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.

Device Description

The modified BioTrend Oxygen Saturation and Hematocrit System is an on-line monitoring instrument that combines both venous (SvO2) and arterial (SaO2) oxygen saturation measurement with hematocrit (Hct) measurement. The BioTrend System consists of the BioTrend Instrument, two Sensor Cables, and a power cord. The BioTrend system is designed to be used with the Tri-optic Measurement Cells.

The Tri-optic Measurement Cell is a disposable device in the extracorporeal circuit that provides a sealed interface between the blood pathway and the BioTrend sensor cable. No change is being made to the Tri-optic Measurement Cell, which was previously cleared under K910421 and K012743.

Using fiber optic technology, the BioTrend System continuously measures the percentage of oxygen saturation and hematocrit and displays the results on large, easy-to-read, color-coded Light Emitting Diodes (LEDs). The display panel indicates operating status and error messages, and provides a means for system calibration.

BioTrend Sensor Cables connect to the BioTrend instrument and the in-line Tri-optic Measurement Cells (TMC) to transmit optical measurement signals. The BioTrend sensor cables isolate the patient from the instrument electronics, providing patient protection. The BioTrend instrument contains a built-in, rechargeable battery pack to provide the battery power. Consequently, the BioTrend instrument can be operated on AC or battery power. A continuous, built-in self-check immediately alerts the operator of equipment failure and displays a corresponding error code.

AI/ML Overview

This submission (K093652) is for a modification to an existing device, the BioTrend Oxygen Saturation and Hematocrit System, and does not include a study to prove the device meets acceptance criteria related to clinical performance.

The modifications are to the hardware and software of the BioTrend Instrument, and the submission emphasizes that the "fundamental scientific technology and the intended use are unchanged." Consequently, clinical testing was not required to establish substantial equivalence.

Here's an analysis based on the provided document, addressing the requested points:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) submission for the modified BioTrend Oxygen Saturation and Hematocrit System (K093652) establishes substantial equivalence to its predicate device (K954501) through a series of preclinical (bench) tests. Clinical effectiveness was not evaluated as part of this submission, as the modifications were to the instrument's hardware and software, with no change to the core measurement technology, intended use, or performance claims. Therefore, specific clinical acceptance criteria, a multi-reader multi-case study, or a standalone algorithm performance study are not relevant to this submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or reported device performance for a clinical outcome. Instead, it lists various "Preclinical testing data were used to establish the performance characteristics of the modifications to this device." These tests were designed to ensure the modified device maintained its original performance and met safety requirements.

Test Category	Acceptance Criteria (Implied)	Reported Performance
Blood Testing	Verify oxygen saturation and hematocrit measurement accuracy. (Implied: maintain accuracy of predicate device)	Not explicitly detailed, but implied as successful
Environmental Testing	Verify operational temperature, storage temperature, thermal shock, storage humidity, vibration, mechanical shock, cautery, defibrillation, spill resistance, and chemical resistance.	Not explicitly detailed, but implied as successful
Packaging Testing	Verify packaging requirements per ASTM D 4169 performance testing (Distribution Cycle 13, Assurance Level 1).	Not explicitly detailed, but implied as successful
System Testing	Verify the device meets system-level requirements.	Not explicitly detailed, but implied as successful
Software Testing	Verify the device meets software requirements.	Not explicitly detailed, but implied as successful
Hardware Testing	Verify PCB assemblies meet design specifications.	Not explicitly detailed, but implied as successful
UL/TUV Testing	Verify the device meets emissions, immunity/susceptibility, and safety requirements.	Not explicitly detailed, but implied as successful

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

Sample Size for Test Set: Not applicable in the context of a clinical performance study. The "test set" for this submission comprised various physical components and software modules of the BioTrend Instrument. The document specifies "Blood testing" was conducted, but it doesn't provide details on the number of blood samples or their characteristics.
Data Provenance: Not applicable in the context of a clinical performance study. The tests were preclinical bench tests, not involving human subjects or clinical data collection.

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

Not applicable. This submission relies on engineering and scientific testing to demonstrate substantial equivalence, not expert consensus on clinical ground truth.

4. Adjudication Method for the Test Set

Not applicable. Clinical adjudication methods are not relevant to the bench testing conducted for this submission.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states, "Clinical testing was not required to establish substantial equivalence."

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

A "Software testing" was done "to verify the device meets the software requirements called out in the software requirements document." This implies testing of the algorithm's performance in isolation from user interaction, but it is not a standalone clinical performance study to assess accuracy against a clinical ground truth. The algorithm for oxygen saturation and hematocrit calculation remains the same as the predicate device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the "Blood testing" mentioned, the ground truth would have been established by a reference method for measuring oxygen saturation and hematocrit. However, the document does not specify this method. For other tests (environmental, packaging, system, software, hardware, UL/TUV), the "ground truth" would be adherence to established engineering specifications, regulatory standards, and internal requirements documents.

