(181 days)
The eMVFit (MVF-10M) Radio frequency is used for:
· Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.
· Temporary reduction in the appearance of cellulite.
eMVFit has MULTI handpiece, EMS handpiece, patient switch, cradle, distilled water injection hose & funnel, key switch and power cable.
eMVFit has a user interface including an LCD touch screen and has MULTI mode and EMS mode.
MULTI mode has RF and EMS functions that use the MULTI handpiece.
In the case of RF, the target temperature can be set and a vacuum can be used together, and a cooling function can be used as a safety system to prevent burns on the skin surface.
In addition, the MULTI handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 43°C.
EMS mode has an EMS function that uses the EMS handpiece.
The provided text describes the eMVFit (MVF-10M) device and its 510(k) summary for substantial equivalence to a predicate device (INMODE LTD. Embody System, K183450). This document primarily focuses on bench testing and compliance with standards to demonstrate safety and effectiveness for a medical device rather than a study with a human test set, expert readers, or ground truth in the context of clinical performance or diagnostic accuracy.
Therefore, many of the requested details, such as sample size, data provenance, number of experts, adjudication methods, MRMC studies, and ground truth types related to human performance or clinical outcomes, are not applicable in this regulatory submission. The acceptance criteria and "proof" in this context are for demonstrating the device's technical specifications, safety, and electromagnetic compatibility through non-clinical testing.
Here's a breakdown of the information that is available or NA (Not Applicable) based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by compliance with international standards for medical electrical equipment. The "reported device performance" is that the device passed all these tests.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance |
|---|---|
| Basic Safety and Essential Performance (IEC 60601-1:2005/A2:2020) | Passed all testing. |
| Electromagnetic Disturbances (IEC 60601-1-2:2014/A1:2020) | Passed all testing. |
| High Frequency Surgical Equipment (IEC 60601-2-2:2017/A1:2023) | Passed all testing. |
| Risk Management (ISO 14971:2019) | Documented by referring to the standard. |
| Usability (IEC 60601-1-6:2010/A2:2020) | Documented by referring to the standard. |
| Biocompatibility (ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021) | Passed testing; materials confirmed biocompatible. |
| Software Verification and Validation (IEC 62304:2015) | Tested and evaluated according to the standard. |
| Performance and Electrical Safety (Internal and FDA Guidance) | Met all requirements; output parameters measured. |
Study Proving Device Meets Acceptance Criteria
As noted, this is a non-clinical, bench testing-focused submission, not a human-in-the-loop or clinical study.
-
A table of acceptance criteria and the reported device performance:
(See table above) -
Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The "test set" here refers to the device and its components undergoing bench testing, not a dataset of patient cases.
- Data Provenance: Not applicable in terms the requested format. The data comes from internal laboratory testing conducted by the manufacturer (WEERO Co.,Ltd.). This is reported as non-clinical (bench) performance data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the sense of expert consensus on clinical findings, is not established for this type of non-clinical, hardware/software compliance testing. The "ground truth" for these tests is the established requirements and limits defined by the international standards themselves.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for subjective interpretations of clinical data by multiple readers. This refers to objective measurements and compliance against specific technical standards.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is an electrosurgical cutting and coagulation device and accessories, intended for therapeutic use (e.g., muscle aches, cellulite), not a diagnostic device involving human readers or AI assistance in image interpretation. Therefore, an MRMC study is not relevant or performed for this submission.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an AI algorithm for diagnostic interpretation that would have "standalone" performance metrics in the way described. The device's performance is assessed through its physical outputs and safety mechanisms.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Regulatory Standards and Design Specifications. The "ground truth" for the non-clinical testing is adherence to the specified technical parameters, safety limits, and performance requirements outlined in the referenced international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2) and internal design specifications. Biocompatibility used data from ISO 10993 testing.
-
The sample size for the training set:
- Not Applicable. This device submission does not describe a machine learning model that requires a "training set" in the context of supervised learning for diagnostic accuracy. The "training" for this device would be its own design and manufacturing process to meet performance specifications.
-
How the ground truth for the training set was established:
- Not Applicable. (See point 8).
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October 9, 2024
Weero Co., Ltd. Moon-young Han Regulatory Affairs A-605, Venture Valley II, 142-10, Saneop-Ro 156 Beon-Gil Gwonseon-Gu Suwon-Si Suwon, Gyeonggi-Do 16648 Korea. South
Re: K240991
Trade/Device Name: eMVFit (MVF-10M) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX, GEI Dated: September 13, 2024 Received: September 13, 2024
Dear Moon-young Han:
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 (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/cdrb/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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(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 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.
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 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-device-advicecomprehensive-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-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).
