(79 days)
Not Found
No
The summary describes a cryogenic surgical device that uses the Joule-Thomson Effect and/or Latent Heat of Vaporization for cooling. It mentions electrical nerve stimulation for targeting but does not describe any AI/ML components or functionalities. The performance studies focus on biocompatibility, software verification (for a "Smart Tip descriptor"), and bench testing of physical properties. There is no mention of training data, test data, or performance metrics typically associated with AI/ML.
Yes.
The device is used to destroy tissue and produce lesions in nervous tissue for pain blocking purposes, and for the relief of pain and symptoms associated with osteoarthritis of the knee, which are therapeutic applications.
No
The device is a surgical device used to destroy tissue and produce lesions, or for pain relief by applying cold, which are all therapeutic actions. While it can facilitate target nerve location by conducting electrical stimulation, this is for guiding the therapeutic procedure, not for diagnosing a condition.
No
The device description explicitly lists hardware components: a reusable Handpiece, a Charging Dock, single-patient use Smart Tips, and a Cartridge (Nitrous Oxide). While software testing is mentioned, the device is fundamentally a hardware system with integrated software.
Based on the provided information, the iovera system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "destroy tissue during surgical procedures by applying freezing cold" and "to produce lesions in peripheral nervous tissue... for the blocking of pain." It also mentions relief of pain associated with osteoarthritis of the knee. These are all in vivo procedures, meaning they are performed directly on a living organism (the patient).
- Device Description: The description details a system that applies cold directly to tissue and nervous tissue using a Smart Tip inserted into the body. This is consistent with an in vivo surgical or therapeutic device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly treat or modify tissue within the body. The iovera system's function is to directly interact with and modify tissue within the patient.
N/A
Intended Use / Indications for 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.
Product codes
GXH, ETN
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:
- A reusable Handpiece
- A Charging Dock
- An assortment of single-patient use Smart Tips
- 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 ioveral 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 ioveras system. The user removes the Smart Tip from the sterile packaging and attaches it to the Handpiece.
The iovera system uses a commercially available nitrous oxide cylinder. The Cartridge is filled with pure N2O.
The device functionality is based on the user introducing the Smart Tip to the selected treatment area: unwanted tissue or the target nervous tissue. The user then initiates the flow of cryogen by pressing the on/off button. Liquid cryogen flows from the Handpiece into the closed-end Smart Tip. The Smart Tip is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization; as the liquid cryogen expands into a gas, the temperature drops around the external surface of the Smart Tip causing the surrounding tissue to freeze. The treatment is completed after a preprogrammed amount of time at which time the user can safely remove the Smart Tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral nervous tissue, Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Biocompatibility Testing:
Biocompatibility testing was conducted on the new Smart Tip needle in accordance with ISO-10993, ‘Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing" as recognized by FDA. The battery of testing included the following test: Cytotoxicity Sensitization Intracutaneous Reactivity Acute System Toxicity Material-Mediated Pyrogenicity.
Software Testing:
Software verification testing for the new Smart Tip descriptor was conducted as recommended by FDA's Guidance document, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” in conjunction with bench testing of the Smart Tip (see below). No other software changes were required for this submission.
Bench Testing:
Bench testing was performed on the new Smart Tip to demonstrate that the product met the design requirements. A risk analysis was used to assess the impact of the modification, as well, and design verification testing was performed as a result of this risk analysis assessment. In all cases, the risk was mitigated to acceptable levels and the performance testing demonstrated that the Smart Tip design is in compliance with pertinent standards. Specifically, the following tests were performed:
- Electrical Safety Testing per IEC 60601-1: PASS
- EMC/Immunity Testing per IEC 60601-1-2: PASS
- Visual and Dimensional Inspection of Smart Tip needle: PASS
- Verification of temperature reproducibility: PASS
- Cryozone Testing: PASS
- Needle Integrity: PASS
- Tip Descriptor verification to confirm treatment parameters: PASS
Preclinical Testing Submitted: No preclinical testing was deemed necessary for the product line extension.
Clinical Testing Submitted: No clinical testing was deemed necessary for the product line extension.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4250 Cryogenic surgical device.
(a)
Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 28, 2018
Myoscience, Inc. Kent Jones Senior Director, RAQACA 46400 Fremont Blvd Fremont, California 94538
Re: K173763
Trade/Device Name: ioveraº system Regulation Number: 21 CFR 882.4250 Regulation Name: Cryogenic Surgical Device Regulatory Class: Class II Product Code: GXH, ETN Dated: December 7, 2017 Received: December 11, 2017
Dear Kent Jones:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michae|J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173763
Device Name ioveraº system
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section 5: 510(k) Summary
Device Information:
| Category | Comments |
|---|---|
| Sponsor / Submitter: | Myoscience, Inc |
| 46400 Fremont Blvd | |
| Fremont, CA 94538 | |
| Ph: 510.933.1500 | |
| Fax: 410.933.1501 | |
| Correspondent Contact | |
| Information: | Kent Jones |
| Sr. Director RAQACA, Myoscience, Inc | |
| Telephone: 510.933.1513 | |
| Email: kjones@myoscience.com | |
| Device Common Name: | Cryogenic surgical device |
| Device Classification & Code: | Class II, GXH, ETN |
| Device Classification Name: | Cryosurgical unit and accessories (21 CFR 882.4250), |
| Surgical nerve stimulator (21 CFR 874.1820) | |
| Device Trade Name: | iovera° system |
a. Predicate Device Information:
| 510(k) Number | Product | Sponsor |
|---|---|---|
| K161835 | iovera° system | Myoscience, Inc |
| K100241 | B Braun Stimuplex D | |
| Insulated Needle | B Braun Medical, Inc |
b. Date Summary Prepared
7 December 2017
c. Description of Device
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.
