(288 days)
Not Found
No
The description focuses on standard measurement and data capture functionalities, with no mention of AI or ML algorithms for analysis or interpretation.
No.
This device is designed to verify the accurate performance of infusion devices (e.g., pumps), not to directly treat a patient. It is used by manufacturers and engineering departments for equipment testing, not for therapeutic intervention.
No
The device is designed to verify the accurate performance of infusion devices, not to diagnose medical conditions in patients. It measures fluid flow and pressure from infusion devices for calibration and troubleshooting purposes of the infusion device itself.
No
The device description clearly outlines physical components like a calibrated burette, pressure transducer, and external communication ports (Centronics parallel and RS232 serial), indicating it is a hardware device with associated software.
Based on the provided information, the "IDA-2 PLUS" is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "verify the accurate performance of infusion devices." This is a quality control or calibration function for other medical devices (infusion pumps), not a test performed on a biological sample from a patient to diagnose a condition or provide information for diagnosis.
- Device Description: The device measures the volume and flow rate of fluid (water or saline) from an infusion device. It also measures pressure. These are physical measurements related to the function of the infusion pump, not biological measurements from a patient.
- Lack of Biological Sample: The device operates using water or saline, not biological samples like blood, urine, or tissue.
- Intended User: The intended users are manufacturers, biomedical engineering departments, and third-party service organizations. These are typically involved in the maintenance and calibration of medical equipment, not clinical diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The IDA-2 PLUS does not fit this definition. It is a test and measurement device for other medical equipment.
N/A
Intended Use / Indications for Use
The "IDA-2 PLUS" is a self reading calibrated burette which measures the volume of fluid flowing from an infusion device into the instrument. Flow rates from 1 to 1000 mL per hour can be administered. This device is designed to be used by manufacturers, biomedical engineering departments in hospitals and third party service organizations to verify the accurate performance of infusion devices that operate in the range stated above. A wide range of infusion devices can be analyzed including: syringe, drop counting, peristaltic, and volumetric types. Non steady flow rate pumps can also be analyzed. The device is designed to operate using water or saline.
Product codes
FRN
Device Description
The "IDA-2 PLUS" is a self reading calibrated burette which measures the volume of fluid flowing from an infusion device into the instrument. Flow rates from 1 to 1000 mL per hour can be administered. This device is designed to be used by manufacturers, biomedical engineering departments in hospitals and third party service organizations to verify the accurate performance of infusion devices that operate in the range stated above. A wide range of infusion devices can be analyzed including: syringe, drop counting, peristaltic, and volumetric types. Non steady flow rate pumps can also be analyzed. The device is designed to operate using water or saline.
Operational modes: The IDA-2 Plus will offer two modes of operation; stand alone and computer control. The computer control mode will allow the user to operate the device from an external program. All possible tests available in the stand alone mode will be available in the computer control mode. The computer control mode allows for a graphical display of data, found to be useful in troubleshooting a faulty drive mechanism in the infusion device under test.
Reading Speed: The device can operate in the Steady Flow Mode, which will give a time to first reading of 6 minutes at 1 mL/hr and 25 seconds at rates above 100ml/hr. In the Non-Steady & High Accuracy Flow Mode it will depend on the time to deliver 1 mL of fluid.
Occlusion Pressure Range: The IDA-2 Plus features a pressure transducer that is operational in the range of 0 to 34.8 psi. It has the ability to display the pressure value in psi or mm Hg. A print out is also available.
Volume Measurement: This feature displays the volume delivered into the IDA-2 Plus. Instantaneous/ Average Flow: This feature displays either the instantaneous or average flows through the device.
External communication links: The device uses a Centronics standard parallel interface that is Epson compatible. The printer can be set to print immediately after determining a rate or at intervals of 5 minutes or 1 hour. The serial RS232 port is used for computer control and is set at 2400 baud, using 8 databits, 1 stop bit and no parity.
Data reduction software: "Graphics Capture Program " This feature of the device allows the user to acquire and continuously graph the flow rate, volume and occlusion pressure from a separate computer. Numerical values for average flow rate, instantaneous flow rate and derived volume can be displayed for any instant along the time axis. The user has the option to erase, print or save the acquired data for future review and statistical evaluation.
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
manufacturers, biomedical engineering departments in hospitals and third party service organizations
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)
Verification and Validation: The IDA-2Plus and its associated Graphics Capture Program was extensively verified and validated to be working per the design and published specifications. In summary the testing established that the IDA-2Plus meets its marketing specifications and is similar to the other devices as claimed in this submission.
