(84 days)
No
The description focuses on fiber optic technology and standard signal processing for measurement, with no mention of AI or ML terms or concepts.
No
The device is described as an "on-line monitoring instrument" that measures oxygen saturation and hematocrit, which are diagnostic indicators, not therapeutic actions.
Yes
The device measures percent oxygen saturation and hematocrit of the blood, providing data for clinical assessment and diagnosis within an extracorporeal circuit.
No
The device description explicitly states that the BioTrend System consists of the BioTrend Instrument, two Sensor Cables, and a power cord, which are all hardware components. The summary also details hardware testing performed on the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device measures oxygen saturation and hematocrit of blood in the extracorporeal circuit. While it analyzes blood, it does so within a system that is external to the body but still connected to the patient. IVDs typically involve testing samples of blood or other bodily fluids outside of the body for diagnostic purposes.
- Device Description: The description emphasizes the device's role in monitoring blood parameters within the extracorporeal circuit using in-line measurement cells. This is a continuous monitoring function within a therapeutic or support system, not a diagnostic test performed on a collected sample.
- Lack of Diagnostic Claim: The intended use and description focus on monitoring parameters during procedures like cardiopulmonary bypass. There is no mention of using the results for diagnosing a disease or condition.
While the device analyzes blood, its function and context within the extracorporeal circuit align more with a patient monitoring device rather than an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DTY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the Medtronic logo. The logo consists of a circular graphic on the left and the word "Medtronic" in bold, black letters on the right. The circular graphic appears to have a stylized representation of a human figure within it.
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
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
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.
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.
Indications for Use
5
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 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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2
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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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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the left.
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
Image /page/4/Picture/8 description: The image shows a free-form sketch of a shape that resembles a mountain range or a stylized crown. The lines are dark and somewhat jagged, giving the impression of a quick, hand-drawn illustration. The shape is simple and abstract, with no shading or additional details.
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:
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.
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_