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510(k) Data Aggregation

    K Number
    K221477
    Device Name
    AG100s
    Manufacturer
    Hospitech Respiration Ltd.
    Date Cleared
    2022-12-29

    (220 days)

    Product Code
    BSK
    Regulation Number
    868.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hospitech Respiration Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AG100s is intended to monitor and control the cuff pressures of endotracheal tube (ETT) or tracheostomy tube (TT) and to evacuate secretions from the subglottic space above the cuff during mechanical ventilation. 1. When used with a standard ETT or TT, the device automatically maintains the cuff pressure as pre-set by the user. 2. When used with ETT or TT with suction line, the device automatically maintains the cuff pressure as pre-set by the user and performs intermittent evacuation of subglottic secretions from above the tube's cuff. 3. When used with ETT with suction and venting lines (e.g., AG ETT), the device automatically maintains the cuff pressure as pre-set by the user, or automatically adjusts the cuff pressure based on monitoring of the Carbon Dioxide (CO2) concentration above the cuff. In addition, it performs evacuation, or rinsing and evacuation of subglottic secretions from above the tube's cuff.
    Device Description
    The AG100s system is comprised of the following main components: - The AG100s control unit - The AnapnoGuard connection kit/harness (AG Connection Kit) connecting a cuffed airway to the AG100s control unit. Additional device components include cart, secretions canister (Trap Bottle), rinsing fluid (saline) bag and antibacterial air filter. When the AG100s, is connected to AG ETT, it monitors leaks between endotracheal cuff and the trachea by measuring the Carbon Dioxide levels in the subglottic area above the cuff through a dedicated lumen in the endotracheal tube. Detection of a high level of Carbon Dioxide is an objective indicator for a leak (improper sealing of the trachea by the AG ETT). The system continuously monitors and adjusts the cuff pressure to prevent a leak at minimum possible pressure (all within pressure limits preset by the user). Preventing a leak reduces the likelihood of aspiration of secretions from the upper airways into the lungs and increases the likelihood for no loss of ventilation and delivery of anesthetic and nebulized drugs into the lungs. Keeping the cuff pressure as low as possible reduces the mechanical pressure of the cuff on the tracheal tissue throughout the intubation period. The system also performs evacuation of secretions from above the endotracheal tube's cuff through a dedicated lumen at the dorsal side of the endotracheal tube. The AG100s also performs cuff pressure monitoring and control in standard FDA cleared TTs and ETTs; depending on the tube type, the system may also perform secretions removal.
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    K Number
    K180991
    Device Name
    AG 100s
    Manufacturer
    Hospitech Respiration Ltd.
    Date Cleared
    2018-10-12

    (179 days)

    Product Code
    BSK
    Regulation Number
    868.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hospitech Respiration Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AG 100s is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.
    Device Description
    The AG100s system is comprised of the following main components: - The AG100s control unit - The AnapnoGuard connection kit/harness (AG Connection Kit) connecting a cuffed airway to the AG100s control unit. - The AnapnoGuard endotracheal tube (ETT) or another FDA cleared cuffed Airway. - Accessories: including cart, secretions canister (Trap Bottle), ● rinsing fluid (saline) bag and antibacterial air filter. AG100s, including its three components, monitors leak between the endotracheal tube's cuff and the trachea by measuring the Carbon Dioxide levels in the subglottic area above the cuff through a dedicated lumen in the endotracheal tube. Detection of a high level of Carbon Dioxide is an objective indicator for a leak (improper sealing of the trachea by the endotracheal tube cuff). The system continuously monitors and adjusts the cuff pressure to prevent a leak at minimum possible pressure (all within pressure limits preset by the user). Preventing a leak reduces the likelihood of aspiration of secretions from the upper airways into the lungs and increases the likelihood for no loss of ventilation and delivery of anesthetic and nebulized drugs into the lungs. Keeping the cuff pressure as low as possible reduces the mechanical pressure of the cuff on the tracheal tissue throughout the intubation period. The system also performs evacuation of secretions from above the endotracheal tube's cuff through a dedicated lumen at the dorsal side of the endotracheal tube.
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    K Number
    K150157
    Device Name
    AnapnoGuard 100 Respiratory Guard System
    Manufacturer
    HOSPITECH RESPIRATION LTD.
    Date Cleared
    2016-02-16

    (389 days)

