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510(k) Data Aggregation

    K Number
    K233026
    Device Name
    Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer
    Manufacturer
    Midmark Corporation
    Date Cleared
    2024-04-04

    (195 days)

    Product Code
    FLE
    Regulation Number
    880.6880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Midmark Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Midmark Smart M9® and Smart M11® Sterilizers can be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable items (including dental handpieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters for detailed information.
    Device Description
    The Midmark Smart M9® and Smart M11® Sterilizers utilize steam flush pressure pulse (SFPP) technology to achieve sterilization on heat and moisture stable items (including dental handbieces) that are compatible with steam sterilization. The Midmark Smart M9® and Smart M11® Sterilizers are compact, self-contained portable units. They can be placed on any level support surface where an electrical outlet is available with no other installation required. The M9 sterilizer models are the smaller of the models with a 9 in (22.9 cm) diameter x 15 in (38.1 cm) deep stainless-steel chamber. The M 1 sterilizer models have an 11" (27.9 cm) diameter x 18" (45.7 cm) deep stainless-steel chamber. The Midmark Smart M9® and Smart M11® Sterilizers use saturated steam at high pressure and temperature as the sterilizing agent to kill infectious bio-organisms on items placed in the chamber for processing. They use the dynamic Steam Flush Pressure Pulse (SFPP) cycle type for the pre-set cycles that include a 4-minute 270°F and a 3-minute 275°F cycle for wrapped or pouched instruments (including dental handpieces) and cassettes, a 30-minute 250°F cvcle for textiles and instrument packs requiring a lower temperature. and a 3-minute 270°F cycle for unwrapped instruments. The 3-minute 275°F is added to align with Table B.2 in AAMI TIR12:2020. In the SFPP type cycle, residual air is removed from the chamber and its contents by a series of controlled pressure pulses and steam flushes. The Midmark Smart M9® and Smart M11® Sterilizers are designed to automate the sterilization process, to the extent possible, and the user interface on the subject models extends this capability to include sterilization record keeping. To use the sterilizer, the operator fills the water reservoir with water (distilled or purified) and loads the included trays with properly cleaned and prepped instruments for sterilization. The loaded trays are then placed inside the chamber, and the chamber door is manually closed by the operator. Based on the cycle parameters that are appropriate for the type of load being processed, the operator then selects the appropriate sterilization cycle on the user interface. On the subject units there are options for the user to enter load type and indicator information. Once the cycle is selected and the operator presses "Start," there is an option to capture the identification of the operator. The sterilizer then automatically performs all the operations necessary to complete the sterilization process without further interaction from the operator. The sterilization cycle is composed of several phases which include Filling, Heating, Sterilization, Venting, and Drying, Audible signals indicate cycle initiation, completion, and/or interruption, and the user interface provides visual communication of device status, operator instructions, and troubleshooting information. The LED light bar also provides an estimate of the cycle progression. At the conclusion of the cycle there is another option to capture the identification of the operator that unloads and approves or rejects the results of the sterilization cycle. All sterilizer cycle and user maintenance (Routine Care) records are stored internally on an SD card. Midmark has developed a Digital Ecosystem Connectivity Module that is incorporated into the Midmark Smart M9® and Smart M11® Sterilizers which adds the ability to transfer electronic sterilization records to the Midmark cloud and to remotely view the current status of, or cycle history for multiple sterilizers. Optional features and settings that may be distributed to multiple sterilizers from the cloud include distribution of software updates to the connectivity module, compliance settings, and entering the results of biological indicator tests. Connectivity is not needed to perform the sterlizer's intended use, and connecting a sterilizer does not change the intended use.
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    K Number
    K201667
    Device Name
    Midmark Extraoral Imaging System (EOIS)
    Manufacturer
    Midmark Corporation
    Date Cleared
    2020-08-06

    (48 days)

