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510(k) Data Aggregation

    K Number
    K192606
    Device Name
    SAC2 - Electrode Cream
    Manufacturer
    Spes Medica S.r.l.
    Date Cleared
    2020-01-17

    (119 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Applicant Name (Manufacturer) :

    Spes Medica S.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SAC2 is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin.
    Device Description
    SAC2 is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin. SAC2 is provided in an aluminum tube of 100g. It's characterized by light grey colour, no crystallization, no flocculation, no adverse smell, opaque. SAC2 function is of conductor between the electrode used and the patient's skin and of getting the impedance lower for a better recording of the signal. SAC2 is for external use with recording electrodes only. SAC2 is made of powders, Potassium Chloride and Sodium Chloride as conductors, combined with thickening agents and humectants, all in an aqueous solvent. The composition is the following: Water, Talc, Celite, Glycerol, CarboxyMethylCellulose, Sodium chloride, Potassium chloride, Phenoxyethanol, Ehylhexylglycerin The pH range is 8÷10, and Impedance at 10Hz is 50 ± 10 Ohm. The Conductivity is 20 mS/cm Shelf life of SAC2 is 3 years if stored properly in the closed aluminum tube kept away from the sunlight.
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    K Number
    K192603
    Device Name
    Spes Medica Subdermal Needle Electrodes
    Manufacturer
    Spes Medica S.r.l.
    Date Cleared
    2019-11-22

    (63 days)

    Product Code
    GXZ
    Regulation Number
    882.1350
    Why did this record match?
    Applicant Name (Manufacturer) :

    Spes Medica S.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spes Medica Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephalography (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.
    Device Description
    Spes Medica Subdermal Needle Electrodes are monopolar needles intented to use for Electromyography (EMG), Electroencephalograph (EEG) and Nerve potential signals in example and they are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. The Subdermal Needle Electrodes are used for recording and stimulation (micro stimulation), this stimulation has no therapeutic purpose but has the purpose of activating an electrical response.
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    K Number
    K190050
    Device Name
    Tech Dots - Adhesive and conductive gel
    Manufacturer
    Spes Medica S.r.l.
    Date Cleared
    2019-07-19

    (190 days)

    Product Code
    GYB
    Regulation Number
    882.1275
    Why did this record match?
    Applicant Name (Manufacturer) :

    Spes Medica S.r.l.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tech Dots are intended for use in clinical and research EEG/EP recordings from humans. They are used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin
    Device Description
    Tech Dots are conductive gel dots to be used with external electrodes as the conductor between skin and electrode and to reduce impedance between the electrode surface and the skin. A single Tech Dot has a 11 ± 1 mm diameter, 2.5 ± 0.5 mm high, and weights 0.14 ± 0.01 g. It's characterized by clear colour, no crystallization, no flocculation, no adverse smell, brightness. Tech Dots function is of conductor between the electrode used and the patient's skin and of getting the impedance lower for a better recording of the signal. Tech Dots are for use with external electrodes only. Tech Dot is made of Potassium Chloride as conductor, combined with thickening agents and humectants, all in an aqueous solvent. The composition is the following: Water, Glycerol (vegetable origin), Polyacrylate co-polymer (proprietary), Potassium chloride. The pH range is 4.1 ± 0.1, and Impedance at 10Hz is 80 ± 10 Ohm. The Conductivity is 2 mS/cm. Shelf life of TechDots is 3 years if stored properly in sealed aluminum pouch and at the limits of temperature indicated on the labeling.
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    K Number
    K133348
    Device Name
    STIM PROBE
    Manufacturer
    SPES MEDICA S.R.L.
    Date Cleared
    2014-11-21

    (387 days)

