evaluated (details not provided).
Performance Characteristics	Evaluated (details not provided).
Substantial Equivalence	Demonstrated to be substantially equivalent to other commercially distributed extracorporeal cardiopulmonary devices when compared to predicate devices.

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

Sample Size: Not specified. The document only mentions "in vitro bench testing."
Data Provenance: The studies were "in vitro bench testing," implying laboratory-based testing. No information on country of origin or whether it was retrospective/prospective is provided.

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

Not applicable or not specified. Since the testing was "in vitro bench testing" and focused on physical and performance characteristics, human expert ground truth as typically understood in diagnostic studies (e.g., radiologists interpreting images) is not relevant here. The ground truth would be based on validated laboratory measurement methods.

4. Adjudication Method for the Test Set:

Not applicable or not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is typically for evaluating diagnostic interpretative performance, which is not the focus of this device's evaluation based on the provided text.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The device itself is an "in-line, full flow, sterile and non-pyrogenic fluid path disposable device" designed to be used with a BioTrend Oxygen Saturation and Hematocrit System. It's a component, not a standalone diagnostic algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not directly apply here. The "performance data" mentioned refers to the physical and functional performance of the device component.

7. The Type of Ground Truth Used:

The ground truth for the "in vitro bench testing" would be based on objective measurements and validated laboratory standards for coating, physical, and performance characteristics (e.g., material analysis, flow dynamics measurements, optical properties, stability testing etc.). The document indicates "acceptable scientific methods" exist for assessing these characteristics.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device modification, not a machine learning algorithm that requires a "training set" in the conventional sense.

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

Not applicable for the same reason as point 8.

Summary

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K012743

SUMMARY OF SAFETY AND EFFECTIVENESS

COMPANY AND CONTACT PERSON

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

Marie L. Holm, Associate Product Regulations Manager, Regulatory Affairs

DEVICE NAME

Trillium™ Tri-optic Measurement Cell

name of predicated or legally marketed device

Tri-optic Measurement Cell (K910421) 117 Splio Mousuremonor with Trillium™ Biopassive Surfaçe (K973760)

DESCRIPTION OF DEVICE

STATEMENT OF INTENDED USE

The Trillium™ Tri-optic Measurement Cell is to be used with the BioTrend Oxygen Saturation and Hematocrit System.

The BioTrend Oxygen Saturation and Hematocrit System measures percent oxygen saturation and hematocrit of the blood in the extracorporeal circuit. The extracorporeal circuit is used for, but is not limited to, cardiopulmonary bypass, closed chest support and limb perfusion

STATEMENT OF INTENDED USE OF PREDICATED/MARKETED DEVICE

The Tri-optic Measurement Cell is to be used with the BioTrend Oxygen Saturation and Hematocrit System.

Special 510(k) Notification Medtronic, Inc. Medtronic Perfusion System Trillium™ Tri-optic Measurement Cell

Confidential

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STATEMENT OF TECHNOLOGICAL CHARACTERISTICS 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 the Tri-optic Measurement Cell. The modification to the current Tri-optic Measurement Cell is to coat the blood contact surfaces with Trillium""

The Trillium™ Tri-optic Measurement Cell is being compared to the following marketed devices:

Tri-optic Measurement Cell (K910421) .
AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface . (K973760)

The Trillium™ Tri-optic Measurement Cell has the same indications statement and intended uses as the:

Tri-optic Measurement Cell (K910421) .
The Trillium" Tri-optic Measurement Cell has "no new technological characteristics (e.g., materials and manufacturing processes)" from the Tri-optic Measurement Cell. The technological characteristic is solely the coating material of the blood pathway:
Trillium™ .
The technological characteristic of the Trillium™ Biopassive Surface is common to other medical devices (hollow fiber oxygenators) 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 "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 Trillium" Tri-optic Measurement Cell is substantially equivalent to other marketed extracorporeal cardiopulmonary bypass devices.

Confidential

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The biocompatibility and in vitro bench testing demonstrated that when compared to the predicate devices, the Trillium™ Tri-optic Measurement Cell does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed extracorporeal cardiopulmonary devices.

The in vitro bench testing included analysis of:

Coating Characteristics

Physical Characteristics

Performance Characteristics

Special 510(k) Notification Medtronic, Inc. Medtronic Perfusion System Confidential

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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked one behind the other.

Public Health Service

SEP 1 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marie L. Holm Medtronic Perfusion Systems 7611 Northland Drive N Minneapolis, MN 55428-1088

Re: K012743

Trade Name: Trillium™ Tri-optic Measurement Cell (TMC 25T, 38T, and 50T) Regulation Number: 21 CFR 870.4330 Regulation Name: Monitor, blood gas, on-line, cardiopulmonary bypass Regulatory Class: Class II (two) Product Code: DRY Dated: August 15, 2001 Received: August 16, 2001

Dear Ms. Holm:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Ms. Marie L. Holm

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri 3 issuation of our device complies with other requirements of the Act that I Dri has made a acternmentations administered by other Federal agencies. You must of ally reachardies and regulations and with the be registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN Part 607), adomig (21 OFR Part 820); and if applicable, the electronic forth in the quality bybellions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w you to over finding of substantial equivalence of your device to a legally prematication: "The Prodication 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of adultionally 21 OF For and 646. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-461 the Office of Compliance at (301) 594-4639. Also, please note the your de revels, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entires, "Thison on your responsibilities under the Act may be obtained from the Oiner general missimal 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 Director 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: K0112743 -

Device Name: Trillium™ Tri-optic Measurement Cell

The Trillium™ Tri-optic Measurement Cell is intended for use in the BioTrend oxygen saturation and hematocrit system.

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number: K0(2743

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter use

Regulation Number and Section

§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.

(a)
Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.(b)
Classification. Class II (performance standards).