(74 days)
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.
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, 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 standard of-the-shelf nerve stimulator device in applications where precise nerve location is desired.
The device comprises four main components:
- A reusable Handpiece
- A Charging Dock
- An assortment of single-patient-use Smart Tips
- A Cartridge containing nitrous oxide
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 ioveraº 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 N20.
This document is a 510(k) premarket notification for the iovera® System, a cryogenic surgical device. The purpose of this notification is to demonstrate that the modified iovera® System is substantially equivalent to previously cleared iovera® Systems (K211334 and K173763).
Based on the provided text, the device is evaluated against its product specifications. The document describes a series of engineering and performance tests rather than a clinical study evaluating diagnostic or prognostic performance with human readers. Therefore, several of the specific questions related to clinical studies (e.g., sample size for training/test sets, expert ground truth, MRMC studies) are not directly applicable or are not detailed in this submission.
Here's a breakdown of the acceptance criteria and the study (design verification testing) that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "The subject iovera® System device met the design verification and validation inputs, passing all predetermined acceptance criteria." However, it does not provide a specific table with numerical acceptance criteria and corresponding reported performance values for each parameter. Instead, it lists categories of testing performed to demonstrate compliance.
| Category of Testing | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Functional & Product Performance | Device operates according to design specifications for its intended use (e.g., proper cooling, cryogen flow). | Met product specifications for intended clinical use. Passed all predetermined acceptance criteria. |
| Smart Tip Functional Testing | Smart Tips perform as designed (e.g., proper cooling, nerve stimulation capability for compatible tips). | Met product specifications. Passed all predetermined acceptance criteria. |
| User Interface Testing (IEC 62366-1) | User interface is safe and effective, and meets usability standards. | Conforms to IEC 62366-1:2015. Passed all predetermined acceptance criteria. |
| Software Testing (IEC 62304) | Software functions correctly and safely. | Conforms to IEC 62304:2006/A. Passed all predetermined acceptance criteria. |
| Electrical & EMC Safety (IEC 60601-1, -1-2) | Device meets electrical safety and electromagnetic compatibility standards. | Conforms to IEC-60601-1: A1 2012 and 60601-1-2:2014. Passed all predetermined acceptance criteria. |
| Mechanical & Thermal Safety (IEC 60601-1) | Device meets mechanical and thermal safety standards. | Conforms to IEC 60601-1: A1:2012. Passed all predetermined acceptance criteria. |
| Sterility Testing (ASTM F1980-16, ISO 11135:2014/A) | Smart Tips achieve and maintain required sterility assurance level (SAL). | Conforms to ASTM F1980-16 and ISO 11135:2014/A. Smart Tip individually packaged and sterile with a SAL of 10-6. Passed all predetermined acceptance criteria. |
| Packaging Testing (ASTM D4332-14) | Packaging protects the device and maintains sterility. | Conforms to ASTM D4332-14. Passed all predetermined acceptance criteria. |
| Biocompatibility Testing (ISO 10993-1) | Patient-contacting materials are biocompatible. | Conforms to ISO 10993-1. All patient contacting materials tested to ISO 10993-1; found biocompatible. Passed all predetermined acceptance criteria. |
| Clinical Effect (Cryoneurolysis) | Device achieves cellular death through cryoneurolysis and Wallerian degeneration, leading to second-degree nerve injury (axonotmesis). | Stated as the Clinical Effect of the device. (This is a principle of operation rather than an acceptance criterion met by a specific test in this submission). |
| Treatment Temperature | Achieves a temperature between -55°C to -75°C (-67°F to -103°F) during treatment. | Stated as the achieved treatment temperature range. (This is a performance characteristic). |
| Timing Parameters (Pre-heat, Cooling, Post-heat) | Meets specified pre-heat, cooling, and post-heat durations for different Smart Tips. | 12 seconds (8.5mm), 1 second (90mm) pre-heat; 33 seconds (8.5mm), 60 seconds (90mm) max cooling; 20 seconds (8.5mm), 45 seconds (90mm) post-heat. |
| Skin Warmer Set Point | Maintains Skin Warmer Set Point at 30°C. | 30°C. |
2. Sample size used for the test set and the data provenance:
The document describes "Design Verification testing" and "Verification and validation testing." These are engineering and performance validation tests, not clinical efficacy or diagnostic performance studies involving patient data. Therefore, the concept of a "test set" in the context of a dataset with patient outcomes or images is not applicable here. The "samples" would be units of the device or its components tested in a lab setting. The document does not specify the number of device units or components tested for each category.