    Product Code
    ETN
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPES MEDICA S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identify nerves and spinal nerve roots and to assess nerve function. IOM Stimulator Probes disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral nerves for location and identification during surgery, including spinal nerve roots.
    Device Description
    IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring, to identify nerves and spinal nerve roots and to assess nerve function. The probes are supplied sterile and are for single use only. The probes are connected to an electrical stimulator using a flexible lead wire(s) and a 'touch-proof' safety connector(s) on the distal end. All IOM Stimulator Probes are sterilized by Ethylene Oxide and single use only. The IOM Stimulator Probes are composed by the part in contact with the patient that is medical grade stainless steels, then there is the handle part and cable in biocompatible plastic; finally the cable has a 'touch-proof' safety connectors.
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    K Number
    K120494
    Device Name
    DISPOSABLE ADHESIVE SURFACE ELECTRODE
    Manufacturer
    SPES MEDICA S.R.L.
    Date Cleared
    2012-06-11

    (115 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPES MEDICA S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spes Medica Disposable Adhesive Surface Electrodes are intended for use with electrodiagnostic or neurological monitoring equipment for the recording of electrophysiological activity and for electrical stimulation. The electrodes are non-sterile and for single patient use only.
    Device Description
    Spes Medica Disposable Adhesive Surface Electrodes are single patient use, disposable devices. Electrodes are non-invasive as they are applied to the patient's skin using a selfadhesive solid-gel surface. The electrodes consist of 3 different layers of materials. The upper layer consists in a cotton non-woven pad, the second layer is the sensor and consists in a conductive layer. The lower layer, then the material in direct contact with the patient's skin consist in a solid Hydro-gel adhesive layer. Spes Medica Disposable Adhesive Surface Electrodes are supplied with leads or with snap connector. The electrodes which are attached to a lead wire terminate at the opposite end using different type of connectors such us: - DIN 42802 "touch proof" safety connectors; . - 0,7 mm "touch proof" pin; . - Concentric "touch proof" bipolar socket; . - 2 mm "touch proof" socket; . The snap connector electrode uses Ag/AgCl pellet(s) as the conductive element. The active surface of the pellet is comprised between the cotton non-woven pad and the Hydro-gel adhesive layer. The pellet is attached to a stainless steel male snap connector which is used as connection.
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    K Number
    K093373
    Device Name
    LARYNGEAL SURFACE ELECTRODE
    Manufacturer
    SPES MEDICA S.R.L.
    Date Cleared
    2010-08-24

    (299 days)

    Product Code
    ETN
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPES MEDICA S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dragonfly Laryngeal Surface Electrode is intended to be used as disposable, self-adhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. It is intended for use only by a licensed physician and in conjunction with these listed below medical grade electromyographic monitors: Neurovision Medical Products Nerveana Axon Eclipse Medtronic - NIM XLTEK EP Works Nicolet Viking Cadwell Cascade Neurosign Avalanche
    Device Description
    Spes Medica Dragonfly Laryngeal Surface Electrode are single used electrodes for evoked EMG monitoring of the larynx and it to be inserted and retained in position against the larvngeal muscle by use of an endotracheal tube. The Electrodes are intended to be used as disposable, self-adhesive electrodes attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures. Spes Medica produces two different families of electrodes: Family A and Family B. The family A and B mentioned above are the same product because, have been developed with same intended use, design, materials, packaging and other technological characteristics. The manufacturing processes are the same for both configurations (Family A and Family B) but the substrates and the shape of the electrodes are different. Indeed, for the family A the substrate for the Silver ink is a polyester film and for the family B the substrate for the Silver ink is carbon loaded vinyl. Furthermore, both families use the same connection to the EMG unit.
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    K Number
    K091410
    Device Name
    DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,
    Manufacturer
    SPES MEDICA S.R.L.
    Date Cleared
    2009-08-11

    (90 days)

    Product Code
    IKT
    Regulation Number
    890.1385
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPES MEDICA S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Recording muscle activity for Electromyography (EMG) applications. For single patient use only. The disposable hypodermic needle is inteded to be used for iniection of the Botulinum Toxin into a muscle. while recording electromyography activity. The electrode has an open lumen and is designed for muscle stimulation, motor unit action, potential recording and Botulinum Toxin injection.
    Device Description
    A diagnostic electromyography needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle). The needle electrodes are for single patient only.
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