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.

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..

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of AI/ML performance. Instead, it is an FDA 510(k) summary for a medical device called the "MIRARI® Cold Plasma System," which is an electrosurgical cutting and coagulation device.

The document focuses on demonstrating substantial equivalence to a predicate device (TempSure FlexSure Applicator) for the purpose of market clearance, not on evaluating the performance of an AI/ML algorithm against specific acceptance criteria.

Therefore, I cannot extract the requested information (such as acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from the provided text because it describes a different type of medical device submission that does not involve AI/ML performance evaluation.

Summary

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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"

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(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).

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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

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Indications for Use

510(k) Number (if known) K242553

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

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary Mirari Cold Plasma System K242553

Applicant	General Vibronics
Address	1615 East Warner RoadSuite #4Tempe, AZ 85284 US
Contact Person	Mr. Huan Truong, President
Contact InformationPreparation DateDevice Trade Name	huan@generalvibronics.comNovember 20, 2024Mirari Cold Plasma System
Common NameRegulation NumberProduct CodeRegulatory ClassLegally Marketed PredicateDevice	RF for Pain Relief878.4400PBX, GEIIITempsure Flexsure Applicator (K200241

Device Description:

Indications for use:

Indication for Use Comparison

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510(K) Summary Mirari Cold Plasma System K242553

Description	Mirari	TempSure	Comparison

	(K)242553	(K)200241
Indicationsfor Use	The Mirari Cold PlasmaSystem provides heating forthe purpose of elevatingtissue temperature forselected medical conditionssuch as temporary relief ofpain, muscle spasms, andincrease in local circulation	The FlexSure™ Applicatorsprovide heating for thepurpose of elevating tissuetemperature for selectedmedical conditions such astemporary relief of pain,muscle spasms, and increasein local circulation	Same

Technology Comparison

TechnicalSpecification	Subject Device: MirariCold Plasma Device	Predicate Device:TempSure FlexSureApplicator	Comparison
Rx/OTC	Prescription	Prescription	Same
Energy Type	Radiofrequency	Radiofrequency	Same
Modality	Dielectric barrierdischarge (DBD)	Diathermy by highvoltage insulatedelectrode	Different
Mechanism of Action	Uses RF energy fortherapeutic purposesthrough a resonantinverter and plasmaarray	Uses RF energy orother sources tocreate localizedheating	Similar RF energygeneration using RFenergy, focusing ontissue heating
Heating Mechanism	RF energy heating at aresonant frequency of~77kHz with specifiedfrequencies	Uses RF energy forlocalized heating atspecified frequencies	Both use RF energyfor heating; subjectdevice uses aresonant frequencyfor precise control
TechnicalSpecification	Subject Device: MirariCold Plasma Device	Predicate Device:TempSure FlexSureApplicator	Comparison
TreatmentModalities	CAP (capacitive coupling)and RES (resistiveheating) modes fordifferent tissue types	CAP and RES modes orsimilar for differentdepths and conditions	Similar modalities,both adapting tovarious tissuecharacteristics
Plasma Array & TipDimensions	Interconnected metalrings, 1.6mm diameter,0.2mm thick	Varies in design buttypically includesmetal elements for RFenergy generation	Both involve speciallydesigned arrays;subject deviceprovides specificdimensions
Handpiece Size	Fleece pouch coveringthe array and connector,6.5cm x 14cm x 0.7cm	Oval shape in large(398 cm²) and medium(250 cm²) sizes	Different
Intended TreatmentSize	29 cm²	Same as applicatorsize	Same
Treatment Area	Defined by plasma arraydesign for consistentenergy distribution	Defined by array orapplicator design	Comparable indefining thetreatment areathrough the array sizeand design
Total Power	Less than 4W	Less than 300W	Different
Maximum OutputPower	Dependent onmodulation duty cycle(30%), controlled byPWM	Varies for safety andeffectiveness	Both control poweroutput for safety;subject devicespecifies detailedcontrol
Electric Field	Less than 80V/m	Less than 1200V/m	Different
WaveformModulation	Uses PWM (pulse widthmodulation) with precisecontrol	Uses PWM or similartechniques	Both use PWM forprecise energydelivery
TechnicalSpecification	Subject Device: MirariCold Plasma Device	Predicate Device:TempSure FlexSureApplicator	Comparison
Output Waveform	80 kHz Sine-wave CW,Fully Rectified	4.0 MHz Sine-waveCW, Fully Rectified,Partially Rectified, 1.7MHz for Bipolar	Different
TemperatureResponse Time	<1 second	<1 second	Same
TreatmentTemperature	Maintains within $\pm$ 2°C oftarget temperature usingtemperature sensor andfeedback algorithm.	Maintainstemperature within aspecified tolerance	Similar temperaturemanagement; subjectdevice specifies $\pm$ 2°Ctolerance
Maximum AllowableTemperature	Adjusts power or shutsdown if safe threshold isexceeded	Adjusts power or shutsdown if temperatureexceeds settings	Both prioritizepreventingtemperature-relatedadverse events
TemperatureMonitoring	High-precision sensorpolled twice per secondwith feedback control	Uses sensors for safeoperatingtemperatures	Comparable focus onreal-time monitoringwith feedback loops
TemperatureTolerance/Accuracy	$\pm$ 2°C tolerance	Typically within similartolerance ranges	Both aim for precisetemperature control
Treatment Duration	Duration of treatmentvaries based on patientneeds. 10 minutes pertreatment protocol	Generally set based onclinical protocols	Similar adaptabilitybased on patientneeds
Safety Measures	Magnetic interlocks,overcurrent shutdown,adaptive control; detectsarray presence toprevent accidental use	Uses interlocks, powercontrol mechanisms,automatic shutdowns	Both prioritizemultiple safety layers;subject device detailsdetection andresponse mechanisms
TechnicalSpecification	Subject Device: MirariCold Plasma Device	Predicate Device:TempSure FlexSureApplicator	Comparison
Patient ContactingMaterial	Polyester fleece, 300grams/m² double layer	Gold-PlatedAluminum, PVDF,Polyetherimide,Loctite, Delrin,Polycarbonate,Hydrogel	Different
Mirari DriverDimensions	2.56" x 3.98" x 1.22"	22.5" x 18" x 12"	Different
Weight	1 lb	30 lbs	Different

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510(K) Summary Mirari Cold Plasma System

K242553

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510(K) Summary Mirari Cold Plasma System

K242553

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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.

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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.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.