Potential System Hazards; are classified as those which could affect the functionality of the system. The primary system function hazards which were reviewed and addressed were: a) Confusion between different IDA hardware and firmware versions. Error codes are given by the software. b) To minimize the possibility of believable but incorrect results being displayed in the "Non-Steady and Higher Accuracy (Flow) Mode" and air-in-line detection monitor with error messages is utilized. c) A third potential hazard is from incorrect behavior of the device when the valve is blocked or partially blocked. If the value is outside of a range an error message is displayed and printed.
User Safety Considerations: The device has been designed to meet the user safety requirements of IEC 1010-1 (1990) "Safety requirements for electronic equipment for measurement, control and laboratory use. Part 1 General requirements". Features such as the sturdy drip proof plastic case were chosen with user safety in mind.
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
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
FEB 26 1997
K 96/862
BIO-TEK 510(k) IDA-2Plus May 10, 1996 APPENDIX G
510(k) SAFETY AND EFFECTIVENESS SUMMARY
Michael N. Sevigny Quality Assurance Manager 802-655-4040 ext 336 Contact Person:
Classification Name: Pump infusion, accessory to, 80 FRN, 21 CFR §880.5725. Class 2
Common Name: Infusion Pump Analyzer or Tester
IDA-2 Plus Proprietary Name:
Establishment Registration Number: 1217454
General: The "IDA-2 PLUS" is a self Description of Device and Intended Use: reading calibrated burette which measures the volume of fluid flowing from an infusion device into the instrument. Flow rates from 1 to 1000 mL per hour can be administered. This device is designed to be used by manufacturers, biomedical engineering departments in hospitals and third party service organizations to verify the accurate performance of infusion devices that operate in the range stated above. A wide range of infusion devices can be analyzed including: syringe, drop counting, peristaltic, and volumetric types. Non steady flow rate pumps can also be analyzed. The device is designed to operate using water or saline.
Operational modes: The IDA-2 Plus will offer two modes of operation; stand alone and computer control. The computer control mode will allow the user to operate the device from an external program. All possible tests available in the stand alone mode will be available in the computer control mode. The computer control mode allows for a graphical display of data, found to be useful in troubleshooting a faulty drive mechanism in the infusion device under test.
Reading Speed: The device can operate in the Steady Flow Mode, which will give a time to first reading of 6 minutes at 1 mL/hr and 25 seconds at rates above 100ml/hr. In the Non-Steady & High Accuracy Flow Mode it will depend on the time to deliver 1 mL of fluid.
Occlusion Pressure Range: The IDA-2 Plus features a pressure transducer that is operational in the range of 0 to 34.8 psi. It has the ability to display the pressure value in psi or mm Hg. A print out is also available.
Volume Measurement: This feature displays the volume delivered into the IDA-2 Plus. Instantaneous/ Average Flow: This feature displays either the instantaneous or average flows through the device.
External communication links: The device uses a Centronics standard parallel interface that is Epson compatible. The printer can be set to print immediately after determining a rate or at intervals of 5 minutes or 1 hour. The serial RS232 port is used for computer control and is set at 2400 baud, using 8 databits, 1 stop bit and no parity.
1
BIQ-TEK 510(k) IDA-2Plus May 10, 1996 APPENDIX G
Data reduction software: "Graphics Capture Program " This feature of the device allows the user to acquire and continuously graph the flow rate, volume and occlusion pressure from a separate computer. Numerical values for average flow rate, instantaneous flow rate and derived volume can be displayed for any instant along the time axis. The user has the option to erase, print or save the acquired data for future review and statistical evaluation.
Similarity to other devices : The IDA-2 Plus is similar to other devices currently marketed in the US as infusion device testers by Datrends. Model Infutest 2000 no 510(k) # found, and Dynatech Nevada, Model 404A, 510(k) # K897096.
Verification and Validation: The IDA-2Plus and its associated Graphics Capture Program was extensively verified and validated to be working per the design and published specifications. In summary the testing established that the IDA-2Plus meets its marketing specifications and is similar to the other devices as claimed in this submission.
Potential System Hazards; are classified as those which could affect the functionality of the system. The primary system function hazards which were reviewed and addressed were: a) Confusion between different IDA hardware and firmware versions. Error codes are given by the software. b) To minimize the possibility of believable but incorrect results being displayed in the "Non-Steady and Higher Accuracy (Flow) Mode" and air-in-line detection monitor with error messages is utilized. c) A third potential hazard is from incorrect behavior of the device when the valve is blocked or partially blocked. If the value is outside of a range an error message is displayed and printed.
User Safety Considerations: The device has been designed to meet the user safety requirements of IEC 1010-1 (1990) "Safety requirements for electronic equipment for measurement, control and laboratory use. Part 1 General requirements". Features such as the sturdy drip proof plastic case were chosen with user safety in mind.
The above information is certified to be truthful and accurate to the best of my knowledge.
Michael H. Liang
Michael N. Sevigny Quality Assurance Manager