(112 days)
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.
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:
- A reusable Handpiece
- A Charging Dock
- An assortment of single-patient use Smart Tips
- A Cartridge (Nitrous Oxide)
The provided text is a 510(k) Summary for the Myoscience iovera® system, a cryogenic surgical device. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study data for a novel device or AI algorithm.
Therefore, much of the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone performance is not present in this document.
However, I can extract the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes several bench tests and software tests with a pass/fail outcome. It doesn't explicitly state quantitative acceptance criteria beyond "PASS," but it implies meeting design requirements and pertinent standards.
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Tip Descriptor verification to confirm treatment parameters (Software testing) | Treatment parameters confirmed correctly | PASS |
| Visual and dimensional inspection of Smart Tip needle (Bench testing) | Met design specifications | PASS |
| Verification of temperature reproducibility (Bench testing) | Consistent and reproducible temperature (within specified range) | PASS |
| Validation of cryozone size (Bench testing) | Cryozone formed within specified parameters | PASS |
| Validation of needle integrity in simulated use conditions (Bench testing) | Maintained integrity | PASS |
| After flexing, needle shall return to straight condition (Bench testing) | Needle returns to straight condition | PASS |
| Needle shall not leak after kink failure (Bench testing) | No leakage after kink failure | PASS |
| Sterility Testing (Bench testing) | Compliant with sterility standards (e.g., ISO 11135-1) | PASS |
| Transit/Shelf Life Testing (Bench testing) | Maintained performance over transit/shelf life | PASS |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the document. The tests performed are described but not the number of units or instances tested for each.
- Data Provenance: Not applicable in the context of this device's testing. The tests are primarily bench and software tests of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/diagnostic device requiring expert ground truth for image interpretation or diagnosis. The ground truth for device performance is based on direct measurement and adherence to engineering specifications and standards.
4. Adjudication method for the test set:
- Not applicable. The tests are objective measurements or functional verifications, not subjective expert reviews.
5. 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:
- Not applicable. This is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. The device performance tests mentioned are standalone tests of the physical device and its software.
7. The type of ground truth used:
- The ground truth for the device's performance tests appears to be based on:
- Engineering specifications and design requirements: For dimensional integrity, temperature reproducibility, cryozone size, and needle integrity.
- International standards: Such as ISO 11135-1 for sterility and ISO-10993 for biocompatibility.
- FDA guidance documents: For software verification testing.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI model.
Summary based on the Provided Text:
The provided document is a 510(k) summary for a medical device (Myoscience iovera® system) seeking substantial equivalence to a predicate device. It focuses on the safety and effectiveness of the device itself through bench testing, software verification, and biocompatibility evaluations, especially for the modified "Smart Tip" component. It explicitly states that "No preclinical testing was deemed necessary for this modification" and "No clinical testing was deemed necessary for this modification," indicating that the decision for substantial equivalence was based on non-clinical data. The document does not describe the evaluation of an AI algorithm or diagnostic performance.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 21, 2015
Myoscience, Inc Tracey Henry VP RAQA, Operations 1600 Seaport Blvd, North Lobby, Suite 450 Redwood City, California 94063-2
Re: K142866 Trade/Device Name: Myoscience Iovera System Regulation Number: 21 CFR 882.4250 Regulation Name: Cryogenic Surgical Device Regulatory Class: Class II Product Code: GXH Dated: October 22, 2014 Received: October 23, 2014
Dear Ms. Henry,
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,
Carlos L. Pena -$ D/△
Carlos L. Peña, PhD, MS 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) K142866
Device Name Myoscience iovera system
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subnart 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}------------------------------------------------
510(k) Summary
| Device Information: | |
|---|---|
| --------------------- | -- |
| Category | Comments |
|---|---|
| Sponsor / Submitter: | Myoscience, Inc |
| 1600 Seaport Blvd | |
| North Lobby, Suite 450 | |
| Redwood City, CA 94063 | |
| Ph: (650) 474-2600 | |
| Fax: (650) 474-2700 | |
| Correspondent Contact | Tracey Henry |
| Information: | Vice President RAQA, Operations |
| 1600 Seaport Blvd | |
| North Lobby, Suite 450 | |
| Redwood City, CA 94063 | |
| Ph: (650) 474-2600 | |
| Fax: (650) 474-2900 | |
| Device Common Name: | Cryogenic surgical device |
| Device Classification & Code: | Class II, GXH |
| Device Classification Name: | Cryosurgical unit and accessories (21 CFR 882.4250) |
| Device Trade Name: | Myoscience iovera® system |
Predicate Device Information: a.
| 510(k) Number | Product | Sponsor |
|---|---|---|
| K133453 | iovera | Myoscience, Inc |
This predicate has not been subject to a design-related recall.
b. Date Summary Prepared
September 30, 2014
c. Description of Device
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.
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 (single cell Lithium lon, 3.7 volts) 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
CONFIDENTIAL
{4}------------------------------------------------
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 iovera system uses a commercially available nitrous oxide cylinder. The Cartridge is filled with pure N-O.
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 pre-programmed amount of time the user can safely remove the Smart Tip.
d. Indications for 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.
The Indications for Use statements for the subject and predicate devices are identical.
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 (K133453) | Subject Device |
| 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 | Smart Tip Needle |
| Length: 6 – 25mm (0.2 – 1.0in) Size: Ø.31 – .52mm (25 – 30 gauge) Patient contacting materials:Closed sharp cutting tip Stainless Steel needle | Length: 6 – 55mm (0.2 – 2.2in) Size: Ø.31 – .72mm (22 – 30 gauge) Patient contacting materials:Closed sharp cutting and blunt tip Stainless Steel needleSingle Smart Tip configurations from 10 mm to 55 mm contain |
{5}------------------------------------------------
| electrochemically etched markingson the needle surface | |
|---|---|
| -- | ------------------------------------------------------------ |
f. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
The biocompatibility evaluation for the Smart Tip needle was conducted in Biocompatibility testing: accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'"and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- . Cytotoxicity
- Sensitization (supplier testing)
- . Intracutaneous reactivity (supplier testing)
The stainless steel Smart Tip needle is considered tissue contacting for a duration of less than 24 hours.
Software testing: Software verification testing was conducted and documentation was provided as recommended by FDA's Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent design flaw in the software could directly result in minor injury to the patient or operator. Specifically, the following test was performed:
| Test Performed | Result |
|---|---|
| Tip Descriptor verification to confirm treatment parameters | PASS |
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 device is in compliance with pertinent standards (i.e., ISO 11135-1). Needle integrity validation test was modified from the predicate to demonstrate safety and effectiveness due to the changes in needle design and longer length. Specifically, the following tests were performed:
| Test Performed | Result |
|---|---|
| Visual and dimensional inspection of Smart Tip needle | PASS |
| Verification of temperature reproducibility | PASS |
| Validation of cryozone size | PASS |
| Validation of needle integrity in simulated use conditions | PASS |
CONFIDENTIAL
{6}------------------------------------------------
| After flexing, needle shall return to straight condition Needle shall not leak after kink failure | |
|---|---|
| Sterility Testing | PASS |
| Transit/Shelf Life Testing | PASS |
Preclinical Testing Submitted: No preclinical testing was deemed necessary for this modification.
Clinical Testing Submitted: No clinical testing was deemed necessary for this modification.
g. Conclusion
The performance data demonstrate that the iovera° system is as safe, as effective, and performs comparably to the predicate device that is 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).