- Data Provenance: Not applicable in the context of patient data. The tests are likely conducted in-house or by accredited testing laboratories.
- Retrospective or Prospective: Not applicable as it's not a clinical study involving patient data. These are design verification tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for these engineering performance tests is established by product specifications, recognized standards (e.g., ISO, IEC, ASTM), and internal design requirements, not by expert consensus on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is for performance testing against established engineering specifications, not for interpretation of clinical data requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This submission is for a medical device (cryogenic surgical system), not an AI/CADe or CADx device that assists human readers in interpreting medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The iovera® system is a physical device used by a human practitioner. It's not a standalone algorithm.
7. The type of ground truth used:
The ground truth for this device's performance is based on:
- Engineering Specifications: Pre-defined design requirements and performance parameters for the device and its components (e.g., temperature range, timing, electrical properties).
- Recognized Standards: Compliance with international and national standards (IEC, ISO, ASTM) for medical devices, software, electrical safety, biocompatibility, and sterility.
- Predicate Device Equivalence: The claim of substantial equivalence to previously cleared iovera® Systems (K211334 and K173763) implies that their performance characteristics serve as a benchmark.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, this is not an AI/machine learning device, so there is no "training set." The performance verification relies on meeting established design specifications and adhering to relevant industry standards.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 20, 2022
Pacira Biosciences, Inc. Danny Rivera Sr. Director, Quality and Regulatory Affairs 10450 Science Center Drive San Diego, California 92121
Re: K220656
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: April 20, 2022 Received: April 21, 2022
Dear Danny Rivera:
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. 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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
510(k) Number (if known) K220656
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 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.
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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510(k) SUMMARY
| Device Trade Name: | iovera º System |
|---|---|
| Device Common Name | Cryogenic Surgical Device |
| Device Class: | II |
| Classification Name: | Cryosurgical Unit and Accessories DeviceSurgical Nerve Stimulator |
| Regulation No.: | 21 CFR Part 882.4250 and 874.1820 |
| Product Code: | GXH, ETN |
| Predicate Device: | ioveraº System K173763 and K211334 |
| Owner/Submitter: | Pacira Biosciences, Inc.10450 Science Center DriveSan Diego, California 92121 |
| Regulatory Contact: | Danny RiveraSenior Director, Quality and Regulatory AffairsTel: 8586252414 Ext 3175Email: Danny.Rivera@Pacira.com |
| Date: | May 20, 2022 |
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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, 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 standard of-the-shelf nerve stimulator device in applications where precise nerve location is desired.
Device Design
The device comprises four main components:
- A reusable Handpiece
- A Charging Dock
- An assortment of single-patient-use Smart Tips ●
- A Cartridge containing nitrous oxide ●
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 ioveraº 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 N20.
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.
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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.
SUMMARY/COMPARISON OF IOVERA® SYSTEM DEVICE CHARACTERISTICS
The iovera System is substantially equivalent in intended use, technology, design, and materials to the above listed legally marketed predicate devices.
