(157 days)
Not Found
No
The summary describes a device that uses plasma sublimation via an electrical arc generated by a radio frequency generator. There is no mention of AI, ML, image processing, or any data-driven algorithms for decision making or analysis. The performance studies focus on electrical safety and tissue effects, not algorithmic performance.
Yes
The device is used for the removal and destruction of skin lesions and coagulation of tissue, which are therapeutic medical procedures.
No
This device is described as being used for the removal, destruction, and coagulation of skin lesions and tissue, indicating a therapeutic or surgical function rather than a diagnostic one.
No
The device description explicitly states it utilizes a "radio frequency generator housed in an electrosurgical unit (handpiece)" and includes a "straight active electrode made of 316L stainless steel," indicating it is a hardware device with electrical components, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "removal and destruction of skin lesions and coagulation of tissue." This is a therapeutic procedure performed directly on the patient's skin.
- Device Description: The device utilizes plasma sublimation to cause controlled skin damage. This is a physical process applied externally to the body.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health. This device does not interact with or analyze any biological specimens.
The device is an electrosurgical unit used for direct treatment of the skin, which falls under the category of therapeutic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
PLASMA IQ is used in the removal and destruction of skin lesions and the coagulation of tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
PLASMA IQ utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the electrode tip and the skin is created by a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316L stainless steel is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance testing was conducted to prove compliance with performance requirements and support substantial equivalence:
- Electrical: Compliance with EN 60601-1, Pass
- Electrical: Compliance with EN 60601-1-2, Pass
- Tissue Testing: Compare thermal spread of devices, Equivalent
- Packaging: Compliance with EN 22248, Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 6, 2020
Neauvia North America, Inc Misty Williams Executive VP Regulatory & Clinical Affairs 8480 Honeycutt Rd Raleigh, North Carolina 27615
Re: K192813
Trade/Device Name: Plasma IQ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 3, 2020 Received: February 4, 2020
Dear Misty Williams:
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
1
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 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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) K192813
Device Name Plasma IQ
Indications for Use (Describe)
Plasma IQ is used in the removal and destruction of skin lesions and coagulation of tissue.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510K Summary - Plasma IQ
As required by 807.92(c)
Date Prepared: March 5, 2020
Sponsor: Neauvia North America
Device Information
| Device Name: | Plasma IQ |
|---|---|
| Common Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Class: | II |
| Product Code: | GEI |
| Regulation: | 878.4400 |
| Submission Type: | Traditional 510k (Original Submission) |
| Predicate Information | |
| Primary Predicate: | K161134 - Bovie Derm 941, Electrosurgical Generator |
| Bovie Medical Corporation, Clearwater, FL |
Contact Information
Misty Williams Executive Vice President of Regulatory and Clinical Affairs Phone: (984) 777-5292 Email: misty(@neauvia-us.com
1. Intended Use
PLASMA IQ is used in the removal and destruction of skin lesions and the coagulation of tissue.
2. Device Description
PLASMA IQ utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the electrode tip and the skin is created by a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316L stainless steel is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.
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3. Performance Testing
The following performance testing was conducted to prove compliance with performance requirements and support substantial equivalence:
| Test | Objective | Results |
|---|---|---|
| Electrical | Compliance with EN 60601-1 | Pass |
| Electrical | Compliance with EN 60601-1-2 | Pass |
| Tissue Testing | Compare thermal spread of | |
| devices | Equivalent | |
| Packaging | Compliance with EN 22248 | Pass |
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4. Substantial Equivalence
| Trade Name | Submission Device | Predicate Device - Bovie DERM 941
Electrosurgical Generator |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Manufacturer | Berger & Kraft | Bovie Medical Corporation |
| 510(k) # | K192813 | K161134 |
| Indications | Intended for the removal and
destruction of skin lesions and
coagulation of tissue | Intended for the removal and destruction of skin
lesions and coagulation of tissue |
| Mode of
Operation | Plasma
Radiofrequency energy ionizes
the air creating a Plasma stream | Radiofrequency |
| Output | Monopolar | Monopolar |
| Power
Supply | 110-250 VAC
50/60 Hz | 100-240 VAC
50-60 Hz |
| Frequency | 40 kHz | 368 kHz |
| Max Output
Power | 5 W | 40 W |
| Output
Impedance | $54,000 \Omega$ | $200 \Omega$ |
| Waveform | Image: waveform | Image: waveform |
| System
Components | System consists of a handpiece
that incorporates the
electrosurgical generator unit,
docking station, and an active
electrode. | System consists of an electrosurgical generator unit,
a handpiece, and dermal tips. |
| Electrical
Safety
Standards | Complies with IEC60601-1,
IEC60601-1-2, IEC60601-2-2 | Complies with IEC60601-1, IEC60601-2*, and
EN60529 |
*As listed in K170188 510(k) Summary
5. Conclusion
The predicate Bovie Derm 941 and the PLASMA IQ both produce RF energy to remove and destroy skin lesions and coagulate the tissue. The maximum output power of the Plasma IQ device is less than that of the Bovie Derm 941; however, the Plasma IQ and Bovie Derm 941 are substantially equivalent. There are no different questions of safety and effectiveness. Therefore, the subject device and predicate device are
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substantially equivalent. Tissue testing, electrical testing (EMC testing) and packaging testing meet the current standards.