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510(k) Data Aggregation

    K Number
    K973609
    Device Name
    IDA-4 AND IPT-MC
    Manufacturer
    BIO-TEK INSTRUMENTS, INC.
    Date Cleared
    1997-12-18

    (87 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-TEK INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This IDA-4 or IPT-MC 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. It is not intended to be used as an infusion device calibrator. A wide range of infusion devices can be analyzed including: syringe, drop counting, peristaltic, and volumetric types. Steady and non-steady flow rate pumps can be analyzed. The device is designed to operate using water or saline only. It incorporates an RS232 serial port for computer control/data output and a Centronics type parallel printer port.
    Device Description
    The "IDA-4 & IPT-MC" incorporate one to four self reading calibrated micro-burettes (transducers)which measure the volume of fluid flowing from one to four infusion devices into the device. Flow rates from 1 to 1000 mL per hour can be administered independently in each channel. 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 only. The device can be used to determine flow rates, flow volume, average flow rate (with from -100 mmHg to +300 mmHg), average bolus volume with total delivery, occlusion pressure.
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    K Number
    K971273
    Device Name
    INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF
    Manufacturer
    BIO-TEK INSTRUMENTS, INC.
    Date Cleared
    1997-10-08

    (184 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-TEK INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The above device family is intended for use as simulators, testers/analyzers for Pulse Oximeters, and their probes. The Oximeter tests can be conducted through a simulated human "finger" (F and EF models) or electronically (E and EF models) as if the tester is a probe. Oximeter probes can be tested, using E and EF models, for shorts, continuity, opens and LED functionality. Basically the devices allow accurate monitoring and verification of the operation of commercially available Pulse Oximeters without use of arterial blood. They can quickly establish the state of any given pulse oximeter and determine its performance qualities. Index 2/CardioSat 100 can test and evaluate virtually any pulse oximeter on the market today. Ear and toe type oximeters and their probes can be tested electronically as components and the probe/oximeter system can be tested fully if the probe fits on the simulated "finger". The testers can also be used as a transfer standard for Pulse Oximeters. That is, a Pulse Oximeter's performance may be compared to another of the same type or a different type. The devices are not intended to be used as Pulse Oximeter calibrators, but can be used for Quality Control purposes. The primarily use for these types of devices is: by Biomedical Engineers and technicians in Hospitals; by third party repair and calibration facilities; and by Original Equipment Manufacturers (OEMs). Other personnel could also learn how to use the devices. The Hospital or third party repair environment varies from, use of the device in a controlled calibration lab, to portable ward use by the Biomed staff. The OEMs use of the device would primarily involve final QC of pulse oximeters in their manufacturing or repair facilities, but could also involve the use of these simulators in the development of new oximeters.
    Device Description
    The device family is intended for use as simulators, testers/analyzers for Pulse Oximeters, and their probes. The Oximeter tests can be conducted through a simulated human "finger" (F and EF models) or electronically (E and EF models) as if the tester is a probe. Oximeter probes can be tested, using E and EF models, for shorts, continuity, opens and LED functionality. Basically the devices allow accurate monitoring and verification of the operation of commercially available Pulse Oximeters without use of arterial blood. They can quickly establish the state of any given pulse oximeter and determine its performance qualities. Index 2/CardioSat 100 can test and evaluate virtually any pulse oximeter on the market today. Ear and toe type oximeters and their probes can be tested electronically as components and the probe/oximeter system can be tested fully if the probe fits on the simulated "finger". The testers can also be used as a transfer standard for Pulse Oximeters. That is, a Pulse Oximeter's performance may be compared to another of the same type or a different type. The devices are not intended to be used as Pulse Oximeter calibrators, but can be used for Quality Control purposes. The primarily use for these types of devices is: by Biomedical Engineers and technicians in Hospitals; by third party repair and calibration facilities; and by Original Equipment Manufacturers (OEMs). Other personnel could also learn how to use the devices. The Hospital or third party repair environment varies from, use of the device in a controlled calibration lab, to portable ward use by the Biomed staff. The OEMs use of the device would primarily involve final QC of pulse oximeters in their manufacturing or repair facilities, but could also involve the use of these simulators in the development of new oximeters. Index 2/CardioSat 100 simulates a human "finger" (toe/ear).utilize technology similar to that which the Pulse Oximeters utilize to measure SpO2 and pulse rate. This aspect of the technology used in Index 2/CardioSat 100 is protected by US Patent No. 5,348,005. Oximeters use the ratio of Red to InfraRed light to simulate readings related to the partial pressure and thus arterial oxygenation level of blood, which is expressed as SpO2 for this method of measurement. In Index 2/CardioSat 100 the pulsation of the signal serves to simulate the heart rate pulsation. This feature is identical to the predicate Index, K933519, SpO2 Simulator with the addition of a near simultaneous pulsing of the Red and InfraRed LEDs to test a wider range of Pulse Oximeter manufacturers models. Most Pulse Oximeters alternate the Red and InfraRed signals. The simulators can also send this same types of signals electronically to the Oximeter under test simulating the Oximeter Probe's signal. Additionally, they can operate as intelligent volt/ohmmeters to analyze Oximeter Probes for continuity, shorts, opens, LED operation and Photodiode Operation.
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    K Number
    K961862
    Device Name
    MODELS IDA-2 PLUS AND IPT-1
    Manufacturer
    BIO-TEK INSTRUMENTS, INC.
    Date Cleared
    1997-02-26

    (288 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-TEK INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended 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.
    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.
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