CRYO-TOUCH II

K102021 · Myoscience, Inc. · GXH · Sep 17, 2010 · Neurology

Device Facts

• Record ID: K102021
• Device Name: CRYO-TOUCH II
• Applicant: Myoscience, Inc.
• Product Code: GXH · Neurology
• Decision Date: Sep 17, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MyoScience Cryo-Touch II is 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 II is not indicated for treatment of central nervous system tissue.

Device Story

Hand-held, single-patient-use cryogenic surgical device; used by qualified medical personnel in hospital/clinical environments. Inputs: manual positioning of needle assembly near target peripheral nerve. Operation: liquid nitrous oxide (N2O) flows from controller into closed-tip stainless steel needle; Joule-Thomson effect cools needle tip to -65°C (-85°F); iceball forms around needle tip to freeze target nerve tissue. Output: localized tissue lesion for pain blocking. User monitors device via controller feedback; may use external nerve stimulator for precise needle placement. Benefits: targeted, reversible-like nerve freezing for pain management. Device includes controller, probe assembly, and replaceable N2O cylinder.

Clinical Evidence

Bench testing only. Verification testing performed to demonstrate temperature profiling during simulated use conditions.

Technological Characteristics

Hand-held cryogenic surgical unit; stainless steel closed-tip needle assemblies (25-30 gauge); N2O cryogen; Joule-Thomson cooling principle; battery-powered controller; single-patient-use; sterile packaging for needles.

Indications for Use

Indicated for adult patients requiring peripheral nerve lesioning for pain management. Contraindicated for central nervous system tissue treatment.

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 (K100447)

Submission Summary (Full Text)

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Cryo-Touch II

### 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

# SEP 1 7 2010

| Device Information: | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Category | Comments |
| Sponsor / Submitter: | MyoScience, Inc<br>525 Chesapeake Drive<br>Redwood City, CA 94063<br>[phone]<br>[phone] |
| Correspondent Contact<br>Information: | Tracey Henry<br>Sr. Director RAQA, Clinical Compliance<br>525 Chesapeake Drive<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 II |

### a. Predicate Device Information:

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

| 510(k) Number | .<br>Product | Sponsor |
|---------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K100447 | A . A separate and a come of a color<br>Crvo-Touch<br>11 11 400 | MyoScience, Inc<br>444-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-4-<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>CONSULTION COLLECTION |

# b. Date Summary Prepared

July 16, 2010

### c. Description of Device

e: Deseription of Denos
The MyoScience Cryo-Touch II is a hand-held, single patient-use disposable, cryogenic device used to me wyosalence aryo courted by on peripheral nervous tissue by the application of cold to the uestroy hervous tissus of blocking pain. The Cryo-Touch II has been developed for applications in screeted one for the more intractable pain involves the location and freezing of the nerve associated with the pain.

The device is based on introduction of a cryoprobe cooled by the cryogenic fluid (liquid nitrous oxide The device is bascu on introduction of the freeze control. An iceball forms around the tip of the needle assembly and the adjacent nerve.

The Cryo-Touch II 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 three main components:

- a control unit (controller), 1)
- probe assembly, and 2)
- a cryogen cylinder assembly (Nitrous Oxide). 3)

Confidential Page 54

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The entire device is hand-held and for single patient-use.

The Cryo-Touch II controller is battery operated; the battery powers electronics within the controller the vace The Cryo-Tudch is controller is better) , eperated.) , ept. and provide feedback to the user when the device is ready to use.

An assortment of needle assemblies is available for the Cryo-Touch II, ranging from a single to a triple All assortment of necdle assemblies is a relies of the 6mm in length. All needle assemblies are made of needie, from 25 googs to be a closed-tip that fully contains the cryogen so that it does not enter the target stamess steel and have a sieed on patient contacting component of the Cryo-Touch II. The user tissue. The needle assembly from the sterile packaging and attaches it to the controller by inserting the needle hub end into the distal end of the controller.

