The Plasma Pen utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the disposable tip and the skin is created by a radio frequency generator housed in an electrosurqical unit (handpiece) that ionizes the gas particles in the air. A straight disposable tip is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.

The system components include the following:

Plasma Pen (Plasma MD (with 2 level switch) and Plasma+ (without switch)
Docking station for Plasma Pen
Cable for Plasma Pen
Power bank battery
Cable for power bank battery
Charging Block

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Plasma Pen (Plasma MD and Plasma +) device. It details the device's characteristics, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, the document does not contain the specific information requested regarding acceptance criteria, a study that proves the device meets those criteria, or details about test sets, ground truth establishment, or expert involvement.

The document focuses on demonstrating substantial equivalence to an existing predicate device (SubNovii Advanced Plasma Technology, K201738) based on similar indications for use, mode of operation, and performance characteristics. The "performance data" mentioned refers to non-clinical bench testing, not a clinical study involving human patients or complex AI-driven analysis.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in the format of a clinical study with metrics like sensitivity, specificity, or AUC. Instead, it compares characteristics and performance benchmarks against a predicate device to claim substantial equivalence. The closest to "acceptance criteria" are the "SAME" or "DIFFERENT" conclusions for various characteristics and the damage depth for thermal effects.

Characteristic	Acceptance Criteria (from Predicate)	Reported Device Performance (Plasma Pen)	Met Criteria? (Substantial Equivalence)
Indications for Use	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.	SAME
Prescription or OTC	Prescription	Prescription	SAME
Mode of Operation	Plasma; Radiofrequency energy ionizes the air creating a plasma stream	Plasma; Radiofrequency energy ionizes the air creating a plasma stream	SAME
Output	Monopolar	Monopolar	SAME
Power Supply	110-250 VAC 50/60 Hz	110-250 VAC 50/60 Hz	SAME
Frequency	40 kHz	40 kHz	SAME
Max Power Output	5W	2W	DIFFERENT (Lower max power output, with intended effect still achievable)
System Components	Handpiece, electrosurgical generator unit, docking station, active electrode.	Handpiece, electrosurgical generator unit, docking station, active electrode.	SAME
Thermal Effects on 4 porcine tissues (liver, kidney, muscle and skin) per FDA Guidance "Premarket Notification (510(K)) Submission for Electrosurgical Devices for General Surgery" (Damage Depth)	Damage depth of <0.25mm	Damage depth of <0.25mm	SAME
Electrical Safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2)	Compliance with standards demonstrating basic safety, essential performance, emissions, and immunity.	Demonstrated appropriate electrical safety and electromagnetic compatibility profile.	Met (Passed)
Electrical system performance	Not explicitly quantified, but expected to meet functional requirements.	Performance was met.	Met
Output waveform at the rated load	Not explicitly quantified, but expected to be appropriate for intended function.	Performance was met.	Met

2. Sample size used for the test set and the data provenance:

Sample size for bench testing: Not specified. The thermal effects testing mentions "4 porcine tissues," but not the number of samples or repetitions.
Data provenance: Not applicable in the context of clinical data for AI performance. The performance testing is "bench/performance testing" and involves "porcine tissues" for thermal effects, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is an electrosurgical tool, not an AI-driven diagnostic device requiring expert interpretation for ground truth. The "ground truth" for its performance is derived from physical measurements (e.g., damage depth, electrical safety compliance) and comparison to a predicate device's established performance.

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

Not applicable. No expert adjudication process for image interpretation or diagnosis.

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:

No. This is not an AI-assisted diagnostic device. The study described is non-clinical bench testing.

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

No. This is a hardware device.

7. The type of ground truth used:

Bench test measurements and compliance with electrical safety standards. For thermal effects, the ground truth is the measured damage depth in porcine tissues. For electrical safety, the ground truth is compliance with the specified IEC standards. Substantial equivalence relies on comparing these performance characteristics to the predicate device.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or AI that requires a training set.

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

Not applicable. No training set for AI.

