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.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and study information for the Plasma IQ device:

Based on the provided text, the Plasma IQ device (K223222) is stated to be the exact same device as the predicate device (K212329), with the only change being an amendment to the labeling to remove a contraindication. Therefore, the device meets the acceptance criteria by being identical to a previously cleared device.

The document explicitly states: "No performance testing data was provided in this submission other than what was provided in the predicate (K212329) to establish substantial equivalence." and "The Plasma IQ that is subject to this submission is the same device that was cleared in K212329. No changes have been made to this device."

This means that all acceptance criteria and study details would be found in the K212329 submission, not in this current K223222 document. Since the K223222 document merely refers to the predicate for performance data, the details you've asked for related to clinical studies are not present here.

Therefore, many of your requested points cannot be answered from this specific document.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

As stated, no new performance testing data was provided in this submission (K223222). The device's performance is accepted by virtue of its substantial equivalence to the predicate (K212329), which would have had its own acceptance criteria and performance data. The table below presents the comparative technical specifications provided for substantiating equivalence, which implies the acceptance of these specifications being met.

Feature	Acceptance Criteria (Predicate K212329)	Reported Device Performance (Plasma IQ K223222)
Indications	Used in the removal and destruction of skin lesions and coagulation of tissue.	Used in the removal and destruction of skin lesions and coagulation of tissue.
Mode of Operation	Plasma	Plasma
Output	Monopolar	Monopolar
Power Supply	110 - 250 VAC, 50/60 Hz	110 - 250 VAC, 50/60 Hz
Frequency	40 kHz	40 kHz
Max Output Power	5 W	5 W
Output Impedance	54,000	54,000
System Components	Handpiece with electrosurgical generator, Charging Station, two active electrode designs.	Handpiece with electrosurgical generator, Charging Station, two active electrode designs.
Electrical Safety Standards	Complies with EN60601-1, EN60601-1-2, EN60601-2-2	Complies with EN60601-1, EN60601-1-2, EN60601-2-2

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided K223222 document, as no new performance testing was conducted for this submission. This data would be found in the K212329 submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided K223222 document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided K223222 document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not available in the provided K223222 document. The device is for physical tissue treatment, not AI-assisted reading.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not available in the provided K223222 document. The device is a physical electrosurgical unit, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not available in the provided K223222 document. Clinical ground truth for electrosurgical devices often involves direct observation of treatment effectiveness (e.g., lesion removal, tissue coagulation) and safety endpoints.

8. The sample size for the training set

This information is not available in the provided K223222 document.

9. How the ground truth for the training set was established

This information is not available in the provided K223222 document.

Summary

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January 17, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Neauvia North America, Inc Joy Willard Director of Quality, Regulatory and Clinical Affairs 8480 Honeycutt Road Raleigh, North Carolina 27615

Re: K223222

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: January 10, 2023 Received: January 11, 2023

Dear Joy Willard:

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 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

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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.

Colin K. Chen -S

for

Long Chen, Ph.D. Acting 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) K223222

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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Date Prepared: October 17, 2022

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:	K212329 – Plasma IQ
Reference Device:	K201738 - Subnovii

Contact Information

Joy Willard

Director of Quality, Regulatory and Clinical Affairs

Phone: (984) 777-5296

Email: Joy@neauvia-us.com

1.Intended Use

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

2. Device Description

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3. Performance Testing

No performance testing data was provided in this submission other than what was provided in the predicate (K212329) to establish substantial equivalence.

Trade Name	Submission Device	Predicate Device K212329
Manufacturer	Berger & Kraft Medical	Berger & Kraft Medical
510(k) #	Pending	K212329
Indications	Used in the removal anddestruction of skin lesions andcoagulation of tissue.	Used in the removal and destruction ofskin lesions and coagulation of tissue.
Mode ofOperation	Plasma	Plasma
Output	Monopolar	Monopolar
PowerSupply	110 - 250 VAC50/60 Hz	110 – 250 VAC50/60 Hz
Frequency	40 kHz	40 kHz
Max OutputPower	5 W	5 W
OutputImpedance	54,000	54,000
SystemComponents	System consists of a handpiece thatincorporates the electrosurgicalgenerator unit, Charging Station andtwo active electrode designs	System consists of a handpiece thatincorporates the electrosurgicalgenerator unit, Charging Station and twoactive electrode designs
ElectricalSafetyStandards	Complies with EN60601-1, EN60601-1-2, EN60601-2-2	Complies with EN60601-1, EN60601-1-2,EN60601-2-2

4. Substantial Equivalence to the Predicate Device

5. Substantial Equivalence to the Reference Device

Trade Name	Submission Device	SubNovii
		K201738

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510K number	Pending	K201738
Mode of Operation	Plasma	Plasma
Output	Monopolar	Monopolar
Power Supply	110 - 250 VAC50/60 Hz	110 - 250 VAC50/60 Hz
Frequency	40 kHz	40 kHz
Max Output Power	5 W	5 W
Output Impedance	54,000	54,000
System Components	System consists of a handpiece that incorporates the electrosurgical generator unit, Charging Station and 2 Electrodes	System consists of a handpiece that incorporates the electrosurgical generator unit, Charging Station and 2 Electrodes
ElectricalSafety Standards	Complies with EN60601-1, EN60601-1-2, EN60601-2-2	Complies with EN60601-1, EN60601-1-2, EN60601-2-2

6. Conclusion

The Plasma IQ that is subject to this submission is the same device that was cleared in K212329. No changes have been made to this device.

The Plasma IQ is substantially equivalent to the predicate device. The intent of this submission is to amend the labeling to remove a contraindication. There are no new questions regarding safety or effectiveness raised by the change in the labeling.

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.