The cryogen is provided as a nitrous oxide cylinder. The cartridge is filled with liquid N₂O (83%) and the rne cryben is pronued as a more of the cylinder treats for approximately 180 seconds. The cylinder, once empty, may be replaced with a new cylinder by the user.

# Device Functionality/Scientific Concepts

The device functionality is based on the user introducing the needle assembly proximate to the target nervous tissue. The user then initiates the flow of cryogen by opening the start/stop valve. Liquid cryogen flows from the controller into the closed-tip needle is cooled by the louled by the Joule-Thompson effect; as the liquid cryogen expands into a gas, an iceball develops around the external surface of the needle assembly causing the surrounding tissue to be frozen. As the iceball grows, its leading edge advances through the tissue and tissue that comes into contact with the needle is frozen to a nominal target temperature of -65°C (-85°F). The user then stops the flow of cryogen by closing the start/stop valve and allows the iceball to thaw before removing the needle assembly.

#### d. Intended Use

The MyoScience Cryo-Touch II is 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 II is not indicated for treatment of central nervous system tissue.

#### e. Comparison to Predicate Devices

er Comparison Cryo-Touch II is substantially equivalent in intended use, technology, design and materials to the above listed legally marketed predicate device. The technological characteristics of the new device in comparison to the predicate devices are summarized below:

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ce 510(k): Device Modification

| | This Device | Predicate Device |
|---------------------------------|-----------------------------|---------------------------------------------------------------------------------------------------------------|
| Parameter | MyoScience<br>Cryo-Touch II | MyoScience Cryo-Touch K100447 |
| Intended Use | Identical | Destroy tissue through freezing |
| Target Population | Identical | Adults |
| Anatomical Sites | Identical | Peripheral nerves |
| Intended users/clinical | Identical | Qualified medical personnel (doctors, specialists) in<br>hospital or medical environment |
| Technology | Identical | Cryogenic surgical device with needle which penetrates<br>treatment area. |
| Energy used/or delivered | Identical | Cryotherapy/<br>Nitrous Oxide |
| Human Factors | Identical | Hand-held and or portable device containing cryogen.<br>Some units have footswitch and detachable cryoprobes. |
| Biocompatibility | Identical | Biocompatible patient contacting materials |
| Operating Principle | Identical | Joule-Thomson Effect |
| Patient contacting<br>materials | Identical | Closed-tip stainless steel cryoprobe<br>Ranging from 25 - 30 gauge |
| Treatment Temperature | Identical | -55° C to -75° C |
| Power Source | Identical | Battery powered |

# f. Summary of Supporting Data

Nonclinical testing:

Verification testing was performed on the Cryo-Touch II device to vermeation testing was poduct met the design requirements for acmonstrate that the perature profiling during simulated use conditions.

Nóne Clinical Testing Submitted:

### g. Conclusion

g. Conclusion
MyoScience concludes that the Cryo-Touch described in this submission is substantialiy equivalent to the predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 eagle emblem, depicted with three curved lines forming the body and head, and three wavy lines representing the legs and feet.

#### Public Health Service

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

MyoScience, Inc. c/o Ms. Tracey Henry Sr. Director, Regulatory Affairs and Ouality Assurance 525 Chesapeake Drive Redwood City, CA 94063

SEP 1 7 2010

Re: K102021

Trade/Device Name: Myoscience Cryo-touch II Regulation Number: 21 CFR 882.4250 Regulation Name: Cryogenic Surgical Device Regulatory Class: II Product Code: GXH Dated: August 23, 2010 Received: August 24, 2010

Dear Ms. Henry:

ﺎ

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. Iisting 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 - Ms. Tracey Henry

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/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,

Keaia Alexander

Malvina B. Evdelman, 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

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MVOSCIE 510(k): Device Modification Cryo-Touch II

# Indications for Use Statment

510(k) Number:

Device Name:

# SEP 1 7 2010

MyoScience Cryo-Touch II

Indications for Use:

The MyoScience Cryo-Touch II is 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 II 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 1

Jas L. Kaufman MA

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K102031