(318 days)
CoreLevée is indicated to be used for:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- Strengthening, toning and firming of buttocks and thighs.
CoreLevée is a non-invasive electromagnetic muscle stimulator that applies high-intensity electromagnetic field to the treatable body areas through two applicators. The coil enclosed in each applicator produces a magnetic field that induces electric currents within neuromuscular tissues. At its optimal level, these electric currents depolarize neuromuscular tissues causing effective muscle contraction.
CoreLevée consists of a Main Body, a software integrated color-touch LCD screen, two applicators, three applicator fixing belts, and a patient switch. The Main Body allows the proper operation of the entire system. The LCD screen works as a control panel and displays step-by-step guides through the entire therapy procedure. The therapeutic parameters such as treatment time, location, and stimulation frequency and intensity are easily set using the touch screen and the dial knob on the device. The micro-controller within the software continuously monitors the device system for its operation and functional normalcies. Two applicators can be used alone or together on top of clothing.
The device is a mobile standalone equipment with four wheels. The device housing protects the patient from electrical shock and mechanical injuries.
The provided document is a 510(k) summary for the CoreLevée device. It details the device's characteristics, indications for use, and a comparison to a predicate device (BTL 799-2). However, it does not contain a study that establishes acceptance criteria for clinical performance and demonstrates the device meets those criteria, nor does it provide a table of acceptance criteria and reported device performance in a clinical context.
The "Performance Data" section primarily focuses on:
- Biocompatibility: Stating it's not applicable as the device doesn't directly contact the skin.
- Electrical Safety and Electromagnetic Compatibility (EMC) Testing: Listing compliance with various IEC standards.
- Sterilization and Shelf-Life: Stating it's not sterile and is reusable with a 5-year expected service life.
- Software Validation and Verification Testing: Classifying the software as "moderate" level of concern and confirming validation.
- Performance Bench Testing: Confirming magnetic field intensity, oscilloscopic characterization, pulse repetition/duration, and theoretically derived induced current in tissues are within specifications and comparable to the predicate.
This document describes technical and safety performance, but not clinical acceptance criteria or a clinical study proving efficacy against such criteria. The 510(k) process relies on demonstrating "substantial equivalence" to a predicate device, which often means showing similar technological characteristics and performance (including safety and, in some cases, limited clinical data if specifically required for a new question of safety/effectiveness). In this case, the manufacturer primarily relies on a comparison of technological characteristics and bench testing to demonstrate substantial equivalence, rather than a separate clinical study with predefined acceptance criteria for patient outcomes.
Therefore, I cannot provide the requested table of acceptance criteria and the study proving the device meets those criteria because the provided text does not contain this information. The document focuses on demonstrating substantial equivalence through technical specifications and bench testing, not clinical efficacy trials with specific acceptance metrics.
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October 14, 2022
Lutronic Corporation Haewon Park Regulatory Affairs Specialist Lutronic Center, 219, Sowon-Ro Deogyang-Gu, Goyang-si, Gyeonggi-do 410220 Korea. South
Re: K213748
Trade/Device Name: CoreLevee Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: August 30, 2022 Received: August 31, 2022
Dear Haewon Park:
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.
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
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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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K213748
Device Name CoreLevée
Indications for Use (Describe)
CoreLevée is indicated to be used for:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- □ Strengthening, toning and firming of buttocks and thighs.