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Sincerely,
Digitally signed by Long H. Chen
Long H. Chen -S-s
Date: 2024.10.09 09:18:09 -04'00'
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
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Indications for Use
Submission Number (if known)
Device Name
eMVFit (MVF-10M)
Indications for Use (Describe)
The eMVFit (MVF-10M) Radio frequency is used for:
· 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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eMVFit
510(k) Summary
1. Submitter and US Official Correspondent
| Submitter : | WEERO Co.,Ltd. |
|---|---|
| Address: | A205 Venture Valley II, 142-10, Saneop-ro 156beon-gil, Gwonseon-gu,Suwon-si, Gyeonggi-do, Republic of Korea |
| Telephone No.: | +82-31-5182-8588 |
| Official Correspondent: | Moon-young Han |
|---|---|
| Correspondent: | WEERO Co.,Ltd. |
| Address: | A205 Venture Valley II, 142-10, Saneop-ro 156beon-gil,Gwonseon-gu, Suwon-si, Gyeonggi-do, Republic of Korea |
| Telephone No.: | +82-31-5182-8588 |
| Email: | ra@weeroweero.com |
2. Device Information
| Trade/Device Name: | eMVFit / MVF-10M |
|---|---|
| Regulation Name: | - Electrosurgical cutting and coagulation device and accessories |
| Classification Name: | - Massager, Vacuum, Radio Frequency Induced Heat |
| Product Code: | PBX |
| Device Class: | Class II (Regulation 21CFR878.4400) |
3. Predicate Device(Equivalent Legally Marketed Device)
| Manufacturer | Device | 510(k) No. |
|---|---|---|
| Main Predicate | ||
| INMODE LTD. | Embody System | K183450 |
4. Description of the Device
eMVFit has MULTI handpiece, EMS handpiece, patient switch, cradle, distilled water injection hose & funnel, key switch and power cable.
eMVFit has a user interface including an LCD touch screen and has MULTI mode and EMS mode.
MULTI mode has RF and EMS functions that use the MULTI handpiece.
In the case of RF, the target temperature can be set and a vacuum can be used together, and a cooling function can be used as a safety system to prevent burns on the skin surface.
In addition, the MULTI handpiece has a temperature sensor, so the output is automatically
turned off when the skin surface temperature exceeds 43°C.
EMS mode has an EMS function that uses the EMS handpiece.
5. Indications for use (intended use)
The eMVFit (MVF-10M) Radio frequency is used for:
- · Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.
- · Temporary reduction in the appearance of cellulite.
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eMVFit
510(k) Summary
6. Substantial Equivalence Discussion
1) Comparison Information
- Main Predicate : PBX
| Name | Subject device | Predicate device | |
|---|---|---|---|
| Device Name | eMVFit(MVF-10M) | EmBody System | Comparison |
| Manufacturer | WEERO Co.,Ltd. | INMODE LTD. | |
| 510(k) No. | K183450 | ||
| Product Code,Class | PBX, IPFClass II | PBX, ISAClass II | N/A |
| Indicationsfor use | Radio frequency is used for:• Relief of minor muscle achesand pain, relief of muscle spasm,temporary improvement of localblood circulation.• Temporary reduction in theappearance of cellulite. | The InMode EmBody Systemwith its designated hand piecesis intended for the treatment ofthe following medicalconditions;The EmBodyPlus hand piece isintended for the temporaryrelief of minor muscle achesand pain, temporary relief ofmuscle spasm, and temporaryimprovement of local bloodcirculationThe EmBodyFX hand piece isintended for the treatment ofthe following medicalconditions using RF combinedwith massage:• Relief of' minor muscle achesand pain, relief of musclespasm, temporaryimprovement of local bloodcirculation.• Temporary reduction in theappearance of cellulite. | The eMVFit device sharesthe same intended for useas EmBody System for theRF technology (PBXcode).Also, the eMVFit devicehas less indications for usethan EmBody System.Therefore, the eMVFitdevice does not have newindications for usecompared to the predicatedevice for RFtechnologies. This does notraise new questions ofsafety and effectiveness. |
| Energy Used /Delivered | RF energy | RF energy | Same |
| Physicalspecification:Dimensions | Dimensions:WDH17.3 x 27.5 x 47 in /44 x 70 x 120 cm | Dimensions:WDH18.2 x 18.2 x 40 in /46 x 46 x 100 cm | Different*Note 1 |
| Weight Console | Weight: 48 kg / 106 lbs | Weight: 20 kg / 44 lbs | Different*Note 1 |
| WeightHandpieces | MULTI handpiece0.52kg [1.1lb]EMS handpiece0.42kg [0.9lb] | EmBodyPLUS Handpiece0.17kg [0.375lb]EmBodyFX Handpiece0.90kg [2.00lb] | Different*Note 1 |
| PerformanceSpecifications:Main LineFrequency(nominal) | 50-60Hz | 50-60Hz | Same |
| Input Voltage(nominal) | 100-240VAC | 100-240VAC | Same |
| InputCurrent(rms) | 4A | 4A | Same |
| Name | Subject device | Predicate device | Comparison |
| Device Name | eMVFit(MVF-10M) | EmBody System | |
| Manufacturer | WEERO Co.,Ltd. | INMODE LTD. | |
| 510(k) No. | - | K183450 | |
| RF Frequency | 1 MHz | 1 MHz | Same |
| Vacuum | 50-350 mbar | 200-500 mbar | Different*Note 2 |
| RF electrical power | Up to 25 watts | Up to 50 watts | Different*Note 2 |
| Cut off Temperature | 32~43°C | 35-43°C | Different*Note 2 |
| Standards Met | IEC 60601-1IEC 60601-1-2IEC 60601-2-2 | IEC 60601-1IEC 60601-1-2IEC 60601-2-2 | Same |
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eMVFit
510(k) Summary
2) Substantial Equivalence Discussion
There are differences on a few things. However, these differences do not affect the significant equivalence of the device and its predicates.
