(339 days)
No
The summary describes a standard electro-surgical device for dermatological procedures and does not mention any AI or ML capabilities.
No.
The device is an electro-surgical device used for electrocoagulation and hemostasis during dermatologic and general surgical procedures, which are considered surgical interventions rather than therapeutic treatments aimed at restoring health.
No
The device description clearly states its purpose is for "electrocoagulation and hemostasis" by "heating the outer layer of the skin" leading to "non-viable" epidermis and "controlled damage to the underlying dermis." This is a treatment, not a diagnostic, function.
No
The device description explicitly lists hardware components such as a system console, footswitch, handpieces, and tip guide, indicating it is not a software-only device.
Based on the provided information, the PlazMagik device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrocoagulation and hemostasis in dermatologic and general surgical procedures." This describes a therapeutic or surgical intervention performed directly on a patient's body.
- Device Description: The description details how the device works by "heating the outer layer of the skin" to achieve a physical effect on tissue. This is a direct interaction with the patient's body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. The PlazMagik does not perform any such analysis of specimens.
In summary, the PlazMagik is an electro-surgical device used for treating tissue directly on a patient, which falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PlazMagik is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Product codes
GEI
Device Description
The AGNES MEDICAL CO.,LTD PlazMagik is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin to that part or all or the epidermis becomes non-viable and there is controlled damage to the underlying dermis.
The PlazMagik system consists of a system console, footswitch, Two type of handpiece and tip guide.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data for the proposed device, including biocompatibility, bench testing, hardware, and software documentation shows that the device should perform as intended in the specified use. In addition, the Electromagnetic Compatibility and Electrical Safety testing shows that the device is safe.
Bench testing was conducted to assure that the PlazMagik operates safely and within predefined design specifications. Tested parameters included Output Energy and Durability of the tip.
Ex Vivo testing was conducted on three types of tissue - Liver, skin and Muscle under GLP Thermal testing.
Clinical testing is not a requirement and has not been performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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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 and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 29, 2024
Agnes Medical Co., Ltd % Sanghwa Myung Regulatory Affair Consultant E&m D-1474, 230, Simin-daero, Dongan-gu Gyeonggi-do, Gyeonggi-do 14067 Korea. South
Re: K230837
Trade/Device Name: PlazMagik Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: February 2, 2024 Received: February 2, 2024
Dear Sanghwa Myung:
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: 2024.02.29
14:11:05 -05'00'
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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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name PlazMagik
Indications for Use (Describe)
PlazMagik is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/4/Picture/2 description: The image shows the logo for Agnes Medical. The word "AGNES" is in large, sans-serif, light blue font. Below "AGNES" is a light blue line. Below the line is the word "MEDICAL" in smaller, sans-serif, light blue font.
6. 510(k) Summary - Traditional 510(K)
The assigned 510(k) Number: K230837
01. Date of Submission: 2024.02.02
02. Applicant / Submitter
AGNES MEDICAL CO.,LTD #401-402, 24 Dunchon-Daero 388beon-Gil, Jungwon-Gu, Seongnam-Si Gyeonggi, KR 13403 TEL: +82-31-8020-9716 Email: rnd@agnesmedical.com
03. Submission Correspondent
Terry Myung E&M. D-1474, 230, Simin-daero, Dongan-gu TEL: +82-70-7807-0550 Email: mshenmc@agnesmedical.com
04. Proposed Device Identification
Device Identification and Regulatory information
Proprietary Name: PlazMagik Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulation Number: 21 CFR 878.4400 Device Class: Class II Product Code: GEI Review Panel: General & Plastic Surgery
Indication for use: PlazMaqik is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
05. Predicate Device Identification
Predicate device 510(k) Number: K201735 Device Name: Pladuo System Manufacturer: ShenB Co. Ltd.
06. Device Description
The AGNES MEDICAL CO.,LTD PlazMagik is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin to that part or all or the epidermis becomes non-viable and there is controlled damage to the underlying dermis.
The PlazMagik system consists of a system console, footswitch, Two type of handpiece and tip guide.
