(612 days)
No
The device description focuses on the physical mechanism of plasma generation and tissue sublimation, with no mention of AI or ML algorithms for analysis, control, or decision-making. The performance studies are bench tests related to safety and functional requirements, not AI/ML performance metrics.
Yes
The device is intended for "removal and destruction of skin lesions and coagulation of tissue," directly addressing a therapeutic purpose.
No
The device is described as being used for the "removal and destruction of skin lesions and coagulation of tissue," and it "uses plasma energy" to cause excess skin to "sublimate." These are all therapeutic actions, not diagnostic ones. There is no mention of the device identifying, analyzing, or classifying any medical condition.
No
The device description explicitly details hardware components including a handpiece, charger, internal battery, and electrode tip, which are integral to its function of generating plasma energy for skin lesion removal.
Based on the provided information, the PLAXPOT™ MULTI PLASMA is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "removal and destruction of skin lesions and coagulation of tissue." This is a direct treatment applied to the patient's skin, not a test performed on a sample taken from the body.
- Device Description: The description details a device that generates plasma energy to act directly on the skin tissue. It does not describe a device that analyzes biological samples (like blood, urine, tissue biopsies, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as reagents, sample handling, or analytical measurements of biological markers.
In summary, the PLAXPOT™ MULTI PLASMA is a therapeutic device that uses plasma energy for skin treatment, not a diagnostic device that analyzes samples to provide information about a patient's health status.
N/A
Intended Use / Indications for Use
PLAXPOT™ MULTI PLASMA is intended for the removal and destruction of skin lesions and coagulation of tissue.
Product codes (comma separated list FDA assigned to the subject device)
QVJ
Device Description
PLAXPOT™ MULTI PLASMA is a device that consists of a handpiece which is the main body and a charger (charging cradle, and power adapter). The high frequency current is exposed to the air and the air is ionized. The electrode tip can perform treatment without direct contact with the tissue.
After the power is applied through the internal battery, the mode is set and the Shot button is pressed, a high voltage alternating current pulse is released according to the set value, and the air is ionized to form a plasma arc.
This device uses plasma energy. This causes excess skink and sublimate (direct passage from the solid to the gaseous state of matter) without affecting the deeper skin layers. The difference in potential distance between device's handpiece and the skin represents the area where the voltaic arc will take place. In this gap, the gases in the air are ionized, thus Plasma is generated. The tissues touched by plasma "sublime" without heat transfer to other unwanted tissues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance bench tests of PLAXPOT™ MULTI PLASMA have been performed, see Table 2. The results from the performance bench testing demonstrate that PLAXPOT™ MULTI PLASMA has met the functional requirements and is substantially equivalent to the predicate device. Performance bench testing is provided in detail.
| Study | Attachment | Test Method | Results |
|---|---|---|---|
| Basic Safety and | |||
| Essential Performance | 18-3 | EN 60601- | |
| 1:2006+A1:2013 or EN | |||
| 60601- | |||
| 1:2006+A12:2014 and | |||
| test report | |||
| IEC60601_1K | Pass | ||
| Manufacturer | |||
| Technical File | 18-5 | N/A | Pass |
| EMC Test | 18-6 | IEC 60601-1-2:2014 | Pass |
| EMC Test | 18-7 | IEC 60601-1-2:2014 | Pass |
| Thermal Effects Test | NA | FDA Submissions for | |
| Electrosurgical Devices | |||
| for General Surgery | Pass |
Key results: All studies passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 27, 2023
GCS Co. Limited % Su Kyung Park Director Compliance Insight 497 Circle Freeway Dr. Unit 230 West Chester, Ohio 45246
Re: K220493
Trade/Device Name: Plaxpot Multi Plasma Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: QVJ Dated: [NOTE: Use date of most recent supplement] Received: September 29, 2023
Dear Su Kyung Park:
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" (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).
1
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, Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.10.27
16:19:00 -04'00' Mark Trumbore, 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
2
Indications for Use
510(k) Number (if known) K220493
Device Name PLAXPOT™ MULTI PLASMA
Indications for Use (Describe) PLAXPOT™ MULTI PLASMA is intended for 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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3
PLAXPOT™ MULTI PLASMA
510(k) Summary
General Information 5.1
18 February 2022 Preparation Date:
26 October 2023 Revision Date:
Submitter/Holder
Su Kyung, Park
Director
GCS Co., Ltd. #1008, 555, Dunchon-daero, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea Tel: 82-2-555-1536 Fax : 82-2-3142-7670 Email: kara21c(@gcsgroup.co.kr
Website: http://www.bestgcs.com/
Primary Contact
Cynthia Ipach President/CEO
Email: cipach@compliance-insight.com
Office +1 513-860-3512 ext. 306 Compliance Insight 497 Circle Freeway Dr Suite 230. Cincinnati, OH 45246
5.2 Regulatory Information
| Subject Device Trade Name | PLAXPOT TM MULTI PLASMA |
|---|---|
| Classification Name | Low Power Electrosurgical Devices For Skin Lesion |
| Destruction | |
| Device Classification | II |
| Regulation Description | Electrosurgical cutting and coagulation device and |
| accessories | |
| FDA Product Code | QVJ |
| CFR References | 21 CFR 878.4400 |
| Review Panel | General & Plastic Surgery |
4
5.3 Identification of Predicate Devices
The primary predicate device for PLAXPOT™ MULTI PLASMA is the SubNovii Advanced Plasma Technology (K201738) and the reference device is Plasma IQ (K192813).