| 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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510(K) SUMMARY (K213748)
Lutronic Corporation CoreLevée
I. SUBMITTER
| 510(k) Owner | Lutronic CorporationLutronic Center219, Sowon-ro, Deogyang-gu, Goyang-si,Gyeonggi-do, 10534Republic of Korea |
|---|---|
| Submission Correspondent | Haewon Park, Ph.D.,Regulatory Affairs Specialist, Lutronic USA19 Fortune DriveBillerica, MA 01821Tel: 888-588-7644Email: hpark@lutronic-usa.com |
| Date Prepared | August 26, 2022 |
II. DEVICE
| Trade Name: | CoreLevée |
|---|---|
| Common or Usual Name: | Electromagnetic stimulator |
| Classification Name: | NGX - Powered Muscle Stimulator |
| 21 CFR 890.5850, Class II |
III. PREDICATE DEVICE
| Trade Name: | BTL 799-2 |
|---|---|
| Regulation Number: | 21 CFR 890.5850 |
| Classification Name: | NGX - Powered Muscle Stimulator21 CFR 890.5850, Class II |
| Premarket Notification: | BTL Industries Inc. K180813 (6/14/2018) |
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IV. DEVICE DESCRIPTION
CoreLevée is a non-invasive electromagnetic muscle stimulator that applies high-intensity electromagnetic field to the treatable body areas through two applicators. The coil enclosed in each applicator produces a magnetic field that induces electric currents within neuromuscular tissues. At its optimal level, these electric currents depolarize neuromuscular tissues causing effective muscle contraction.
CoreLevée consists of a Main Body, a software integrated color-touch LCD screen, two applicators, three applicator fixing belts, and a patient switch. The Main Body allows the proper operation of the entire system. The LCD screen works as a control panel and displays step-by-step guides through the entire therapy procedure. The therapeutic parameters such as treatment time, location, and stimulation frequency and intensity are easily set using the touch screen and the dial knob on the device. The micro-controller within the software continuously monitors the device system for its operation and functional normalcies. Two applicators can be used alone or together on top of clothing.
The device is a mobile standalone equipment with four wheels. The device housing protects the patient from electrical shock and mechanical injuries.
V. INDICATIONS FOR USE
CoreLevée is indicated to be used for:
· Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
· Strengthening, Toning and Firming of buttocks and thighs.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
CoreLevée has the same indications for use and similar technological characteristics and principles of operation as its predicate device. Both subjective device and its predicate are comprised of a main body and applicators. The main body consists of the electromagnetic field generators, computer, and the touchscreen as a control panel. Both subjective device and its predicate control the treatment parameters using the touchscreen, and the magnetic field intensity using the touchscreen and a dial knob. Both subjective device and its predicate use the same type of energy and operation and have the same pulse characteristics and therapy time. When using the applicators, both subjective device and its predicate use two outputs with comparable magnetic field intensities. They also produce similar induced current in tissues. Therefore, CoreLevee is substantially equivalent to the predicate device and the technological differences between CoreLevée and its predicate do not raise any new types of safety or effectiveness questions.
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| Characteristic | Subject device | Predicate device |
|---|---|---|
| Device Name | CoreLevée | BTL 799-2 |
| Manufacturer | Lutronic Corporation | BTL Industries Ltd |
| 510(k) Number | K213748 | K180813 |
| Product Code andRegulation | NGX-Stimulator Muscle, Powered,Muscle conditioning21 CFR 890.5850 | NGX-Stimulator Muscle, Powered,Muscle conditioning21 CFR 890.5850 |
| Indications ForUse | • Improvement of abdominal tone,strengthening of the abdominalmuscles, development of firmerabdomen.• Strengthening, Toning and Firmingof buttocks and thighs. | • Improvement of abdominal tone,strengthening of the abdominalmuscles, development of firmerabdomen.• Strengthening, Toning and Firmingof buttocks and thighs. |
| Primary Function | Muscle stimulation | Muscle stimulation |
| Principle ofAction | Initiating action potential of nervesresults in muscle contraction | Initiating action potential of nervesresults in muscle contraction |
