(90 days)
No
The summary describes a standard electro-surgical device and does not mention any AI or ML components or functionalities. The testing described is for electrical safety, software validation, and thermal effects, not AI/ML performance.
Yes.
The device is used for electrocoagulation, hemostasis, removal and destruction of skin lesions, and coagulation of tissue, all of which are therapeutic medical procedures.
No
The device description and intended use state that the PlaDuo system is an electro-surgical device used for electrocoagulation, hemostasis, and the removal/destruction of skin lesions, which are therapeutic procedures, not diagnostic.
No
The device description explicitly lists hardware components such as a system console, gas tanks, footswitch, handpieces, and tips. While software verification and validation are mentioned, the device is clearly a physical electro-surgical system with integrated software, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "electrocoagulation and hemostasis" and the "removal and destruction of skin lesions and the coagulation of tissue" in surgical procedures. This describes a therapeutic or surgical intervention performed directly on the patient's body.
- Device Description: The description details an "electro-surgical device" that uses gas to generate power and heat the skin. This is consistent with a surgical tool, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to directly treat tissue.
- Performance Studies: The performance studies focus on electrical safety, software validation, biocompatibility of patient-contacting materials, and thermal effects on ex vivo tissue. These are all relevant to a surgical device, not an IVD.
In summary, the PlaDuo System is a surgical device used for therapeutic purposes, not a device used to perform diagnostic tests on samples outside the body.
N/A
Intended Use / 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.
Product codes
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 no 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.
Key Metrics
Not Found
Predicate Device(s)
Pladuo System (K201735)
Reference Device(s)
Subnovii Advanced Plasma Technology (K201738)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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"
1
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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)
| Research Use (Part 21 CFR 361.1 Subject to Review) |
|---|
| Therapeutic Goods Use (21 CFR part 312) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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4
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
Address | ShenB Co., Ltd.
Shenb Bldg 148, Seongsui-ro
Seongdong-Gu, Seoul, 04796
Republic of Korea |
|-----------------------------------|---------------------------------------------------------------------------------------------------|
| Contact Person | Aubrey Thompson, Regulatory Consultant |
| Contact Information | aubreythompson@hoyregulatory.com
(323)533-8994 |
| 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.
5
| | Proposed Device
PlaDuo | Predicate Device
PlaDuo | Reference Device
SubNovii | Comparison |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The PlaDuo is
intended for use in
dermatologic and
general surgical
procedures for
electrocoagulation
and hemostasis. | The SubNovii is
used in the
removal and
destruction of skin
lesions and the
coagulation of
tissue. | The proposed PlaDuo
device shares the
indications for use
with its previous
generation device.
The addition of the
argon handpiece adds
the indications that
are identical to the
Subnovii device. |
Substantial Equivalence –Technical Specifications Comparison:
| | Proposed Device
ShenB PlaDuo | Predicate Device
ShenB PlaDuo | Reference Device
Subnovii | Comparison |
|-----------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Mode of
operation | Plasma Radiofrequency
energy ionizes the air
creating a Plasma
stream | Plasma
Radiofrequency
energy ionizes the air
creating a Plasma
stream | Plasma
Radiofrequency
energy ionizes the
air creating a
Plasma stream | Same |
| Electrical
Voltage | AC 100-230V/ 50/60Hz | AC 100-230V/
50/60Hz | 110-250 VAC
50/60 Hz | Same |
| Output
Energy | Nitrogen Gas: 0.5 – 4J
Argon Gas: 0.12J - 0.7J | Nitrogen Gas: 0.5 – 4J | 5J | Same for Nitrogen,
No argon option on
predicate. See
discussion below for
Reference device
power level
difference. |
| Power
Consumption | 1000 VA | 1000 VA | Not listed | Same for Predicate 1 |
| Repetition
Rate | 1 – 3 Hz | 1 – 3 Hz | N/A | Same for Predicate 1 |
| Emitting Time | Nitrogen:
5 - 40ms +/- 20%
Argon: 4-18ms | Nitrogen: 5-40ms | N/A | Same for Predicate 1.
The pulse width is
lower with the Argon
because of the low
discharge efficiency |
6
| | | | | of argon and the
potential for the build
up of heat in the
device with a longer
pulse width. |
|--------------------|---------------------------------------------------|---------------------------|-----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Gas
Requirement | Medical Grade Argon and
Medical Grade Nitrogen | Medical Grade
Nitrogen | Air | Different. The
predicate device uses
Nitrogen gas
exclusively. The
subject device adds
argon. The reference
device does not use a
medical grade gas for
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.
7
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.