Note 1: "Weight" and "Dimensions"
Although "Weight" and "Dimensions" of subject device are different from the predicate device, they all comply with IEC 60601-1, IEC 60601-2-2, IEC 60601-2-10 requirements, thus the differences of the function specifications does not raise any safety or effectiveness issue.
Note 2:
"Vacuum"
The "Vacuum" of the subject device is within the predicate device's vacuum output range or lower than the predicate device's output. Therefore the difference doesn't impact essential performance, basic safety or substantial equivalence.
"RF electrical power"
Although the "RF electrical power" of the subject device is different than in the predicate device, it was all tested and is compliant with IEC 60601-2-2. Therefore the difference doesn't impact essential performance, basic safety or substantial equivalence.
"Cut off Temperature"
The "Cut off Temperature" of the subject device is within the predicate device's cut off temperature range or lower than the predicate device. Therefore the difference doesn't impact essential performance, basic safety or substantial equivalence.
3) Conclusion
"Embody System" was chosen as predicate for the subject device in consideration of the intended use, indications, performance and principles of operation. Minor variations between the subject and the predicate device were found and listed within the above discussion. Considerable amount of testing, including electrical safety, electromagnetic compatibility, performance, software verification and validation and usability testing were performed to support the claims of appropriately chosen predicate
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eMVFit
510(k) Summary
device. The test results show that the specifications and performance of eMVFit are as safe and effective as legally marketed predicate devices.
Therefore, it is concluded that the eMVFit is substantially equivalent to the legally marketed predicate devices.
Non-Clinical (Bench) Performance Data: 7.
As part of demonstrating safety and effectiveness of the eMVFit and in showing substantial equivalence to the predicate device that are subject to this 510(k) submission, we completed a number of non-clinical performance tests against applicable standards.
- Basic safety and essential performance of the eMVFit was tested and evaluated according to the IEC 60601-1:2005/A2:2020.
- Effect to the device by electromagnetic disturbances was tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2:2014/A1:2020.
- Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories was tested and evaluated according to the IEC 60601-2-2:2017/A1:2023.
- Risk management was recorded by referring to ISO 14971:2019.
- Usability was documented by referring to IEC 60601-1-6:2010/A2:2020.
- Biocompatibility was tested and evaluated according to ISO 10993-5:2009, ISO 10993-10:2021, and ISO 10993-23:2021.
- Software was tested and evaluated according to IEC 62304:2015
- Content of Premarket Submissions for Device Software Functions
The eMVFit passed all the testing in accordance with internal requirements, national standards, and international standards shown above, to support substantial equivalence of the subject device.
Also, to demonstrate that the eMVFit meets all design specifications and performance requirements, and to measure the accuracy of the output parameters of eMVFit and to compare the output parameters with predicate devices, nonclinical bench testing was performed in accordance with the internal process in compliance with the recommendations of the FDA Guidance for Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery.
The testing results support that the requirements for performance and electrical safety were met for the acceptance of the device. The eMVFit passed all testing and supports the claims of substantial equivalence to the predicate device.
Sterilization/Disinfection/Cleaning/Shelf Life 8.
The eMVFit is intended for multiple use and therefore must be cleaned according to the instructions provided in the device Instructions for Use.
There are no sterilized parts or accessories involved with this device.
9. Biocompatibility
| Part | Material | Patient Contact | Duration ofContact by ISO10993-1 | Bio-compatibility |
|---|---|---|---|---|
| Electrodes of handpiece | SUS 304 | Intact Skin | Limited(< 24 hours) | Yes |
| External plastic materialof hand-piece | PC (GN1006FL) | Intact Skin | Limited(<24 hours) | Yes |
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eMVFit
510(k) Summary
10. Conclusion
Based on the comparison with the predicate devices and on the non-clinical performance testing results demonstrating that the eMVFit is as safe and effective as the predicate devices, it can be concluded that the eMVFit is substantially equivalent to the legally marketed predicate devices.
§ 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.