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, closedchest support, and limb perfusion.

Device Description

The Medtronic Tri-optic Measurement Cell is a sterile, single-use cell used with the BioTrend Oxygen Saturation and Hematocrit System. This 510(k) premarket notification was submitted to add Balance Biosurface to the disposable cell as update the labeling information for all Tri-optic Measurement Cell versions. The disposable cell is coated on its blood contacting surfaces with Balance Biosurface. Previously cleared disposable cells are also available in uncoated form, and with Carmeda BioActive Surface coating or Trillium Biosurface coating.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Tri-optic Measurement Cell with Balance Biosurface," a cardiopulmonary bypass in-line blood gas monitor. The notification aims to demonstrate substantial equivalence to previously cleared predicate devices.

Based on the information provided, here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (Implied)	Reported Device Performance
Coverage Testing	Coating applied successfully	Pass
Leaching Testing	Coating adheres properly	Pass
Accuracy Testing	Coating does not interfere with the accuracy of reading the flow rate	Pass
Biocompatibility	(Implied: Coating is biocompatible)	(Balance Biosurface is stated to be biocompatible, similar to Carmeda and Trillium)
Intended Use	Same as predicate devices	Same
Design and Materials	Same as predicate devices	Same (with additional coating option)
Principles of Operation and Technology	Identical to predicate devices	Identical
Overall Performance	Meets performance specifications, unchanged from predicate devices	Unchanged, continues to meet specifications

Note: The document does not explicitly state numerical acceptance criteria for "Pass" results (e.g., a specific percentage for accuracy, or a specific limit for leaching). The "Pass" indicates the device met the internal Medtronic requirements for these tests.

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

Sample Size: Not explicitly stated. The document refers to "bench testing" but does not provide numbers of units tested for each specific test (Coverage, Leaching, Accuracy).
Data Provenance: Bench testing. No information on country of origin. The testing is described as occurring prior to submission (February 11, 2014) and is therefore retrospective in nature for the submission.

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

Not applicable. This device is a measurement cell, and the testing described (coverage, leaching, accuracy of flow rate reading) does not involve expert interpretation or diagnosis of images/data for ground truth establishment in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this testing does not involve human expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. The device is an in-line blood gas monitor, not a diagnostic imaging AI tool that would typically involve human readers.

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

Yes, the described "bench testing" represents standalone performance of the physical device components (measurement cell and its coating) as they relate to its function in reading flow rate and ensuring coating integrity. The "algorithm" here implies the underlying technology that reads oxygen saturation and hematocrit, which is considered unchanged from the predicate device.

7. The Type of Ground Truth Used:

For Coverage and Leaching testing: The ground truth would be based on validated analytical or chemical methods to confirm the presence, uniformity, and adhesion of the coating.
For Accuracy testing (related to not interfering with the accuracy of reading the flow rate): The ground truth would likely be established through standard metrology or a reference method for flow rate measurement, against which the device's reading (or its lack of interference) is compared. The document implies the "BioTrend instrument" itself provides the reading, and the test is to ensure the coating doesn't degrade this established accuracy.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a device would be its initial design, engineering, and calibration processes, which are not detailed here.

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

Not applicable, as there is no specific "training set" in the context of an AI/ML algorithm.

Summary

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

October 23, 2014

Medtronic, Inc. Jessica Sixberry Senior Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, Minnesota 55428

Re: K133157

Trade/Device Name: Tri-optic Measurement Cell with Balance Biosurface Regulation Number: 21 CFR 870.4330 Regulation Name: Cardiopulmonary Bypass In-Line Blood Gas Monitor Regulatory Class: II Product Code: DRY Dated: September 18, 2014 Received: September 19, 2014

Dear Ms. Jessica Sixberry:

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. Isting 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 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.

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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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 vours.

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) K133157

Device Name Tri-Optic Measurement Cells

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CER 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subnart C)

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510(k) Summary

Date Prepared:	February 11, 2014
Submitter:	Medtronic, Inc.Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428Establish Registration Number: 2184009
Contact Person:	Jessica SixberrySenior Regulatory Affairs SpecialistPhone: (763) 514-9849Fax: (763) 367-8360Email: jessica.m.sixberry@medtronic.com

Device Name and Classification:

Trade Name:	Tri-optic Measurement Cell with Balance™ Biosurface
Common Name:	Cardiopulmonary bypass in-line blood gas monitor
Regulation Number:	21 CFR 870.4330
Product Code:	DRY
Classification:	Class II

Predicate Devices

Medtronic MX2 Oxygen Saturation and Hematocrit Monitoring System (K910421) Medtronic BioTrend Oxygen Saturation and Hematocrit System (K093650) Medtronic Tri-optic Measurement Cell with Trillium Biosurface (K012743)

Device Description

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Models	Description
BBTMC25,BBTMC38,BBTMC50	Tri-optic Measurement Cell with Balance Biosurface
CB4714R1,CB4715R1,CB4716R1	Tri-optic Measurement Cell with additional tubing extension withCarmeda BioActive Surface
TMC25T,TMC38T,TMC50T	Tri-optic Measurement Cell with Trillium Biosurface
TMC25,TMC38,TMC50	Tri-optic Measurement Cell
1473R1,1474R1,1475R1	Tri-optic Measurement Cell with additional tubing extension

Table 5-1: Model Descriptions

Indications for Use

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.

Comparison to Predicate Devices

The Tri-optic Measurement Cells have the same intended use, design and materials, and principles of operation and technology when compared to the predicate devices.

Intended Use: The Tri-optic Measurement Cells have the same intended use as the . currently marketed Tri-optic Measurement Cells.
Design and Materials: The design and the materials of the Tri-optic Measurement Cells are the same as the predicate devices. The devices are available uncoated and three coating options, Carmeda, Trillium and Balance, which are biocompatible surface coatings that increase the thromboresistance of the blood contact surfaces. Carmeda and Trillium are available coatings on the predicate Tri-optic Measurement Cell devices. Balance is a heparin-free version of Trillium coating. Balance is available on the Affinity Pixie Arterial Filter as well as numerous other previously cleared Medtronic devices.

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. Principles of Operation and Technology: The technology of the subject device and the predicate devices are identical. The disposable cells are included within the cardiopulmonary bypass circuit. The disposable cells are connected to a sensor cable connected to the BioTrend instrument that reads the oxygen saturation and hematocrit of the blood going through the circuit.
. Performance: The performance of the Tri-optic Measurement Cells remains unchanged and continues to meet the performance specifications.

Summary of Performance Data

Bench testing was used to demonstrate the performance characteristics of the Tri-optic Measurement Cells with Balance Biosurface coating. The testing summarized in Table 5-2 was performed to demonstrate substantial equivalence:

Test	Description	Results
CoverageTesting	Ensures the coating has beenapplied successfully	Pass
LeachingTesting	Ensures the coating adheresproperly	Pass
Accuracy	Ensures coating does not interferewith the accuracy of reading theflow rate	Pass

Table 5-2: Testing Summary

Clinical testing was not required to establish substantial equivalence. Performance testing was deemed unnecessary for the labeling changes related to the remainder of the models described in this 510(k).

Conclusion

Medtronic has demonstrated that the Tri-optic Measurement Cells are substantially equivalent to the predicate devices based upon design, test results, and indications for 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).