07. Summary of Technological Characteristics Comparison
1) Predicate
| Subject Device | Predicate Device | |
|---|---|---|
| Manufacturer | AGNES MEDICAL CO.,LTD | ShenB |
| Product Name | PlazMagik | PlaDuo System |
| 510(k) Number | Not assigned | K201735 |
| Product code / | GEI | GEI |
| Regulation | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Classification | Class II | Class II |
| Indication for | ||
| use | The PlazMagik is intended for use in | |
| dermatologic and general surgical | ||
| procedures for electrocoagulation and | ||
| hemostasis. | The Pladuo is intended for use in | |
| dermatologic and general surgical | ||
| procedures for electrocoagulation and | ||
| hemostasis. | ||
| Mode of | Helium gas | Nitrogen gas |
| operation | ||
| Principal of | ||
| operation | Argon gas | |
| Plasma energy is delivered to the skin | ||
| and energy is rapidly transferred to | ||
| the skin surface. As the plasma | ||
| energy passes through the tissue it | ||
| generates an electrothermal reaction | ||
| which is capable of coagulating tissue | Plasma energy is delivered to the skin | |
| and energy is rapidly transferred to the | ||
| skin surface. As the plasma energy | ||
| passes through the tissue it generates | ||
| an electrothermal reaction which is | ||
| capable of coagulating tissue | ||
| Frequency | 24KHz | 2.54GHz |
| Max Power (w) | Single H/P: 53.3W | |
| Triple H/P 34.13W | 100 W | |
| Repetition Rate | 0.67Hz - 3Hz | 1 - 3Hz |
| Emitting Time | 100ms, 150ms, 166ms, 200ms, | |
| 250ms, 300ms, 400ms, 500ms, | ||
| 1500ms | 5 - 40ms | |
| Gas | ||
| requirement | Medical grade Helium / Medical grade | |
| Argon | Medical grade Nitrogen | |
| Electrical | ||
| voltage | AC 100-240V 50/60Hz | AC 100-230V 50/60Hz |
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Image /page/5/Picture/2 description: The image shows the logo for Agnes Medical. The logo is blue and features the word "AGNES" in a stylized font, with a line underneath. Below the line, the word "MEDICAL" is written in a smaller, sans-serif font. The overall design is clean and modern.
The subject devices are substantially equivalent to the predicate and reference devices with respect to indications for use, technology and construction. The differences between the predicate devices and the subject devices are minor and any risks have been mitigated through testing. The PlazMagik and the predicate device have same indication for use, Technology, mechanism of actions, operational principles and performance for the proposed indications for use.
The non-clinical data for proposed device, including biocompatibility, bench testing, hardware, and software documentation shows that the device should perform as intended in the specified use. In addition, the Electromagnetic Compatibility and Electrical Safety testing shows that the device is safe
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Image /page/6/Picture/2 description: The image shows the logo for AGNES MEDICAL. The word "AGNES" is in a sans-serif font with rounded edges, and it is in a light blue color. Below the word "AGNES" is a horizontal line, and below that is the word "MEDICAL" in a smaller sans-serif font, also in light blue.
to use and meets requirement.
There are no significant differences between Subject device and the predicate devices (K201735) that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics standards. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this
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Image /page/7/Picture/2 description: The image shows the logo for AGNES MEDICAL. The word "AGNES" is in a sans-serif font and is in a light blue color. Below the word "AGNES" is the word "MEDICAL" in a smaller sans-serif font and is also in a light blue color. There is a horizontal line separating the two words.
08. Non-clinical Testing Data
(1) Biocompatibility
| Test type | Standard | Results |
|---|---|---|
| Cytotoxicity | ISO 10993-05:2009, | |
| Biological evaluation of | ||
| medical devices - Part 5: | ||
| Tests for in vitro cytotoxicity | Pass | |
| Sensitization | ISO 10993-10:2010, | |
| Biological evaluation of | ||
| medical devices - Part 10: | ||
| Tests for irritation and skin | ||
| sensitization | Pass | |
| Irritation or Intracutaneous | ||
| Reactivity | ISO 10993-10:2010, | |
| Biological evaluation of | ||
| medical devices - Part 10: | ||
| Tests for irritation and skin | ||
| sensitization | Pass |
(2) Electrical Safety and electromagnetic compatibility (EMC)
Electrical safety, EMC and device-related electrical safety for high frequency were conducted on the PlazMagik according to the following consensus standards:
· IEC 60601-1:2005, AMD1:2012, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
· IEC 60101-2-2:2017, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surqical equipment and high frequency surgical accessories
· IEC 60601-1-2:2020, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic
(3) Software Verification and Validation Testing
Software verification and validation testing was conducted for the subject device, and documentation was provided in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005, commensurate with a moderate level of concern.
(4) Bench Testing
AGNES MEDICAL conducted bench testing to assure that the PlazMagik operates safely and within the predefined design specifications. Tested parameters included:
- · Output Energy
- · Durability of the tip
- (5) Ex Vivo Study
Ex Vivo testing conducted on three types of tissue - Liver, skin and Muscle under GLP Thermal testing in accordance with FDA's "Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", August 15, 2014
09. Clinical Testing
Clinical testing is not a requirement and has not been performed.
10. Substantial Equivalence Conclusion
The comparison between the subject devices and the predicate devices shows that the general information, some technical and material information are the same. Although there are some differences, the performance test reports are supported to the substantial equivalence of the subject device, the performance test reports are provided to demonstrate substantial equivalence of the
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subject devices. Therefore, we conclude that the different characteristics do not raise different questions of safety and effectiveness, and thus the subject devices are substantially equivalent to the predicate devices.