In summary, the provided document describes a 510(k) submission for an electrosurgical device, focused on demonstrating substantial equivalence based on physical characteristics and non-clinical bench testing. It does not involve an AI component or complex clinical study with human patients, which are the typical contexts for the detailed acceptance criteria and study designs outlined in your request.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 2, 2023

Plasma Concepts % Richelle Helman Senior Regulatory Consultant MEDIcept, LLC 200 Homer Avenue Ashland, Massachusetts 01721

Re: K223440

Trade/Device Name: Plasma Pen (Plasma MD); Plasma Pen (Plasma +) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: OVJ Dated: February 6, 2023 Received: February 6, 2023

Dear Richelle Helman:

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 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

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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 (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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and -CDRH Learn (https://www.fda.gov/training-and-continuing-education/odrh-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-devices/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,

Mark	Digitally signed by
Trumbore -S	Mark Trumbore -SDate: 2023.03.02
	13:29:42 -05'00'

On behalf of 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) K223440

Device Name Plasma Pen (Plasma MD); Plasma Pen (Plasma +)

Indications for Use (Describe)

The Plasma MD or Plasma + is intended for 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Date:	22-February-2023
Company:	Plasma Concepts800 W Cummings ParkWoburn, MA 01801Phone: (617) 519-5570
Official Contact:	Richelle HelmanSenior Regulatory Consultant
Proprietary or Trade Name:	Plasma MD and Plasma +
Common/Usual Name:	Electrosurgical cutting and coagulation device and accessories
Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number:	21 CFR 878.4400, Class IIClassification Product Code: GEI
Predicate Device:	K201738: SubNovii Advanced Plasma Technology

Device Description:

The system components include the following:

1. Plasma Pen (Plasma MD (with 2 level switch) and Plasma+ (without switch)
1. Docking station for Plasma Pen
1. Cable for Plasma Pen
1. Power bank battery
1. Cable for power bank battery
1. Charging Block

Image /page/3/Picture/12 description: The image shows six different objects, each labeled with a number from 1 to 6. Object 1 is a pen-like device, while object 2 is a stand. Objects 3 and 5 are cables with USB connectors on one end. Object 4 is a rectangular device with four small dots on its surface, and object 6 is a small, rectangular adapter.

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Indications for Use:

The Plasma MD or Plasma + is intended for the removal and destruction of skin lesions and coagulation of tissue.

Substantial Equivalence:

The Plasma Concepts Plasma Pen is substantially equivalent to the predicate device, the SubNovii Advanced Plasma Technology (510(k) K201738). The table below presents the similarities and differences between the products for substantial equivalence purposes. The differences between the subject device and the predicate device do not raise any new issues of safety and effectiveness. Performance data are available to support substantial equivalence.

Characteristic	Subject Device:Plasma Pen	Predicate Device:SubNovii AdvancedPlasma Technology[510(k) K201738]	SubstantialEquivalence
Indications for Use	Intended for the removaland destruction of skinlesions and coagulationof tissue.	Intended for the removaland destruction of skinlesions and coagulationof tissue.	SAME
Prescription or OTC	Prescription	Prescription	SAME
Mode of Operation	PlasmaRadiofrequency energyionizes the air creating aplasma stream	PlasmaRadiofrequency energyionizes the air creating aplasma stream	SAME
Output	Monopolar	Monopolar	SAME
Power Supply	110-250 VAC 50/60 Hz	110-250 VAC 50/60 Hz	SAME
Frequency	40 kHz	40 kHz	SAME
Max Power Output	2W	5W	DIFFERENTThe subject device has alower max power output,with intended effect stillachievable. Refer totable SE.2 below foradditional details.
System Components	System consists of ahandpiece thatincorporates theelectrosurgical generatorunit, docking station, andan active electrode.	System consists of ahandpiece thatincorporates theelectrosurgical generatorunit, docking station, andan active electrode.	SAME

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Characteristic	Subject Device:Plasma Pen	Predicate Device:SubNovii AdvancedPlasma Technology[510(k) K201738]	SubstantialEquivalence
Thermal Effects on 4porcine tissues (liver,kidney, muscle and skin)per FDA GuidancePremarket Notification(510(K)) Submission forElectrosurgical Devices forGeneral Surgery	Damage depth of<0.25mm	Damage depth of<0.25mm	SAME

From the comparison form above, the subject device and predicate device have similar intended use, are both prescription use, and have the same operating principle and method of removing and destroying skin lesions and coagulating tissue. The differences in the devices do not raise different questions of safety or effectiveness.

Non-clinical performance testing:

Electrical Safety:

Electrical safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-2 to demonstrate the basic safety, essential performance and emissions and immunity characteristics of the device. The testing demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device.

Bench / Performance Testing -

Comparative performance testing included:

. Electrical system performance
Output waveform at the rated load
Testing for thermal effects on tissue in accordance with FDA Guidance "Premarket . Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery"

The results demonstrated that the device performance was met and was substantially equivalent to the predicate device.

Substantial Equivalence Conclusion

The Plasma Concepts Plasma MD and Plasma + devices have the same technology, principle of operation and indications for use as the predicate device. The performance testing demonstrated that the subject device can perform the same intended use as safely and effectively as the predicate device. Therefore, the subject device is substantially equivalent to the predicate device.

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.