(132 days)
The myoscience ioveral device 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 selected site for the blocking of pain. The iovera® device is not indicated for treatment of central nervous system tissue.
The myoscience iovera® device 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 has the added functionality of having the treatment parameters being preprogrammed into its secure processor. The Smart Tip is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. The iovera® device 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 1.
- A Charging Dock 2.
- A single-patient use Smart Tip 3.
- A Cartridge (Nitrous Oxide)
The provided text describes a 510(k) submission for the myoscience iovera® cryogenic surgical device. This document focuses on the substantial equivalence of the new device to a predicate device based on non-clinical performance testing. It does not include information about acceptance criteria and clinical study results in the format typically used for AI/ML device submissions, such as detailed performance metrics, ground truth establishment, or human reader studies.
Here's a breakdown of the requested information based only on the provided text, highlighting what is present and what is absent:
Acceptance Criteria and Device Performance
For this device, the "acceptance criteria" are implicitly meeting the design requirements and demonstrating substantial equivalence to the predicate device through non-clinical testing. The "reported device performance" is a simple pass/fail for each test, indicating it met the criteria for substantial equivalence.
| Acceptance Criteria (Test Performed) | Reported Device Performance (Result) |
|---|---|
| Temperature reproducibility | PASS, Substantially equivalent to predicate |
| Mechanical Integrity for System | PASS, Substantially equivalent to predicate |
| Nitrous Exposure | PASS, Substantially equivalent to predicate |
| Cryozone Size | PASS, Substantially equivalent to predicate |
| Needle Integrity | PASS, Substantially equivalent to predicate |
| Sterilization and Shelf Life Testing | PASS, Substantially equivalent to predicate |
| Electrical Safety Testing | PASS, Substantially equivalent to predicate |
| Software Testing | PASS, Substantially equivalent to predicate |
| Safety Testing | PASS, Substantially equivalent to predicate |
| Biocompatibility Testing | PASS, Substantially equivalent to predicate |
Study Details:
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document states "Verification testing was performed on the Nonclinical myoscience iovera® device to demonstrate that the product met the design requirements for system performance." It does not specify sample sizes for these non-clinical tests (e.g., number of devices tested, number of cycles performed).
- Data provenance is not explicitly mentioned but would be from internal lab testing at myoscience, Inc. The nature of the tests (e.g., temperature reproducibility, cryozone size) implies prospective testing in a lab setting.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable/Not provided. The "ground truth" for non-clinical performance tests like temperature reproducibility or mechanical integrity is typically established by engineering specifications and objective measurements, not by expert human reviewers.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Adjudication methods are relevant for subjective human interpretations, often in clinical or image-based studies. These non-clinical tests rely on objective measurements against predefined engineering specifications.
-
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. The document explicitly states: "Clinical Testing Submitted: None." This is a non-clinical submission, and therefore, no MRMC study or AI-related effectiveness study was performed or required for this 510(k). The device is a surgical tool, not an AI diagnostic/interpretive tool.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical, cryogenic surgical device, not a software algorithm. Therefore, "standalone algorithm performance" is not applicable. The device's "performance" is its ability to meet specified engineering parameters (e.g., temperature, mechanical integrity) during its operation.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is based on engineering specifications and objective measurements (e.g., specific temperatures, physical dimensions, material properties, electrical safety standards). It is not dependent on expert consensus, pathology, or outcomes data, as these are not clinical tests.
-
The sample size for the training set:
- Not applicable/Not provided. As this is not an AI/ML device, there is no "training set" in the machine learning sense. The device's design and functionality are based on established physical principles (Joule-Thomson Effect, Latent Heat of Vaporization) and engineering.
-
How the ground truth for the training set was established:
- Not applicable/Not provided, as there is no training set for an AI/ML device.