    Product Code
    OAS, MUH
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Midmark Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Midmark EOIS is to provide dental radiographic examination to aid in the diagnosis of diseases of the teeth, jaw and oral structures. When the system is equipped with the cephalometric option, the system will provide cephalometric radiographic examinations for use in orthodontic treatment planning and evaluation. When the system is equipped with the CBCT option, the system will also provide volumetric and tomographic images of the oral and maxillofacial region, for diagnostic examination of teeth, jaws, oral structures, and some cranial bones.
    Device Description
    The Midmark Extraoral Imaging System (EOIS) is a diagnostic X-ray system using an extraoral source intended for dental radiographic examination and diagnosis of diseases for the following regions of the patient's anatomy: - . dental (teeth) - . oral and maxillofacial region (mouth and jaw) It produces the following radiographic images: - . Panoramic (PAN) images used for diagnostic examination of dentition (teeth), jaws and oral structures. - Cephalometric (CEPH) images of maxillofacial region and parts of the skull for CEPH examination, if equipped with the CEPH feature. - . Carpal images assisting in estimating bone-age, if equipped with the CEPH feature, and when the carpal attachment is used. - . Cone Beam Computed Tomography (CBCT) volumetric and tomographic images of the oral and maxillofacial region for diagnostic examination of dentition (teeth), jaws, oral structures, and some cranial bones, if equipped with the CBCT small or medium feature. The main modality is limited to PAN radiographic images but can be upgraded by installing the CEPH imaging feature, allowing the device to provide CEPH radiographic images for use in orthodontic treatment planning and evaluation. This extension is also intended to allow carpal imaging to assist in estimating bone-age. The Midmark EOIS can be upgraded by installing a 3D option allowing the device to produce computed volumetric and tomographic images of the listed above anatomy regions by computed tomographic reconstruction of the digital X-ray data. The X-ray data is captured by two dimensional images taken by exposing the patient anatomy at different anales with a cone shaped X-ray beam. Reconstruction software converts these two-dimensional images into a three-dimensional data set.
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    K Number
    K163337
    Device Name
    Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer
    Manufacturer
    Midmark Corporation
    Date Cleared
    2017-08-31

    (276 days)

    Product Code
    FLE
    Regulation Number
    880.6880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Midmark Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and the Ritter M9D AutoClave® Automatic Sterilizer can be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable items (including dental handpieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters on the following page for detailed information.
    Device Description
    The Midmark and Ritter M9 and M11 UltraClave and Ritter M9D AutoClave Self-Contained steam sterilizers are designed to sterilize medical, surgical, laboratory, and dental items, using pressurized steam. The M9 UltraClave models include a variation designated as the M9D Autoclave, the only difference being that the M9 UltraClave includes a motor to automatically open the door for drying and the M9D Autoclave is a manual model which requires the operator to open the door for drying. They are self-contained devices that are electrically powered with automatic controls for controlling time and temperature that are designed for safe, easy operation with minimal operator training.
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    K Number
    K161909
    Device Name
    IQvitals Zone
    Manufacturer
    Midmark Corporation
    Date Cleared
    2016-11-17

    (128 days)

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

    Midmark Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IQvitals Zone is intended to be used by clinicians and medically qualified personnel for measuring and monitoring: · Noninvasive blood pressure for adult and pediatric patients (3 years and above) - · Pulse rate for adult and pediatric patients - · Noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2) for adult and pediatric patients - · Body temperature measured at Temporal Artery for adult and pediatric patients The most likely location for IQvitals Zone device to be used is for monitoring patient in general medical locations, hospitals and alternative care environments.
    Device Description
    The IQvitals Zone is designed to be used for measuring and monitoring systolic and diastolic blood pressure, pulse rate, temperature and oxygen saturation (SpO2) for adult and pediatric patients. All functions of the device are performed via the touch screen display, except the power on/off function, which is a separate button on the back of the device. The IQvitals Zone can be wirelessly connected with low energy Bluetooth to mobile computers or be connected with a USB cable to computers and has the ability to send the measurement results to the computers. The device has a rechargeable lithium ion battery and two mounting options: a mobile cart and a wall mount. All vitals parameters can be simultaneously measured and easily viewed on the touch screen display or the connected computer. Temperature is measured at Temporal Artery and the Temperature Probe is connected serially to the IQvitals Zone.
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    K Number
    K122643
    Device Name
    VANTAGE MODEL V5000, V5100, V5000C, V5100C
    Manufacturer
    MIDMARK CORP.
    Date Cleared
    2013-01-07

