(88 days)
Not Found
No
The document does not mention AI, ML, deep learning, neural networks, or any related terms, and the device description focuses on the physical mechanism of plasma sublimation.
Yes
The device is used for medical treatments involving the removal and destruction of skin lesions, coagulation of tissue, and hemostasis in dermatologic and general surgical procedures.
No
The device is described for "removal and destruction of skin lesions and coagulation of tissue" and "dermatologic and general surgical procedures for coagulation and hemostasis," which are therapeutic and surgical functions, not diagnostic ones.
No
The device description explicitly mentions hardware components like a radio frequency generator housed in an electrosurgical unit (handpiece) and a straight active electrode made of 316 stainless steel. It also describes a physical treatment method involving an electrical arc. While software verification and validation were conducted, the device is clearly not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- Mjolnir Pro Function: The Mjolnir Pro is described as a device used for the "removal and destruction of skin lesions and coagulation of tissue" and for "coagulation and hemostasis" in dermatologic and general surgical procedures. It directly interacts with the patient's skin and tissue using plasma technology.
- Lack of Sample Analysis: The description does not mention the device analyzing any samples taken from the body. Its function is to directly treat tissue.
Therefore, based on the provided information, the Mjolnir Pro is a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Miolnir Pro. With single-electrode plasma tip is used in the removal and destruction of skin lesions and coagulation of tissue.
Mjolnir Pro. With Multi-electrode plasma tip is intended for use in dermatologic and general surgical procedures for coagulation and hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
QVJ
Device Description
Mjolnir Pro. With single-electrode plasma tip is used in the removal and destruction of skin lesions and coagulation of tissue. With Multi-electrode plasma tip is intended for use in dermatologic and general surgical procedures for coagulation and hemostasis. Under the controllable way, the device utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the electrode tip and the skin is created by a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316 stainless steel is available with the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin (lesions)
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 tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:
ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and ANSI/AAMI A2:2010/(R)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.
ISO 10993-5 Third Edition 2009-06, Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
ISO 10993-10 Third Edition 2021-11, Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization. (Biocompatibility)
ISO 10993-23 first Edition 2021-01, Biological Evaluation of Medical Devices - Part 23: Tests for irritation. (Biocompatibility)
Performance Testing for Tissue Thermal Effect Test Report. The tests were conducted on freshly ex vivo pig tissue. Histological evaluation with Hematoxylin-Eosin (H&E) demonstrated the tissue damages by the subject device are less than 0.25mm, which is considered superficial and substantially equivalent to the tissue damages.
Performance and safety tests that demonstrate that the device meets the requirements of the design inputs, including: accuracy of power output, and intended device functionality.
Software Verification and Validation Testing was conducted per "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", and the level of concern was determined to be Moderate for the proposed device.
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.
Not Found
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 contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 20, 2024
Shenzhen Leaflife Technology Co., Ltd Qiang Cheng Regulatory Affairs Manager 4F, Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd., Baolong Industrial Area, Longgang District Shenzhen, Guangdong 518116, China
Re: K233760
Trade/Device Name: Mjolnir Pro. (Multi-electrode plasma) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: QVJ Dated: November 24, 2023 Received: November 24, 2023
Dear Qiang Cheng:
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 medical devices and radiation-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 Date: 2024.02.20 11:14:11
-05'00' Trumbore -S 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
2
Indications for Use
510(k) Number (if known) K233760
Device Name Mjolnir Pro. (Multi-electrode plasma)
Indications for Use (Describe)
Miolnir Pro. With single-electrode plasma tip is used in the removal and destruction of skin lesions and coagulation of tissue.
Mjolnir Pro. With Multi-electrode plasma tip is intended for use in dermatologic and general surgical procedures for coagulation and hemostasis.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for LEAFLIFE. The logo is in blue and green, with the word "LEAFLIFE" in blue and green letters. There is a green leaf above the word "LEAFLIFE". There are also some Chinese characters in gray below the word "LEAFLIFE".
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
l. Contact Details
Shenzhen Leaflife Technology Co., Ltd 4F, Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd., Baolong Industrial Area, Longgang Dist., Shenzhen, RP China Contact Person: Cheng Qiang Position: Regulatory Affairs Manager Phone: 086-(0)17875910506
Fax: 086-0755-27215592
| Primary Contact Person: | Cheng Qiang |
|---|---|
| Regulatory Affairs Manager | |
| Shenzhen Leaflife Technology Co., Ltd | |
| Tel: 086-0755-27216609 | |
| Fax: 086-0755-27215592 | |
| Phone: 086-(0)17875910506 | |
| Email: cq@leaflife.cn | |
| Secondary Contact Person: | Vini Zeng |
| Regulatory Affairs Specialist | |
| Shenzhen Leaflife Technology Co., Ltd | |
| Tel: 086-0755-27216609 | |
| Fax: 086-0755-27215592 |
Email: zengvini@gmial.com
Date Prepared:
5/2/2024
4
Image /page/4/Picture/0 description: The image shows the logo for LEAFLIFE. The logo consists of the word "LEAFLIFE" in a stylized font, with the first half of the word in blue and the second half in green. Above the word is a green leaf enclosed in a green arc, and to the right of the leaf are some green bubbles. Below the word are two Chinese characters in gray.
