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510(k) Data Aggregation

    K Number
    K013840
    Device Name
    MICROJET CRONO PAR AND CRONO APO-GO
    Manufacturer
    CANE SRL
    Date Cleared
    2002-05-14

    (176 days)

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

    CANE SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "Microjet Crono K" and "Crono go" ambulatory infusion pump device has been designed for use in subcutaneous and intravenous infusion of prescribed liquid medicines.
    Device Description
    Canè s.r.l., a company that specializes in the production of ambulatory pumps, has now produced a new generation of compact pumps: Crono K, a perfect combination of high technology and innovative design. The infusion pumps which use normal commercial syringes are inevitably cumbersome and thus difficult to use in everyday life. This provokes in the patients a refuse of the therapy. A special syringe, an integral part of the Crono K allows an efficient reduction of the pump size. In this way, the patients can freely carry out the therapy at any time of the day, even during their everyday life. Patients who have been following a iron chelation therapy for a long time, often experience difficulties in absorbing the drug subcutaneously; this may lead to a catheter occlusion with consequent interruption of the infusion. Crono K has a particular mechanism which pushes directly the rubber syringe piston: so it is possible to reach a thrust force up to 3 times higher with respect to conventional pumps. In case of catheter occlusion, an innovative infusion control system makes it possible to proceed with the infusion automatically and, after the occlusion is eliminated, to complete it. For a better absorption of the drug, Crono K makes the infusion up to 3 times more fractionated with respect to traditional pumps (22 ml per impulse, using a 10/20 ml syringe). Crono K is fitted with a liquid crystal display which shows the time it takes to complete the delivery and battery charge status.
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    K Number
    K013822
    Device Name
    MICROJET CRONO PCA
    Manufacturer
    CANE SRL
    Date Cleared
    2002-05-08

    (173 days)

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

    CANE SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microjet Crono PCA ambulatory infusion pump device has been designed for use in intravenous or subcutaneous infusion of medicines for pain management.
    Device Description
    Microjet Crono PCA has been designed for the analgesic therapy with a flexible and precise drug's administration causing the minimum discomfort to the patient allowing to walking about. Microjet Crono PCA results to be, within its field, the most innovative instrument available in the market due to small dimension and easy-to-use. Outstanding technology degree has allowed to obtain high reliability degree for long time use without maintenance. A microprocessor runs the electronic circuitry allowing to program the flow seeing the duration of the infusion. A button allows the patient to administer an additional bolus as well seeing the infused volume when in process. The screen also allows to indicate the total of bolus that have been delivered within the infusion in course. A safety system is foreseen to unlock the keyboard to avoid unauthorized variation of the programmed parameters. In the event of occlusion of the catheter, Microjet Crono PCA allows to carry on the administration after the occlusion has been removed. This function is capable to highly reduce the risk of infusion not brought to end. Microjet Crono PCA is equipped with a liguid crystal display where the programmed data can be seen as well as the battery status.
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    K Number
    K013234
    Device Name
    MICROJET CRONO
    Manufacturer
    CANE SRL
    Date Cleared
    2002-04-26

    (211 days)

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

    CANE SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The portable Crono infusion device has been designed only for use in subcutaneous infusion of prescribed liquid medicines. The Microjet Crono ambulatory infusion pump device has been designed for use in subcutaneous infusion of prescribed liquid medicines.
    Device Description
    Cane s.r.l., a company that specializes in the production of ambulatory pumps, has now produced a new generation of compact pumps: Crono, a perfect combination of high technology and innovative design. The infusion pumps which use normal commercial syringes are inevitably cumbersome and thus difficult to use in everyday life. This provokes in the patients a refuse of the therapy. A special syringe, an integral part of the Crono allows an efficient reduction of the pump size. In this way, the patients can freely carry out the therapy at any time of the day, even during their everyday life. Patients who have been following a liquid medicine therapy for a long time, often experience difficulties in absorbing the drug subcutaneously; this may lead to a catheter occlusion with consequent interruption of the infusion. Crono has a particular mechanism which pushes directly the rubber syringe piston: so it is possible to reach a thrust force up to 3 times higher with respect to conventional pumps. In case of catheter occlusion, an innovative infusion control system makes it possible to proceed with the infusion automatically and, after the occlusion is eliminated, to complete it. For a better absorption of the drug, Crono makes the infusion up to 3 times more fractionated with respect to traditional pumps (22 ml per impulse, using a 10/20 ml syringe). Crono is fitted with a liquid crystal display which shows the time it takes to complete the delivery and battery charge status.
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    K Number
    K013807
    Device Name
    MICROJET QUARK, MODEL U100 OR U40
    Manufacturer
    CANE SRL
    Date Cleared
    2001-12-12

    (27 days)

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

    CANE SRL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The portable Quark infusion device has been designed only for use in subcutaneous infusion for insulin infusion therapy. Canè S.r.l. declines all responsibility for the administration of drugs in treatments and with methods other than the above. The Microjet Quark U-100 ambulatory infusion pump has been designed only for use in subcutaneous infusion of insulin for the treatment of diabetes mellitus. (Home use. prescription device)
    Device Description
    Microjet Quark U-100 is an ambulatory insulin pump using syringe, battery powered and available to employ 2 ml syringes. A special micromotor acting the mechanical parts transforming the rotating movement of the motor into a linear movement of the slider which determines the moving of the syringe piscon. The characteristics of the pump working allow w administer insuling to two infusion ways: the fust one, basal rate, cnsure an insulin basal feed within 24 hours, the second one, bolus, allows to administer insulin additional doses and finds its most common use at meal-time. During the basal rate, the motor is driven with impulses at regular intervals by mean of a particular clectronic circuit and the infusion is effected by administering of small quantities repeated over the time. The programmed insulin quantity is distributed with 304 administrations within 24 hours, one every 4 minutes and 44 seconds. The bolus is delivered with fast insulin administrations of 0.5 International Units (U1) each time, with intervals of 10 seconds pauses. The administration of the insulin basal quantity is programmed operating on a specific selector allowing an accurate delivery of insulin, depending on the various daily needs. Insulin delivery as bolus is programmed using a specific button. The pump starts delivering insulin in basal speed to the sclected value. It remains operating until, by mean of manual command, the administration of the bolus is primed; after it returns automatically to work again. The pump is equipped of safety systems, acoustic signals for different operating functions and acoustic alert signals in the event of irregular working.
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