iovera° System

K243677 · Pacira Biosciences, Inc. · GXH · Dec 26, 2024 · Neurology

Device Facts

• Record ID: K243677
• Device Name: iovera° System
• Applicant: Pacira Biosciences, Inc.
• Product Code: GXH · Neurology
• Decision Date: Dec 26, 2024
• Decision: SESE
• Submission Type: Special
• 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. When stimulation compatible components are used, the iovera System can also facilitate target nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator.

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. Creates ice balls to destroy tissue or produce peripheral nerve lesions for pain blocking. Handpiece is battery-powered; includes LCD for status feedback; connects to Smart Tip and N2O cartridge. Some Smart Tips include electrical stimulation capability to facilitate nerve location using 3rd party stimulators. Used in professional clinical settings by qualified medical personnel. Output is localized tissue freezing; affects clinical decision-making by providing non-pharmacological pain relief. Benefits include targeted nerve block for knee osteoarthritis symptoms.

Clinical Evidence

Bench testing only. Performance testing included functional/product testing, usability engineering (IEC 62366-1), software lifecycle (IEC 62304), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), sterility (ISO 11135), packaging integrity (ASTM standards), and biocompatibility (ISO 10993-1). All tests met predetermined acceptance criteria.

Technological Characteristics

Cryogenic surgical device; N2O-cooled stainless steel closed-end needles. Joule-Thomson/latent heat of vaporization cooling principle. Battery-powered handpiece (3.6V Li-ion) with LCD. Connectivity: USB/SD (internal/service use only). Sterilization: EO. Software: Class B. Materials: Stainless steel needles, biocompatible components per ISO 10993-1.

Indications for Use

Indicated for patients requiring tissue destruction during surgical procedures or peripheral nerve lesioning for pain management, including relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. 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

• iovera System (K220656)
• iovera System (K211334)

Submission Summary (Full Text)

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December 26, 2024

Image /page/0/Picture/1 description: The image shows 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 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.

Pacira Biosciences, Inc. Niloufa Insanally Director, Regulatory Affairs Clinical Strategy 10410 Science Center Drive, Building A San Diego, California 92121

Re: K243677

Trade/Device Name: iovera System Regulation Number: 21 CFR 882.4250 Regulation Name: Cryogenic Surgical Device Regulatory Class: Class II Product Code: GXH, ETN Dated: November 27, 2024 Received: November 27, 2024

Dear Niloufa Insanally:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

Digitally signed by Adam D. Adam D. Pierce -S Pierce -S Date: 2024.12.2 Date: 2024.12.26

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Submission Number (if known)

#### K243677

Device Name

iovera® 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 ioveras System is not indicated for treatment of central nervous system tissue.

When stimulation compatible components are used, the ioveras System can also facilitate target nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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| Device Trade Name: | ioveraº System |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Device Common Name | Cryogenic Surgical Device |
| Device Class: | II |
| Classification Name: | Cryosurgical Unit and Accessories Device<br>Surgical Nerve Stimulator |
| Regulation No.: | 21 CFR Part 882.4250 and 874.1820 |
| Product Code: | GXH, ETN |
| Predicate Device: | ioveraº System K220656 and K211334 |
| Owner/Submitter: | Pacira Pharmaceuticals, Inc.<br>10410 Science Center Drive, Building A,<br>San Diego, California 92121 |
| Regulatory Contact: | Niloufa Insanally, Ph.D., RAC<br>Director, Regulatory Affairs Clinical Strategy<br>Tel: [phone]<br>Email: [e-mail] |
| Date: | December 26, 2024 |

# 510(k) SUMMARY - K243677

# DEVICE DESCRIPTION

The iovera System 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, NoO) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or latent heat of vaporization. The iovera8 System may be used in conjunction with standard of-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 .
- A Charging Dock ●
- An assortment of single-patient-use Smart Tips ●
- A Cartridge containing nitrous oxide ●

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The iovera? System 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 contains an LCD display 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 iovera8 system. All Smart Tip needles are made of stainless steel and have a closed-end design 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' System. The user removes the Smart Tip from its sterile packaging and attaches it to the Handpiece immediately before use. Certain Smart Tip designs provide a connection to an external nerve stimulator to facilitate nerve location prior to treatment.

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 into the selected treatment area 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 from the treatment site.

# INTENDED USE/INDICATIONS FOR 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.

When stimulation compatible components are used, the iovera System can also facilitate target nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator.

# Subject Device

The iovera System's "1x180" Smart Tip configuration (indicating one needle which is 180 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator.

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# SUMMARY/COMPARISON OF IOVERA® SYSTEM DEVICE CHARACTERISTICS

The ioveraº System is substantially equivalent in intended use, technology, design, and materials to the listed legally marketed predicate devices.

