(147 days)
Body Control System is indicated for the improvement of arms and thighs muscles tone, for strengthening of arms and thighs 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 is a 2 channel battery operated muscle stimulation system specifically designed to exercise the arms and thighs muscles, It comprises namely an electronic stimulator module which generates the required stimulation signals.
Body Control System comprises accessories 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 510(k) submission describes the SPORT-ELEC Body Control System, a muscle stimulator intended for improving muscle tone and strengthening arm and thigh muscles in healthy individuals. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving specific performance metrics through clinical trials. As such, the information you've requested regarding detailed performance criteria and study results in the context of typical AI/diagnostic device evaluations is largely not present in this document.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
This 510(k) submission does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, effect size on muscle strength). Instead, it focuses on demonstrating compliance with recognized safety and regulatory standards, and substantial equivalence to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Electrical Safety Standards Compliance | Testing was carried out to assure compliance with: - IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment) - IEC 60601-2-10 (Particular requirements for the basic safety and essential performance of nerve and muscle stimulators) |
| Electromagnetic Compatibility (EMC) Compliance | Testing was carried out to assure compliance with: - IEC 60601-1-2 (Collateral Standard: Electromagnetic disturbances - Requirements and tests) |
| Software Life-Cycle Process Compliance | Testing was carried out to assure compliance with: - IEC 60601-1-4 (Collateral Standard: Programmable electrical medical systems) - Note: The document also mentions ISO 14971, which is for risk management, but primarily refers to IEC 60601-1-4 for software. |
| FDA Guidance for Premarket Submissions and Software Compliance | Performance data were verified "versus the requirements of the FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices." |
| Substantial Equivalence (Technological Characteristics) | The technological characteristics, features, specifications, materials, mode of operation, and intended use of the Body Control System Arms and Thighs device are substantially equivalent to the predicate devices (SPORT-ELEC Body Control System REF BCS K 081026, Slendertone System-Arms K 072553, Slendertone flex bottom and thighs toning system K022855). The accessories use the same stimulation signal delivery and have similar parameter settings, with electrode positioning integrated into the garment. The differences existing between the devices "do not raise new issues of safety or effectiveness." |
Study Details (as inferable from the document)
Given that this is a 510(k) submission primarily based on substantial equivalence and compliance with engineering standards, traditional clinical study details are not provided.
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Sample size used for the test set and the data provenance: Not applicable in the context of a clinical performance test set for this 510(k). The "testing" mentioned refers to engineering and regulatory compliance rather than clinical efficacy/performance and thus wouldn't involve a 'test set' of patient data in the typical sense. The provenance of any data used for engineering tests is not specified, but it would have been conducted by the manufacturer (SPORT-ELEC S.A., France).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" established by experts for a clinical test set as part of this submission.
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Adjudication method for the test set: Not applicable.
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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, and involves no human "readers" or AI assistance in interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. The "ground truth" here is the adherence to electrical safety, EMC, and software standards, which is evaluated through engineering tests and documentation. Substantial equivalence relies on comparing the device's technical specifications and intended use to legally marketed predicate devices.
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The sample size for the training set: Not applicable. There is no mention or indication of a "training set" in the context of machine learning or AI algorithm development.
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How the ground truth for the training set was established: Not applicable.
Summary:
The SPORT-ELEC Body Control System's 510(k) clearance (K091865) relies on demonstrating substantial equivalence to existing predicate devices and compliance with recognized electrical safety and software standards. It is not a submission that presents clinical performance data from a prospective study with a test set, ground truth established by experts, or AI performance metrics. The "acceptance criteria" are regulatory and engineering compliance, rather than clinical efficacy metrics.
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K091/565
Image /page/0/Picture/1 description: The image contains the text "SPORT-ELEC" in a bold, sans-serif font. Below this, there is smaller text that appears to say "ELECTRO-MUSCULATION". The text is black and the background is white. The overall impression is that of a logo or brand name.
PREMARKET NOTIFICATION 510(K) SUBMISSION
Body Control System Page 5 / 23
| 5. 510(K) SUMMARY[As Required by 21 CFR 807.92]Summary of Safety and Effectiveness | NOV 13 2 | ||
|---|---|---|---|
| 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 21st 2009 | ||
| 2 | Device name | Body Control System | |
| 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-Arms K 072553 Cleared Dec 14th 2007Slendertone flex bottom and thighs toning system K022855 ClearedMarch 06th 2003 | |
| 4 | Description | Body Control System is a 2 channel battery operated musclestimulation system specifically designed to exercise the arms andthighs muscles, It comprises namely an electronic stimulator modulewhich generates the required stimulation signals. | |
| Body Control System comprises accessories 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 accessories.The garment is worn as shown on picture. | |||
| There is no current passed from side to side. The user cannot accessthe wiring or connectors within the accessories. | |||
| Intended use | The Body Control is intended for use by healthy persons to apply trans-coetaneous electrical muscle stimulation (EMS) through skin contactelectrodes for the following purposes; | ||
| - Improvement of muscle tone of the muscles of arms and thighs. |
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PREMARKET NOTIFICATION 510(K) SUBMISSION
Body Control System Page 6 / 23
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| 5Performance data | Testing was carried out to assure compliance with recognized electricalsafety standards:IEC 60601-1 and -2-10 standards for electrical safetyIEC 60601-1-2 standard for electromagnetic compatibilityIEC 60601-1-4 standard for the software (ISO14971).Performance data were also verified versus the requirements of theFDA Guidance for Pre Market Submissions and for Software containedin Medical Devices. |
|---|---|
| 6Substantial equivalencesummary | The technological characteristics, features, specifications, materials,mode of operation, and intended use of the Body Control System Armsand Thighs device are substantially equivalent to the predicate devicesquoted above.The differences that exist between the devices do not raise new issuesof safety or effectiveness regarding the Body Control System Device.The accessories of the Body Control System Arms and Thighs use thesame as the BCS training system and Slendertone System Arms in it'sdelivery of the stimulation signal and has similar parameter setting.There are similar restrictions between the two devices in that electrodepositioning is governed by and is integrated to the garment. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a stylized graphic. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement. The graphic element is a stylized representation of a human figure with outstretched arms, symbolizing care and protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Sport-Elec % Kimberly Jones, Ph.D. Senior Regulatory Specialist Registrar Corp. 144 Research Drive Hampton, Virginia 23666
NOV 1 3 2009
Re: K091865
Trade Name: Sport-Elec Body Control System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulation Class: II Product Code: NGX Dated: November 9, 2009 Received: November 10, 2009
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.
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 - Kimberly Jones, Ph.D.
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/CDRH0ffices/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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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SPORT-ELEC PREMARKET NOTIFICATION 510(K) SUBMISSION
Body Control System Page 4 / 23
CATION CATION 4 4 INDICATIONS FOR USE - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
N/A 510(k) Number (if known):
Device Name:
Body Control System Arms and Thighs
Indications for Use: Body Control System is indicated for the improvement of arms and thighs muscles tone, for strengthening of arms and thighs 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 × 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)
KIMBERLY M. TAYLOR FOR M. MELKERSON
(Division Sign-Off) (Division Sign of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091865
§ 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).