(86 days)
Not Found
No
The description focuses on RF energy emission and temperature maintenance, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The "Intended Use / Indications for Use" section states that the device "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," which are therapeutic benefits. Additionally, the "Summary of Performance Studies" mentions demonstrating that the device can "maintain a therapeutic temperature".
No
The device description and intended use clearly state that it provides heating to elevate tissue temperature for therapeutic purposes (pain relief, muscle spasms, increased circulation), not for diagnosing medical conditions.
No
The device description explicitly details hardware components including an RF generator, power supply, batteries, and a plasma array. The performance studies also include testing against hardware standards (IEC 60601 series).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device 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. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a system that emits RF energy to heat tissue. This aligns with a therapeutic device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body. This device operates in vivo (on the body) for therapeutic purposes.
N/A
Intended Use / 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.
Product codes
PBX, GEI
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..
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench testing was conducted to show that the [Mirari Cold Plasma System] can safely elevate the tissue temperature and hold that temperature for 10 minutes, which is the therapeutic requirement for a pain relief device. 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.
Key Metrics
Not Found
Predicate Device(s)
TempSure FlexSure Applicator (K200241
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(K) Summary Mirari Cold Plasma System K242553
| Applicant | General Vibronics |
|---|---|
| Address | 1615 East Warner Road |
| Suite #4 | |
| Tempe, AZ 85284 US | |
| Contact Person | Mr. Huan Truong, President |
| Contact Information | |
| Preparation Date | |
| Device Trade Name | huan@generalvibronics.com |
| November 20, 2024 | |
| Mirari Cold Plasma System | |
| Common Name | |
| Regulation Number | |
| Product Code | |
| Regulatory Class | |
| Legally Marketed Predicate | |
| Device | RF for Pain Relief |
| 878.4400 | |
| PBX, GEI | |
| II | |
| 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 | |||
| for Use | The 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 | The FlexSure™ Applicators | ||
| provide 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 | Same |
Technology Comparison
| Technical
Specification | Subject Device: Mirari
Cold Plasma Device | Predicate Device:
TempSure FlexSure
Applicator | Comparison |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Rx/OTC | Prescription | Prescription | Same |
| Energy Type | Radiofrequency | Radiofrequency | Same |
| Modality | Dielectric barrier
discharge (DBD) | Diathermy by high
voltage insulated
electrode | Different |
| Mechanism of Action | Uses RF energy for
therapeutic purposes
through a resonant
inverter and plasma
array | Uses RF energy or
other sources to
create localized
heating | Similar RF energy
generation using RF
energy, focusing on
tissue heating |
| Heating Mechanism | RF energy heating at a
resonant frequency of
~77kHz with specified
frequencies | Uses RF energy for
localized heating at
specified frequencies | Both use RF energy
for heating; subject
device uses a
resonant frequency
for precise control |
| Technical
Specification | Subject Device: Mirari
Cold Plasma Device | Predicate Device:
TempSure FlexSure
Applicator | Comparison |
| Treatment
Modalities | CAP (capacitive coupling)
and RES (resistive
heating) modes for
different tissue types | CAP and RES modes or
similar for different
depths and conditions | Similar modalities,
both adapting to
various tissue
characteristics |
| Plasma Array & Tip
Dimensions | Interconnected metal
rings, 1.6mm diameter,
0.2mm thick | Varies in design but
typically includes
metal elements for RF
energy generation | Both involve specially
designed arrays;
subject device
provides specific
dimensions |
| Handpiece Size | Fleece pouch covering
the array and connector,
6.5cm x 14cm x 0.7cm | Oval shape in large
(398 cm²) and medium
(250 cm²) sizes | Different |
| Intended Treatment
Size | 29 cm² | Same as applicator
size | Same |
| Treatment Area | Defined by plasma array
design for consistent
energy distribution | Defined by array or
applicator design | Comparable in
defining the
treatment area
through the array size
and design |
| Total Power | Less than 4W | Less than 300W | Different |
| Maximum Output
Power | Dependent on
modulation duty cycle
(30%), controlled by
PWM | Varies for safety and
effectiveness | Both control power
output for safety;
subject device
specifies detailed
control |
| Electric Field | Less than 80V/m | Less than 1200V/m | Different |
| Waveform
Modulation | Uses PWM (pulse width
modulation) with precise
control | Uses PWM or similar
techniques | Both use PWM for
precise energy
delivery |
| Technical
Specification | Subject Device: Mirari
Cold Plasma Device | Predicate Device:
TempSure FlexSure
Applicator | Comparison |
| Output Waveform | 80 kHz Sine-wave CW,
Fully Rectified | 4.0 MHz Sine-wave
CW, Fully Rectified,
Partially Rectified, 1.7
MHz for Bipolar | Different |
| Temperature
Response Time |