| Parameter | Proposed | Predicate 1 | Predicate 2 | |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| | iovera® System | iovera® System | iovera® System | |
| | STT21180STIM | K220656 | K211334 | |
| | Subject of this Special 510(k) | | | |
| Intended Use | Destroy tissue through freezing | Same | Same | |
| Indications for<br>Use | The iovera® System is used to<br>destroy tissue during surgical<br>procedures by applying freezing<br>cold. It can also be used to<br>produce lesions in peripheral<br>nervous tissue by the<br>application of cold to the<br>selected site for the blocking of<br>pain. It is also indicated for the<br>relief of pain and symptoms<br>associated with osteoarthritis of<br>the knee for up to 90 days. The<br>iovera System is not indicated<br>for treatment of central nervous<br>system tissue.<br>When stimulation compatible<br>components are used, the iovera®<br>System can also facilitate target<br>nerve location by conducting<br>electrical nerve stimulation from a<br>compatible 3rd party nerve<br>stimulator. | The over® System is used to<br>destroy tissue during surgical<br>procedures by applying freezing<br>cold. It can also be used to<br>produce lesions in peripheral<br>nervous tissue by the application<br>of cold to the selected site for<br>the blocking of pain. It is also<br>indicated for the relief of pain<br>and symptoms associated with<br>osteoarthritis of the knee for up<br>to 90 days. The iovera® system is<br>not indicated for treatment of<br>central nervous system tissue.<br>When stimulation compatible<br>components are used, the<br>iovera® System can also<br>facilitate target nerve location<br>by conducting electrical nerve<br>stimulation from a compatible<br>3rd party nerve stimulator. | The iovera® System is used to<br>destroy tissue during surgical<br>procedures by applying freezing<br>cold. It can also be used to<br>produce lesions in peripheral<br>nervous tissue by the<br>application of cold to the<br>selected site for the blocking of<br>pain. It is also indicated for the<br>relief of pain and symptoms<br>associated with osteoarthritis<br>of the knee for up to 90 days.<br>The iovera® system is not<br>indicated for treatment of<br>central nervous system tissue. | |
| Anatomical Sites | Peripheral nerves | Same | Same | |
| Intended Users | Qualified medical personnel<br>(doctors, specialists) | Same | Same | |
| Where used?<br>Clinical Setting | Hospital or medical<br>environment (professional<br>clinical setting) | Same | Same | |
| Technology | Cryogenic surgical device with<br>needle which penetrates treatment<br>area | Same | Same | |
| Energy used/or<br>delivered | Cryotherapy removes energy<br>from the body.<br>Cryogen used: Nitrous Oxide | Same | Same | |
| Parameter | Proposed<br>iovera® System<br>STT21180STIM<br>Subject of this Special 510(k) | Predicate 1<br>iovera® System<br>K220656 | Predicate 2<br>iovera® System<br>K211334 | |
| Cryogen cartridge size | 21ml (14.3 gram fill) nitrous oxide<br>cartridge | Same | Same | |
| Cryogen cartridge<br>loading | Cartridge is loaded via a hinged<br>door on the side of the device.<br>Closing the door provides the force<br>necessary to pierce the cartridge. | Same | Same | |
| Cryogen<br>cartridge<br>piercing<br>point/filter | In-line piercing point and filter<br>assembly resides in a replaceable<br>assembly within the device. | Same | Same | |
| Cartridge<br>status/detection | Measurement of cryogen pressure;<br>detection switch. | Same | Same | |
| Cartridge<br>heating | Resistive flex circuit with redundant<br>monitoring thermistors. | Same | Same | |
| Human Factors | Hand-held device containing<br>cryogen. Detachable cryoprobes<br>(Smart Tips). | Same | Same | |
| Information<br>display | Color graphic LCD on rear of<br>device. Additional information<br>regarding failure mode is also<br>displayed. | Same | Same | |
| Charging Dock<br>display | LED light bar indicating Charging<br>Dock is receiving power from AC-<br>DC adapter (Power Supply).<br>Light bar changes color when<br>Charging Dock is charging current<br>to Handpiece. | Same | Same | |
| Digital Interfaces | USB Type B Port and SD Card Slot.<br>The SD Card slot is inactive; the<br>USB Port is not for customer use<br>and is for log retrieval by<br>company staff. Cybersecurity<br>aspects of both the SD Card Slot<br>and USP Port are covered and<br>tested in the Software<br>Development Life Cycle activities. | Same | Same | |
| Method of Smart<br>Tip attachment | Push-on / pull-off design | Same | Same | |
| Skin-warmer<br>heating | Semiconductor device used as<br>heating element - this element is<br>thermally connected to skin<br>warmer (heating block) and<br>monitored with redundant<br>thermistors. | Same | Same | |
| Parameter | Proposed<br>iovera ® System<br>STT21180STIM<br>Subject of this Special 510(k) | Predicate 1<br>iovera® System<br>K220656 | Predicate 2<br>iovera® System<br>K211334 | |
| | compliant sealing element.<br>Valve is controlled by stepper-<br>motor-based linear actuator.<br>Switch detects valve open<br>position. | | | |
| Power Source | Battery powered<br>Battery type: Single cell Lithium<br>Ion, 3100mAh<br>Battery voltage: 3.6Volts Mains<br>powered Charging Dock with<br>Manufacturer- supplied, medical<br>grade power supply (5V DC). | Same | Same | |
| Operating<br>Principle | Joule-Thomson Effect / Latent<br>Heat (enthalpy) of Vaporization | Same | Same | |
| Patient<br>contacting<br>materials | Closed tip stainless steel needle | Same | Same | |
| Biocompatibility | Biocompatible patient<br>contacting materials, tested to<br>"ISO 10993-1:2018,<br>Biological evaluation of<br>medical devices - Part 1: Evaluation<br>and testing within a risk<br>management process." | Same | Same | |
| Needle Sizes | 27G (STT2309)<br>20G (STT2190)<br>20G (STT2190STIM)<br>25G (STT21180STIM) | 27G (STT2309)<br>20G (STT2190)<br>20G (STT2190STIM) | 27G (STT2309)<br>20G (STT2190) | |
| Catalog<br>Numbers | STT2309, STT2190, STT2190STIM<br>and STT21180STIM…