(268 days)
Body Control System 4M is indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas.
Contraindicated use on injured or otherwise impaired muscles
Not intended for use in any therapy or for the treatment of any medical conditions or diseases
Body Control System "4M" is a 2 channel battery operated muscle stimulation system specifically designed to exercise the muscles, It comprises namely an electronic stimulator module which generates the required stimulation signals. Body Control System "4M" comprises 4 electrodes, which connects the signals from the stimulator to the skin. The product is supplied with a User's Guide and a carry case.
The provided text is a 510(k) summary for the SPORT-ELEC Body Control System "4M," a muscle stimulator. It details predicate devices, general device description, intended use, and states that testing was performed to assure compliance with electrical safety and electromagnetic compatibility standards. However, it does not contain information about acceptance criteria or specific studies proving the device meets performance criteria related to its intended use (muscle firming, toning, strengthening).
Therefore, I cannot provide the requested information in the table format because the data is absent from the provided document.
Here's a breakdown of why each point cannot be addressed:
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A table of acceptance criteria and the reported device performance: The document states that performance data "were also verified versus the requirements of the FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices." However, it does not specify what those performance requirements (acceptance criteria) were for muscle tone, firmness, or strengthening, nor does it present any reported device performance data against such criteria. The "Performance data" section only lists compliance with electrical safety, electromagnetic compatibility, and software standards.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No performance study data is presented, so sample size and provenance are not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable as no performance study is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no performance study is described.
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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: Not applicable. This device is a muscle stimulator, not an AI diagnostic tool involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a muscle stimulator, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no performance study is described.
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The sample size for the training set: Not applicable as no performance study or machine learning algorithm is described.
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How the ground truth for the training set was established: Not applicable as no performance study or machine learning algorithm is described.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with general safety standards, rather than presenting clinical or performance data for the specific indications of use (muscle toning, firming, strengthening).
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PREMARKET NOTIFICATION 510(K) SUBMISSION
Body Control System 4M Page 5 / 22
| 5. 510(K) SUMMARY[As Required by 21 CFR 807.92]Summary of Safety and Effectiveness | |||
|---|---|---|---|
| 1 | Submitter | SPORT-ELEC S.A.Route de Rouen BP 3527520 BourgtherouldeFrance | MAY - 7 2010 |
| Contact Person | Karine Coral / Sylviane LardeurPhone number : (+33) 2 32 96 50 50Fax number : (+33) 2 32 96 50 59 | ||
| Preparation date | Jan 20th 2009 | ||
| 2 | Device name | Body Control System "4M" | |
| Trade Name | SPORT-ELEC® | ||
| Common Name | Muscle stimulator | ||
| Code product and classification name | Stimulator, muscle, powered for muscle conditioning (NGX)21 CFR Section 890.5850Powered Muscle Stimulator | ||
| 3 | Predicate devices | SPORT-ELEC Body Control System, manufactured bySport-Elec REF BCS K 081026 Cleared Nov 5th 2008Sport-Elec REF BCS AT K 091865 Cleared Nov 13th 2009Sport-Elec REF BCS BS K 092142 Cleared Feb 5th 2010 | |
| 4 | Description | Body Control System "4M" is a 2 channel battery operated muscle stimulation systemspecifically designed to exercise the muscles, It comprises namely an electronicstimulator module which generates the required stimulation signals.Body Control System "4M" comprises 4 electrodes, which connects the signals fromthe stimulator to the skin. (EXHIBIT C)The product is supplied with a User's Guide and a carry case. | |
| Explanation of how the device operates | Power is supplied from 3 batteries located in a compartment protected by a removablebattery cover. The user cannot access the wiring or connectors. | ||
| Intended use | The Body Control "4M" is intended for use by healthy persons to apply trans-coetaneous electrical muscle stimulation (EMS) through skin contact electrodes for thefollowing purposes-improvement of muscle tone and firmness, for strengthening muscles in arms,abdomen, thighs and buttocks areas | ||
| 5 | Performance data | Testing was carried out to assure compliance with recognized electrical safetystandards: | |
| IEC 60601-1 and -2-10 standards for electrical safety | |||
| IEC 60601-1-2 standard for electromagnetic compatibility | |||
| IEC 60601-1-4 standard for the software (ISO 14971). | |||
| Performance data were also verified versus the requirements of the FDA Guidance forPre Market Submissions and for Software contained in Medical Devices. | |||
| 6 | Substantial equivalencesummary | The technological characteristics, features, specifications, materials, mode ofoperation, and intended use of the Body Control System "4M" device are substantiallyequivalent to the predicate devices quoted above. | |
| The differences that exist between the devices do not raise new issues of safety oreffectiveness regarding the Body Control System Device. | |||
| The Body Control System "4M" use the same as the BCS system in its delivery of thestimulation signal and has similar parameter setting. There are similar restrictionsbetween the two devices in that electrode positioning is governed by the user manual. |
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・ ・ PREMARKET NOTIFICATION 510(K) SUBMISSION
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Body Control System 4M Page 6 / 22
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sport-Elec S.A. % Ms. Camille D. Thornton, M.S. Regulatory Specialist 144 Research Drive Hampton, Virginia 23666
MAY - 7 2010
Re: K092476
Trade/Device Name: Body Control System "4M" Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: NGX Dated: April 27, 2010 Received: April 28, 2010
Dear Ms. Thornton:
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. 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 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 803); good manufacturing practice requirements as set
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Page 2 - Ms. Camille D. Thornton, M.S.
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Mark McMillan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PREMARKET NOTIFICATION 510(K) SUBMISSION
Body Control System 4M Page 4 / 22
4. INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Body Control System "4M"
Indications for Use: Body Control System 4M is indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas.
Contraindicated use on injured or otherwise impaired muscles
Not intended for use in any therapy or for the treatment of any medical conditions or diseases
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR
(21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
×
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092476
§ 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).