(248 days)
No
The provided text describes a medical device for electrocoagulation and hemostasis. It details its components, intended use, and non-clinical testing. There is no mention of "AI," "DNN," or "ML," nor any description of AI model functionalities like image processing, data analysis for diagnostic purposes, or adaptive learning algorithms. The device functions as an electrosurgical tool with selectable modes and parameters, which are typical functionalities of non-AI electronic devices.
Yes
The device is used for electrocoagulation and hemostasis in dermatologic and general surgical procedures, which are therapeutic interventions.
No
The device is described as an electrosurgical device for electrocoagulation and hemostasis, which are therapeutic procedures, not diagnostic ones.
No
The device is described as "a medical device combined with RF current, to function as an electrosurgical device." Its description explicitly lists physical components like "the main device, LCD screen, two handpieces, single use electrodes, electrode pad, NE pad cable, food switch," and mentions delivering "RF energy through the disposable electrode in the handpiece." It also includes "Electrical Testing and EMC Testing" and "Biocompatibility" in its non-clinical testing, which are typical for hardware-based medical devices. These descriptions indicate it is a physical medical device that delivers energy, not a software-only device.
No
This device is an electrosurgical device for dermatologic and general surgical procedures, used for electrocoagulation and hemostasis, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
RO handpiece and AGNES RF handpiece of RFMagik Lite are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
RFMagik Lite is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures. It is possible to select and change modes, parameters, outputs, etc. using the panel on the main body. It consists of the main device, LCD screen, two handpieces, single use electrodes, electrode pad, NE pad cable, food switch. There are two handpieces. RO handpiece and AGNES RF handpiece that delivers RF energy through the disposable electrode in the handpiece.
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
dermatologic and general surgical procedures
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 Testing:
- Electrical Testing and EMC Testing in accordance with FDA recognized standards: AAMI ES60601-1:2005/AMD2:2021, IEC60601-2-2:2017/AMD1:2023, IEC 60601-1-2:2014+A1:2020, TR IEC 60601-4-2: 2024.
- Biocompatibility in accordance with FDA recognized standards: ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-11:2017, ISO 10993-23:2021.
- Sterility (EO gas sterilization) in accordance with FDA recognized standards: ISO 11135: 2014, ISO 11138-1:2017, ISO 11138-2: 2017, ISO 10993-7: 2008.
- Shelf life in accordance with FDA recognized standards: ISO 11607-1: 2019, ISO 11607-2:2019, ASTM F1929-15, ASTM F88M-21.
- Performance Testing: Bench testing conducted to assure safe operation within predefined design specifications.
- Ex Vivo Study: Thermal testing conducted on three types of tissue (Liver, skin, and Muscle) under GLP in accordance with FDA's "Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" March 9, 2020.
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.
FDA 510(k) Clearance Letter - RFMagik Lite
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.07.05
Silver Spring, MD 20993
www.fda.gov
April 25, 2025
Agnes Medical Co., Ltd
℅ Sanghwa Myung
Regulatory Affair Specialist
E&m
D1474, PyeongCheon Arco Tower, 230, Simin-Daro, Dongan-gu
Anyangsi, Gyeonggi-do 14067
Korea, South
Re: K242469
Trade/Device Name: RFMagik Lite
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories
Regulatory Class: Class II
Product Code: GEI
Dated: March 27, 2025
Received: March 27, 2025
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"
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K242469 - Sanghwa Myung Page 2
(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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K242469 - Sanghwa Myung Page 3
Sincerely,
James H. Jang -S Digitally signed by James H. Jang -S Date: 2025.04.25 13:41:51 -04'00'
For
Long Chen, 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known): K242469
Device Name: RFMagik Lite
Indications for Use (Describe):
RO handpiece and AGNES RF handpiece of RFMagik Lite are intended for use in dermatologic and general surgical procedures for electrocoagulation 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."
Page 5
510(k) Summary
This summary of 510(K) – safety and effectiveness information are being submitted in accordance with requirements of 21 CFR Part 807.92.
Submitter: AGNES MEDICAL CO., LTD.
(Seohyeon-Dong, 5f Cocoplaza), 20, Seohyeon-Ro 210beon-Gil, Bundang-Gu,
Seongnam-Si, Gyeonggido, Korea (ZIP code: 13591)
Telephone: +82-31-8020-9702
Fax: +82-31-701-5162
E-mail: phee3928@agnesmedical.com
Contact: E&M
Regulatory Affair/Terri Myung
Telephone: +82-70-7807-0550
FAX: +82-31-388-9263
Cellphone: +82-10-4952-6638
E-mail: mshenmc@gmail.com
Primary Contact: Terri Myung
Date 510(k) summary prepared: April 24th, 2025
1. Proposed Device Identification
- Product Name: RF Electrosurgical Device
- Trade Name (Model): RFMagik Lite
- 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
2. Primary Predicate Device Identification
- Manufacturer: Jeisys Medical Inc.
