(410 days)
Not Found
No
The description focuses on RF energy generation, handpiece types, and user-adjustable parameters. There is no mention of AI, ML, or any data-driven decision-making or analysis within the device's operation.
Yes
The device is intended for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite, all of which are therapeutic applications.
No
The device is described as an energy generator for aesthetic applications, providing relief for minor muscle aches and pain, improving blood circulation, and reducing cellulite. These are therapeutic uses, not diagnostic ones.
No
The device description explicitly lists multiple hardware components including a main unit (RF energy generator), handpieces, a footswitch, and a touchscreen, indicating it is not software-only.
Based on the provided information, the MTX-C1 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended uses listed are for the relief of muscle aches and pain, muscle spasm, improvement of local blood circulation, and reduction in the appearance of cellulite. These are all therapeutic applications performed directly on the patient's body.
- Device Description: The device is described as an RF energy generator with handpieces applied to the skin for treatment. This is consistent with a physical therapy or aesthetic device, not a device used to test samples (like blood, urine, or tissue) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MTX-C1's function and intended use clearly fall outside of this definition.
N/A
Intended Use / Indications for Use
The MTX-C1 is intended for the following medical condition; using three types of handpieces for delivery of non-thermal RF combined with massage:
- · Relief of minor muscle aches and pain, relief of muscle spasm
- Temporary improvement of local blood circulation
- · Temporary reduction in the appearance of cellulite
Product codes (comma separated list FDA assigned to the subject device)
PBX
Device Description
The MTX-C1 main unit is a RF(Radio-frequency) energy generator employed for a variety of aesthetic applications. The Main unit output is set and monitored via touchscreen and controlled by a footswitch.
The main unit can be used with 3 different types of handpieces for treatment.
The system consists of ;
-
Main unit
-
3 type treatment handpiece
-
Footswitch
-
- Touch screen(User interface)
The three treatment handpieces differ in size and configuration and are indicated for the treatment of various size areas.
- Touch screen(User interface)
The operator can adjust treatment parameters such as the power level and treatment time from the user interface on the Main Unit.
The handpiece is applied with a rubbing/massaging technique and the applicator should be moved continuously on the skin.
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
Prescription Use
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)
Biocompatibility testing:
The patient contact components and materials are tested and validated according to ISO10993-1. They are identical to the predicate device.
Non Clinical testing:
IEC 60601-1 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance. The requirements of specified standards were fulfilled.
IEC 60601-1-2 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility.
IEC 60601-2-2 Medical electrical equipment
Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
The requirements of specified standards were fulfilled.
Performance bench testing :
The three handpieces of MTX-C1 were tested to achieve superficial skin temperature (40 - 45°C) and maintain it for the required therapy time.
The testing data demonstrated that the device can achieve therapeutic parameters substantially equivalent to the currently cleared predicate device for the intended use.
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
September 27, 2022
Image /page/0/Picture/1 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, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.
ILOODA Co., Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 7505 Fannin St. Ste 610 Houston, Texas 77054
Re: K212561
Trade/Device Name: Mtx-c1 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX Dated: July 22, 2022 Received: August 1, 2022
Dear Dave Kim:
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 (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 located 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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.
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
2
Indications for Use
510(k) Number (if known) K212561
Device Name MTX-C1
Indications for Use (Describe)
The MTX-C1 is intended for the following medical condition; using three types of handpieces for delivery of non-thermal RF combined with massage:
- · Relief of minor muscle aches and pain, relief of muscle spasm
- Temporary improvement of local blood circulation
- · Temporary reduction in the appearance of cellulite
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
Image /page/3/Picture/2 description: The image shows the logo for ilooda. The logo consists of the word "ilooda" in lowercase letters, with a stylized graphic above it. The graphic is made up of vertical lines of varying lengths, arranged in a pattern that resembles sound waves or a stylized cityscape. The logo is simple and modern, with a focus on clean lines and a minimalist design.
Traditional 510(k) Summary K212561
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date 510k summary prepared: 9/19/2022
I. SUBMITTER
| Submitter's Name : | Ilooda Co.,Ltd | |
|---|---|---|
| Submitter's HQ Address: | 120, Jangan-ro 458 Beon-gil, Jangan-Gu, | |
| Suwon-Si Gyeonggido, KOREA, 16200 | ||
| Submitter's Telephone: | +82-31-278-4660 | |
| Contact person: | Yun-Jung HA (yjha@ilooda.com) / RD Manager | |
| Official Correspondent: | Dave Kim (davekim@mtech-inc.net) | |
| Address: | 7505 Fannin St, Suite 610, Houston, TX 77054 | |
| Telephone: | +713-467-2607 | |
| PROPOSED DEVICE | ||
| Trade/proprietary name: | MTX-C1 | |
| Common or Usual Name: | Electrosurgical cutting and coagulation device and accessories | |
| Regulation Number: | 21 CFR 878.4400 (Product Code: PBX) | |
| Regulatory Class: | Class II | |
| Prescription Use. | ||
| PREDICATE DEVICE | ||
| Trade/proprietary name: | Venus Legacy CX | |
| 510k number: | K143554 | |
| Regulation Number: | 21 CFR 878.4400 (Product Code: PBX) | |
| Regulatory Class: | Class II | |
| Prescription Use. | ||
| This predicate has not been subject to a design-related recall. |
II. DEVICE DESCRIPTION
The MTX-C1 main unit is a RF(Radio-frequency) energy generator employed for a variety of aesthetic applications. The Main unit output is set and monitored via touchscreen and controlled by a footswitch.