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510(k) Summary
Device Information:
| Category | Comments |
|---|---|
| Sponsor / Submitter: | myoscience, Inc.1600 Seaport Blvd.North Lobby, Suite 450Redwood City, CA 94063(650) 474-2600(650) 474-2700 |
| Correspondent ContactInformation: | Bijesh ChandranDirector Regulatory Affairs andQuality Assurance1600 Seaport Blvd.North Lobby, Suite 450Redwood City, CA 94063(650) 421-2110(650) 474-2900 |
| Device Common Name: | Cryogenic Surgical Device |
| Device Classification & Code: | Class II, GXH |
| Device Classification Name &Regulation: | Cryosurgical unit and accessories(21 CFR 882.4250) |
| Device Proprietary Name: | iovera° |
a. Predicate Device Information:
The iovera® device is substantially equivalent to the following currently legally marketed devices:
| 510(k) Number | Product | Sponsor |
|---|---|---|
| K123516 | Cryo-Touch IV | myoscience, Inc |
Date Summary Prepared b.
November 07, 2013
c. Description of Device
The myoscience iovera® device is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through application of extreme cold to the
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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 has the added functionality of having the treatment parameters being preprogrammed into its secure processor. The Smart Tip is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. The iovera® device 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 1.
- A Charging Dock 2.
- A single-patient use Smart Tip 3.
- A Cartridge (Nitrous Oxide) র্য :
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 The user activates a treatment cycle through a control Tip. 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® device. All Smart Tips 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® device. The user removes the Smart Tip from the sterile packaging and attaches it to the Handpiece.
The iovera® device uses a commercially available nitrous oxide cylinder (N2O). The Cartridge is filled with pure N2O.
Device Functionality/Scientific Concepts
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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 pre-programmed amount of time at which time the user can safely remove the Smart Tip.
d. Intended Use
The myoscience iovera® device 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. The iovera® device is not indicated for treatment of central nervous system tissue.
e. Comparison to Predicate Devices
The myoscience iovera® device is substantially equivalent in intended use, technology, design and materials to the above listed legally marketed predicate device.
f. Summary of Supporting Data
Verification testing was performed on the Nonclinical myoscience iovera® device to demonstrate testing: that the product met the design requirements for system performance. These specific tests are listed below.
| Test Performed | Result |
|---|---|
| Temperaturereproducibility | PASS, Substantially equivalent to predicate |
| Mechanical Integrityfor System | PASS, Substantially equivalent to predicate |
| Nitrous Exposure | PASS, Substantially equivalent to predicate |
| Cryozone Size | PASS, Substantially equivalent to predicate |
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| Test Performed | Result |
|---|---|
| Needle Integrity | PASS, Substantially equivalent to predicate |
| Sterilization and ShelfLife Testing | PASS, Substantially equivalent to predicate |
| Electrical Safety Testing | PASS, Substantially equivalent to predicate |
| Software Testing | PASS, Substantially equivalent to predicate |
| Safety Testing | PASS, Substantially equivalent to predicate |
| Biocompatibility Testing | PASS, Substantially equivalent to predicate |
This performance testing demonstrated that the device is in compliance with pertinent standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-1 and ISO 11135-1), the product labeling, and is substantially equivalent to the predicate.
Clinical Testing Submitted: None
g. Conclusion
myoscience concludes that the iovera® device described in this submission is substantially equivalent to the predicate device.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2014
Myoscience, Inc. c/o Mr. Bijesh Chandran Director of Regulatory Affairs and Quality Assurance 1600 Seaport Blvd., North Lobby Suite 450 Redwood City, California 94063
Re: K133453
Trade/Device Name: iovera® Regulation Number: 21 CFR 882.4250 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GXH Dated: February 18, 2014 Received: February 20, 2014
Dear Mr. Chandran:
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
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Page 2 - Mr. Bijesh Chandran
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K133453
Device Name iovera®
Indications for Use (Describe)
The myoscience ioveral device 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 selected site for the blocking of pain. The iovera® device is not indicated for treatment of central nervous system tissue.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
[] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
PSC Publishung Services (30)) 443-6740
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§ 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).