Plasma IQ

K192813 · Neauvia North America, Inc. · GEI · Mar 6, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K192813
• Device Name: Plasma IQ
• Applicant: Neauvia North America, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 6, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PLASMA IQ is used in the removal and destruction of skin lesions and the coagulation of tissue.

Device Story

Plasma IQ is a cordless, handheld electrosurgical device used for skin lesion removal and tissue coagulation. It operates via plasma sublimation; a radio frequency generator within the handpiece ionizes air between a 316L stainless steel electrode tip and the patient's skin, creating an electrical arc. The device is charged in a docking station between uses. It is intended for professional clinical use. The healthcare provider manually operates the device to target specific skin areas; the resulting plasma arc provides controlled thermal damage to the tissue. The device's output power is lower than the predicate, ensuring safe and effective tissue destruction and coagulation while maintaining substantial equivalence to existing electrosurgical generators.

Clinical Evidence

Bench testing only. Testing included electrical safety compliance (EN 60601-1, EN 60601-1-2), comparative tissue thermal spread analysis demonstrating equivalence to the predicate, and packaging integrity testing (EN 22248). No clinical data was provided.

Technological Characteristics

Handheld, cordless electrosurgical device. Active electrode: 316L stainless steel. Energy source: RF generator (40 kHz, 5W max output). Power supply: 110-250 VAC, 50/60 Hz. Output: Monopolar. System includes handpiece with integrated generator and docking/charging station. Electrical safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2. Sterilization: Not specified.

Indications for Use

Indicated for the removal and destruction of skin lesions and coagulation of tissue in patients requiring electrosurgical procedures.

Regulatory Classification

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.

Predicate Devices

• Bovie Derm 941, Electrosurgical Generator (K161134)

Reference Devices

• K170188

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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<br>Bovie Medical Corporation, Clearwater, FL |

#### Contact Information

Misty Williams Executive Vice President of Regulatory and Clinical Affairs Phone: [phone] 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<br>devices | Equivalent |
| Packaging | Compliance with EN 22248 | Pass |

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## 4. Substantial Equivalence

| Trade Name | Submission Device | Predicate Device - Bovie DERM 941<br>Electrosurgical Generator |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Manufacturer | Berger & Kraft | Bovie Medical Corporation |
| 510(k) # | K192813 | K161134 |
| Indications | Intended for the removal and<br>destruction of skin lesions and<br>coagulation of tissue | Intended for the removal and destruction of skin<br>lesions and coagulation of tissue |
| Mode of<br>Operation | Plasma<br>Radiofrequency energy ionizes<br>the air creating a Plasma stream | Radiofrequency |
| Output | Monopolar | Monopolar |
| Power<br>Supply | 110-250 VAC<br>50/60 Hz | 100-240 VAC<br>50-60 Hz |
| Frequency | 40 kHz | 368 kHz |
| Max Output<br>Power | 5 W | 40 W |
| Output<br>Impedance | $54,000 \Omega$ | $200 \Omega$ |
| Waveform | Image: waveform | Image: waveform |
| System<br>Components | System consists of a handpiece<br>that incorporates the<br>electrosurgical generator unit,<br>docking station, and an active<br>electrode. | System consists of an electrosurgical generator unit,<br>a handpiece, and dermal tips. |
| Electrical<br>Safety<br>Standards | Complies with IEC60601-1,<br>IEC60601-1-2, IEC60601-2-2 | Complies with IEC60601-1, IEC60601-2*, and<br>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.