| ElectricalProtection | Class II, BF | Class II, BF |
| User Interface | Touch screen | Touch screen |
| Touch Screen Size | 10.1" | 15.6" |
| FirmwareControlled | Yes | Yes |
| Type of Energy | Magnetic field | Magnetic field |
| Number ofOutputs | 2 | 2 |
| Number ofMagnetic Coils inthe Applicator | 1 | 1 |
| Applicatordimensions | 181 x 266 x 93mm (W * L * H) | Not publicly available |
| Surface area ofApplicators | 152 cm² | Not publicly available |
| Magnetic FieldIntensity at theApplicator center | 0 - 1.2 T (+/- 20%) | 0.5 - 1.154 T (+/- 20%) |
| Magnetic FieldIntensity at Core | 0-1.45 T (+/- 20%) | 0.5 - 1.8 T (+/- 20%) |
| Total InducedCurrent in Tissue(mA) | 262 mA | 285 mA |
| Type of Operation | Continuous | Continuous |
| Pulse RepetitionRate | 1 - 150 Hz | 1 - 150 Hz |
| Pulse Duration | 280μs | 280μs |
| Pulse Amplitude | Up to 100% | Up to 100% |
| Selection ofparameters(intensity, time) | Yes | Yes |
| Treatment Time | Up to 60 min | Up to 60 min |
| Pulse Type | Sine, Biphasic wave | Sine, Biphasic wave |
| ElectricalRequirements | AC 100-120V, 50/60HzMax2500VA (Fuse: 125V / 25A) | AC 100-240 V, 50-60 Hz |
| Systemdimensions(WxHxD mm) | 400.6 x 1182.4 x 661mm | 500 x 1380 x 580mm |
| EnvironmentalSpecifications | For indoor use only | For indoor use only |
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalation determination.
Biocompatibility Testing
The applicators of CoreLevee do not contact patients' skin directly. They are directed to be used on top of clothing. Therefore, the biocompatibility evaluation according to ISO 10993-1, 10993-10 for CoreLevée were not conducted.
Electric Safety and Electromagnetic Compatibility Testing
CoreLevée was tested for electrical safety and electromagnetic compatibility, and found to be in compliance with the following applicable medical device safety standards:
| IEC 60601-1 | Medical electrical equipment – Part 1: General requirements for basic safetyand essential performance |
|---|---|
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements for basicsafety and essential performance – Collateral standard: Electromagneticdisturbances - Requirements and tests |
| IEC 60601-1-6 | Medical electrical equipment – Part 1-6: General requirements for basicsafety and essential performance – Collateral standard: Usability |
| IEC 60601-2-10 | Medical electrical equipment – Part 2-10: Particular requirements for theBasic Safety and Essential Performance of Nerve and Muscle Stimulators |
| IEC 62366-1 | Medical devices – Application of usability engineering to medical devices |
| IEC 62304 | Medical devices software - software life cycle processes |
| ISO14971 | Medical devices – Application of risk management to medical devices |
Sterilization and Shelf Life
CoreLevée is not provided sterile and does not need to be sterilized. The applicators and the main body are cleaned with a soft cloth moistened with isopropyl alcohol or ethanol of 70% strength or higher. Applicator fixing belts can be reused after washing them with mild detergent. CoreLevée is reusable and does not have a restricted shelf-life. The expected service life of applicators and the main body are about 5 years.
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Software Validation and Verification Testing
Software verification and valuation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern since a failure of the software could result in minor injury to a patient or to a user of the device.
Performance Bench Testing
Bench tests were performed to ensure that CoreLevée performs as intended and documentation was provided. Tested parameters include the magnetic field intensity and its oscilloscopic characterization, pulse repetition and duration, and induced current in tissues was theoretically derived based on the bench test results. These results confirmed that both applicators operate within the magnetic field intensity specifications and the induced current in tissues at its maximum intensity is within the values comparable to its predicate.
VIII. CONCLUSIONS
CoreLevée has the same intended use and almost identical tharacteristics to its predicate device. Any differences between the predicate device and CoreLevée, such as the system dimensions and the size of touchscreen have no significant effect on safety or effectiveness of CoreLevée. Therefore, CoreLevee is as safe, as effective, and performs as well as the legally marketed predicate device.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).