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510(k) Data Aggregation
K Number
K241465Device Name
Midas Flowmeter; eAVS
Manufacturer
Parker Hannifin Corporation
Date Cleared
2024-09-19
(119 days)
Product Code
BZR, CBN
Regulation Number
868.5330Why did this record match?
Applicant Name (Manufacturer) :
Parker Hannifin Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Midas Flowmeter is intended for use as a continuous flow conscious sedation system to deliver a mixture of nitrous oxide and oxygen gases to a patient. When used with the electronic automatic vacuum switch (eAVS), the Midas Flowmeter is used to control the scavenging of waste analgesic gas.
Device Description
The Midas Flowmeter is used within a healthcare environment during a nitrous oxide (N20)/oxygen (O2) conscious sedation system. The device is a digitally controlled, software driven, continuous flow device that precisely meters nitrous oxide and oxygen medical gases and delivers gas mixtures to a conscious, spontaneously breathing patient. The Midas Flowmeter uses electronic mechanisms to control the flowrate and mixture percentage of gases delivered to a patient. The optional eAVS is an accessory to the Midas Flowmeter. It is used within the nitrous oxide/oxygen conscious sedation system to allow removal of waste analgesic gases through a connected vacuum source. The eAVS connects the exhalation line of the patient's breathing circuit to vacuum tubing from the vacuum source and controls the vacuum flowrate (i.e., scavenging flowrate). The eAVS is specifically designed to work with the Midas Flowmeter and all functionality control of the eAVS has been integrated into the user interface of the Midas Flowmeter.
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K Number
K223452Device Name
Nitronox Scavenger Plus
Manufacturer
Parker Hannifin Corporation
Date Cleared
2023-03-05
(110 days)
Product Code
CBN
Regulation Number
868.5430Why did this record match?
Applicant Name (Manufacturer) :
Parker Hannifin Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitronox® Scavenger Plus is intended to control the vacuum flowrate for scavenging of waste analgesic gas.
Device Description
The Nitronox® Scavenger Plus (Scavenger Plus) is used within a nitrous oxide/oxygen conscious sedation system to allow removal of waste analgesic gases through a connected vacuum source. The device is used during a dental or medical procedure in a healthcare facility environment. The device is not intended to be used for general anesthesia. The Scavenger Plus is operated by a licensed healthcare professional during conscious sedation of a patient.
The Scavenger Plus connects the exhalation line of the patient's breathing circuit to vacuum tubing from the vacuum source and controls the vacuum flowrate (i.e., scavenging flowrate). The rate at which the gas is removed (i.e., scavenged) is specified by the Scavenger Plus, which uses a control knob and reservoir bag to limit the amount of vacuum applied to the exhalation line of the breathing circuit.
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K Number
K202480Device Name
Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
Manufacturer
Parker Hannifin
Date Cleared
2021-04-22
(237 days)
Product Code
BZR
Regulation Number
868.5330Why did this record match?
Applicant Name (Manufacturer) :
Parker Hannifin
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitronox Plus is intended to provide a mixture of N20/02, on demand, to a conscious, spontaneously breathing patient. The Nitronox Plus is designed for use with adult and pediatric patients and is not intended to be used with infants or neonates.
Device Description
The Nitronox Plus is a portable "on demand" analgesia system used to deliver a mixture of nitrous oxide and oxygen gases to a conscious, spontaneously breathing patient. The device is designed for use with adult and pediatric patients and is not intended to be used with infants or neonates. It is only for use in a healthcare setting by healthcare professionals. The Nitronox Plus is available in three models which differ only in adjustability and maximum ratio of nitrous oxide that can be delivered. The Nitronox Plus features a 0-70% N2O adjustable model, 0-50% N2O adjustable model, and 50% N2O/50% O2 fixed model.
The Nitronox Plus is a pneumatic system. Oxygen and nitrous oxide are supplied to the device through flexible hoses. Inlet gas is regulated and equalized through the use of an oxygen piloted dual diaphragm regulator. The inlet pressure of both gases and the mixed gas pressure are displayed on the front panel of the device through the use of pressure gauges. The device is designed to function with a medical breathing circuit and face mask or mouthpiece accessory.
Delivery of mixed gas starts with a patient's demand; upon inhalation through a face mask or mouthpiece, a demand valve opens and supplies mixed gas to the patient through the connected Medical Breathing Circuit. In adjustable models, the healthcare professional is able to set the desired concentration through the use of a control knob on the front panel. Mixed gas is supplied through the breathing circuit until inhalation ceases.
The Nitronox Plus contains several safety features. Pneumatically powered alarms for both gas inlets alert the user when either gas supply begins to deplete. The device will also maintain delivery of the set concentration with depleting oxygen pressure. Once the oxygen pressure drops below a certain threshold, the device will allow ambient air to be delivered through an Emergency Air Intake valve. The device also features a key lock to control the nitrous oxide gas supply, allowing healthcare professionals to prevent unauthorized use of the device.
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K Number
K171334Device Name
Indego
Manufacturer
Parker Hannifin Corporation
Date Cleared
2017-09-08
(123 days)
Product Code
PHL
Regulation Number
890.3480Why did this record match?
Applicant Name (Manufacturer) :
Parker Hannifin Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Indego® orthotically fits to the lower limbs and the trunk; the device is intended to enable individuals with spinal cord injury at levels T3 to L5 to perform ambulatory functions with supervision of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels C7 to L5 to perform ambulatory functions in rehabilitations in accordance with the user assessment and training certification program. The Indego is not intended for sports or stair climbing.