8. The Sample Size for the Training Set

Not applicable. This device is an on-line monitoring instrument, not an AI/ML algorithm that undergoes a training phase for a specific diagnostic task from a dataset. The phrase "Same Algorithm used to calculate oxygen saturation and hematocrit" indicates that the core calculation method is pre-established and carried over from the predicate device.

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

Not applicable, as this device does not utilize a "training set" in the context of machine learning. The algorithm is based on established principles of optical measurement for oxygen saturation and hematocrit.

Summary

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K093652

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FEB 1 7 2010

510(k) Summary

Date Prepared	November 24, 2009
Submitter	Medtronic, Inc.710 Medtronic Parkway NE
	Minneapolis, MN 55432-5604
	Establish Registration Number: 2184009
Contact Person	Jeffrey L. Koll
	Regulatory Affairs Specialist
	Phone: (763) 514-9842
	Fax: (763) 367-8360
	Email: jeffrey.l.koll@medtronic.com

Device Name and Classification

Trade Name: Common Name: Regulation Number: Product Code: Classification:

BioTrend® Oxygen Saturation and Hematocrit System Cardiopulmonary bypass in-line blood gas sensor. 21 CFR 870.4410 DTY Class II

Predicate Device

BioTrend® Oxygen Saturation and Hematocrit System (K954501)

Device Description

Using fiber optic technology, the BioTrend System continuously measures the percentage of oxygen saturation and hematocrit and displays the results on large, easy-to-read, color-coded

Alleviating Pain · Restoring Health · Extending Life

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Light Emitting Diodes (LEDs). The display panel indicates operating status and error messages, and provides a means for system calibration.

Indications for Use

Comparison to Predicate Device

A comparison of the modified product and the currently marketed oxygen saturation and hematocrit system has the following similarities to the system which received 510(k) clearance:

. Same intended use.
. Same operating principle.
Same performance claims. .
Same Tri-Optic Measurement Cells (K910421 and K012743) for transmission of . optical measurement signals.
Same Algorithm used to calculate oxygen saturation and hematocrit. .

Intended Use

The intended use is unchanged.

Labeling

A summary of the labeling changes is as follows:

Update IFU and labeling to address hardware and software changes to the device. .
Add model number to device label. .

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Summary of Performance Data

Preclinical testing data were used to establish the performance characteristics of the modifications to this device. Clinical testing was not required to establish substantial equivalence. The following bench testing was conducted:

Blood testing: to verify oxygen saturation and hemacrit measurement accuracy .
Environmental testing: to verify operational temperature, storage temperature, . thermal shock, storage humidity, vibration, mechanical shock, cautery, defibrillation, spill resistance, and chemical resistance
Packaging testing: to verify packaging requirements per ASTM D 4169 performance . testing of shipping Containers and Systems, Distribution Cycle 13, Assurance Level 1. :
System testing: to verify the device meets the system level requirements called out in . the system requirements document
Software testing: to verify the device meets the software requirements called out in . the software requirements document
Hardware testing: to verify the PCB assemblies meet the performance requirements . called out in the design specifications
UL/TUV testing: to verify the device meets the emissions, immunity/susceptibility, . and safety requirements

Conclusion

The modifications to the BioTrend® Oxygen Saturation and Hematocrit System described in this submission result in a substantially equivalent device because the fundamental scientific technology and the intended use are unchanged.

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Food and Druq Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

FEB 1 7 2010

Medtronic Cardiovascular MVS83 c/o Mr. Jeffrey L. Koll Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112

Re: K093650

BioTrend® Oxygen Saturation and Hematocrit System Regulation Number: 21 CFR 870.4410 Regulation Name: Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass Regulatory Class: Class II Product Code: DTY Dated: January 13, 2010 Received: January 14, 2010

Dear Mr. Koll:

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.

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Page 2 - Mr. Jeffrey L. Koll

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ycm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

ie R. -Vachner

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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): K د و 3 65 O

Device Name: BioTrend Oxygen Saturation and Hematocrit System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

una R. viclunen

(Division Sign-Off) Division of Cardiovascular Devices

K093650 510(k) Number_

Regulation Number and Section

§ 870.4410 Cardiopulmonary bypass in-line blood gas sensor.

(a)
Identification. A cardiopulmonary bypass in-line blood gas sensor is a transducer that measures the level of gases in the blood.(b)
Classification. Class II (performance standards).