CRYO-TOUCH IV

K123516 · Myoscience, Inc. · GXH · Jan 10, 2013 · Neurology

Device Facts

• Record ID: K123516
• Device Name: CRYO-TOUCH IV
• Applicant: Myoscience, Inc.
• Product Code: GXH · Neurology
• Decision Date: Jan 10, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4250
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Myoscience Cryo-Touch IV 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 IV is not indicated for treatment of central nervous system tissue.

Device Story

Portable cryogenic surgical device; uses nitrous oxide (N2O) cartridge to cool single-patient use stainless steel Smart Tip via Joule-Thomson effect and latent heat of vaporization. Physician-operated in clinical setting; device includes battery-powered handpiece, charging dock, and disposable Smart Tip. User initiates treatment cycle via handpiece control; LEDs provide status feedback. Cryogen expands within closed-end tip, freezing surrounding tissue. Used for tissue destruction or peripheral nerve lesioning to block pain. May be used with off-the-shelf nerve stimulator for precise targeting. Benefits include controlled, localized tissue freezing for surgical and pain management applications.

Clinical Evidence

Bench testing only. No clinical data presented. Verification testing confirmed system performance, including temperature reproducibility, mechanical integrity, nitrous exposure, cryozone size, needle integrity, durability, sterilization, shelf life, electrical safety, software, and biocompatibility per IEC 60601-1, IEC 60601-1-2, ISO 10993-1, and ISO 11137-1.

Technological Characteristics

Portable cryogenic surgical unit; stainless steel closed-end Smart Tip; nitrous oxide (N2O) cryogen; Joule-Thomson effect/latent heat of vaporization cooling; battery-powered handpiece with LED feedback; charging dock. Standards: IEC 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 11137-1.

Indications for Use

Indicated for surgical tissue destruction and production of lesions in peripheral nervous tissue for pain blocking. Contraindicated for central nervous system tissue.

Regulatory Classification

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.

Predicate Devices

• Cryo-Touch II (K102021)
• Cryo-Touch III (K120415)

Submission Summary (Full Text)

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Cryo-Touch IV

Premarket Notification

### Section 5: 510(k) Summary

### Device Information:

| Category | Comments |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor / Submitter: | Myoscience, Inc<br>1600 Seaport Blvd<br>North Lobby, Suite 450<br>Redwood City, CA 94063<br>[phone]<br>[phone] |
| Correspondent Contact<br>Information: | Tracey Henry<br>Vice President RAQA, Operations<br>1600 Seaport Blvd<br>North Lobby, Suite 450<br>Redwood City, CA 94063<br>[phone]<br>[phone] |
| 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 IV |

#### a. Predicate Device Information:

The Cryo-Touch IV is substantially equivalent to the following currently legally marketed devices:

| 510(k) Number | Product | Sponsor |
|---------------|----------------|-----------------|
| K102021 | Cryo-Touch II | Myoscience, Inc |
| K120415 | Cryo-Touch III | Myoscience, Inc |

#### b. Date Summary Prepared

November 6, 2012

#### c. Description of Device

The Myoscience Cryo-Touch IV 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, N-O) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. The Cryo-Touch IV 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.
- 2. A Charging Dock
- 3. A single-patient use Smart Tip
- 4. A Cartridge (Nitrous Oxide)

The Cryo-Touch IV 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

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## myoscience

# Cryo-Touch IV

### Premarket Notification

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 Cryo-Touch IV. 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 Cryo-Touch IV. The user removes the Smart Tip from the sterile packaging and attaches it to the Handpiece.

The Cryo-Touch IV uses a commercially available nitrous oxide cylinder. The Cartridge is filled with pure N20.

### 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 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 Cryo-Touch IV 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 IV is not indicated for treatment of central nervous system tissue.

#### e. Comparison to Predicate Devices

The Myoscience Cryo-Touch IV is substantially equivalent in intended use, technology, design and materials to the above listed legally marketed predicate devices.

#### f. Summary of Supporting Data

Nonclinical testing:

Verification testing was performed on the Cryo-Touch IV device to demonstrate that the product met the design requirements for system performance. These specific tests are listed below.

| Test Performed | 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 |
| 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 |

Section 5: 510k Summary

Page 16

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# myoscience

# Cryo-Touch IV

Premarket Notification

| Test Performed | Result |
|--------------------------|---------------------------------------------|
| 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 11137-1), the product labeling, and is substantially equivalent to the predicates.

| . | .<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>FILES AND POST OF CO., CO., AND AND<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |

### g. Conclusion

Myoscience concludes that the Cryo-Touch IV described in this substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

January 10, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Myoscience, Inc. % Tracey Henry Vice President RAQA, Operations 1600 Seaport Boulevard North Lobby, Suite 450 Redwood City, CA94063

. Re: K123516

Trade/Device Name: MyoScience Cryo-Touch IV Regulation Number: 21 CFR 882.4250 Regulation Name: Cryogenic Surgical Device Regulatory Class: II Product Code: GXH Dated: November 06, 2012 Received: November 14, 2012

Dear Tracey 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

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Page 2 - Tracey Henry

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Victor Krauthamer -S

Victor Krauthamer, Ph.D. Acting 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): _ K123516

Device Name: _ MyoScience Cryo-Touch IV

Indications For Use:

The Myoscience Cryo---Touch IV 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 IV is not indicated for treatment of central nervous system tissue.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vith Saath

ision of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K123516