- 510(k) Number: K231216
- Device Name: POTENZA
- Common Name: Electrosurgical cutting and coagulation device and accessories
- Classification Name: Electrosurgical cutting and coagulation device and accessories
- Classification Product Code and Regulation: GEI, 21CFR 878.4400
- Device Class: II
3. Secondary predicate Device identification
- 510(k) Number: K223805
- Device Name: AGNES
Page 6
Manufacturer: AGNES MEDICAL CO., LTD.
Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories
Regulation Number: 21 CFR 878.4400
Device Class: Class II
Product Code: GEI, KCW
Review Panel: General & Plastic Surgery
4. Device Description
RFMagik Lite is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures. It is possible to select and change modes, parameters, outputs, etc. using the panel on the main body. It consists of the main device, LCD screen, two handpieces, single use electrodes, electrode pad, NE pad cable, food switch. There are two handpieces. RO handpiece and AGNES RF handpiece that delivers RF energy through the disposable electrode in the handpiece.
5. Indication for use
RO handpiece and AGNES RF handpiece of RFMagik Lite are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
6. Summary of Technological Characteristics Comparison
The following comparison table is presented to demonstrate substantial equivalence.
Primary predicate device
| Subject device | Primary Predicate Device | |
|---|---|---|
| Manufacturer | AGNES Medical Co., Ltd. | Jeisys Medical Inc |
| Device Name | RFMagik Lite | POTENZA |
| 510(k) number | - | K231216 |
| Classification Name | Electrosurgical cutting and coagulation device and accessories (21 CFR Part 878.4400) | Electrosurgical cutting and coagulation device and accessories (21 CFR Part 878.4400) |
| Product code | GEI | GEI |
| Indication for use | RO handpiece and AGNES RF handpiece of RFMagik Lite are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. | The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. |
| Mode of operation | Monopolar | Monopolar/Bipolar |
| Output energy | Radiofrequency | Radiofrequency |
| Output Frequency | 1MHz | 1MHz, 2 MHz |
| Rated Input | AC 100-240V, 50/60Hz | AC 100-240V, 50/60Hz |
| Output Power | Max. 32W | Max 50W |
Page 7
| Subject device | Primary Predicate Device | |
|---|---|---|
| Maximum Power Delivered to Patient | Up to 32W (200ohm) | Up to 50W (200ohm) |
| Impedance | 200 ohm | 200 ohm |
| Electrode Needles | RO-25S, RO-25D | - Ten different electrode tips for the motor handpiece: S-49 TIP, I-49 TIP S-25 TIP, I-25TIP, S-16 TIP, and I-16TIP, C21-2 TIP, C21-1TIP, CP-21 TIP, and C9TIP |
- Three electrode needle tips for the AC handpiece: P1-08, A1-12, and A1-15
- Three electrode tips for the motor handpiece: CP-16 TIP, CP-25 TIP and CP-49 TIP. |
| Electrode type | Micro needle type | Micro needle type |
| Electrode needle shelf life | 3 years | 3 years |
| Materials | Stainless Steel + No coating | Paracyclophane+STS304 |
| Needle length | 0.4mm, 1.2mm | 0.5~2.5 mm |
| Needle thickness | 0.2 mm | 0.25 mm, 0.35mm |
| Needle amount | 25ea | CP-49: 49ea
CP-25: 25ea
CP-16: 16ea |
| Treatment Area | RO-25S: 8.5mm ⨉ 9.3mm
RO-25D: 8.5mm ⨉ 9.3mm | CP-49: 7.8mm ⨉ 7.8mm
CP-25: 8.0mm ⨉ 8.0mm
CP-16: 3.9mm ⨉ 3.9mm |
| Inter needle spacing | RO-25S, RO-25D: 2.0mm | CP-49: 1.3mm
CP-25: 2.0mm
CP-16: 1.3mm |
| Max insertion depth | 1.2mm | 2.5mm |
| Min insertion depth | 0.4mm | 0.5mm |
| Thickness of the needle | 0.2mm | 0.35mm |
Secondary predicate Device
| Descriptive Information | Subject Device | Secondary Predicate device |
|---|---|---|
| Manufacturer | AGNES MEDICAL CO., LTD | AGNES MEDICAL CO., LTD |
| Device Name | RFMagik Lite | AGNES |
| 510(k) number | - | K223805 |
| Primary Product Code / Regulatory Number | GEI / 878.4400 | GEI / 878.4400 |
| Secondary Product Code | N/A | KCW / 878.5350 |
Page 8
| Subject Device | Secondary Predicate device | |
|---|---|---|
| Maximum Power Delivered to Patient | Up to 32W (200ohm) | Up to 50W (200ohm) |
| Impedance | 200 ohm | 200 ohm |
| Electrode Needles | RO-25S, RO-25D | - Ten different electrode tips for the motor handpiece: S-49 TIP, I-49 TIP S-25 TIP, I-25TIP, S-16 TIP, and I-16TIP, C21-2 TIP, C21-1TIP, CP-21 TIP, and C9TIP |
- Three electrode needle tips for the AC handpiece: P1-08, A1-12, and A1-15
- Three electrode tips for the motor handpiece: CP-16 TIP, CP-25 TIP and CP-49 TIP. |
| Electrode type | Micro needle type | Micro needle type |
| Electrode needle shelf-life | 3 years | 3 years |
| Materials | Stainless Steel + No coating | Paracyclophane+STS304 |
| Needle length | 0.4mm, 1.2mm | 0.5~2.5 mm |
| Needle thickness | 0.2 mm | 0.25 mm, 0.35mm |
| Needle amount | 25ea | CP-49: 49ea