| Parameter | Proposediovera o System | Predicate 1iovera o SystemK211334 | Predicate 2iovera o SystemK173763 |
|---|---|---|---|
| Intended Use | Destroy tissue throughfreezing | Same | Same |
| Indications for Use | The ioverao System is usedto destroy tissue duringsurgical procedures byapplying freezing cold. Itcan also be used to producelesions in peripheral nervoustissue by the application ofcold to the selected site forthe blocking of pain. It isalso indicated for the reliefof pain and symptomsassociated with osteoarthritisof the knee for up to 90days. The ioverao system isnot indicated for treatmentof central nervous systemtissue.When stimulation | The ioverao System is used todestroy tissue during surgicalprocedures by applyingfreezing cold. It can also beused to produce lesions inperipheral nervous tissue bythe application of cold to theselected site for the blockingof pain. It is also indicated forthe relief of pain andsymptoms associated withosteoarthritis of the knee forup to 90 days. The ioveraosystem is not indicated fortreatment of central nervoussystem tissue. | The ioverao System is used todestroy tissue during surgicalprocedures by applyingfreezing cold. It can also beused to produce lesions inperipheral nervous tissue bythe application of cold to theselected site for the blockingof pain. It is also indicated forthe relief of pain andsymptoms associated withosteoarthritis of the knee forup to 90 days. The ioveraosystem is not indicated fortreatment of central nervoussystem tissue.The ioverao System's"1x90" Smart Tip |
| compatible components areused, the ioverao System canalso facilitate target nervelocation by conductingelectrical nerve stimulationfrom a 3rd party nervestimulator. | configuration (indicatingone needle which is 90mm long) can alsofacilitate target nervelocation by conductingelectrical nervestimulation from aseparate nerve stimulator. | ||
| Anatomical Sites | Peripheral nerves | Same | Same |
| Parameter | Proposediovera o System | Predicate 1iovera o SystemK211334 | Predicate 2iovera o SystemK173763 |
| Technology | Cryogenic surgical devicewith needle whichpenetrates treatment area | Same | Same |
| Cryogen cartridge size | 21ml (14.3 gram fill)nitrous oxide cartridge | Same | 10ml (7.5 gram fill) nitrousoxide cartridge |
| Cryogen cartridge loading | Cartridge is loaded via ahinged door on the side ofthe device. Closing thedoor provides the forcenecessary to pierce thecartridge. | Same | Cartridge is loaded from theback of the device. Screwingon the cap provides the forcenecessary to pierce thecartridge. |
| Cryogen cartridgepiercing point/filter | In-line piercing point andfilter assembly resides in areplaceable assemblywithin the device. | Same | In-line piercing point andfilter are part of cryogencartridge assembly. |
| Human Factors | Hand-held device containingcryogen. Detachablecryoprobes (Smart Tips). | Same | Same |
| Information display | Color graphic LCD on rearof device. Additionalinformation regardingfailure mode is also | Same | Array of different coloredLEDs located around thedevice. |
| Charging Dock display | LED light bar indicatingCharging Dock is receivingpower from AC-DCadapter. Light bar changescolor when Charging Dockis supply charging currentto Handpiece. | Same | LED indicating ChargingDock is receiving powerfrom AC-DC adapter. |
| Digital Interfaces | USB and SD card. The SDcard is not part of theproduct offering to thecustomer. This tool is usedfor troubleshooting duringin-house failureinvestigation. The SD cardhas no impact on | Same | USB |
| Method of Smart Tipattachment | Push-on/pull-off design | Same | Screw-on tip attachment |
| Skin-warmer heating | Semiconductor device usedas heating element - thiselement is thermallyconnected to heating blockand monitored withredundant thermistors. | Same | Resistors used as heatingelement - this element isthermally connected toheating block and monitoredwith redundant thermistors. |
| Parameter | Proposediovera® System | Predicate 1iovera® SystemK211334 | Predicate 2iovera® SystemK173763 |
| Cryogen valve | Valve comprises needlevalve in compliant sealingelement.Valve is controlled bystepper-motor-based linearactuator.Switch detects valve openposition. | Same | Valve comprises face-to-face seal against compliantsealing element.Valve is controlled bystepper-motor-based linearactuator. |
| Power Source | Battery poweredBattery type: Single cellLithium Ion, 3100mAhBattery voltage: 3.6VoltsMain powered ChargingDock | Same | Same |
| Operating Principle | Joule-Thomson Effect/Latent Heat ofVaporization | Same | Same |