5.4 Subject Device Description
PLAXPOT™ MULTI PLASMA is a device that consists of a handpiece which is the main body and a charger (charging cradle, and power adapter). The high frequency current is exposed to the air and the air is ionized. The electrode tip can perform treatment without direct contact with the tissue.
After the power is applied through the internal battery, the mode is set and the Shot button is pressed, a high voltage alternating current pulse is released according to the set value, and the air is ionized to form a plasma arc.
This device uses plasma energy. This causes excess skink and sublimate (direct passage from the solid to the gaseous state of matter) without affecting the deeper skin layers. The difference in potential distance between device's handpiece and the skin represents the area where the voltaic arc will take place. In this gap, the gases in the air are ionized, thus Plasma is generated. The tissues touched by plasma "sublime" without heat transfer to other unwanted tissues.
ર્સ્ટ Indications for Use
PLAXPOT™ MULTI PLASMA is intended for the removal and destruction of skin lesions and coagulation of tissue.
Substantial Equivalence Discussion 5.6
In Table 1 on the following page please find a characteristics comparison summary. The review of the indications for use and comparison characteristics provided in Table 1 demonstrate that PLAXPOT™ MULTI PLASMA is substantially equivalent to the primary predicate device, the SubNovii Advanced Plasma Technology K201738.
5
| Device
Characteristics | Proposed
Device | Primary
Predicate | Reference
Device |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Product Name | PLAXPOTTM
MULTI PLASMA | SubNovii
Advanced
Plasma
Technology | Plasma IQ |
| 510(k) | K220493 | K201738 | K192813 |
| Manufacturer | GCS Co. Ltd. | Cartessa
Aesthetics | Neauvia North
America |
| FDA Product
Code | QVJ | GEI | GEI |
| CFR Reference | 878.4400 | 878.4400 | 878.4400 |
| Device Class | II | II | II |
| Prescription or
OTC | Prescription | Prescription | Prescription |
| Implanted
Device | No | No | No |
| Indications for
Use Statement | PLAXPOT™
MULTI PLASMA
is intended for the
removal and
destruction of skin
lesions and
coagulation of
tissue. | The SubNovii is
intended for the
removal and
destruction of
skin lesions and
coagulation of
tissue. | Plasma IQ is
used in the
removal and
destruction of
skin lesions and
coagulation of
tissue. |
| Mode of
Operation | Plasma high
frequency current
ionizing 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. |
| Output Mode | Continuous | Continuous | Continuous |
| Energy Type | High Frequency | High Frequency | High Frequency |
| Power Level | 3 modes at 0.7W,
1W, 2W | Max 5W | Max 5W |
| Reusable or
Single Use | Reusable | Reusable | Reusable |
| Output | Monopolar | Monopolar | Monopolar |
| Max Power
Output | 3W | 5W | 5W |
| Power Supply | Internal
Rechargeable
Lithium Ion
Battery 7.4 VDC
1000mAh | Internal
Rechargeable
Lithium Ion
Battery 11.1
VDC | Internal
Rechargeable
Lithium Ion
Battery 11.1
VDC |
| Frequency | 70 kHz | 40kHz | 40kHz |
| System
Components | A handpiece that
incorporates the
electrosurgical
generator unit,
OLED display,
software, and
docking station. | A handpiece that
incorporates the
electrosurgical
generator unit,
docking station
and an active
electrode. | A handpiece
that
incorporates the
electrosurgical
generator unit,
docking station
and an active
electrode. |
| Electrical
Safety
Standards | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2 |
| Software | Yes | No | No |
| Software
Compliance | IEC 62304 | N/A | N/A |
Table 1. Summary Comparison of Characteristics
6
PLAXPOT™ MULTI PLASMA
5.7 Sterilization and Shelf Life
The PLAXPOT™ MULTI PLASMA is sold non-sterile.
7
Shelf-life is not applicable because of low likelihood of time-dependent product degradation.
Performance Testing - Bench 5.8
Performance bench tests of PLAXPOT™ MULTI PLASMA have been performed, see Table 2. The results from the performance bench testing demonstrate that PLAXPOT™ MULTI PLASMA has met the functional requirements and is substantially equivalent to the predicate device. Performance bench testing is provided in detail.
| Study | Attachment | Test Method | Results |
|---|---|---|---|
| Basic Safety and | |||
| Essential Performance | 18-3 | EN 60601- | |
| 1:2006+A1:2013 or EN | |||
| 60601- | |||
| 1:2006+A12:2014 and | |||
| test report | |||
| IEC60601_1K | Pass | ||
| Manufacturer | |||
| Technical File | 18-5 | N/A | Pass |
| EMC Test | 18-6 | IEC 60601-1-2:2014 | Pass |
| EMC Test | 18-7 | IEC 60601-1-2:2014 | Pass |
| Thermal Effects Test | NA | FDA Submissions for | |
| Electrosurgical Devices | |||
| for General Surgery | Pass |
Table 2. Performance Testing Summary
5.9 Conclusion
The subject device PLAXPOT™ MULTI PLASMA has the same technology, principle of operation, indications for use and technical specifications as the primary predicate device Subnovii and the reference device Plasma IQ. PLAXPOT™ MULTI PLASMA shares a substantially equivalent design, indications for use and technology (i.e. features, materials, and principles of operation) as the predicate device and no new elements pertaining to safety or effectiveness have been identified. Performance test results demonstrate that the subject device can perform the same intended use as safely as the predicate and reference devices. Therefore, the subject device is substantially equivalent to the predicate.