CP-25: 25ea
CP-16: 16ea |
| Treatment Area | RO-25S: 8.5mm ⨉ 9.3mm
RO-25D: 8.5mm ⨉ 9.3mm | CP-49: 7.8mm ⨉ 7.8mm
CP-25: 8.0mm ⨉ 8.0mm
CP-16: 3.9mm ⨉ 3.9mm |
| Inter needle spacing | RO-25S, RO-25D: 2.0mm | CP-49: 1.3mm
CP-25: 2.0mm
CP-16: 1.3mm |
| Max insertion depth | 1.2mm | 2.5mm |
| Min insertion depth | 0.4mm | 0.5mm |
| Thickness of the needle | 0.2mm | 0.35mm |
Secondary predicate Device
| Descriptive Information | Subject Device | Secondary Predicate device |
|---|---|---|
| Manufacturer | AGNES MEDICAL CO., LTD | AGNES MEDICAL CO., LTD |
| Device Name | RFMagik Lite | AGNES |
| 510(k) number | - | K223805 |
| Primary Product Code / Regulatory Number | GEI / 878.4400 | GEI / 878.4400 |
| Secondary Product Code | N/A | KCW / 878.5350 |
Page 9
| Subject Device | Secondary Predicate device | |
|---|---|---|
| Regulatory Class | II | II |
| Indications for Use | RFMagik Lite is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis | AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. |
| Prescription or OTC | Prescription | Prescription |
| Mode of Operation | Monopolar | Monopolar |
| Waveform | Oscillating rectangular wave | Oscillating rectangular wave |
| Output frequency | 1MHz | 1MHz |
| Output operating time | Min 50ms / Max 2,000ms | Min 50ms / Max 2,000ms |
| Output power levels | 0~20 levels (0, 2 to 32W) | 25 levels (2 to 46 W) |
| Max. output power | 0, 2 ~ 32W at 200 ohm | 2 ~ 46 W at 200 ohm |
| Electrical Safety Standards Complies | with IEC 60601-1, IEC 60601-1-2, IEC60601-2-2 | with IEC 60601-1, IEC 60601-1-2, IEC60601-2-2 |
| Connected Handpiece | Two Type of Handpiece |
- RO Handpiece
- AGNES RF Handpiece | One Agnes RF handpiece |
| Connect Patient contact Electrode Tip | | |
| Sterilization | EO Gas | EO Gas |
| Shelf Life | 3 Years | 3 Years |
| FDA Cleared Tip | K171707(GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GAF1A) | K171707(GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GAF1A) |
| New Tips | RO-25S, RO-25D | N/A |
| Neutral electrode pad | 510(k) cleared by FDA (K073360) | 510(k) cleared by FDA (K102372) |
| Foot Switch | Single pedal, IPX8 | Single pedal, IPX6 |
The different characteristics do not raise different questions of safety and effectiveness.
7. Non-Clinical Testing
1) Electrical Testing and EMC Testing
The electrical and EMC tests were performed with the compatible radio frequency electrosurgical devices in accordance with the FDA recognized standards,
- AAMI ES60601-1:2005/AMD2:2021, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC60601-2-2:2017/AMD1:2023, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency.
- IEC 60601-1-2:2014+A1:2020, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- TR IEC 60601-4-2: 2024 Medical electrical equipment. Guidance and interpretation. Electromagnetic
Page 10
immunity: performance of medical electrical equipment and medical electrical system
2) Biocompatibility
The biocompatibility tests were performed in accordance with the FDA recognized standards,
- ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Test for irritation
3) Sterility
The EO gas sterilization was verified and validated in accordance with the FDA recognized standards
- ISO 11135: 2014, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11138-1:2017, Sterilization of health care products - Biological Indicators – Part 1: General requirements
- ISO 11138-2: 2017, Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
- ISO 10993-7: 2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
4) Shelf life
- ISO 11607-1: 2019, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2:2019, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- ASTM F1929-15, Standard test method for detecting seal leaks in porous medical packaging by dye Penetration
- ASTM F88M-21, Standard test method for seal strength of flexible barrier materials
5) Performance Testing
AGNES MEDICAL conducted bench testing to assure that the operates safely and within the predefined design specifications.
6) 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" March 9, 2020
8. Conclusion
The RFMagik Lite 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 the subject 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.
The comparison between the subject device and the predicate devices shows that the indication for use and technological characteristic are substantially equivalent 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 subject devices. Therefore, we conclude that the different characteristics do not raise different questions of safety and effectiveness, and thus the subject device is substantially equivalent to the predicate devices.