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The Diros OWL Sterile Single Use Trident™ R.F. Insulated Cannulae Models DTR and DTRH are injection needles which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.

The Diros OWL Sterile Single Use Trident™ RF Cannulae DTR and DTRH models are very similar in construction, materials, energy source and intended use to predicate devices of 466 and DHC. They are single use disposable devices to be used with the Diros OWL RF Generators. Sterile Single Use Trident™ RF Cannulae model DTR: The DTR device consists of a sharp insulated needle with a partially uninsulated part of the shaft near the tip. Needle shaft is permanently attached to the hub that is used as a handle and the fluid injection port. The active tip has expandable tines, which are normally withdrawn and only expanded once the device is placed in desired position. The device also has a detachable stylet with cap. The device is supplied with a protection tube that protects the needle from damage. The protection tube is detached from the device prior to use. Sterile Single Use Trident™ RF Hybrid Cannulae model DTRH: The DRTH device consists of a sharp insulated needle with a partially uninsulated part of the shaft near the tip. The Needle shaft is permanently attached to the active tip has expandable tines, which are normally withdrawn and only expanded once the device is placed in desired position. The handle also is permanently attached to the thermocouple probe, cable (with connector) and injection port. The Thermocouple probe is used to deliver the RF energy from the generator and measure the needle tip temperature. The injection port is used for fluid injection. The device is supplied with a protection tube that protects the needle from damage. The protection tube is detached from the device prior to use.

The Diros OWL cannulae are injection needles which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.

The Diros OWL Sterile Single Use Disposable 16Ga Cannulae models 466, DHC are identical in construction, materials, energy source and intended use to predicate devices. They are single use disposable devices to be used with the Diros OWL RF Generators. The 466 series 16Ga cannula consists of a sharp insulated needle with a partially uninsulated part of the shaft near the tip. Needle shaft is permanently attached to the hub that is used as a handle and the fluid injection port. The device also has a detachable stylet with cap. The device is supplied with a protection tube that protects the needle from damage. The protection tube is detached from the device prior to use. The DHC series 16Ga cannula consists of a sharp insulated needle with a partially uninsulated part of the shaft near the tip. The Needle shaft is permanently attached to the handle. The handle also is permanently attached to the thermocouple probe, cable (with connector) and injection port. The Thermocouple probe is used to deliver the RF energy from the generator and measure the needle tip temperature. The injection port is used for fluid injection. The device is supplied with a protection tube that protects the needle from damage. The protection tube is detached from the device prior to use.

The Diros OWL cannulae are injection needles which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.

The Diros OWL Sterile Single Use Disposable Cannulae models 466, 467, DXE, DRC, DST, DHC are single use disposable cannulae designed for use with the Diros OWL RF Lesion Generator, model URF-3AP. The models DRC, DXE, DHC and DST provide flexible injection ports and are used to administer for the delivery of local anaesthesia. The DXE and DHC models along with the standard RF cannulae product line additionally provide the capability for delivery of RF therapy. The DHC model includes an embedded thermocouple for thermally controlled lesion generation. The Diros OWL Sterile Single Use Disposable Cannulae are available in multiple sizes. The cannulae gauge ranges from 18 to 24 and the length from 30mm to 200mm. All cannulae in this submission are for single use only and are supplied sterile.

The OWL Sterile Single Use Disposable R.F. Probe/Temperature Sensor is intended for use in Radio-Frequency Heat Lesion procedures for relief of pain.

The Diros OWL RF Probe/Temperature Sensor is a modification of the previously 510(k) cleared OWL Reusable RF Probes. The modification includes the change of the device from reusable to sterile and single use as well as the option to include a thermocouple in place of a thermistor for temperature measurement.

The DIROS OWL™ URF-3AP(ML) SYSTEM is intended for the following: 1. Lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or 2. radiofrequency heat lesion procedures for the relief of pain The MLA-4 Multi-Lesion adaptor is not intended for use in brain surgery.

The Diros OWL™ radiofrequency generator URF-3AP(ML) is used by qualified medical personnel to make heat ablative lesions in central or peripheral nerve tissue for the treatment of movement disorders or for the relief of pain. The lesions are ablative in order to be therapeutic; i.e. the destruction of a small portion of the thalamus within the brain interferes with the motor pathway causing the tremor of Parkinson's disease, thereby relieving the tremor; or the destruction of the facet joint nerves in the lumbar vertebrae to block pain transmission by these nerves and thereby relieve certain types of low back pain. The URF-3AP(ML) supplies up to 50 Watts of Radio Frequency energy at 481kHz under power or temperature control while continuously monitoring and displaying actual power delivered, measured probe temperature, time of power duration, and measured impedance. This 50W RF source can be directed to one of four channels, one at a time, to create simultaneously up to four lesions. When used with monopolar probes, the system also delivers low-frequency stimulus pulses in either voltage or current controlled modes.

The OWL Radiofrequency System, Model URF-3AP, intended use is for: 1. Lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or 2. radiofrequency heat lesion procedures for the relief of pain

The OWL radiofrequency generator URF-3AP is used by qualified medical personnel to make heat ablative lesions in central or peripheral nerve tissue for the treatment of movement disorders or for the relief of pain. The lesions are ablative in order to be therapeutic; i.e. the destruction of a small portion of the thalamus within the brain interferes with the motor pathway causing the tremor of Parkinson's disease, thereby relieving the tremor, or the destruction of the facet joint nerves in the lumbar vertebrae to block pain transmission by these nerves and thereby relieve certain types of low back pain. The URF-3AP supplies up to 50 Watts of Radio Frequency energy at 481kHz in bipolar or monopolar modes under power or temperature control while continuously monitoring and displaying actual power delivered, measured probe temperature, time of power duration, and measured impedance. When used with monopolar probes, the system also delivers low-frequency stimulus pulses in either voltage or current controlled modes.

The OWL Radiofrequency System, Model URF-2AP, intended use is for: 1. lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or 2. radiofrequency heat lesion procedures for the relief of pain.

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