IOVERA

K133453 · Myoscience, Inc. · GXH · Mar 24, 2014 · Neurology

Device Facts

• Record ID: K133453
• Device Name: IOVERA
• Applicant: Myoscience, Inc.
• Product Code: GXH · Neurology
• Decision Date: Mar 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4250
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Portable cryogenic surgical device; uses nitrous oxide (N2O) to cool a single-patient use Smart Tip via Joule-Thomson effect/latent heat of vaporization. Handpiece contains battery, controls, and LEDs for user feedback; connects to N2O cartridge and Smart Tip. Smart Tip features pre-programmed treatment parameters in a secure processor. Used by clinicians to freeze target tissue or peripheral nerves; can be used with off-the-shelf nerve stimulators for precise localization. Output is localized tissue freezing (lesion formation). Benefits include targeted pain relief through nerve lesioning. Device is reusable (handpiece/dock) with disposable tips.

Clinical Evidence

No clinical data. Evidence consists of nonclinical bench testing including temperature reproducibility, mechanical integrity, nitrous exposure, cryozone size, needle integrity, sterilization/shelf-life, electrical safety, and software verification. All tests passed.

Technological Characteristics

Portable cryogenic surgical unit. Components: reusable handpiece, charging dock, single-use stainless steel Smart Tip, N2O cartridge. Cooling mechanism: Joule-Thomson effect/latent heat of vaporization. Standards: IEC 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 11135-1. Software: embedded processor in Smart Tip for treatment parameter control.

Indications for Use

Indicated for destruction of tissue during surgical procedures 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 IV (K123516)

Submission Summary (Full Text)

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## 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: | Bijesh Chandran<br>Director Regulatory Affairs and<br>Quality Assurance<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 &<br>Regulation: | Cryosurgical unit and accessories<br>(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 |
|------------------------------------|---------------------------------------------|
| Temperature<br>reproducibility | PASS, Substantially equivalent to predicate |
| Mechanical Integrity<br>for 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 Shelf<br>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 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 [phone] or [phone] 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 [phone] or [phone] 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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