Plexr Plus 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 high frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A stainless steel straight disposable active sterilized tip is not available with the system and is not supplied by the company. Three cordless handpieces with three fixed powers are charged in a docking/charging station prior to use.

AI/ML Overview

The provided document does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device.

The document is a 510(k) premarket notification for a medical device called PLEXR PLUS, which is an electrosurgical cutting and coagulation device. The focus of this submission is to demonstrate substantial equivalence to a predicate device (Plasma IQ), not to prove performance against specific acceptance criteria using a clinical study as would be typical for an AI/ML device.

Here's what the document does discuss regarding performance and comparison:

Performance Testing:
The document mentions that the following performance testing was conducted to prove compliance with performance requirements and support substantial equivalence:

Electrical: Compliance with EN 60601-1 (Pass) and EN 60601-1-2 (Pass).
Tissue Testing: Compare thermal spread of devices (Result: Equivalent).
Packaging: Compliance with EN 22248 (Pass).

Substantial Equivalence:
The primary study presented is a comparison to a predicate device (Plasma IQ) to demonstrate substantial equivalence, not to meet specific performance acceptance criteria for a novel AI/ML function. The comparison charts highlight device characteristics and explain differences:

Intended Use: Same
Indications for Use: Same
Mode of Operation: Same (Plasma, Radiofrequency energy ionizes air)
Output: Monopolar (Same)
Power Supply: Same power input parameters
Frequency: PLEXR PLUS (80 kHz) vs. Plasma IQ (40 kHz). The document states: "The output frequency is substantially the same in the electromagnetic spectrum. The minimal difference does not impact the efficacy of safety at all."
Max Output Power: PLEXR PLUS (2 W) vs. Plasma IQ (5 W). The document states: "The output power is not linear, and it is calculated as P=V²/R, so 3 W of difference is not impacting the efficacy and the safety of the device."
Output Impedance: PLEXR PLUS (60,000 Ω) vs. Plasma IQ (54,000 Ω). The document states: "The output impedance is substantially the same."
Wave Form: Sinusoidal for both with similar amplitudes and frequencies.
System Components: PLEXR PLUS has three different wireless handpieces with fixed power each, while Plasma IQ has one wireless handpiece with two buttons for choosing fixed power. The document states: "The operation is the same, just the configuration is different."
Tips/Raw Materials/Electrical Safety Standards: Same.

Missing Information:

The document does not provide the following information relevant to your request for AI/ML device study details:

A table of acceptance criteria and the reported device performance (for an AI/ML function): The "Tissue Testing" result of "Equivalent" is very broad and doesn't provide specific numerical performance metrics.
Sample size used for the test set and the data provenance: Not applicable to this type of device comparison.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not explicitly stated beyond "Tissue Testing" leading to an "Equivalent" finding. This suggests some form of experimental comparison rather than a ground truth derived from expert consensus, pathology, or outcomes data in a clinical setting.
The sample size for the training set: Not applicable (this is not an AI/ML device).
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 22. 2022

GMV S.r.l. Andrea Cancelli OA Manager Via Roberto Parabeni 37 Rome 00173 Italy

Re: K210693

Trade/Device Name: PLEXR PLUS Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 19, 2022 Received: January 25, 2022

Dear Andrea Cancelli:

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) K210693

Device Name PLEXR PLUS

Indications for Use (Describe)

Plexr Plus 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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510 (k) SUMMARY

SUBMITTER INFORMATION

A. Company Name:	GMV S.r.l.
B. Company Address:	Via Roberto Paribeni, 3700173 Rome -Italy
C. Company Phone:Company Fax:Company e-mail:	+39-06 94315964+39 06 98380555info@gruppogmv.it
D. Contact person:	Andrea CancelliQA ManagerGMV S.r.l.
E. Date Summary Prepared:	2nd March 2021
DEVICE IDENTIFICATION
A. Device Name:	PLEXR PLUS
B. Common Name:	Electrosurgical, Cutting & Coagulation &Accessories
C. Classification:	Class II
D. Product Code:	GEI

E. Submission Type: 510k (Original Submission)

LEGALLY MARKETED PREDICATE DEVICE

E. Regulation Number:

Primary predicate device	510 (k) Holder	510 (k) No.
Plasma IQ	Neauvia North America, Inc	K192813

878.4400

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DEVICE DESCRIPTION

Performance Testing and data

The following performance testing was conducted to prove compliance with performance requirements and support substantial equivalence:

Test	Objective	Result
Electrical	Compliance with EN 60601-1	Pass
	Compliance with EN 60601-1-2	Pass
Tissue Testing	Compare thermal spread of devices	Equivalent
Packaging	Compliance with EN 22248	Pass

Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.

