iovera system

K173763 · Myoscience, Inc. · GXH · Feb 28, 2018 · Neurology

Device Facts

• Record ID: K173763
• Device Name: iovera system
• Applicant: Myoscience, Inc.
• Product Code: GXH · Neurology
• Decision Date: Feb 28, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iovera? 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 selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera" system is not indicated for treatment of central nervous system tissue. The ioveraº system's "1x90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator.

Device Story

Portable cryogenic surgical device; uses nitrous oxide (N2O) to cool a closed-end Smart Tip via Joule-Thomson effect/latent heat of vaporization. Input: user-initiated treatment cycle via handpiece control. Output: localized tissue freezing at Smart Tip surface. Used in clinical settings by physicians. 1x90 Smart Tip configuration allows integration with external nerve stimulators for precise nerve localization. Handpiece provides LED feedback on readiness and treatment status. Benefits include targeted nerve block for pain relief and osteoarthritis symptom management. System includes reusable handpiece, charging dock, single-use Smart Tips, and N2O cartridge.

Clinical Evidence

No clinical testing was performed; substantial equivalence supported by bench testing, biocompatibility testing, and software verification.

Technological Characteristics

Cryogenic surgical device; N2O coolant; reusable battery-powered handpiece; single-use stainless steel Smart Tip needles with Parylene C coating. Sensing: monitors N2O delivery and cooling rate. Connectivity: integrates with off-the-shelf nerve stimulators. Sterilization: EO. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 10993 (biocompatibility).

Indications for Use

Indicated for patients requiring tissue destruction during surgery, peripheral nerve lesioning for pain block, and relief of pain/symptoms associated with knee osteoarthritis for up to 90 days. Not indicated 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

• ioveraº system (K161835)
• B Braun Stimuplex D Insulated Needle (K100241)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 28, 2018

Myoscience, Inc. Kent Jones Senior Director, RAQACA 46400 Fremont Blvd Fremont, California 94538

### Re: K173763

Trade/Device Name: ioveraº system Regulation Number: 21 CFR 882.4250 Regulation Name: Cryogenic Surgical Device Regulatory Class: Class II Product Code: GXH, ETN Dated: December 7, 2017 Received: December 11, 2017

Dear Kent Jones:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

{1}------------------------------------------------

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michae|J. Hoffmann -S

Carlos L. Peña, PhD, MS for 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) K173763

Device Name ioveraº system

#### Indications for Use (Describe)

The iovera? 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 selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera" system is not indicated for treatment of central nervous system tissue.

The ioveraº system's "1x90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator.

Type of Use (Select one or both, as applicable)

| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.6 2.4L2.4 13.6M2.4 2.4L13.6 13.6" stroke="#000" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.6"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <rect height="14.4" rx="1.6" stroke="#000" stroke-width="1.6" width="14.4" x="0.8" y="0.8"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### 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 [e-mail]

"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}------------------------------------------------

# Section 5: 510(k) Summary

#### Device Information:

| Category | Comments |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Sponsor / Submitter: | Myoscience, Inc<br>46400 Fremont Blvd<br>Fremont, CA 94538<br>Ph: 510.933.1500<br>Fax: [phone] |
| Correspondent Contact<br>Information: | Kent Jones<br>Sr. Director RAQACA, Myoscience, Inc<br>Telephone: [phone]<br>Email: [e-mail] |
| Device Common Name: | Cryogenic surgical device |
| Device Classification & Code: | Class II, GXH, ETN |
| Device Classification Name: | Cryosurgical unit and accessories (21 CFR 882.4250),<br>Surgical nerve stimulator (21 CFR 874.1820) |
| Device Trade Name: | iovera° system |

#### a. Predicate Device Information:

| 510(k) Number | Product | Sponsor |
|---------------|-----------------------------------------|----------------------|
| K161835 | iovera° system | Myoscience, Inc |
| K100241 | B Braun Stimuplex D<br>Insulated Needle | B Braun Medical, Inc |

#### b. Date Summary Prepared

7 December 2017

#### c. Description of Device

The iovera system is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue creating a nerve block 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. The iovera® system 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:

- 1. A reusable Handpiece
- 2. A Charging Dock
- 3. An assortment of single-patient use Smart Tips
- 4. A Cartridge (Nitrous Oxide)

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 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

{4}------------------------------------------------

# ioveraº svstem Premarket Notification

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 ioveral 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 ioveras 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 N2O.

