(244 days)
The Electromagnetic Stimulation System 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, thighs and calves.
- Improvement of muscle tone and firmness, for strengthening muscles in arms.
The HS-591 Electromagnetic Stimulation System is a non-invasive therapeutic device which comprised of a main unit and applicators that deliver electromagnetic energy to the targeted tissue of adult patients. The device is equipped with a color touch-screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch-screen of the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
The provided text is a 510(k) summary for an Electromagnetic Stimulation System. It describes the device, its indications for use, and a comparison to a predicate device. However, it explicitly states that "Clinical Testing" is "not applicable" and relies on performance testing and validation studies to demonstrate substantial equivalence to the predicate device.
Therefore, the document does not contain any information regarding specific acceptance criteria for device performance related to a clinical study, nor does it provide details of a study that proves the device meets such criteria. It is a regulatory submission focused on demonstrating equivalence for marketing clearance, not a report on a clinical trial with performance metrics.
For that reason, I cannot provide the requested information, as it is not present in the provided text.
If you are looking for information about clinical acceptance criteria and performance studies for a medical device, you would typically need to consult clinical trial reports, peer-reviewed publications, or more detailed regulatory submissions (like a PMA, if applicable, which this device is not).
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April 10, 2024 Shanghai Apolo Medical Technology Co., Ltd. Felix Li RA Supervisor Building 11, Lane 1566, Nanle Road, Songjiang District Shanghai, Shanghai 201613 China
Re: K232409
Trade/Device Name: Electromagnetic Stimulation Systems Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: March 10, 2024 Received: March 11, 2024
Dear Felix Li:
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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(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 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 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.
Julia E. 2024.04.10 Slocomb -S_08:30:53 -04'00'
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K232409
Device Name Electromagnetic Stimulation Systems
Indications for Use (Describe)
The Electromagnetic Stimulation System 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, thighs and calves.
- Improvement of muscle tone and firmness, for strengthening muscles in arms.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) summary K232409
l Submitter
Shanghai Apolo Medical Technology Co., Ltd. Building 11, Lane 1566, Nanle Road, Songjiang District, 201613 Shanghai, China Establishment Registration Number: 3007120647 Date of preparation: Feb 19th, 2024
Contact Person
Felix Li
Position: Regulatory Affairs
Phone: +86-138 4919 0618
Fax: +86-21-34622840
E-mail: liqiang@apolo.com.cn
II Proposed Device
| Trade Name of Device: | Electromagnetic Stimulation Systems |
|---|---|
| Common name: | Electromagnetic Stimulation Systems |
| Regulation Number: | 21 CFR 890.5850 |
| Classification Name: | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Regulatory Class: | Class II |
| Product code: | NGX |
| Review Panel | Physical Medicine |
| III Predicate Devices | |
| 510(k) Number: | K200382 |
| Trade name: | BTL-703-2 |
| Common name: | BTL-703-2 |
| Common name: | BTL-703-2 |
|---|---|
| Classification: | Class II |
| Product Code: | NGX |
| Manufacturer | BTL Industries, Inc. |
IV Device description
The HS-591 Electromagnetic Stimulation System is a non-invasive therapeutic device which comprised of a main unit and applicators that deliver electromagnetic energy to the targeted tissue of adult patients.
The device is equipped with a color touch-screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch-screen of the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
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V Indication for use
The Electromagnetic Stimulation System 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, thighs and calves.
- Improvement of muscle tone and firmness, for strengthening muscles in arms. ●
VI Comparison of technological characteristics with the predicate devices
| Item | Proposed device | Predicate device(K200382) | Discussion |
|---|---|---|---|
| Product Code | NGX | NGX | Identical |
| Regulation No. | 21 CFR 890.5850 | 21 CFR 890.5850 | Identical |
| Class | Class II | Class II | Identical |
| Indication for use | The Electromagnetic Stimulation Systemis indicated to be used for:Improvement of abdominal tone,strengthening of the abdominalmuscles, development of firmer abdomen. Strengthening, Toning and Firming ofbuttocks, thighs and calves. Improvement of muscle tone andfirmness, for strengthening muscles in arms. | The Electromagnetic Stimulation Systemis indicated to be used for:Improvement of abdominal tone,strengthening of the abdominalmuscles, development of firmer abdomen. Strengthening, Toning and Firming ofbuttocks, thighs and calves. Improvement of muscle tone andfirmness, for strengthening muscles in arms. | Identical |
| Principle of Action | Electromagnetic stimulation | Electromagnetic Stimulationaccompanied by bipolarradiofrequency | Different |
| Clinical Use | Prescription use | Prescription use | Identical |
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| Application | Hands-free, applicator fixed by fixation belt | Hands-free, applicator fixed by fixation belt | Identical |
|---|---|---|---|
| Electrical Protection | Class I, BF | Class II, BF | Different |
| User Interface | Touch screen | Touch screen | Identical |
| Firmware Controlled | Yes | Yes | Identical |
| Type of Energy | Magnetic field | Magnetic field | Identical |
| Number of outputs | 4 | 2 | Different |
| Number of magnetic coils | 1 | 1 | Identical |
| Maximum Magnetic Field Intensity atApplicator Center Surface | 1.2 Tesla | BTL-899-AP-C-1applicator: 908mTBTL-899-AP-C-2applicator: 1238mT | Similar |
| Magnetic FieldIntensity on the coilsurface | 0.46-1.38T | BTL-899-AP-C-1applicator: 0.5-1.8TBTL-899-AP-C-2applicator: 0.7-2.0T | Similar |
| Pulse Repetition Rate | 1~100Hz | 1 - 150 Hz | Similar |
| Pulse Duration | 330μs | BTL-899-AP-C-1applicator: 280 ± 20% μsBTL-899-AP-C-2applicator: 190 ± 20% μs | Similar |
| Selection ofparameters(Intensity, Time) | Yes | Yes | Identical |
| Energy Source | 110~240V, 50/60Hz | 100 - 240 V AC, 50-60 Hz | Identical |
| System Dimensions(W×H×D) | 580×650×1520mm | 592×985×730 mm(23×39×29 in) | Similar |
| AmbientTemperature | -40°C to +55°C | -10°C to +55°C | Similar |
| Relative Humidity | Up to 93% | 10% to 85% | Similar |
| EnvironmentalSpecifications | For indoor use only | For indoor use only | Identical |
VII Non-Clinical Testing
A series of tests have been performed to verity that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards:
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Electrical safety and electromagnetic compatibility
- IEC 60601-1 : 2005+A1 : 2012+A2 : 2020 / EN 60601-1: 2006+A1: 2013+A12:2014+A2:2021 Medical electrical equipment. General requirements for basic safety and essential performance
- IEC60601-1-2:2014+A1:2020 / EN 60601-1-2:2015+A1:2021 Medical electrical equipment - part 1-2 General requirements for basic Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 62304:2006+AMD1:2015 Medical device software Software life cycle processes .
Biocompatibility Evaluation:
Per FDA's Biocompatibility Guidance issued on September 04, 2020 and with regard to Table A.1 Evaluation Tests for consideration in ISO, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" " the following tests performed on the material which contacts with human for Biocompatibility:
- Cytotoxicity; ●
- Skin irritation;
- Skin Sensitization.;
VIII Clinical Testing
lt is not applicable.
IX Conclusion
Base on the performance testing and validation studies that the subject device is substantially equivalent to the 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).