Device Description
Parker Hannifin's Indego® device is a wearable powered exoskeleton that actively assists individuals to stand and walk; these are patients with walking impairments resulting from lower extremity weakness or paralysis. The Indego consists of snap-together components weighing 26 pounds total. The hip component houses a rechargeable battery pack, central processor, and Bluetooth radio, while each upper leg component houses two motors as well as embedded sensors and controllers. On-board microprocessors receive signals from integrated sensors which provide information on the user's posture and tilt. This allows the device to function in a manner similar to the Segway personal mobility device, which is controlled by the user's tilt. A user similarly controls of the Indego by means of postural changes (e.g., to walk forward, the user just leans forward). The technology of the design links the low weight and low profile to advanced battery technology (smaller size), motors (smaller and more powerful), and micro controllers (state-of-the art). Visual cues from the LED lights on the hip and vibratory feedback inform both the patient and therapist or trained support person of the status and mode of operation. The Indego controls are self-contained, with forearm crutches or a walker used solely for stability. Users can perform sit-to-stand and stand-to-sit transitions and walk along even or uneven terrain up to about five degree (5°) grades. Taller torso "wings" are provided to support users who may need additional trunk support while walking. A physical therapist can configure, operate, and monitor the device during therapy and training to make adjustments as needed. This is achieved through the support of a wireless application that will run on mobile/wifi connected smart devices such as an iPod or iPhone. The patient and physical therapist will be able to work in concert to achieve the actions of transitioning from sitting to standing, standing to walking, stop walking, and return from standing to sitting. The untethered, free roaming design of the device will allow it to be utilized in multiple indoor and outdoor locations in either a rehabilitation setting with a certified Indego Specialist or a personal setting with a trained support person.
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K Number
K161731Device Name
Cleveland Multiport Ventricular Catheter Set
Manufacturer
Parker Hannifin Corp.
Date Cleared
2017-03-27
(277 days)
Product Code
HCA
Regulation Number
882.4100Why did this record match?
Applicant Name (Manufacturer) :
Parker Hannifin Corp
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cleveland Multiport Ventricular Catheter Set is indicated for gaining access to the ventricles of the brain for the removal of cerebrospinal fluid (CSF) or for injecting Cytarabine.
Device Description
The Cleveland Multiport Ventricular Catheter contains a main or central lumen for the insertion stylet which is surrounded by four minor lumens (equally spaced) that contain the microcatheters. The catheter includes a ribbed distal tip, a housing for locking the insertion stylet, and proximal male Luer fittings at the end of each micro-catheter. The ribbed distal tip of the main catheter allows the micro-catheters to retract into the main catheter, by stretching the catheter when the insertion stylet is fully inserted and locked. This stretched state allows the catheter tip outside diameter to reduce slightly for atraumatic insertion into the ventricles of the brain. Once the insertion stylet is removed the catheter tip returns to its relaxed state (larger outside diameter) and the micro-catheters deploy. The enlarged tip aids in backflow prevention during injection of fluids. The distal Luer fittings allow for connectivity to a standard syringe or infusion pumps for removal of CSF and/or infusion. The biocompatible metal insertion stylet provides temporary rigidity to the distal portion of the device during catheter insertion and is removed after placement. The Cleveland Multiport Ventricular Catheter has no software, power sources, or radiation emitting components.
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K Number
K152416Device Name
Indego
Manufacturer
PARKER HANNIFIN CORPORATION
Date Cleared
2016-02-26
(184 days)
Product Code
PHL
Regulation Number
890.3480Why did this record match?
Applicant Name (Manufacturer) :
PARKER HANNIFIN CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Indego® orthotically fits to the lower limbs and the trunk; the device is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions with supervision of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels T4 to T6 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. The Indego is not intended for sports or stair climbing.
Device Description
Parker Hannifin's Indego® device is a wearable powered exoskeleton that actively assists individuals to stand and walk. Unique in design, the Indego consists of five (5) snap-together components (the lumbar/hip section, right and left upper leg sections, and right and left lower leg sections) weighing 26 pounds total. The hip component houses a rechargeable battery pack, central processor, and Bluetooth module, while each upper leg component houses two motors as well as embedded sensors and controllers.
On-board microprocessors receive signals from integrated sensors which provide information on the user's posture and tilt. This allows the device to function in a manner similar to the Segway personal mobility device, which is controlled by the user's tilt. A user similarly controls the Indego by means of postural changes (e.g., to walk forward, the user just leans forward). The technology of the design links the low weight and low profile to battery technology (smaller size), motors (smaller and more powerful), and micro controllers. Visual cues from LED lights on the hip unit and vibratory feedback inform both the therapist and patient of the status and mode of operation.
The Indego controls are self-contained, with crutches or a walker used solely for stability. Users can perform sit-to-stand and stand-to-sit transitions and walk along even or uneven terrain up to about five degree (5°) grades. Taller torso "wings" are provided to support users who may need additional trunk support while walking. A physical therapist can configure, operate, and monitor the device during therapy and training to make adjustments as needed. This is achieved through the support of a wireless application that will run on mobile/wifi connected smart devices such as an iPod or iPhone. Through the use of a Bluetooth connection, the Indego device's mode of operational parameters such as gait speed and step length/height, will be able to be changed or modified in real time. The device can be utilized in multiple indoor and outdoor locations within a rehabilitation setting or personal setting.
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