(569 days)
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No
The summary describes a system for monitoring blood flow using electromagnetic technology and does not mention any AI or ML components or functionalities.
No
The device is used for monitoring blood flow rate during open heart surgery; it does not provide therapy or treatment to the patient.
No
The device is used for monitoring blood flow rate during surgery, not for diagnosing a condition or disease.
No
The device description explicitly states it is composed of three components: a monitor display unit, a transducer, and a sterile flow-through probe, indicating hardware components are included.
Based on the provided information, the Accuflo™ Electromagnetic Flow System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor blood flow rate during open heart surgery within the extracorporeal cardiopulmonary bypass circuit. This is a measurement of a physiological parameter in vivo (within the living body's circulation, albeit outside the main body) rather than an analysis of a sample taken from the body (in vitro).
- Device Description: The components (monitor, transducer, probe) are designed to interact with the blood flow directly within the bypass circuit, not to analyze a sample of blood.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, chemical reactions, or diagnostic tests performed on a sample.
IVD devices are typically used to examine specimens such as blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening. The Accuflo™ system is a monitoring device for a physiological process during surgery.
N/A
Intended Use / Indications for Use
The Accuflo™ Electromagnetic Flow System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. The device will function in circuits utilizing centrifugal pump heads as well as circuits utilizing roller pumps. There are no other intended uses for the device. The equivalent device, the Bioprobe, is primarily used with centrifugal pumps.
Product codes
DPT
Device Description
The Accuflo™ Electromagnetic Flow Monitoring System is composed of three (3) components, a monitor display unit, a transducer and a sterile flow-through probe.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
open heart surgery
Description of the training set, sample size, data source, and annotation protocol
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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 Accuflo™ System enhances the uniformity of the field within the probe so that a single electrode pair can be used to pick up the signal with improved accuracy.
Accuracy: Accurate within 50 ml.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Accurate within 50 ml
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/0 description: The image shows the letters "IBC" in a stylized font, with a globe design incorporated into each letter. The globe design features a grid pattern and outlines of continents. The letters are bold and black, creating a strong visual impact. The overall design suggests a global or international theme.
510(k) SUMMARY
Accuflo™ Electromagnetic Flow Monitoring System
The Accuflo™ Electromagnetic Flow Monitoring System is composed of three (3) components, a monitor display unit, a transducer and a sterile flow-through probe. The system is substantially equivalent to the Biomedicus Bioprobe Electromagnetic Flow System which is marketed by Medtronic, Inc.
TABLE OF COMPARISON:
APR - 8 1998
| CHARACTERISTIC | ACCUFLO™ SYSTEM | BIOPROBE SYSTEM |
|---|---|---|
| Components | 3 | 3 |
| Separate Monitor | Yes | Yes |
| Digital Display | Yes | Yes |
| Zero Offset Control | Yes | Yes |
| Electromagnetic Transducer | Yes | Yes |
| Electromagnets | 2 | 1 |
| Disposable Flow Probe | Yes | Yes |
| Construction | Insert Injection Molded | Insert Injection Molded |
| Electrodes | 3 in a row | 3 pairs in a row |
| Inside Diameter | 3/8" | 3/8" |
| Material | Polycarbonate | Polycarbonate |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Accuracy | Accurate within 50 ml | Accurate within 300 ml |
DISCUSSION OF SIMILARITIES AND DIFFERENCES:
The use of a single electromagnet in the Bioprobe System compromises the uniformity of field within the flow-through cell. To compensate for this, two pair of electrodes are used to pick up the signal on opposite sides of the probe wall. The use of two electromagnets in the Accuflo™ System enhances the uniformity of the field within the probe so that a single electrode pair can be used to pick up the signal with improved accuracy. The Biomedicus Bioprobe System is sold as an integral part of the Biomedicus Pump Console. The Accuflo™ System is a free standing system permitting expanded utilization of this more accurate flow measurement in non centrifugal, i.e., Roller Pump, pump systems. All remaining differences are cosmetic only.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
H. David Shockley, Jr. President Official Correspondent International Biophysics Corporation 4020 S. Industrial Drive, Suite 160 Austin, TX 78744
APR - 8 1998
K963703 Re : Accuflo™ Electromagnetic Flow Monitoring System Regulatory Class: II (Two) Product Code: DPT Dated: January 8, 1998 Received: January 12, 1998
Dear Mr. Shockley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. H. David Shockley, Jr.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K963703
Device Name: Accuflo_Monitoring_System
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Indications For Use:
INTENDED USE
The Accuflo™ Electromagnetic Flow System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. The device will function in circuits utilizing centrifugal pump heads as well as circuits utilizing roller pumps. There are no other intended uses for the device. The equivalent device, the Bioprobe, is primarily used with centrifugal pumps.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
Division of Cardiovascular, Respiratory
Division of Cardiovascular, Respiratory, and Neurological Devices 1963703 510(k) Number_
Prescription Use_C_C_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)