INDICATIONS FOR USE STATEMENT

Plexr Plus is used in the removal and destruction of skin lesions and coagulation of tissue.

SUBSTANTIAL EQUIVALENCE

All information provided with the present submission supports the substantial equivalence for PLEXR PLUS with the predicate device and its accessories that have identical characteristics and intended use and similar indication statement. In addition all clinical data and all performance tests that have been performed in accordance with the Standards for the Software Evaluation and for the Electrical and Electromagnetic Safety test, demonstrate PLEXR PLUS's safety and effectiveness for its intended use.

The following matrix illustrates the equivalencies of PLEXR PLUS, as well as the substantial equivalent predicate device.

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PREDICATE DEVICES COMPARISON CHART

Table 1

COMPARISON CHART PLEXR PLUS		Explanation ofDifferences betweenthe devices
	GMV S.r.l.PLEXR PLUSNew Device	Berger & KraftPLASMA IQPredicate device
"K" NUMBERS	K210693	K192813
Proprietary name	PLEXR PLUS	PLASMA IQ
CFR Section	878.4400	878.4400	none
Pro-code	GEI	GEI	none
Intended Use	Intended for use duringnon-invasive surgery. Isintended for use only inprofessional health caresettings.	Intended for use during non-invasive surgery. Is intendedfor use only in professionalhealth care settings.	Same intended use
Indications foruse	Intended for the removaland destruction of skinlesions and coagulation oftissue	Intended for the removaland destruction of skinlesions and coagulation oftissue	Same indications for use
Mode ofoperation	PlasmaRadiofrequency energyionizes the air creating aPlasma stream	PlasmaRadiofrequency energy ionizesthe air creating a Plasmastream	Same mechanism ofaction
Output	Monopolar	Monopolar	Same kind of output
Power Supply	100-240VAC50/60Hz	110-250 VAC50/60 Hz	Same power inputparameters
Frequency	80 kHz	40 kHz	The output frequency issubstantially the same inthe electromagneticspectrum. The minimaldifference does notimpact the efficacy ofsafety at all.
Max OutputPower	2 W	5 W	The output power is notlinear, and it iscalculated as P=V²/R, so3 W of difference is notimpacting the efficacyand the safety of thedevice.
Output	60,000 Ω	54,000 Ω	The output impedance is
Impedance			substantially the same.
Wave form	Image: waveform	Image: waveform	The waveform is sinusoidal for both the devices with similar amplitudes and frequencies.
System Components	System consists of a docking station and three handpieces	System consists of a handpiece that incorporates the electrosurgical generator unit, docking station, and an active electrode.	Plasma IQ presents one wireless handpiece with two buttons for choosing the fixed power output.Plexr Plus has three different wireless handpieces with a fixed power each. The operation is the same, just the configuration is different.
Tips	Needle electrode	Needle electrode	Same
Raw Materials	Tips: stainless steelBox and Handpieces: ABS	Tips: stainless steelBox and Handpieces: ABS	Same
Electrical Safety Standards	Complies with IEC60601-1, IEC60601-1-2, IEC60601-2-2	Complies with IEC60601-1, IEC60601-1-2, IEC60601-2-2	Same

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TECHNICAL CHARACTERISTICS

A comparison of the technological characteristics of PLEXR PLUS and the predicate device has been performed. The results of this comparison demonstrate that the technologic characteristics and the operating principle of PLEXR PLUS are the same or very similar to those of the claimed predicate device. Where any differences arise from the analysis of the predicate device characteristics and those of the device subject of this submission, the clinical data evaluated from scientific publications give scientific evidence of the safety and the effectiveness of PLEXR PLUS. The system was evaluated and found compliant with IEC 60601-1 for electrical safety, IEC 60601-1-2 for IEC60601-1-2, IEC60601-2-2, and 10993-1 for biocompatibility of the treatment tips. Verification and validation data show that the device meets all product specifications.

CONCLUSION

Based on the foregoing, the PLEXR PLUS is substantially equivalent to the legally marketed, claimed predicate devices for the purposes of this 510(k) submission. Safety and effectiveness were reasonably assured, justifying 510 (k) clearance.

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.