ll. Proposed Device
| Trade Name: | Mjolnir Pro. (Multi-electrode plasma) | |||
|---|---|---|---|---|
| Model(s): | LE-EPSMC | |||
| Common Name: | Low Power Electrosurgical Devices For Skin Lesion | |||
| Destruction | ||||
| Classification Name: | Electrosurgical cutting and coagulation device and | |||
| accessories. | ||||
| Regulation Number | 878.4400 | |||
| Regulation Class: | II | |||
| Product Code: | QVJ |
III. Legally Marketed Predicate Device
| Predicate device (Primary) | |
|---|---|
| 510(k) Number: | K212329 |
| Device Name: | Plasma IQ |
| Manufacturer: | Neauvia North America, Inc |
| Predicate device (1#) | |
| 510(k) Number: | K201738 |
| Device Name: | SubNovii Advanced Plasma Technology |
| Manufacturer: | Cartessa Aesthetics |
| Predicate device (2#) | |
| 510(k) Number: | K201520 |
| Device Name: | The Alma Opus System, Colibri Applicator and Tips |
| Manufacturer: | Alma Lasers Inc. |
The predicates have not been subject to a design-related recall.
IV. DEVICE DESCRIPTION SUMMARY
Mjolnir Pro. With single-electrode plasma tip is used in the removal and destruction of skin lesions and coagulation of tissue. With Multi-electrode plasma tip is intended for use in dermatologic and general surgical procedures for coagulation and hemostasis. Under the controllable way, the device utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the electrode tip and the skin is created by a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas
5
Image /page/5/Picture/0 description: The image shows the logo for LEAFLIFE. The logo is in blue and green, and it features a stylized leaf above the text. The text "LEAFLIFE" is in blue, with a green line running through the middle of each letter. Below the text is some Chinese characters.
particles in the air. A straight active electrode made of 316 stainless steel is available with the system.
V. Indications for use
Mjolnir Pro. With single-electrode plasma tip is used in the removal and destruction of skin lesions and coagulation of tissue.
Mjolnir Pro. With Multi–electrode plasma tip is intended for use in dermatologic and general surgical procedures for coagulation and hemostasis.
VI. Comparison of Indications for Use and Technological Characteristics
The Mjolnir Pro. (Multi-electrode plasma) is the same or similar to the cleared predicate devices.
The Mjolnir Pro. (Multi-electrode plasma) has the same intended use, and similar technological characteristics. Please refer to the following table for details:
6
Image /page/6/Figure/0 description: The image is a logo for a company called LEAFLIFE. The logo features the company name in a stylized font, with the letters "LEAF" in blue and "LIFE" in blue. There is a green line through the middle of the letters. Above the company name is a green arc with a leaf on top. Below the company name are two Chinese characters.
| Item | Proposed Device
K233760 | Predicate Device
K212329 (Primary) | Predicate Device (1#)
K201738 | Predicate Device (2#)
K201520 | Remark |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Device name | Mjolnir Pro (Multi-electrode
plasma) | Plasma IQ | SubNovii Advanced
Plasma Technology | The Alma Opus System,
Colibri Applicator and Tips | / |
| Product model | LE-EPSMC | | ZHFIPL-II, ZHF-IPL-III | LM-LNIRA, LM-LNIRB | / |
| K number | K233760 | K212329 | K201738 | K201520 | / |
| Product code | QVJ | GEI | GEI | GEI | Same |
| Classification
regulation | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| Indications for
use | With
Mjolnir
Pro.
single-electrode plasma tip is
used in the removal
and
destruction of skin lesions and
coagulation of tissue.
Mjolnir
Pro.
With
Multi-electrode plasma tip is
intended for use in
dermatologic and general
surgical procedures for
coagulation and hemostasis. | PLASMA IQ is used in the
removal and destruction of
skin lesions and coagulation
of tissue. | Intended for the removal
and destruction of skin
lesions and coagulation of
tissue. | The Opus Plasma Tips
(Focus and Glide), when
used with the unipolar
applicator,
are indicated
for
dermatological
procedures
requiring
ablation and resurfacing of
the skin. | Same |
| Prescription
use or not | Prescription use | Prescription use | Prescription use | Prescription use | Same |
| Item | Proposed Device
K233760 | Predicate Device
K212329 (Primary) | Predicate Device (1#)
K201738 | Predicate Device (2#)
K201520 | Remark |
| Mode of
operation | Plasma | Plasma | Plasma | Plasma | Same |
| Handle mode | Multi-electrode plasma handle:
• Single-electrode plasma tip
• Multi-electrode plasma tip
• Dot matrix shape settings:
3dots, 5dots, 9dots, 13dots,
21dots, 25dots.