    (131 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIDMARK CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indications for use of the Progeny Vantage Panoramic X-Ray System is to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. When the system is equipped with the cephalometric option, the system will also provide cephalometic radiographic examinations for use in orthodontic treatment planning and evaluation.
    Device Description
    The Progeny Vantage Panoramic X-Ray System is an extraoral radiographic imaging system for producing digital radiographs in panoramic and cephalometric views of the teeth, jaw and oral structure. The Progeny Vantage Panoramic Extraoral Radiographic Imaging System consists of the following main components: X-ray tubehead with integrated collimation, Digital Image Receptor, Rotating C-Arm for tubehead and image receptor mounting, Overhead Arm, Elevating Column, Patient Positioning Table, Electronic Control Unit, Computer Display Workstation, 8 ft. coil cord with exposure switch, Optional cephalometric extension arm.
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    K Number
    K120239
    Device Name
    ELEVANCE
    Manufacturer
    MIDMARK
    Date Cleared
    2012-08-24

    (211 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIDMARK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Elevance is intended for use by professional dental practitioners in providing treatment to dental patients in a dental operatory. The system is designed to deliver air, water, vacuum and low-voltage electricity to hand-held dental instruments.
    Device Description
    The Elevance Delivery Unit includes components to deliver air, water, electrical power, and vacuum to dental handpieces and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, console mount housing, and a junction box that houses a power supply and air/water regulators. Handpiece accessories or instruments can be added to the Unit, Midmark does not manufacture these accessories but, do provide means to connect them into the Unit. These include high and low speed pneumatic handpiece tubing, electric handpiece motors, scalers, intraoral cameras, curing lights, air/water syringe, and SE and HVE vacuum instruments.
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    K Number
    K112380
    Device Name
    CLEARVISION
    Manufacturer
    MIDMARK CORP.
    Date Cleared
    2011-11-22

    (97 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIDMARK CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ClearVision is intended to be used by dentists and other qualified professionals for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
    Device Description
    ClearVision is a digital imaging system for dental radiographic application. The product is to be used for routine dental radiographic examinations such as bitewings, periapicals, etc. Two different sized sensors (size 1 and size 2) are utilized to image different anatomy and for different patient sizes. The CMOS sensor connects directly to a USB connection in a PC without the need for an intermediate electrical interface. ClearVision works with a standard dental intraoral x-ray source without any connection to the x-ray source. ClearVision captures an image automatically upon sensing the production of x-ray and after the x-ray is complete, transfers the image to an imaging software program on the PC. Disposable sheaths are used with each use to prevent cross-contamination between patients.
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    K Number
    K091866
    Device Name
    PROGENY VANTAGE PANORAMIC X-RAY SYSTEM
    Manufacturer
    MIDMARK
    Date Cleared
    2009-07-20

    (26 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIDMARK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indications for use of the Progeny Vantage Extra-Oral Panoramic X-Ray System is to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
    Device Description
    The Progeny Vantage Panoramic X-ray System is an extraoral radiographic imaging system for producing digital radiographs in a panoramic view of the teeth, jaw, and oral structure. The Progeny Vantage Panoramic Extraoral Radiographic Imaging System consists of the following main components: X-ray tubehead with integrated collimation. Digital Image Receptor Rotating C-Arm for tubehead and image receptor mounting Overhead arm Elevating Column Patient Positioning Table Electronic Control Unit Computer Display Workstation 8 ft. coil cord with exposure switch
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    K Number
    K090670
    Device Name
    MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER
    Manufacturer
    MIDMARK CORP.
    Date Cleared
    2009-07-07

    (116 days)

