PlaDuo System

K232223 · ShenB Co., Ltd. · GEI · Oct 24, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K232223
• Device Name: PlaDuo System
• Applicant: ShenB Co., Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 24, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PlaDuo is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Argon handpiece is intended for the removal and destruction of skin lesions and the coagulation of tissue.

Device Story

PlaDuo System is an electrosurgical device for dermatological applications. It uses nitrogen or argon gas to generate plasma via radiofrequency energy. The device consists of a console, footswitch, two handpieces, and interchangeable tips. It is operated by a clinician in a clinical setting. The device heats the outer skin layer to induce controlled thermal damage for lesion removal or coagulation. The clinician controls the power level and gas type. The output provides precise thermal effects on tissue, aiding in hemostasis and lesion destruction. The device benefits patients by providing a controlled method for dermatological surgery.

Clinical Evidence

Bench testing only. Verification and validation activities included electrical safety (IEC 60601-1, IEC 60601-2-2), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-1). Thermal testing on ex vivo skin, liver, and muscle tissue models demonstrated that the argon gas feature achieves consistent thermal damage profiles comparable to predicate and reference devices.

Technological Characteristics

Plasma radiofrequency energy ionizes nitrogen or argon gas to create a plasma stream. Console supports two gas tanks. Patient-contacting materials (space guides) tested per ISO 10993-1. Electrical: 100-230V, 50/60Hz. Output: Nitrogen 0.5-4J, Argon 0.12-0.7J. Repetition rate: 1-3 Hz. Pulse width: Nitrogen 5-40ms, Argon 4-18ms. Software lifecycle per IEC 62304.

Indications for Use

Indicated for dermatologic and general surgical procedures requiring electrocoagulation and hemostasis; Argon handpiece indicated for removal/destruction of skin lesions and tissue coagulation.

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

• Pladuo System (K201735)

Reference Devices

• Subnovii Advanced Plasma Technology (K201738)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 24, 2023

ShenB Co Ltd % Aubrey Thompson Regulatory Consultant Hoy and Associates Regulatory Consultants 1830 Bonnie Way Sacramento, California 95825

Re: K232223

Trade/Device Name: PlaDuo System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: July 26, 2023 Received: July 26, 2023

Dear Aubrey Thompson:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.10.24
15:45:03 -04'00'

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices

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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) K232223

Device Name PlaDuo System

Indications for Use (Describe)

The PlaDuo is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Argon handpiece is intended for the removal and destruction of skin lesions and the coagulation of tissue.

Type of Use (Select one or both, as applicable)

| <div> <input checked="true" type="checkbox"/> <span>Research Use (Part 21 CFR 361.1 Subject to Review)</span> </div> |
|----------------------------------------------------------------------------------------------------------------------|
| <div> <input type="checkbox"/> <span>Therapeutic Goods Use (21 CFR part 312)</span> </div> |

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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K232223

This 510(K) Summary of safety and effectiveness for the PlaDuo System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

| Applicant<br>Address | ShenB Co., Ltd.<br>Shenb Bldg 148, Seongsui-ro<br>Seongdong-Gu, Seoul, 04796<br>Republic of Korea |
|-----------------------------------|---------------------------------------------------------------------------------------------------|
| Contact Person | Aubrey Thompson, Regulatory Consultant |
| Contact Information | [e-mail]<br>[phone] |
| Preparation Date | July 26, 2023 |
| Device Trade Name | PlaDuo System |
| 510(k) number | K232223 |
| Classification Name | Electrosurgical Cutting and Coagulation Device and Accessories |
| Regulation Number | 878.4400 |
| Product Code | GEI |
| Regulatory Class | II |
| Legally Marketed Predicate Device | Pladuo System (K201735) |

Legally Marketed Reference Device Subnovii Advanced Plasma Technology (K201738)

## Device Description:

The PlaDuo System is an electro-surgical device for use in dermatological applications. The device utilizes nitrogen and argon gas to be used separately to generate the desired power level to patients. The effect of the device is achieved by heating the outer layer of the skin so that part or all of it becomes non-viable and there is controlled damage to the underlying skin.

The PlaDuo system consists of a system console with wells for 2 gas tanks, footswitch, 2 handpieces, and tip with 3 interchangeable guides.

#### Indications for use:

The PlaDuo is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Argon handpiece is intended for the removal and destruction of skin lesions and the coagulation of tissue.