| Needle Size | 20G, 27G | Same | 20G |
| Catalog Numbers | STT2309, STT2190, andSTT2190STIM | STT2309 and STT2190 | STT0811 |
| Needle Working Length | 8.5mm, 90mm | Same | 90mm length |
| Needles/Tip | 1 x 20G (90mm)3 x 27G (8.5mm) | Same | 1 x 20G (90mm) |
| Nerve Stimulation Support | Yes¹ | N/A | Yes |
| Pre-heat time (min) | 12 seconds (8.5mm)1 second (90mm) | Same | 1 second (90mm) |
| Cooling Time (max) | 33 seconds (8.5mm)60 seconds (90mm) | Same | 60 seconds (90mm) |
| Post -heat Time | 20 seconds (8.5mm)45 seconds (90mm) | Same | 45 seconds (90mm) |
| Skin Warmer Set Point | 30°C | Same | Same |
| Clinical Effect | Cellular death throughcryoneurolysis andWallerian degenerationSecond degree nerveinjury (axonotmesis) | Same | Same |
| Treatment Temperature | -55° C to -75°C (-67°F to -103°F) | Same | Same |
| Parameter | Proposediovera o System | Predicate 1iovera o SystemK211334 | Predicate 2iovera o SystemK173763 |
| Treatment Time | Preprogrammed into thesmart tip. | Same | Same |
| Treatment Options | Multiple Smart Tipoptions are available forproducing differentcryozone (ice ball) sizes. | Same | Same |
| Single-patient Use | Smart Tips are single-patientuse. Handpiece is reusable. | Same | Same |
| Sterility Assurance Level | Smart Tip individuallypackaged and sterile witha SAL of 10-6. | Same | Same |
| Shelf Life | 37-month | Same | Same |
| Biocompatible | Biocompatible. All patientcontacting materials, testedto ISO 10993-1 | Same | Same |
Substantial Equivalence Comparison Table
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4 Nerve-stim tips have a thin, electrically insulating coating (Parylene C) over most of the needle and include an electrical connection between the needle and an external, off-the-shelf PENS device. All other aspects of the design are identical to the non-nerve-stim version of the tip.
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SUMMARY OF PERFORMANCE TESTING
Design Verification testing was performed for the ioveras System to demonstrate that the device meets product specifications for its intended clinical use. Using a risk-based approach for the modifications, design verification testing was performed according to recognized standards, and is consistent with the predicate device and test methods described in previous 510(k) submissions for the iovera system. The verification methods used and applied are appropriate for the changes. The verification and validation testing assures the modified subject device meet design input requirements, product specifications and relevant standards.
- Functional and Product Performance Testing of the Handpiece and Cartridge
- Smart Tip Functional Testing
- User Interface Testing: IEC 62366-1:2015 ●
- Software Testing: Conforms to IEC 62304:2006/A ●
- Electrical and EMC Safety Testing: Conforms to IEC-60601-1: A1 2012 and 60601-1-2:2014 ●
- Mechanical and Thermal Safety Testing: Conforms to IEC 60601-1: A1:2012 ●
- Sterility Testing: Conforms to ASTM F1980-16 and ISO 11135:2014/A ●
- Packaging Testing: Conforms to ASTM D4332-14. ●
- Biocompatibility Testing: Conforms to ISO 10993-1 ●
Verification and validation testing performed on the subject device supports the substantial equivalence of the modified ioveraº System to the predicate device. The subject ioveraº System device met the design verification and validation inputs, passing all predetermined acceptance criteria. No new issues of safety or effectiveness were identified during design verification and validation testing.
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CONCLUSION
The subject ioveraº System, with the same intended use, indications for use, design, materials, technological features, and principles of operation as the cleared ioveraº Systems (K211334 and K173763), is substantially equivalent to these predicate devices. The modification to the Indications for Use proposed in this 510(k) does not affect the safety and effectiveness of the device as the intended therapeutic use for the creation of lesions with the application of cold in peripheral nerves to block pain has not changed.
The modification described, and the information presented, in this special premarket notification demonstrates that ioveraº System is safe and effective, does not introduce or raise new questions of safety and effectiveness, and is substantially equivalent in intended use, technology, design, and materials to the legally marketed predicate devices.
§ 882.4250 Cryogenic surgical device.
(a)
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.(b)
Classification. Class II (performance standards).