MIRARI® Cold Plasma System ( GV-M2-01)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" and the words "U.S. Food & Drug Administration". November 21, 2024 General Vibronics, Inc. Huan Truong President 1615 East Warner Road Suite #4 Tempe, Arizona 85284 Re: K242553 Trade/Device Name: MIRARI® Cold Plasma System ( GV-M2-01) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX, GEI Dated: October 31, 2024 Received: October 31, 2024 Dear Huan Truong: 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" {1}------------------------------------------------ (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). 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 OS regulation requires device manufacturers to review and approve changes to device design and production (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 (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 Rule"). The UDI Rule requires, among other things, that a 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-advice-comprehensiveregulatory-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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH and 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-devices/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). {2}------------------------------------------------ Sincerely, Image /page/2/Picture/3 description: The image shows a digital signature. The signature is from Long H. Chen. The date of the signature is 2024.11.21 13:57:10-05'00'. Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K242553 Device Name MIRARI® Cold Plasma System ( GV-M2-01 ) #### Indications for Use (Describe) MIRARI® Cold Plasma System provides heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms and increase in local circulation. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <div style="display:inline-block;"> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | |--------------------------------------------------------------------------------------------------------------------------------| | <div style="display:inline-block;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</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 PRAStaff(@fda.hhs.gov "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." {4}------------------------------------------------ ## 510(K) Summary Mirari Cold Plasma System K242553 | Applicant | General Vibronics | |--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | Address | 1615 East Warner Road<br>Suite #4<br>Tempe, AZ 85284 US | | Contact Person | Mr. Huan Truong, President | | Contact Information<br>Preparation Date<br>Device Trade Name | huan@generalvibronics.com<br>November 20, 2024<br>Mirari Cold Plasma System | | Common Name<br>Regulation Number<br>Product Code<br>Regulatory Class<br>Legally Marketed Predicate<br>Device | RF for Pain Relief<br>878.4400<br>PBX, GEI<br>II<br>Tempsure Flexsure Applicator (K200241 | ## Device Description: The Mirari Cold Plasma System is a portable, hand-held device that emits RF energy at 80kHz. The system is comprised of a battery-operated RF generator, a rechargeable power supply powered by a pair of lithium batteries and a plasma array which is placed in fleece pouch. The plasma array is then placed in a fleece pouch which is then placed on the RF energy is emitted through the array.. #### Indications for use: MIRARI® Cold Plasma System provides heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms and increase in local circulation. Indication for Use Comparison {5}------------------------------------------------ # 510(K) Summary Mirari Cold Plasma System K242553 | Description | Mirari | TempSure | Comparison | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | | | | | | (K)242553 | (K)200241 | | | Indications<br>for Use | The Mirari Cold Plasma<br>System provides heating for<br>the purpose of elevating<br>tissue temperature for<br>selected medical conditions<br>such as temporary relief of<br>pain, muscle spasms, and<br>increase in local circulation | The FlexSure™ Applicators<br>provide heating for the<br>purpose of elevating tissue<br>temperature for selected<br>medical conditions such as<br>temporary relief of pain,<br>muscle spasms, and increase<br>in local circulation | Same | ## Technology Comparison | Technical<br>Specification | Subject Device: Mirari<br>Cold Plasma Device | Predicate Device:<br>TempSure FlexSure<br>Applicator | Comparison | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | Rx/OTC | Prescription | Prescription | Same | | Energy Type | Radiofrequency | Radiofrequency | Same | | Modality | Dielectric barrier<br>discharge (DBD) | Diathermy by high<br>voltage insulated<br>electrode | Different | | Mechanism of Action | Uses RF energy for<br>therapeutic purposes<br>through a resonant<br>inverter and plasma<br>array | Uses RF energy or<br>other sources to<br>create localized<br>heating | Similar RF energy<br>generation using RF<br>energy, focusing on<br>tissue heating | | Heating Mechanism | RF energy heating at a<br>resonant frequency of<br>~77kHz with specified<br>frequencies | Uses RF energy for<br>localized heating at<br>specified frequencies | Both use RF energy<br>for heating; subject<br>device uses a<br>resonant frequency<br>for precise control | | Technical<br>Specification | Subject Device: Mirari<br>Cold Plasma Device | Predicate Device:<br>TempSure FlexSure<br>Applicator | Comparison | | Treatment<br>Modalities | CAP (capacitive coupling)<br>and RES (resistive<br>heating) modes for<br>different tissue types | CAP and RES modes or<br>similar for different<br>depths and conditions | Similar modalities,<br>both adapting to<br>various tissue<br>characteristics | | Plasma Array & Tip<br>Dimensions | Interconnected metal<br>rings, 1.6mm diameter,<br>0.2mm thick | Varies in design but<br>typically includes<br>metal elements for RF<br>energy generation | Both involve specially<br>designed arrays;<br>subject device<br>provides specific<br>dimensions | | Handpiece Size | Fleece pouch covering<br>the array and connector,<br>6.5cm x 14cm x 0.7cm | Oval shape in large<br>(398 cm²) and medium<br>(250 cm²) sizes | Different | | Intended Treatment<br>Size | 29 cm² | Same as applicator<br>size | Same | | Treatment Area | Defined by plasma array<br>design for consistent<br>energy distribution | Defined by array or<br>applicator design | Comparable in<br>defining the<br>treatment area<br>through the array size<br>and design | | Total Power | Less than 4W | Less than 300W | Different | | Maximum Output<br>Power | Dependent on<br>modulation duty cycle<br>(30%), controlled by<br>PWM | Varies for safety and<br>effectiveness | Both control power<br>output for safety;<br>subject device<br>specifies detailed<br>control | | Electric Field | Less than 80V/m | Less than 1200V/m | Different | | Waveform<br>Modulation | Uses PWM (pulse width<br>modulation) with precise<br>control | Uses PWM or similar<br>techniques | Both use PWM for<br>precise energy<br>delivery | | Technical<br>Specification | Subject Device: Mirari<br>Cold Plasma Device | Predicate Device:<br>TempSure FlexSure<br>Applicator | Comparison | | Output Waveform | 80 kHz Sine-wave CW,<br>Fully Rectified | 4.0 MHz Sine-wave<br>CW, Fully Rectified,<br>Partially Rectified, 1.7<br>MHz for Bipolar | Different | | Temperature<br>Response Time | <1 second | <1 second | Same | | Treatment<br>Temperature | Maintains within $\pm$ 2°C of<br>target temperature using<br>temperature sensor and<br>feedback algorithm. | Maintains<br>temperature within a<br>specified tolerance | Similar temperature<br>management; subject<br>device specifies $\pm$ 2°C<br>tolerance | | Maximum Allowable<br>Temperature | Adjusts power or shuts<br>down if safe threshold is<br>exceeded | Adjusts power or shuts<br>down if temperature<br>exceeds settings | Both prioritize<br>preventing<br>temperature-related<br>adverse events | | Temperature<br>Monitoring | High-precision sensor<br>polled twice per second<br>with feedback control | Uses sensors for safe<br>operating<br>temperatures | Comparable focus on<br>real-time monitoring<br>with feedback loops | | Temperature<br>Tolerance/Accuracy | $\pm$ 2°C tolerance | Typically within similar<br>tolerance ranges | Both aim for precise<br>temperature control | | Treatment Duration | Duration of treatment<br>varies based on patient<br>needs. 10 minutes per<br>treatment protocol | Generally set based on<br>clinical protocols | Similar adaptability<br>based on patient<br>needs | | Safety Measures | Magnetic interlocks,<br>overcurrent shutdown,<br>adaptive control; detects<br>array presence to<br>prevent accidental use | Uses interlocks, power<br>control mechanisms,<br>automatic shutdowns | Both prioritize<br>multiple safety layers;<br>subject device details<br>detection and<br>response mechanisms | | Technical<br>Specification | Subject Device: Mirari<br>Cold Plasma Device | Predicate Device:<br>TempSure FlexSure<br>Applicator | Comparison | | Patient Contacting<br>Material | Polyester fleece, 300<br>grams/m² double layer | Gold-Plated<br>Aluminum, PVDF,<br>Polyetherimide,<br>Loctite, Delrin,<br>Polycarbonate,<br>Hydrogel | Different | | Mirari Driver<br>Dimensions | 2.56" x 3.98" x 1.22" | 22.5" x 18" x 12" | Different | | Weight | 1 lb | 30 lbs | Different | {6}------------------------------------------------ # 510(K) Summary Mirari Cold Plasma System ### K242553 {7}------------------------------------------------ # 510(K) Summary Mirari Cold Plasma System ### K242553 {8}------------------------------------------------ # 510(K) Summary Mirari Cold Plasma System ## K242553 Frequency: The frequencies are different as the Mirari delivers energy at 80kHz and the predicate delivers energy at 4mHz. The Mirari demonstrated in the thermal testing that was conducted that it can safely elevate the tissue temperature and hold that temperature for 10 minutes, which is the therapeutic requirement for a pain relief device. According to the Tempsure FlexSure application 510K Summary, the same testing was conducted, specifically: Bench testing was conducted to show that the new FlexSure single use applicator and large neutral pad, when used in a simulated clinical condition, was able to heat and maintain temperature of the treatment area for 10 minutes. There is no new concern for safety or efficacy because both devices performed the same test and achieved the same result. Applicator Size: The applicator for the Mirari is smaller than the predicate device. There is no new concerns for safety or efficacy because both devices performed the same test and achieved the same result. Patient Contacting Material: The patient contacting material for the Mirari is different than the predicate device. There are no new concerns for safety or efficacy as these materials have been evaluated for biocompatibility. The materials are safe for their intended use and introduce no additional risk. {9}------------------------------------------------ ## 510(K) Summary Mirari Cold Plasma System K242553 ### Performance Testing Verification and validation activities were successfully completed and establish that the Mirari Cold Plasma System control unit performs as intended. Testing included the following: - 60601-1 Edition 3.2 2020-08; Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance; - . IEC 60601-1-2:2014 + A1:2020; Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests; - . IEC 60601-2-2:2017; Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories; - IEC 62304:2006+A1:2015; Medical Device Software Life Cycle Processes; ● - EN ISO 14971:2019+A11:2021; Medical Devices - Application of Risk Management To Medical Devices Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices. In addition, tests were performed to demonstrate that the device can maintain a therapeutic temperature for 10 minutes of treatment for every electrode used. Tests included three subjects and a the therapeutic temperature was maintained for 10 minutes of treatment. Performance testing was performed to demonstrate the accuracy of the output power, output frequency, and output voltage. ## Conclusion The Mirari Cold Plasma System shares similar technological characteristics, theory of operation, design, and indications with its predicate TempSure FlexSure device as described above. Despite the differences in the Mirari Cold Plasma System and the TempSure FlexSure applicator bench testing was conducted to support that the device can successfully heat the treatment area. Based on the above information and test reports, it is determined that the proposed Mirari Cold Plasma System is substantially equivalent to the predicate device and there are no new concerns raised for safety or efficacy.