(29 days)
Not Found
No
The summary describes a disposable blood flow probe and its use with a blood pumping console. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The focus is on the physical and performance characteristics of the probe and its substantial equivalence to a predicate device.
No
The device is described as a "blood flow monitoring system" used to "measure directly the blood flow in the extracorporeal perfusion circuit." Its purpose is measurement, not therapy.
No
The device measures blood flow in an extracorporeal circuit, which is a monitoring function, not a diagnostic one. It provides data about the performance of the circuit, not about a patient's medical condition or disease.
No
The device description explicitly states it is a "Disposable Blood Flow Probe," which is a physical, single-use insert, not a software-only component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "measure directly the blood flow in the extracorporeal perfusion circuit." This is a measurement of a physical parameter (blood flow) within a medical device circuit, not an analysis of a biological sample (like blood, urine, tissue) to diagnose a disease or condition.
- Device Description: The device is a "single-use insert designed to be used in the Bio-Probe Blood Flow Monitoring System." This further reinforces its role as a component within a system for monitoring a physical process.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of analytes, or diagnostic purposes related to a patient's health status based on sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic, monitoring, or screening purposes. This device measures blood flow within an external circuit, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
The Trillium™ Bio-Probe Disposable Blood Flow Probe is designed for use in the Bio-Probe Blood Flow Monitoring System.
The Bio-Probe blood flow monitoring system is to be used with an appropriate model Bio-Console® extracorporeal blood pumping console to measure directly the blood flow in the extracorporeal perfusion circuit.
Product codes
DPT
Device Description
The Trillium™ Bio-Probe Disposable Blood Flow Probe is a single-use insert designed to be used in the Bio-Probe Blood Flow Monitoring System.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The biocompatibility and in vitro bench testing demonstrated that when compared to the Bio-Probe Disposable Blood Flow Probe does not predicu te donooo, the wand effectiveness and are substantially equivalent to other Significally direct career and or oreal cardiopulmonary devices. The in vitro bench testing included analysis of:
- Coating Characteristics .
- Physical Characteristics .
- Performance Characteristics .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2120 Extravascular blood flow probe.
(a)
Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.(b)
Classification. Class II (performance standards).
0
SEP 1 4 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 L. Holm, Associate Product Regulations Manager, Regulatory Affairs
DEVICE NAME
Trillium™ Bio-Probe Disposable Blood Flow Probe
NAME OF PREDICATED OR LEGALLY MARKETED DEVICE
Bio-Probe Disposable Blood Flow Probe (K830858) ലിറ്റ് Tribe Biopodable Diosa provith Trillium™ Biopassive Surface (K973760)
DESCRIPTION OF DEVICE
The Trillium™ Bio-Probe Disposable Blood Flow Probe is a single-use insert designed to be used in the Bio-Probe Blood Flow Monitoring System.
STATEMENT OF INTENDED USE
The Trillium™ Bio-Probe Disposable Blood Flow Probe is a single-use insert designed to be used in the Bio-Probe Blood Flow Monitoring System.
The Bio-Probe Blood Flow Monitoring System is to be used with an appropriate model Bio-Console to measure directly the blood flow in the extracorporeal perfusion circuit.
STATEMENT OF INTENDED USE OF PREDICATED/MARKETED DEVICE
The Bio-Probe Disposable Blood Flow Probe is a single use insert designed to be used in the Bio-Probe Blood Flow Monitoring System.
The Bio-Probe Blood Flow Monitoring System is to be used with an appropriate model Bio-Console to measure directly the blood flow in the extracorporeal perfusion circuit.
STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON
Information regarding technological characteristics comparison is provided in the following section, "Determination of Substantial Equivalence".
Special 510(k) Notification Medtronic, Inc.
1
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
This "SPECIAL 510(k)" is being submitted for a modification to the Bio-Probe Disposable Blood Flow Probe. The modification to the current Bio-Probe Disposable Blood Flow Probe is to coat the blood contact surfaces with Trillium™.
The Trillium™ Bio-Probe Disposable Blood Flow Probe is being compared to the following Marketed Devices:
- Bio-Probe Disposable Blood Flow Probe (K830858) ●
- AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface . (K973760)
The Trillium"" Bio-Probe Disposable Blood Flow Probe has the same indications statement and intended uses as the:
-
Bio-Probe Disposable Blood Flow Probe (K830858) .
The Trillium™ Bio-Probe Disposable Blood Flow Probe has "no new technological characteristics (e.g., materials and manufacturing processes)" from the Bio-Probe Disposable Blood Flow Probe. 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" Bio-Probe Disposable Blood Flow Probe is substantially equivalent to other marketed extracorporeal cardiopulmonary devices.
2
The biocompatibility and in vitro bench testing demonstrated that when compared to the The bloompatibility and in Willie benon tool Disposable Blood Flow Probe does not predioute donooo, the wand effectiveness and are substantially equivalent to other Significally direct career and or oreal cardiopulmonary devices. The in vitro bench testing included analysis of:
- Coating Characteristics .
- Physical Characteristics .
- Performance Characteristics .
Special 510(k) Notification Medtronic, Inc.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces right and appears to be in flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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: K012747
Trade Name: Trillium™ Bio-Probe Disposable Blood Flow Probe (DP38T and DP38PT) Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular Blood Flow Probe Regulatory Class: Class II (two) Product Code: DPT 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.
4
Page 2 - Ms. Marie L. Holm
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i loast of advisou that I Drivision that your device complies with other requirements of the Act that I Dr Has Intact a and regulations administered by other Federal agencies. You must or any I colorated and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic ford in and quality by overns (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) I mis letter with and h your e FDA finding of substantial equivalence of your device to a legally promated predicated 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of 1 1 1 1 1 1 1 - 4646. Additionally, for questions on the promotion and advertising of Compliance please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oivision 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 Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510 (k) Number if known: K012747 -
Device Name: Trillium™ Bio-Probe Disposable Blood Flow Probe
The Trillium™ Bio-Probe Disposable Blood Flow Probe is designed for use in the Bio-Probe Blood Flow Monitoring System.
Indications for Use:
The Bio-Probe blood flow monitoring system is to be used with an appropriate model Bio-Console® extracorporeal blood pumping console to measure directly the blood flow in the extracorporeal perfusion circuit.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012747
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter use _