(205 days)
Body Control System is indicated for the improvement of buttocks muscles tone, for strengthening of buttocks muscles.
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 "BS" is a 2 channel battery operated muscle stimulation system specifically designed to exercise the buttocks' muscles, It comprises namely an electronic stimulator module which generates the required stimulation signals.
Body Control System "BS" comprises a short with integral electrodes, which connects the signals from the stimulator to the skin. The built-in electrodes are located on the inner surface of the accessories. The product is supplied with the cream VC 57B/53 - 148, a User's Guide and a carry case.
This document outlines the acceptance criteria and supporting study for the "Body Control System 'BS'" muscle stimulator.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 and -2-10 standards. | Testing was carried out to assure compliance with recognized electrical safety standards: IEC 60601-1 and -2-10 standards for electrical safety. (Implied compliance through "assurance of compliance"). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 standard. | Testing was carried out to assure compliance with IEC 60601-1-2 standard for electromagnetic compatibility. (Implied compliance through "assurance of compliance"). |
| Software Functionality | Compliance with IEC 60601-1-4 standard. | Testing was carried out to assure compliance with IEC 60601-1-4 standard for the software. (Implied compliance through "assurance of compliance"). |
| Risk Management | Compliance with ISO 14971:2007 (implied as it's listed with software standard). | (ISO 14971 : 2007) - Implied compliance through inclusion in the list of standards applied for performance data verification. |
| FDA Guidance | Verification against requirements of FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices. | Performance data were also verified versus the requirements of the FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices. (Implied compliance through "verification"). |
| Substantial Equivalence to Predicate Devices | Technological characteristics, features, specifications, materials, mode of operation, and intended use are substantially equivalent to predicate devices (SPORT-ELEC Body Control System K081026 and Slendertone System Short K070142). Differences do not raise new issues of safety or effectiveness. | The technological characteristics, features, specifications, materials, mode of operation, and intended use of the Body Control System Short summary device are substantially equivalent to the predicate devices quoted above. The differences that exist between the devices do not raise new issues of safety or effectiveness regarding the Body Control System Device. The short of the Body Control System "BS" use the same as the BCS training system and Slendertone System Short in it's delivery of the stimulation signal and has similar parameter setting. There are similar restrictions between the two devices in that electrode positioning is governed by and is integrated to the garment. (Explicit statement of substantial equivalence). |
2. Sample Size for the Test Set and Data Provenance
The provided document does not specify a separate "test set" in the context of clinical performance testing. The reported "performance data" refers to compliance with various electrical safety, EMC, software, and risk management standards. These typically involve testing conducted on the device itself and its components, rather than human subjects or a clinical test set in the traditional sense of evaluating diagnostic or therapeutic accuracy.
Therefore, information on:
- Sample size used for the test set: Not applicable/not provided in the context of clinical outcomes.
- Data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/not provided. The performance data is based on compliance testing to international standards, which is generally conducted by accredited labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided as the "performance data" focuses on engineering and regulatory compliance (electrical safety, EMC, software) rather than a clinical performance study requiring a ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not applicable/not provided for the reasons stated above.
5. 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
An MRMC comparative effectiveness study was not done. The device is an electro-muscle stimulator, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study in the context of an algorithm's performance was not done. The "performance data" refers to the device's compliance with safety and technical standards for a physical medical device.
7. The type of ground truth used
The "ground truth" for the reported performance data is the established international standards (IEC 60601-1, -2-10, -1-2, -1-4) and regulatory guidance (FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices) themselves. Compliance is assessed against the requirements and specifications outlined in these standards.
8. The sample size for the training set
This information is not applicable/not provided. The device is not an AI/machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reason as above.
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FEB - 5 2010
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Image /page/0/Picture/2 description: The image shows the logo for SPORT-ELEC in a bold, sans-serif font. Below the main logo, the words "ELECTRO-MUSCULATION" are printed in a smaller, sans-serif font. The logo appears to be for a sports or fitness-related product or service, possibly related to electro-muscle stimulation.
PREMARKET NOTIFICATION 510(K) SUBMISSION
Body Control System Buttock's Short Page 5 / 23
| 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 |
| Contact Person | Karine Coral / Jean Philippe BrouckePhone number : (+33) 2 32 96 50 50Fax number : (+33) 2 32 96 50 59 | |
| Preparation date | January 24th 2009 | |
| 2 | Device name | Body Control System "BS" |
| Trade Name | SPORT-ELEC® | |
| Common Name | Muscle stimulator | |
| Code product andclassification 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 2008 and:Slendertone System Short K070142 Cleared March 23th 2007 |
| 4 | Description | Body Control System "BS" is a 2 channel battery operated musclestimulation system specifically designed to exercise the buttocks'muscles, It comprises namely an electronic stimulator module whichgenerates the required stimulation signals.Body Control System "BS" comprises a short with integral electrodes,which connects the signals from the stimulator to the skin. The built-inelectrodes are located on the inner surface of the accessories.The product is supplied with the cream VC 57B/53 - 148, a User's Guideand a carry case. |
| Explanation of how thedevice operates | Power is derived from 3 batteries located in a compartment protectedby a removable battery cover.The electrodes are integrated in the inner surface of the short. Thegarment is worn as shown on picture.There is no current passed from side to side. The user cannot accessthe wiring or connectors within the short. | |
| Intended use | The Body Control "BS" is intended for use by healthy persons to applytrans-coetaneous electrical muscle stimulation (EMS) through skincontact electrodes for the following purposes;- Improvement of muscle tone of the muscles of buttocks |
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PREMARKET NOTIFICATION 510(K) SUBMISSION
Body Control System Buttock's Short Page 6 / 23
Testing was carried out to assure compliance with recognized electrical 5 Performance data safety standards: 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 : 2007) Performance data were also verified versus the requirements of the FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices. The technological characteristics, features, specifications, materials, 6 Substantial equivalence mode of operation, and intended use of the Body Control System Short summary device are substantially equivalent to the predicate devices quoted above. The differences that exist between the devices do not raise new issues of safety or effectiveness regarding the Body Control System Device. The short of the Body Control System "BS" use the same as the BCS training system and Slendertone System Short in it's delivery of the stimulation signal and has similar parameter setting. There are similar restrictions between the two devices in that electrode positioning is governed by and is integrated to the garment.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
FEB = 5 2010
Sport-Elec % Registrar Corp Kimberly Jones, Ph.D. Senior Regulatory Specialist Compliance Department 144 Research Drive Hampton, Virginia 23666
Re: K092142
Trade Name: Sport-Elec Body Control System "BS" Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulation Class: Class II Product Code: NGX Dated: January 21, 2010 Received: January 25, 2010
Dear Dr. Jones:
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.
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Page 2 - Kimberly Jones, Ph.D
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 forth in the quality systems (QS) 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/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark A Millhuser
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 Buttock's Short Page 4 / 23
4. INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Body Control System "BS"
Indications for Use: Body Control System is indicated for the improvement of buttocks muscles tone, for strengthening of buttocks muscles.
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 Over-The-Counter Use x — AND/OR (Part 21 CFR 801 Subpart D) (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)
KATHY M. OLSEN FOR M. MELKERSON
Division Sign Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number: K092142
§ 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).