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510(k) Data Aggregation
K Number
K173763Device Name
iovera system
Manufacturer
Myoscience, Inc
Date Cleared
2018-02-28
(79 days)
Product Code
GXH, ETN
Regulation Number
882.4250Why did this record match?
Applicant Name (Manufacturer) :
Myoscience, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The iovera? system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera" system is not indicated for treatment of central nervous system tissue.
The ioveraº system's "1x90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator.
Device Description
The iovera system is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue creating a nerve block through application of extreme cold to the selected site. The device is based on introduction of a Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, N2O) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. The iovera® system may be used in conjunction with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired.
The device is comprised of four main components:
1. A reusable Handpiece
2. A Charging Dock
3. An assortment of single-patient use Smart Tips
4. A Cartridge (Nitrous Oxide)
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K Number
K161835Device Name
iovera system
Manufacturer
Myoscience, Inc
Date Cleared
2017-03-24
(262 days)
Product Code
GXH
Regulation Number
882.4250Why did this record match?
Applicant Name (Manufacturer) :
Myoscience, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The iovera? system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera" system is not indicated for treatment of central nervous system tissue.
Device Description
The ioveras system is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue creating a nerve block through application of extreme cold to the selected site. The device is based on introduction of a Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, N2O) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. The ioveraº system may be used in conjunction with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired.
The device is comprised of four main components:
1. A reusable Handpiece
2. A Charging Dock
3. An assortment of single-patient use Smart Tips
4. A Cartridge (Nitrous Oxide)
The iovera Handpiece is battery powered and provides feedback to the user during device preparation and use. The Handpiece connects to both the Cartridge and to the Smart Tip. The user activates a treatment cycle through a control on the Handpiece, which starts and stops the treatment. The Handpiece also contains LEDs for providing feedback to the user when the device is ready to use. The Charging Dock stores the Handpiece between uses and provides power for charging the battery.
An assortment of Smart Tips is available for the iovera system. All Smart Tip needles are made of stainless steel and have a closed-end that fully contains the cryogen so that it does not enter the target tissue. The Smart Tip is the only patient contacting component of the iovera° system. The user removes the Smart Tip from the sterile packaging and attaches it to the Handpiece.
The ioveras system uses a commercially available nitrous oxide cylinder. The Cartridge is filled with pure N2O.
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K Number
K142866Device Name
Myoscience iovera system
Manufacturer
Myoscience, Inc
Date Cleared
2015-01-21
(112 days)
Product Code
GXH
Regulation Number
882.4250Why did this record match?
Applicant Name (Manufacturer) :
Myoscience, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The myoscience ioveraº system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the blocking of pain. The ioveraº system is not indicated for treatment of central nervous system tissue.
Device Description
The iovera° system is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through application of extreme cold to the selected site. The device is based on introduction of a Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, N₂O) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. iovera° may be used in conjunction with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired.
The device is comprised of four main components:
1. A reusable Handpiece
2. A Charging Dock
3. An assortment of single-patient use Smart Tips
4. A Cartridge (Nitrous Oxide)
Ask a Question
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