Device Design
The device is comprised of four main components:
-
- A reusable Handpiece
-
- A Charging Dock
-
- An assortment of single-patient use Smart Tips
-
- 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
4
ioveraº svstem Premarket Notification
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 ioveral 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 ioveras system. The user removes the Smart Tip from the sterile packaging and attaches it to the Handpiece.
The iovera system uses a commercially available nitrous oxide cylinder. The Cartridge is filled with pure N2O.
Device Functionality/Scientific Concepts
The device functionality is based on the user introducing the Smart Tip to the selected treatment area: unwanted tissue or the target nervous tissue. The user then initiates the flow of cryogen by pressing the on/off button. Liquid cryogen flows from the Handpiece into the closed-end Smart Tip. The Smart Tip is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization; as the liquid cryogen expands into a gas, the temperature drops around the external surface of the Smart Tip causing the surrounding tissue to freeze. The treatment is completed after a preprogrammed amount of time at which time the user can safely remove the Smart Tip.
d. Indications for Use
The 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 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 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. The iovera system is not indicated for treatment of central nervous system tissue.
e. Comparison of Technological Characteristics with the Predicate Device
Following are the similarities/differences in technological characteristics between the subject and predicate devices. The differences in technological characteristics do not raise different questions of safety and effectiveness for the subject device as compared to the predicate device.
| Technological Characteristics | |
|---|---|
| Predicate Device (K142866) | Subject Device |
| 1x90 Smart Tip | |
| Cryogenic device | Same |
| Nitrous oxide coolant, pressurized cylinder | Same |
| Reusable handpiece, battery powered | Same |
| Single use tip for subdermal cooling, EO sterilized | Same |
| Charging dock | Same |
| Sensors, monitor nitrous oxide deliver and rate of cooling | Same |
| Smart Tip Needle range | Smart Tip Needle |
| Length: 6 – 55mm (0.2 – 2.2 in) | Length: 90mm (3.5 in) |
| Size: Ø.31 – .72mm (25 – 30 gauge) | Size: Ø.91mm (20 gauge) |
| Patient contacting materials: | Patient contacting materials: |
5
myoscie ice
ioveraº system Premarket Notification
| Closed sharp cutting and blunt tip
Stainless Steel needle | Closed sharp cutting Stainless
Steel needle with Parylene C
coating
• Includes electrical nerve
stimulation capability (using
off-the-shelf nerve stimulator) |
| -------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
| Technological Characteristics | |
|---|---|
| Predicate Device (K100241) | Subject Device |
| B Braun Stimuplex D Insulated Needle | 1x90 Smart Tip |
| Single use needle | Same |
| Electrical nerve stimulation capability (using Stimuplex nerve stimulator) | Same |
| Needle range | |
| · Length: 35 – 120mm (1-3/8 in – 4-3/8 in) | |
| · Size: Ø.91 – .51mm (20 – 25 gauge) | |
| · Patient contacting materials: | |
| Open sharp cutting Stainless Steel needle with clear dielectric coating. | Smart Tip Needle |
| · Length: 90mm (3.5 in) | |
| · Size: Ø.91mm (20 gauge) | |
| · Patient contacting materials: | |
| Closed sharp cutting Stainless Steel needle with Parylene C coating |
f. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
| Biocompatibility Testing | Biocompatibility testing was conducted on the new Smart Tip needle in accordance with ISO-10993, ‘Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing" as recognized by FDA. The battery of testing included the following test:
Cytotoxicity Sensitization Intracutaneous Reactivity Acute System Toxicity Material-Mediated Pyrogenicity |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software Testing | Software verification testing for the new Smart Tip descriptor was conducted as recommended by FDA's Guidance document, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” in conjunction with bench testing of the Smart Tip (see below). No other software changes were required for this submission. |
| Bench Testing | Bench testing was performed on the new Smart Tip to demonstrate that the product met the design requirements. A risk analysis was used to assess the impact of the modification, as well, and design verification testing was performed as a result of this risk analysis assessment. In all cases, the risk was |
6
| myoscience | ioveraº system
Premarket Notification
mitigated to acceptable levels and the performance testing
demonstrated that the Smart Tip design is in compliance with
pertinent standards. Specifically, the following tests were
performed: | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | | |
| | Test Performed | Result |
| | Electrical Safety Testing per IEC 60601-1 | PASS |
| | EMC/Immunity Testing per IEC 60601-1-2 | PASS |
| | Visual and Dimensional Inspection of Smart Tip
needle | PASS |
| | Verification of temperature reproducibility | PASS |
| | Cryozone Testing | PASS |
| | Needle Integrity | PASS |
| | Tip Descriptor verification to confirm treatment
parameters | PASS |
| Preclinical Testing
Submitted: | No preclinical testing was deemed necessary for the product line
extension | |
| Clinical Testing Submitted: | No clinical testing was deemed necessary for the product line
extension. | |
g. Conclusion
The performance data demonstrate that the iovera° system is as safe, effective and performs comparably to the predicate devices that are currently marketed for the same intended use.