    Product Code
    FLE
    Regulation Number
    880.6880
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIDMARK CORP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Midmark M3 UltraFast™ Automatic Sterilizer can be used in medical, dental, and veterinary offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters, in Table-1, on the following page, for detailed information:
    Device Description
    The M3 UltraFast™ Automatic Sterilizer is a small table-top steam sterilizer that uses saturated steam at high temperature and pressure to kill infectious bio-organisms. The device is composed of a water reservoir, an oscillatory pump, a small electric boiler, an ASME certified pressure vessel, surface heaters for drying, a removable door/tray assembly, an electric gear motor for opening and closing the door/tray, and a solenoid valve for venting. The action of all of these components is coordinated by an integral proprietary design electronic control system, which includes a PC board, an LCD display, and a user interface membrane switch. The entire device is enclosed by a plastic and steel case. External to this device is a condensation tank, which is connected to the back of the unit, via a plastic tube. Three different fully automatic pre-programmed sterilization cycles with parameters specific to the different load characteristics provide fast and easy use for efficient instrument processing. This sterilizer provides both audible and visual notification upon cycle completion and will dry the load in accordance with the CDC guidelines. A programmable dry cycle allows the user to customize the dry times from 20-60 minutes. This sterilizer has integrated technology to let the operator know if they have low water in the reservoir, or a full external condensing tank eliminating the need to continually monitor water levels.
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    K Number
    K072516
    Device Name
    MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR
    Manufacturer
    MIDMARK DIAGNOSTICS GROUP
    Date Cleared
    2007-10-18

    (41 days)

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

    MIDMARK DIAGNOSTICS GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Midmark Diagnostics IQmark® Vital Signs Monitor is intended to be used by clinicians and medically qualified personnel for monitoring adult, pediatric and neonatal patients for noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature. In adults and pediatric patients, temperature is monitored orally, rectally, or at axillary sites. In neonates (to 1 month) temperature is monitored at axillary sites only. The most likely locations for patients to be monitored are general medical locations, hospitals, and alternative care environments.
    Device Description
    The Midmark Diagnostics IQmark® Vital Signs Monitor consists of the following three individual measurement Modules: a. Noninvasive blood pressure (NIBP) b. Pulse Oximeter c. Temperature In the Automatic or STAT Modes of operation, the NIBP Module automatically inflates an occluding cuff placed around the patient's arm or leg. It uses the oscillometric measurement technique to measure and record the patient's systolic and diastolic pressure as well as pulse rate. From these measurements the IQmark VSM also calculates the mean arterial blood pressure (MAP). Measurement results along with operator prompts and error messages are indicated on the front panel display. The frequency of NIBP determination can be selected by the operator at fixed times between one and ninety minutes. The Manual Mode of operation also covers a variety of clinical uses. A variety of reusable and disposable cuff types and sizes is available for adult, pediatric, and neonatal applications. The NIBP Module requires routine calibration and maintenance. The Pulse Oximeter Module measures and records the patient's arterial oxyhemoglobin saturation by measuring the absorption of red and infrared light passing through tissue (SpO₂). Changes in absorption caused by pulsations of blood in the patient's vascular bed are used to determine arterial oxygen saturation and pulse rate. Oxygen saturation and heart rate are indicated on the front panel display. A bar graph display gives the user a pulse visual indication of waveform signal quality. An audible indicator can be enabled which automatically generates a sound each time the SpO2 sensor detects a pulse. The 1Qmark VSM utilizes the Masimo Set" oximeter. A variety of reusable and disposable sensor types and sizes is available for adult, pediatric and neonatal applications. These oximeter does not require routine calibration or maintenance. The Temperature Module measures and records a patient's temperature in either the Predictive or Continuous Mode of operation using either oral (also used for axillary) or rectal probes. In the Predictive Mode, the thermometer's software predicts body temperature in about 15 seconds for oral and axillary temperatures. The IQmark VSM Temperature Module does not support Predictive Mode measurements for the rectal temperature probe. The default mode used by the IQmark VSM for oral temperature determinations is the Predictive Mode. The Continuous Mode is usually used for longer-term monitoring or when difficult situations prevent accurate patient temperature measurement in the Predictive Mode. Temperature probe covers are required and are available for the oral/axillary and rectal probes. The Temperature Module requires routine calibration and maintenance. When the Alarm Setting Mode is activated, high and low alarm limits can be set (within specification and safety limits) for heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and SpO2.
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