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

This document is a 510(k) Premarket Notification from the FDA regarding the Plasma IQ device. It primarily focuses on demonstrating "substantial equivalence" to previously cleared predicate devices, rather than presenting a performance study for a novel AI or diagnostic device.

Therefore, many of the requested elements for describing the acceptance criteria and study that proves a device meets acceptance criteria (especially those related to AI algorithm performance, human reader studies, and ground truth establishment for image analysis) are not applicable to this document. This document describes a device for direct physical interaction (removal and destruction of skin lesions, coagulation of tissue) using electrosurgery, not an AI or diagnostic tool.

However, I can extract information relevant to the device's technical specifications and the basis for its clearance.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance (as inferred from Substantial Equivalence)

For a device like Plasma IQ, "acceptance criteria" for FDA clearance through the 510(k) pathway are primarily demonstrating substantial equivalence to a previously cleared predicate device. This means the new device is as safe and effective as the predicate. The "study" proving this largely involves comparing technical specifications and intended use.

Inferred Acceptance Criteria for Substantial Equivalence:

Identical Intended Use: The device must have the same indications for use as the predicate.
Similar Technological Characteristics: Key physical and operational characteristics must be substantially similar.
No New Questions of Safety/Effectiveness: Any differences must not raise new safety or effectiveness concerns.

Table of Acceptance Criteria (as demonstrated by comparison to predicates) and Reported Device Performance:

Feature/Characteristic	Acceptance Criteria (from Predicate K192813 and K201738)	Reported Device Performance (Plasma IQ K212329)
Indications for Use	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 Compliance	EN60601-1, EN60601-1-2, EN60601-2-2	Complies with EN60601-1, EN60601-1-2, EN60601-2-2

Study Details (as related to Substantial Equivalence for this type of device)

Sample sizes used for the test set and the data provenance:
- N/A. This submission is for an electrosurgical device cleared via the 510(k) pathway, primarily demonstrating "substantial equivalence" to predicate devices. It states: "No performance testing data was provided in this submission other than what was provided in the predicate (K192813) to establish substantial equivalence."
- The "study" here is a comparison of technical specifications, safety standards compliance, and intended use to predicate devices. The data provenance is implied to be existing documentation and specifications of the predicate devices.
- The intent of this specific K212329 submission was to amend labeling to remove a contraindication, which was supported by clinical evidence (though not detailed here beyond this statement).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is not an AI/diagnostic device where expert "ground truth" for image data or clinical outcomes is established for a test set in the conventional sense. The "ground truth" for demonstrating substantial equivalence is the existing safety and effectiveness profiles of the cleared predicate devices, confirmed by technical comparisons.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not relevant for this type of 510(k) submission.
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:
- No. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a medical device for direct physical treatment, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this 510(k) clearance is the established safety and effectiveness of the predicate devices (K192813 and K201738) based on their prior FDA clearances and compliance with recognized standards (EN60601-1, EN60601-1-2, EN60601-2-2). The clinical evidence mentioned for the contraindication removal would refer to outcomes data from relevant studies, but these are not presented in this summary document.
The sample size for the training set:
- N/A. This is not an AI/machine learning device that uses a "training set."
How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set for this device type.

Conclusion stated in the document: "The Plasma IQ that is subject to this submission is the same device that was cleared in K192813. 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. This removal of the contradiction is supported by clinical evidence. There are no new questions regarding safety or effectiveness raised by the change in the labeling."

Summary

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December 9, 2021

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

Re: K212329

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: October 18, 2021 Received: October 19, 2021

Dear Joy Willard:

We have reviewed vour 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 mediation-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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212329

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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510K Summary Plasma IQ K212329

Date Prepared: December 7, 2021

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:Reference Device:	K192813 – Plasma IQK201738 - Subnovii
Contact Information
	Joy WillardDirector of Quality, Regulatory and Clinical Affairs
	Phone: (984) 777-5296Email: 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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510K Summary Plasma IQ K212329

3. Performance Testing

No performance testing data was provided in this submission other than what was provided in the predicate (K192813) to establish substantial equivalence.

Trade Name	Submission Device	Predicate Device K192813
Manufacturer	Berger & Kraft Medical	Berger & Kraft Medical
510(k) #	K212329	K192813
Indications	Used in the removal anddestruction of skin lesions andcoagulation of tissue.	Used in the removal and destruction ofskin lesions andcoagulation of tissue.
Mode of Operation	Plasma	Plasma
Output	Monopolar	Monopolar
Power	110 – 250 VAC	110 – 250 VAC
Supply	50/60 Hz	50/60 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 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
ElectricalSafety Standards	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

న్. Substantial Equivalence to the Reference Device

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510K Summary Plasma IQ K212329

Trade Name	Submission Device	SubNoviiK201738
510K number	K212329	K201738
Mode ofOperation	Plasma	Plasma
Output	Monopolar	Monopolar
PowerSupply	110 – 250 VAC50/60 Hz	110 – 250 VAC50/60 Hz
Frequency	40 kHz	40 kHz
MaxOutputPower	5 W	5 W
OutputImpedance	54,000	54,000
SystemComponents	System consists of a handpiece thatincorporates the electrosurgicalgenerator unit, Charging Station and 2Electrodes	System consists of a handpiece thatincorporates the electrosurgical generatorunit, Charging Station and 2 Electrodes
ElectricalSafetyStandards	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 K192813. 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. This removal of the contradiction is supported by clincial evidence. 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.