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510(k) Data Aggregation

    K Number
    K170871
    Device Name
    DigniCap Scalp Cooling System
    Manufacturer
    Date Cleared
    2017-07-03

    (102 days)

    Product Code
    Regulation Number
    878.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dignitana AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DigniCap® Scalp Cooling System is indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors.
    Device Description
    The DigniCap® Scalp Cooling System consists of a computer controlled system that includes a refrigerated tank containing the liquid coolant that is maintained at -7 ± 2°C. The coolant circulates from the cooling unit to and through the channels of the cap and back to the cooling unit. The scalp temperature is monitored by three separate sensors. Deviations from the treatment temperature are automatically adjusted by the system (scalp temperature can be controlled with an accuracy of ± 2.0°C). The DigniCap® Scalp Cooling System components include the following: Digni C3 – Is a refrigerator unit with an integral control system operated via a touch screen and is capable of controlling two separate DigniCap® Cooling caps independently of each other. Scalp cooling is performed in conjunction with a silicone inner cap (DigniCap®), an outer neoprene cap (DigniTherm), and the liquid coolant (DigniCool). DigniCap® – A soft, tight-fitting silicone cap which has two separate cooling circuits, one for the front and one for the back of the head. Each cooling circuit is equipped with a temperature sensor, and the cap is also equipped with a third sensor for safety control. The cap is available in different sizes. DigniCool - The liquid coolant monopropylene glycol. DigniTherm - The outer neoprene cap that insulates and keeps the inner cap in place. This neoprene cover cap, called the DigniTherm, comes in different sizes and is colored coded to match the corresponding DigniCap® Cooling cap. DigniStick- A component used to save data from a treatment or for troubleshooting. It can also be used to update software. DigniCard - A key card which has to be inserted in order to start a treatment.
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    K Number
    DEN150010
    Device Name
    Dignitana AB DigniCap System
    Manufacturer
    Date Cleared
    2015-12-08

    (277 days)

    Product Code
    Regulation Number
    878.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIGNITANA AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DigniCap™ Scalp Cooling System is indicated to reduce the likelihood of chemotherapy induced alopecia in women with breast cancer.
    Device Description
    The Dignitana DigmiCap™ Scalp Cooling System consists of a computer controlled system that includes a refrigerated tank containing the cooling agent that is maintained at -8 ± 1 ℃. The liquid coolant circulates from the cooling unit to and through the channels of the cap and back to the cooling unit. The scalp temperature is monitored by three separate thermometers. Deviations from the pre-set temperature are automatically adjusted by the system (scalp temperature can be controlled with an accuracy of ±2.0℃). The DigniCap™ Scalp Cooling System components include the following: Digni C3 system - Is a refrigerator unit with an integral control system operated via a touch screen monitor and is capable of controlling two separate cooling caps independently of each other. Scalp cooling is performed in conjunction with a silicon inner cap (DigniCap™), an outer neoprene cap (DigniTherm™), and the liquid coolant (DigniCool™). DigniCap™ - A soft, tight-fitting silicon cap which has two separate cooling circuits, one for the front of the head and one for the back of the head plus a third sensor for overall safety control. DigniCool™ - The liquid coolant monopropylene glycol (MPG5). DigniTherm™ - The outer neoprene cap that insulates and keeps the inner cap in place. To improve cooling and ensure proper fitting, this cap is covers the DigniCap™ and includes a chin strap which is used to hold the cap in place. This neoprene cover cap, called the DigniTherm™, comes in different sizes and is colored coded to match the corresponding correct silicone Cooling Cap. In addition to acting as a means of maintaining cooling cap placement, this outer cap also provides insulation which improves cooling efficiency DIGNISTICK™ – A component used to save data from a treatment or for troubleshooting when inserted in the slot. It can also be used to update software. DIGNICARD™ – A key card which has to be inserted in order to start a treatment.
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