Low power plasma handle,
Single tip. | Single tip | Single tip | Glide (Roller):
• Roller Rows: 6
• Diameter: 12mm
• Distance between
pixels: 1mm
• Width: 10mm
• Focus:IN and Focus:
• Diameter: 12mm
• Distance between
pixels: 1mm | Similar |
| Power supply | 110–230Va.c.
50/60Hz | 110 – 250Va.c.
50/60 Hz | 110-250Va.c.
50/60 Hz | 120VAC, 50/60Hz | Similar |
| Frequency | 40/82KHz | 40KHz | 40KHz | 40.68MHz | Similar |
| Max output
power | 5W | 5W | 5W | 5-100W | Same |
7
Image /page/7/Figure/0 description: The image is a logo for a company called LEAFLIFE. The logo is composed of the word "LEAFLIFE" in blue and green, with a green leaf above the "C" in LEAFLIFE. Below the word "LEAFLIFE" are two Chinese characters. The logo is simple and modern, and it conveys a sense of nature and health.
Discussion
As we can see from the table above, the proposed device differ slightly in terms of power supply, frequency, and system components, and this difference can be demonstrated in non-clinical trials to have no safety implications.
8
Image /page/8/Picture/0 description: The image is a logo for a company called LEAFLIFE. The logo features the company name in a stylized font, with the letters "LEAF" in blue and "LIFE" in green. There is a green leaf above the letters. Below the company name, there are two Chinese characters in gray.
In addition, there are some differences in the handle treatment heads, the main Predicate Device K212329 and K201738 have only one spot output mode (Single tip). Whereas the Proposed device has multiple disperse electrode modes in addition to one spot output mode. The source of energy is still the same as one spot, but at the end of the output, it is designed as a matrix mode, which can be overridden by the Glide (Roller) mode in the Predicate Device K201520, which belongs to the Roller mode, which is also a dot matrix output mode.
The power supply range of the proposed device is within the coverage of the predicate device. Through performance testing, it can be determined that the range of thermal damage to ex vivo animal tissue from the proposed device is the same as that of the Predicate Device. Therefore, these differences in frequency between the Predicate Device do not affect the safety and effectiveness of the device.
| Item | Proposed Device | Predicate Device
K212329 (Primary) | Predicate Device
K201738 | Predicate Device
K201520 | Remark |
|-------------------|------------------------------------|---------------------------------------------------|---------------------------------------------------|------------------------------------------------------|--------|
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | No Cytotoxicity | / | Same |
| Sensitization | No evidence of sensitization | No evidence of
sensitization | No evidence of
sensitization | / | Same |
| Irritation | No evidence of irritation | No evidence of irritation | No evidence of irritation | / | Same |
| Electrical Safety | Comply with ANSI/AAMI
ES60601-1 | Comply with ANSI/AAMI
ES60601-1, IEC 60601-2-2 | Comply with ANSI/AAMI
ES60601-1, IEC 60601-2-2 | Comply with
ANSI/AAMI ES60601-1,
IEC 60601-2-2 | Same |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC
60601-1-2 | Comply with IEC
60601-1-2 | Comply with IEC
60601-1-2 | Same |
9
Image /page/9/Picture/0 description: The image is a logo for LEAFLIFE. The logo features the word "LEAFLIFE" in blue and green, with a green leaf above the "F". There are also some green dots above the "F". Below the word "LEAFLIFE" are two Chinese characters in gray.
VII. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:
ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and ANSI/AAMI A2:2010/(R)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.
ISO 10993-5 Third Edition 2009-06, Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
ISO 10993-10 Third Edition 2021-11, Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization. (Biocompatibility)
ISO 10993-23 first Edition 2021-01, Biological Evaluation of Medical Devices - Part 23: Tests for irritation. (Biocompatibility)
Performance Testing for Tissue Thermal Effect Test Report. The tests were conducted on freshly ex vivo pig tissue. Histological evaluation with Hematoxylin-Eosin (H&E) demonstrated the tissue damages by the subject device are less than 0.25mm, which is considered superficial and substantially equivalent to the tissue damages.
Performance and safety tests that demonstrate that the device meets the requirements of the design inputs, including: accuracy of power output, and intended device functionality.
Software Verification and Validation Testing was conducted per "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", and the level of concern was determined to be Moderate for the proposed device.
10
Image /page/10/Picture/0 description: The image shows the logo for LEAFLIFE. The logo is composed of the word "LEAFLIFE" in blue, with a green arc above the word. A green leaf is attached to the arc. Below the word "LEAFLIFE" are two Chinese characters in gray.
VIII. Conclusions
This comparison of the specifications demonstrates the functional equivalence of the devices. Shenzhen Leaflife Technology Co., Ltd. believes that the Mjolnir Pro. (Multi-electrode plasma) is as safe and effective and performs in a substantially equivalent manner to the predicates.