The main unit can be used with 3 different types of handpieces for treatment.
4
Image /page/4/Picture/2 description: The image shows the logo for ilooda. The logo consists of a stylized graphic above the word "ilooda". The graphic is made up of vertical lines of varying lengths, arranged in a symmetrical pattern. The lines are dark gray, and the word "ilooda" is in a sans-serif font.
The system consists of ;
-
Main unit
-
3 type treatment handpiece
-
Footswitch
-
- Touch screen(User interface)
The three treatment handpieces differ in size and configuration and are indicated for the treatment of various size areas.
- Touch screen(User interface)
The operator can adjust treatment parameters such as the power level and treatment time from the user interface on the Main Unit.
The handpiece is applied with a rubbing/massaging technique and the applicator should be moved continuously on the skin.
III. INDICATIONS FOR USE:
The MTX-C1 is intended for the treatment of the following medical condition; using three types of handpieces for delivery of non-thermal RF combined with massage:
- · Relief of minor muscle aches and pain, relief of muscle spasm
- Temporary improvement of local blood circulation
- · Temporary reduction in the appearance of cellulite
5
IV. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Proposed device | Predicated device | |
|---|---|---|
| Model name | MTX-C1 | Venus Legacy CX |
| Manufacturer | Ilooda Co.,Ltd | Venus Concept Ltd., Weston FL, USA |
| 510(k)number | K212561 | K143554 |
| Product code | PBX | PBX |
| Intended use | The MTX-C1 is intended for the | |
| treatment of the following medical | ||
| condition; using three types of | ||
| handpieces for delivery of non- | ||
| thermal RF combined with massage: | ||
| • Relief of minor muscle aches | ||
| and pain, relief of muscle spasm | ||
| • Temporary improvement of | ||
| local blood circulation | ||
| • Temporary reduction in the | ||
| appearance of cellulite | The Venus Legacy CX device is intended | |
| for the treatment of the following | ||
| medical conditions; using the LB2 and | ||
| LF2 applicators for delivery of non- | ||
| thermal RF combined with massage and | ||
| magnetic field pulses: | ||
| • Relief of minor muscle aches and pain, relief | ||
| of muscle spasm | ||
| • Temporary improvement of local blood | ||
| circulation | ||
| • Temporary reduction in the appearance of | ||
| cellulite | ||
| Type of Energy | ||
| Delivered | RF energy | RF energy |
| Components | Main unit | |
| 3 type handpieces | ||
| (Small, Medium, Large) | ||
| Footswitch | ||
| Touch screen | Main unit | |
| 2 type applicators | ||
| (LB2, LF2) | ||
| Footswitch / finger switch | ||
| Touch screen | ||
| User interface | Touchscreen on front of the | |
| generator allows the user to select | ||
| mode and output | Touchscreen on front of the generator allows | |
| the user to select mode and output | ||
| Safey features | - Indicator(Ready/Standby) |
- An independent electronic
circuit stops the operation
of the system in case of a
software error | Applicators are equipped with a treatment
area temperature monitoring system |
| Frequency | 1MHz ± 10% | 1MHz ± 10% |
| Max power | Max 55W @ medium , Large
Max 7.5W @ small | Up to 150W |
| RF mode of
operation | Bipolar | Bipolar |
| Materials | Materials are biocompatible | Materials are biocompatible |
| Power
requirements | 100-240V~, 50/60Hz | 100-120 VAC / 60Hz
220-240 VAC / 50Hz |
As described in the comparison tables above, the MTX-C1 subject device has the same intended use and indications for use, principles of operation and similar technological characteristics such as type of energy delivered, user interface, frequency, RF mode of operations, as its predicate
6
510(k) Submission -Non invasive RF system
device.
The technological differences, for example, the max power outputs between the subject device and its predicate, are based on the same heating using radio frequency for the same indications for use.
The design and components in the subject device, including the main unit and the handpieces, are similar to the design and components found in the predicate device.
The technological differences do not alter the device's core technology or performance and have been addressed by the manufacturer through the applicable safety standards (General controls and mitigation measures) and through non-clinical performance bench testing (Skin temperature)
Thus, this does not raise any additional issues of safety and efficacy.
V. PERFORMANCE DATA
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility testing:
The patient contact components and materials are tested and validated according to ISO10993-1. They are identical to the predicate device.
Non Clinical testing:
IEC 60601-1 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance. The requirements of specified standards were fulfilled.
IEC 60601-1-2 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility.
IEC 60601-2-2 Medical electrical equipment
Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
The requirements of specified standards were fulfilled.
Performance bench testing :
The three handpieces of MTX-C1 were tested to achieve superficial skin temperature (40 - 45°C) and maintain it for the required therapy time.
The testing data demonstrated that the device can achieve therapeutic parameters substantially equivalent to the currently cleared predicate device for the intended use.
VI. CONCLUSIONS
The intended use of the MTX-C1 is within the scope of the predicate device. MTX-C1 system, from both a design and clinical perspective, uses similar or identical technology as the cited predicate device and has the same intended uses.
7
510(k) Submission –Non invasive RF system
Based upon the predicted overall performance characteristics for the MTX-C1, Ilooda Co.,Ltd ., believes that no significant differences exist in the usage of its underlying technological principles between MTX-C1 and the cited predicate device.
Image /page/7/Picture/4 description: The image shows the logo for ilooda. The logo consists of the word "ilooda" in a sans-serif font, with a stylized graphic above it. The graphic is made up of vertical bars of varying heights, arranged in two rows. The bars are all the same color, which appears to be a dark gray or black.