#### 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 preprogrammed amount of time at which time the user can safely remove the Smart Tip.

#### d. Indications for Use

The 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 selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The system's "1x90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera system is not indicated for treatment of central nervous system tissue.

#### 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 (K142866) | Subject Device<br>1x90 Smart Tip |
| 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 range | Smart Tip Needle |
| Length: 6 – 55mm (0.2 – 2.2 in) | Length: 90mm (3.5 in) |
| Size: Ø.31 – .72mm (25 – 30 gauge) | Size: Ø.91mm (20 gauge) |
| Patient contacting materials: | Patient contacting materials: |

{5}------------------------------------------------

# myoscie ice

# ioveraº system Premarket Notification

| Closed sharp cutting and blunt tip<br>Stainless Steel needle | Closed sharp cutting Stainless<br>Steel needle with Parylene C<br>coating<br>• Includes electrical nerve<br>stimulation capability (using<br>off-the-shelf nerve stimulator) |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Technological Characteristics | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device (K100241) | Subject Device |
| B Braun Stimuplex D Insulated Needle | 1x90 Smart Tip |
| Single use needle | Same |
| Electrical nerve stimulation capability (using Stimuplex nerve stimulator) | Same |
| Needle range<br>· Length: 35 – 120mm (1-3/8 in – 4-3/8 in)<br>· Size: Ø.91 – .51mm (20 – 25 gauge)<br>· Patient contacting materials:<br>Open sharp cutting Stainless Steel needle with clear dielectric coating. | Smart Tip Needle<br>· Length: 90mm (3.5 in)<br>· Size: Ø.91mm (20 gauge)<br>· Patient contacting materials:<br>Closed sharp cutting Stainless Steel needle with Parylene C coating |

## f. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

| Biocompatibility Testing | Biocompatibility testing was conducted on the new Smart Tip needle in accordance with ISO-10993, ‘Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing" as recognized by FDA. The battery of testing included the following test:<br>Cytotoxicity Sensitization Intracutaneous Reactivity Acute System Toxicity Material-Mediated Pyrogenicity |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software Testing | Software verification testing for the new Smart Tip descriptor was conducted as recommended by FDA's Guidance document, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” in conjunction with bench testing of the Smart Tip (see below). No other software changes were required for this submission. |
| 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 |

{6}------------------------------------------------

| myoscience | ioveraº system<br>Premarket Notification<br>mitigated to acceptable levels and the performance testing<br>demonstrated that the Smart Tip design is in compliance with<br>pertinent standards. Specifically, the following tests were<br>performed: | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | | |
| | Test Performed | Result |
| | Electrical Safety Testing per IEC 60601-1 | PASS |
| | EMC/Immunity Testing per IEC 60601-1-2 | PASS |
| | Visual and Dimensional Inspection of Smart Tip<br>needle | PASS |
| | Verification of temperature reproducibility | PASS |
| | Cryozone Testing | PASS |
| | Needle Integrity | PASS |
| | Tip Descriptor verification to confirm treatment<br>parameters | PASS |
| Preclinical Testing<br>Submitted: | No preclinical testing was deemed necessary for the product line<br>extension | |
| Clinical Testing Submitted: | No clinical testing was deemed necessary for the product line<br>extension. | |

#### g. Conclusion

The performance data demonstrate that the iovera° system is as safe, effective and performs comparably to the predicate devices that are currently marketed for the same intended use.