    Product Code
    BSK, BTR
    Regulation Number
    868.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOSPITECH RESPIRATION LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AnapnoGuard 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.
    Device Description
    AnapnoGuard 100 Respiratory Guard System is comprised of the following three main components: The AnapnoGuard endotracheal tube (ETT) with inflatable cuff (FDA cleared under K093126). The AnapnoGuard 100 Respiratory Guard System interconnection harness of tubes, connecting the ETT to the AnapnoGuard 100 control unit The AnapnoGuard 100 Respiratory Guard System control unit which consists of the following main modules: Host computer (PC) Microcontroller (MCU) Suction module (regulator and flow potency meter): including . a set of valves and pipes controlling the secretions suction/evacuation from above the ETT cuff. Rinsing module: Pumps saline to rinse the Suction and Vent/ ● CO2 lumens. CO2 analyzer module: including CO2 analyzer assembly, ● pump, valve and flow filter which sucks air from the subglottic space above the ETT cuff into the CO2 analyzer. . Cuff pressure module: includes two pressure gauges which monitor cuff pressure, a miniature air pump and two valves. Pneumatic module: valves, pipes and filters . Connectors panel for connecting the interconnection harness . (ETT), vacuum, trap bottle, rinsing fluid and filters. Operation buttons panel and navigation wheel . I/O communication panel . Display monitor . AnapnoGuard 100 Respiratory Guard System, including its three components monitors leak between the endotracheal tube's cuff and the trachea by measuring the Carbon Dioxide levels in the subglottic area above the cuff through a dedicated lumen in the endotracheal tube. Detection of a high level of Carbon Dioxide is an objective indicator for a leak (improper sealing of the trachea by the endotracheal tube cuff). The system continuously monitors and adjusts the cuff pressure to prevent a leak at minimum possible pressure (all within pressure limits preset by the user). Preventing a leak reduces the likelihood of aspiration of secretions from the upper airways into the lungs and increases the likelihood for no loss of ventilation and delivery of anesthetic and nebulized drugs into the lungs. Keeping the cuff pressure as low as possible reduces the mechanical pressure of the cuff on the tracheal tissue throughout the intubation period. The system also performs evacuation of secretions from above the endotracheal tube's cuff through a dedicated lumen at the dorsal side of the endotracheal tube.
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    K Number
    K131099
    Device Name
    AG MASS
    Manufacturer
    HOSPITECH RESPIRATION LTD.
    Date Cleared
    2013-05-13

    (24 days)

    Product Code
    JCX
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOSPITECH RESPIRATION LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AG MASSTM Suction Pump System is intended for the application of low flow suction for the removal of fluids, including irrigation fluids, body fluids and infectious materials.
    Device Description
    The AG MASS™ is a sterile injection and draining device. The device is intended to deliver Saline fluid in order to dilute secretions accumulated above the cuff of an Endotracheal Tube and drain out all fluids. The AG MASS™ contains two syringes of 35 CC and 10 CC that are enclosed within MASS main body and is designed for use with Hospitech's AnapnoGuard ETT. The AG MASSTM is provided sterile for single use.
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    K Number
    K122721
    Device Name
    AG GUFFILL
    Manufacturer
    HOSPITECH RESPIRATION LTD.
    Date Cleared
    2013-05-03

    (240 days)

    Product Code
    BSK
    Regulation Number
    868.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOSPITECH RESPIRATION LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hospitech AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways). The Hospitech AG Cuffill is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities and outpatient clinics, where a patient may be intubated.
    Device Description
    The AG Cuffill is a disposable hand held measuring device intended to measure and manually regulate intra-cuff pressure of Endotracheal, Tracheotomy and LMAs tubes. AG Cuffill is configured as a syringe and consists of a sensitive pressure gauge embedded within the syringe plunger. AG Cuffill is battery powered. AG Cuffill is intended for one patient; it is limited to 100 operations and can be cleaned with disinfectant.
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    K Number
    K093126
    Device Name
    ANAPNOGUARD ENDOTRACHEAL TUBE
    Manufacturer
    HOSPITECH RESPIRATION LTD.
    Date Cleared
    2010-03-02

    (151 days)

    Product Code
    BTP, BTR
    Regulation Number
    868.5420
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOSPITECH RESPIRATION LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacuation or drainage of the subglottic space.
    Device Description
    The AnapnoGuard™ Endotracheal Tube is a sterile, single-use device supplied with main lumen with a standard 15mm connector. Four lumens are embedded within tube walls. One is a standard lumen used for the inflation/deflation of the cuff. Two suction lumens are embedded in the dorsal side of the tube having spatially unified into one success above the cuff. The two suction lumens are unified into one external lumen. These lumens are used to evacuate secretions that accumulate above the cuff. A forth lumen is embedded on the ventral side of the tube having an inlet port above the cuff. It is used for a) venting the subglottis space during suction to avoid vacuum b) for saline (or other fluid) rinsing above the cuff to dilute the secretions and ease the suction c) for air sampling above the cuff to detect leakage of air from the lungs past the cuff. The AnapnoGuard ETT is comprised of the following components: Main lumen (PVC or Silicone), Cuff (Polyurethane for PVC tube and Silicone for Silicon tube), Cuff inflate/deflate lumen, Two suction lumens combined into one outside of the tube sealed with a cap, Venting/air and CO2 sampling lumen sealed with a cap, Murphy eye (with or without).
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