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510(k) Data Aggregation

    K Number
    K160705
    Device Name
    Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,
    Manufacturer
    Y. JACOBS MEDICAL, INC
    Date Cleared
    2016-11-23

    (254 days)

    Product Code
    NEW
    Regulation Number
    878.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    JACOBS MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Y. JACOBS YOUNG'S THREAD is intended for use in soft tissue approximation where use of an absorbable suture is appropriate.
    Device Description
    Y . JACOBS YOUNG'S THREAD synthetic absorbable PDO suture is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. It degrades and dissolves over time in tissue. Each dyed (violet) suture has uni-directional barbs along the axis of the suture monofilament without needle attachment. The Y. JACOBS YOUNG'S THREAD Synthetic Absorbable PDO suture approximates tissues without the need to tie surgical knots, because of the presence of barbs on the suture surface which imbed in the tissues after precise placement by the surgeon. Y. JACOBS YOUNG'S THREAD consists of absorbable polydioxanone (PDO) suture. Y. JACOBS YOUNG'S THREAD consists of: - absorbable polydioxanone (PDO) suture - absorbable PLGA cone with each suture - disposable polycarbonate hub which has no patient contact
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    K Number
    K143413
    Device Name
    J+PRAS YOUNG'S Thread
    Manufacturer
    Y. Jacobs Medical, Inc.
    Date Cleared
    2015-09-11

    (287 days)

    Product Code
    NEW
    Regulation Number
    878.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jacobs Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Y. JACOBS YOUNG'S THREAD is intended for use in soft tissue approximation where use of an absorbable suture is appropriate.
    Device Description
    Y. JACOBS YOUNG'S THREAD synthetic absorbable PDO suture is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. The Y. JACOBS YOUNG'S THREAD will be available in single use packages, sterile after ethylene oxide (EO) gas sterilization. It degrades and dissolves over time in tissue. Each dyed (violet) suture has uni-directional barbs along the axis of the suture monofilament without needle attachment. The Y. JACOBS YOUNG'S THREAD Synthetic Absorbable PDO suture approximates tissues without the need to tie surgical knots, because of the presence of barbs on the suture surface which imbed in the tissues after precise placement by the surgeon. Y. JACOBS YOUNG'S THREAD consists of: - absorbable polydioxanone (PDO) suture
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    K Number
    K110953
    Device Name
    VISENSIA, VISENSIA WITH ALERT
    Manufacturer
    OBS MEDICAL
    Date Cleared
    2011-06-15

    (71 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    OBS MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Visensia® with alert is an accessory to multi-parameter patient monitors (bedside, ambulatory, or centralized location) or clinical information systems and is indicated for use by health care professionals with those non-pediatric high dependency care patients for whom multi-parameter patient monitoring has been routine. Visensia® provides the clinician with a patient status index (Visensia® Index) based on a weighted average of five or (four) vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The Visensia® Index is a single measure of a patient's condition and represents how different the patient's vital signs are with respect to normality. Visensia® is an adjunct to and is not intended to replace vital sign monitoring. When a Visensia® alert has activated, it means that the Visensia® Index has reached and/or surpassed the default threshold and indicates that attention should be brought to the patient.
    Device Description
    Visensia® software is a computerized analysis software program designed as an adjunct to standard patient monitors or medical information systems. It operates by forming an aggregate score of patient status based on five vital signs; heart rate; respiratory rate; temperature; noninvasive blood pressure and arterial oxygen saturation. The aggregate score, the Visensia® Index, is displayed on a scale of 0-5, with 0 representing the normal end of the scale and 5 representing extreme physiological deterioration. An audible and visual alert is provided when the Visensia® index exceeds a threshold value for a period of time. The Visensia® Index is calculated whenever new data is received. The Visensia® display consists of a combination of the following: - An identifier for each monitored patient and location . - The Visensia® Index value for each patient (shown as a number, trend or other graphical . representation). - The vital signs for each patient (shown as a number, trend or other graphical . representation). - A status bar area showing the state of the system . Visensia® may also be implemented as a data processing server with no graphical interface.
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    K Number
    K081140
    Device Name
    VISENSIA
    Manufacturer
    OBS MEDICAL
    Date Cleared
    2008-07-17

    (86 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    OBS MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Visensia with Alert is an accessory to multi-parameter patient monitors (bedside, ambulatory, or centralized location) or clinical information systems and is indicated for use by health care professionals with those non-paediatric high dependency care patients for whom multi-parameter patient monitoring has been routine. Visensia® provides the clinician with a patient status index (Visensia® Index) based on a weighted average of five or four vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The Visensia 9 Index is a single measure of a patient's condition and represents how different the patient's vital signs are with respect to normality. Visensia with Alert is an adjunct to and is not intended to replace vital sign monitoring and as such does not contain alarms, but alerts the physician to changes in the patient's physiological status. When a Visensia® Alert has activated, it means that the Visensia® Index has reached and/or surpassed the default threshold and indicates that attention should be brought to the patient.
    Device Description
    Visensia® is a software accessory to standard multiple parameter physiological patient v benturs (bedside or ambulatory) or clinical information systems. It operates on a standard PC, or personal computer. Visensia® is a software device that through advanced signal processing can combine physiological signals in order to produce a single index (Visensia® index) representation of patient condition. Visensia® is a computerized analysis system that can accept multiple channels of Prisonological data (for example heart rate, respiratory rate, temperature, blood pressure and oxygen saturation as inputs). Through advanced signal processing, Visensia® can identify changes in patient status.
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    K Number
    K071606
    Device Name
    BIOSIGN CENTRAL STATION
    Manufacturer
    OBS MEDICAL
    Date Cleared
    2007-08-31

    (80 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OBS MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioSign™ Central Station is an accessory to nulti-parameter patient monitors (bedside or ambulatory) or clinical information system and is indicated for use by health care professionals with those non-pediatric high dependency care patients for whom multi-parameter patient monitoring has been routine. The BioSign 146 Central Station provides the clinician with a patient status index (BioSign™ Index) based on a weighted average of five vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The BioSign™ index is a single measure of the patient's condition and represents how different the patient's vital signs are with respect to normality. BioSign™ is an adjunct to and is not intended to replace vital signs monitoring. The BioSign™ Central Station displays BioSign indices for multiple patients. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician
    Device Description
    BioSign™ Central Station is a software accessory to standard multiple parameter physiological patient monitors (bedside or ambulatory) or clinical information systems. It operates on a standard PC, or personal computer. BioSign™ is a software device that through advanced signal processing can combine physiological signals in order to produce a single index (BioSign index) representation of patient condition. BioSign™ is a computerized analysis system that can accept multiple channels of physiological data (for example heart rate, respiratory rate, temperature, blood pressure and oxygen saturation as inputs). Through advanced signal processing, BioSign can identify changes in patient status.
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