(133 days)
Not Found
No
The description focuses on the physical mechanism of cooling (Joule-Thomson effect, Latent Heat of Vaporization) and its application for tissue destruction and nerve blocking. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used to destroy tissue and produce lesions for blocking pain, which constitutes therapeutic action.
No
Explanation: The device is described as a surgical device used to destroy tissue and produce lesions, indicating a therapeutic or procedural function rather than a diagnostic one. It does not mention identifying or assessing medical conditions.
No
The device description clearly states it is a "portable cryogenic surgical device" that uses a "needle probe" and "cryogenic fluid" to apply cold, indicating it is a hardware device.
Based on the provided information, the Myoscience Cryo-Touch III is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "destroy tissue during surgical procedures" and "produce lesions in peripheral nervous tissue... for the blocking of pain." This describes a surgical device used directly on a patient's body.
- Device Description: The description reinforces this by detailing a "portable cryogenic surgical device" that uses a needle probe applied to a "selected area" of the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a person's health. The Cryo-Touch III does not perform this function.
Therefore, the Myoscience Cryo-Touch III is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Myoscience Cryo-Touch III 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 Cryo-Touch III is not indicated for treatment of central nervous system tissue.
Product codes
GXH
Device Description
The Myoscience Cryo-Touch III 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 needle probe, "Tip" cooled by the cryogenic fluid (liguid nitrous oxide, N₂O) to a selected area. The Tip is cooled by the Joule-Thomson effect and/or Latent Heat of Vaporization. The Cryo-Touch III 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 re-usable Control Unit,
-
- a re-usable Handpiece,
- a single patient use Tip, and 3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tissue, peripheral nervous tissue
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
| Test Performed | Result |
|---|---|
| Temperature reproducibility | PASS, Substantially equivalent to predicate |
| Mechanical Integrity for system | PASS, Substantially equivalent to predicate |
| Disable valve reliability | PASS, Substantially equivalent to predicate |
| Thermal fuse testing | 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 |
| Device Durability | 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 |
This performance testing demonstrated that the device is in compliance with pertinent standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 11137-1, ISO 11607, and ASTM F882-84), the product labeling, and is substantially equivalent to the predicates.
Clinical Testing Submitted: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
myoscience
Cryo-Touch III
Premarket Notification
Section 5: 510(k) Summary
Device Information:
| Category | Comments |
|---|---|
| Sponsor / Submitter: | Myoscience, Inc |
| 525 Chesapeake Drive | |
| Redwood City, CA 94063 | |
| (650) 474-2600 | |
| (650) 474-2700 | |
| Correspondent Contact | |
| Information: | Tracey Henry |
| Vice President RAQA, Clinical Compliance | |
| 525 Chesapeake Drive | |
| Redwood City, CA 94063 | |
| (650) 474-2600 | |
| (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 Proprietary Name: | Myoscience Cryo-Touch III |
a. Predicate Device Information:
The Cryo-Touch III is substantially equivalent to the following currently legally marketed devices:
| 510(k) Number | Product | Sponsor |
|---|---|---|
| K083493 | Cryo-Touch | Myoscience, Inc |
| K102021 | Cryo-Touch II | Myoscience, Inc |
b. Date Summary Prepared
February 8, 2012
c. Description of Device
The Myoscience Cryo-Touch III 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 needle probe, "Tip" cooled by the cryogenic fluid (liguid nitrous oxide, N₂O) to a selected area. The Tip is cooled by the Joule-Thomson effect and/or Latent Heat of Vaporization. The Cryo-Touch III 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 re-usable Control Unit,
-
- a re-usable Handpiece,
- a single patient use Tip, and 3.
Page
1
myoscience
| Test Performed | Result |
|---|---|
| Temperature | |
| reproducibility | PASS, Substantially equivalent to predicate |
| Mechanical | |
| Integrity for system | PASS, Substantially equivalent to predicate |
| Disable valve | |
| reliability | PASS, Substantially equivalent to predicate |
| Thermal fuse | |
| testing | 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 |
| Device Durability | 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 |
This performance testing demonstrated that the device is in compliance with pertinent standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 11137-1, ISO 11607, and ASTM F882-84), the product labeling, and is substantially equivalent to the predicates.
Clinical Testing Submitted: None
g. Conclusion
Myoscience concludes that the Cryo-Touch III described in this submission is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol, with three overlapping, curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MyoScience, Incorporated % Ms. Tracey Henry Sr. Director, Regulatory Affairs and Quality Assurance 525 Chesapeake Drive Redwood City, CA 94063
JUN 2 2 2012
Re: K120415
Trade/Device Name: Myoscience Cryo-touch III Regulation Number: 21 CFR 882.4250 Regulation Name: Cryogenic Surgical Device Regulatory Class: II Product Code: GXH Dated: June 13, 2012 Received: June 15, 2012
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 for answer 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 additeration. Thease now u, 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 1 toure be actived a determination that your device complies with other requirements of the Act that I DA has made a actoring administered by other Federal agencies. You must
3
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 n you attp://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 1000 the 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Health Center for Devices and Radiological Health
Enclosure
4
Cryo-Touch III Premarket Notification
Section 4: Indications for Use Statement
510(k) Number:
Device Name: Myoscience Cryo-Touch III
Indications for Use:
The Myoscience Cryo-Touch III 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 Cryo-Touch III is not indicated for treatment of central nervous system tissue.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Daryl Kausin
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear. Nose and Throat Devices
K120415 510(k) Number.