(209 days)
Body Control is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles. It is indicated for use on the abdominal 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 is a 2 channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is comprised of an electronic stimulator module which generates the required stimulation signals.
Body Control is comprised of a belt 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 belts. The product is supplied with the cream VC 57B/53 -148, a User's Guide and a carry case.
Here's a breakdown of the acceptance criteria and the study information for the Body Control device, based on the provided text:
Preamble:
It's important to note that the provided document is a 510(k) Premarket Notification summary for a traditional submission, which focuses on demonstrating substantial equivalence to a predicate device. This type of submission often relies on a comparison to existing devices and adherence to recognized standards rather than extensive clinical efficacy studies with specific acceptance criteria related to a novel clinical endpoint. The "performance data" described here primarily refers to electrical safety and electromagnetic compatibility, which are foundational for any medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance (Compliance) |
|---|---|---|
| Electrical Safety | IEC 60601-1 | Compliance Assured |
| Electrical Safety (Specific) | IEC 60601-2-10 | Compliance Assured |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Compliance Assured |
| Software | IEC 60601-1-4 | Compliance Assured |
| Performance Data (General) | FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices | Verified vs. requirements |
| Substantial Equivalence | Technological characteristics, features, specifications, materials, mode of operation, and intended use are substantially equivalent to predicate device (SPORT-ELEC ABDOMINAL Training System, K061914). Differences do not raise new safety or effectiveness issues. | Achieved (FDA concurrence with 510(k) clearance) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific clinical "test set" in the context of efficacy or clinical performance for the Body Control device. The testing mentioned relates to adherence to electrical safety, EMC, and software standards. These types of tests are typically conducted on a representative sample of the devices themselves, rather than a human "test set" for clinical outcomes.
- Sample Size for Test Set: Not applicable in the context of clinical efficacy; refers to device samples for engineering standards testing.
- Data Provenance: Not applicable in the context of clinical efficacy; testing against standards is typically done in controlled lab environments.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document as it pertains to clinical performance evaluation, which was not the primary focus of this 510(k) submission. The "ground truth" here is the adherence to engineering standards.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of a human-centric "test set" requiring adjudication for clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices where human readers interpret data, often with and without AI assistance. The Body Control device is a powered muscle stimulator, and its approval relies on electrical safety, EMC, software compliance, and substantial equivalence to a predicate device, not on interpreting diagnostic images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. The Body Control device is a physical muscle stimulator, not an algorithm or AI system for standalone performance evaluation in the typical sense of AI/ML devices. Its "performance" relates to its physical function and electrical characteristics.
7. The Type of Ground Truth Used
The "ground truth" for this submission is primarily:
- Compliance with recognized electrical safety standards (IEC 60601-1, IEC 60601-2-10).
- Compliance with electromagnetic compatibility standards (IEC 60601-1-2).
- Compliance with software standards (IEC 60601-1-4).
- Demonstrated substantial equivalence to a previously cleared predicate device (SPORT-ELEC ABDOMINAL Training System, K061914) in terms of technological characteristics, features, specifications, materials, mode of operation, and intended use.
8. The Sample Size for the Training Set
Not Applicable. The document describes a physical medical device (muscle stimulator), not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As no AI/ML algorithm training set is mentioned, the method for establishing its ground truth is not relevant.
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Image /page/0/Picture/1 description: The image shows the logo for SPORT-ELEC. The logo is in black and white, with the words "SPORT-ELEC" in large, bold letters. Below the main logo, the words "ELECTRO-MUSCULATION" are written in a smaller font. The logo appears to be for a company that specializes in electro-muscle stimulation products.
PREMARKET NOTIFICATION 510(K) TRADITIONAL SUBMISSION
Body Control
14
.
| 5. 510(K) SUMMARY | ||
|---|---|---|
| [As Required by 21 CFR 807.92]Summary of Safety and Effectiveness | ||
| 1 | Submitter | SPORT-ELECRoute de Rouen27520 BourgtherouldeS.A.BP 35FranceNOV - 5 2008 |
| Contact Person | Karine Coral / Jean Philippe Broucke | |
| Phone number: (+33)2 32 96 50 50Fax number : (+33) 2 32 96 50 59 | ||
| Preparation date | Jan 10, 2008 | |
| 2 | Device name | Body Control |
| Trade Name | SPORT-ELEC® | |
| Common Name | Powered Muscle stimulator | |
| Product code andclassification name | Stimulator, muscle, powered for muscle conditioning(NGX)21 CFR Section 890.5850 | |
| 3 | Predicate devices | SPORT-ELEC ABDOMINAL Training System,manufactured by |
| Sport-Elec REF CT 5 K061914 Cleared July 26th2007 | ||
| 4 | Description | Body Control is a 2 channel battery operated musclestimulation system specifically designed to exercise theabdominal muscles. It is comprised of an electronicstimulator module which generates the requiredstimulation signals. |
| Body Control is comprised of a belt with integralelectrodes, which connects the signals from thestimulator to the skin. The built-in electrodes are locatedon the inner surface of the belts. The product is suppliedwith the cream VC 57B/53 -148, a User's Guide and acarry case. | ||
| Explanation of how | Power is derived from 3 batteries located in a | |
| the device operates | compartment protected by a removable battery cover forthe Body Control. | |
| The electrodes are integrated in the inner surface of thebelt. The garment is worn secured by hooks and loopsfastening patches. | ||
| There is no current passed from side to side. The usercannot access the wiring or connectors within the belt. |
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SPORT-ELEC®
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PREMARKET NOTIFICATION 510(K) TRADITIONAL SUBMISSION
The Body Control device is intended for use by healthy Intended use persons to apply trans-coetaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes;
- Improvement of muscle tone of the muscles in the abdomen.
5 Performance data Testing was carried out to assure compliance with recognized electrical 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.
Performance data was also verified versus the requirements of the FDA Guidance for Pre Market Submissions and for Software contained in Medical Devices.
Substantial equivalence The technological summary
characteristics, features, specifications, materials, mode of operation, and intended use of the Body Control device is substantially equivalent to the predicate device quoted above.
The differences that exist between the devices do not raise new issues of safety or effectiveness regarding the Body Control Device.
The Body Control is the same as the CT5 Abdominal training system in its delivery of the stimulation signal and has similar parameter settings. There are similar restrictions between the two devices in that electrode positioning is governed by and is integrated into the garment.
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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services (USA). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sport-Elect S.A. % FDA Registrar Corp Ms. Sharon Scannell Senior Compliance Specialist 144 Research Drive Hampton, Virginia 23666
NOV - 5 2008
K081026 Re:
Trade Name: Body Control Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 15, 2008 Received: October 27, 2008
Dear Ms. Scannell:
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 such 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); good manufacturing practice requirements as set
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Page 2 - Ms. Sharon Scannell
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) promarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Mark N. Mullin
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for SPORT-ELEC, a company specializing in electro-musculation. The words "SPORT-ELEC" are written in large, bold, sans-serif font. Below the company name, the words "ELECTRO-MUSCULATION" are written in a smaller, sans-serif font.
PREMARKET NOTIFICATION 510(K) TRADITIONAL SUBMISSION
Body Control
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- INDICATIONS FOR USE AND ASSOCIATIONS FOR MODE
510(k) Number (if known):
Device Name:
Body Control
Indications for Use: Body Control is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles. It is indicated for use on the abdominal 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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(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)
CARD THE COURT FOR COURT COLLECT CAR CAR CAR SELL CONSULT AND SCHENCY U T COLL
Nithan Kumar
Vision of General, Restorative, nd Neurological Devices
:(k) Number K081026
§ 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).