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| | Proposed Device<br>PlaDuo | Predicate Device<br>PlaDuo | Reference Device<br>SubNovii | Comparison |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The PlaDuo is intended<br>for use in dermatologic<br>and general surgical<br>procedures for<br>electrocoagulation and<br>hemostasis. The Argon<br>handpiece is intended<br>for the removal and<br>destruction of skin<br>lesions and the<br>coagulation of tissue. | The PlaDuo is<br>intended for use in<br>dermatologic and<br>general surgical<br>procedures for<br>electrocoagulation<br>and hemostasis. | The SubNovii is<br>used in the<br>removal and<br>destruction of skin<br>lesions and the<br>coagulation of<br>tissue. | The proposed PlaDuo<br>device shares the<br>indications for use<br>with its previous<br>generation device.<br>The addition of the<br>argon handpiece adds<br>the indications that<br>are identical to the<br>Subnovii device. |

# Substantial Equivalence –Technical Specifications Comparison:

| | Proposed Device<br>ShenB PlaDuo | Predicate Device<br>ShenB PlaDuo | Reference Device<br>Subnovii | Comparison |
|-----------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Mode of<br>operation | Plasma Radiofrequency<br>energy ionizes the air<br>creating a Plasma<br>stream | Plasma<br>Radiofrequency<br>energy ionizes the air<br>creating a Plasma<br>stream | Plasma<br>Radiofrequency<br>energy ionizes the<br>air creating a<br>Plasma stream | Same |
| Electrical<br>Voltage | AC 100-230V/ 50/60Hz | AC 100-230V/<br>50/60Hz | 110-250 VAC<br>50/60 Hz | Same |
| Output<br>Energy | Nitrogen Gas: 0.5 – 4J<br>Argon Gas: 0.12J - 0.7J | Nitrogen Gas: 0.5 – 4J | 5J | Same for Nitrogen,<br>No argon option on<br>predicate. See<br>discussion below for<br>Reference device<br>power level<br>difference. |
| Power<br>Consumption | 1000 VA | 1000 VA | Not listed | Same for Predicate 1 |
| Repetition<br>Rate | 1 – 3 Hz | 1 – 3 Hz | N/A | Same for Predicate 1 |
| Emitting Time | Nitrogen:<br>5 - 40ms +/- 20%<br>Argon: 4-18ms | Nitrogen: 5-40ms | N/A | Same for Predicate 1.<br>The pulse width is<br>lower with the Argon<br>because of the low<br>discharge efficiency |

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| | | | | of argon and the<br>potential for the build<br>up of heat in the<br>device with a longer<br>pulse width. |
|--------------------|---------------------------------------------------|---------------------------|-----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Gas<br>Requirement | Medical Grade Argon and<br>Medical Grade Nitrogen | Medical Grade<br>Nitrogen | Air | Different. The<br>predicate device uses<br>Nitrogen gas<br>exclusively. The<br>subject device adds<br>argon. The reference<br>device does not use a<br>medical grade gas for<br>plasma generation. |

# Performance Testing

Verification and validation activities were successfully completed and establish that the PlaDuo System control unit performs as intended. Testing included the following:

- IEC 60601-1:2005 + A1:2012; Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
- . IEC 60601-1-2:2014; Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests;
- IEC 60601-2-2:2017; Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories;
- IEC 62304:2006+A1:2015; Medical Device Software Life Cycle Processes; ●
- EN ISO 14971:2012; Medical Devices - Application Of Risk Management To Medical Devices

Biocompatibility –The only patient contacting material in the device are the space guides attached to each handpiece. Biocompatibility testing for cytotoxicity, irritation, and sensitization per ISO 10993-1:2018 are included with the submission and show now concern for patient contacting materials.

Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.

In addition, thermal testing on ex vivo tissue specimens was conducted to verify the performance of the argon gas used with the device. The Test device at stacked pulses produced measurable thermal damage in skin and in liver models and traceable thermal effect in muscle. The study demonstrated the ability of the device to achieve consistent thermal damage profiles in line with the target treatment and comparable to the profiles produced by the predicate and reference devices. Thus, it can be concluded that treatment by such a device at the appropriate testings will possess a desirable clinical treatment effect.

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## Conclusion

The PlaDuo System that is the subject of this application is a next-generation of the currently cleared PlaDuo with Nitrogen only. Besides the addition of the gas and handpiece tip for use with Argon, there have been no changes to the device. Performance testing shows that the newly added argon feature produces consistent thermal damage profiles similar to predicate and reference devices. The subject device is substantially equivalent to the predicate device for the requested indications for use.