(79 days)
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.
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)
Based on the provided text, the document is a 510(k) Premarket Notification for the Myoscience iovera® system, primarily focused on an extended Smart Tip configuration. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance data submitted to demonstrate substantial equivalence to predicate devices, rather than a clinical outcome study in the traditional sense of proving clinical efficacy for a new indication.
Here's an breakdown of the requested information based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this submission are primarily focused on demonstrating the safety and performance of the new Smart Tip configuration (1x90mm) as being substantially equivalent to existing predicate devices, particularly regarding its physical characteristics and operational performance within the iovera® system. The acceptance criteria are essentially implied by the "PASS" results for various tests.
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity | PASS |
| Sensitization | PASS | |
| Intracutaneous Reactivity | PASS | |
| Acute System Toxicity | PASS | |
| Material-Mediated Pyrogenicity | PASS | |
| Software Functionality | Software verification for new Smart Tip descriptor | PASS |
| Bench/Hardware Performance | 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 |
Study Details
-
Sample sizes used for the test set and the data provenance:
- The document does not specify numerical sample sizes for each of the performance tests (e.g., number of Smart Tips tested for dimensional inspection, or number of cycles for temperature reproducibility).
- Data Provenance: The tests were conducted by Myoscience, Inc. as part of their premarket notification for the device. The document does not specify a country of origin for the data or whether it was retrospective or prospective, but given it's a premarket submission, it would be prospective testing conducted for the purpose of the submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For this type of device and submission (a 510(k) for a modification to an existing device, emphasizing engineering and material performance), "ground truth" is established through standardized engineering tests, material testing protocols (like ISO-10993), and software verification, rather than clinical expert consensus on complex diagnostic images. Therefore, the concept of "experts establishing ground truth" in the clinical sense is not directly applicable. The "experts" would be qualified engineers, test technicians, and quality assurance personnel performing the described tests according to recognized standards.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication methods like 2+1 or 3+1 are typical for clinical studies involving multiple human readers assessing medical images or outcomes. This document details engineering and biocompatibility testing, not a clinical reader study. Therefore, no such adjudication method was used or is relevant to the data presented.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not performed. This device is a cryogenic surgical system, not an AI-powered diagnostic or assistive tool for human readers. The concept of "human readers improve with AI vs without AI assistance" is not relevant to this device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this term typically applies to AI algorithms. The "software testing" mentioned is for the device's embedded software (e.g., for controlling treatment parameters), not a standalone AI algorithm for medical image analysis or diagnosis.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance data provided, the "ground truth" is based on:
- Standardized Test Specifications: For electrical safety, EMC, dimensional accuracy, temperature reproducibility, cryozone formation, and needle integrity, the ground truth is defined by pre-established engineering specifications and international standards (e.g., IEC 60601-1, ISO-10993).
- Chemical/Biological Standards: For biocompatibility, the ground truth is determined by the results of specific standardized biological tests (Cytotoxicity, Sensitization, etc.) against accepted pass/fail criteria from ISO-10993.
- Software Design Requirements: For software verification, the ground truth is the confirmed meeting of the software design requirements for the new Smart Tip descriptor.
- For the performance data provided, the "ground truth" is based on:
-
The sample size for the training set:
- This document describes performance testing for a 510(k) submission, not an AI model development. Therefore, there is no "training set" as understood in machine learning. The device itself (the iovera® system) has undergone extensive development and testing, but the term "training set" is not applicable here.
-
How the ground truth for the training set was established:
- As there is no "training set" in the context of this 510(k) submission, this question is not applicable.
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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.
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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
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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) |
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Section 5: 510(k) Summary
Device Information:
| Category | Comments |
|---|---|
| Sponsor / Submitter: | Myoscience, Inc46400 Fremont BlvdFremont, CA 94538Ph: 510.933.1500Fax: 410.933.1501 |
| Correspondent ContactInformation: | Kent JonesSr. Director RAQACA, Myoscience, IncTelephone: 510.933.1513Email: 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 DInsulated 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
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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 Device1x90 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: |
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myoscie ice
ioveraº system Premarket Notification
| Closed sharp cutting and blunt tipStainless Steel needle | Closed sharp cutting StainlessSteel needle with Parylene Ccoating• Includes electrical nervestimulation capability (usingoff-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 |
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| myoscience | ioveraº systemPremarket Notificationmitigated to acceptable levels and the performance testingdemonstrated that the Smart Tip design is in compliance withpertinent standards. Specifically, the following tests wereperformed: | |
|---|---|---|
| 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 Tipneedle | PASS | |
| Verification of temperature reproducibility | PASS | |
| Cryozone Testing | PASS | |
| Needle Integrity | PASS | |
| Tip Descriptor verification to confirm treatmentparameters | PASS | |
| Preclinical TestingSubmitted: | No preclinical testing was deemed necessary for the product lineextension | |
| Clinical Testing Submitted: | No clinical testing was deemed necessary for the product lineextension. |
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.
§ 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).