(385 days)
CT5 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles and for the development of a firmer abdomen
CT5 is a 2 channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It comprises namely an electronic stimulator module which generates the required stimulation signals.
CT5 comprises 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 belt, which take the place of the lead wires.
The product is supplied with the cream VC 57B/53 -148, a User's Guide and a carry case.
The provided text describes the SPORT-ELEC CT5 muscle stimulator and its premarket notification to the FDA. The information focuses on its substantial equivalence to a predicate device and compliance with safety standards, rather than a clinical study demonstrating specific performance metrics against pre-defined acceptance criteria for muscle improvement.
Here's a breakdown based on your request, highlighting where information is not present in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated for Muscle Tone Improvement) | Reported Device Performance |
|---|---|
| No specific quantitative acceptance criteria for "improvement of muscle tone," "strengthening," or "development of a firmer abdomen" are provided in the document. | The device (CT5) is stated to be substantially equivalent to a predicate device (SLENDERTONE FLEX ABDOMINAL Training System, K030708) in its delivery of the stimulation signal and similar parameter settings. The differences between the devices "do not raise new issues of safety or effectiveness." |
| Compliance with electrical safety standards (e.g., IEC 60601-1 and -2-10) | Compliance claimed. |
| Compliance with electromagnetic compatibility (IEC 60601-1-2) | Compliance claimed. |
| Compliance with software standards (IEC 60601-1-4) | Compliance claimed. |
| Compliance with FDA Guidances for Pre Market Submissions and for Software contained in Medical Devices | Compliance claimed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not mentioned. The document describes compliance with electrical and software standards, but no clinical study with a test set of participants for evaluating muscle improvement is detailed.
- Data Provenance: Not applicable for a clinical test set from the provided text, as no such study is described. The device is manufactured by SPORT-ELEC S.A. based in France.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable: No clinical study or test set requiring expert ground truth establishment for muscle improvement is described in the provided text. The document focuses on regulatory compliance and substantial equivalence to a predicate device.
4. Adjudication Method for the Test Set
- Not Applicable: No clinical study or test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No: The provided text does not mention an MRMC comparative effectiveness study, or any clinical study comparing human readers (or users) with and without AI assistance for muscle improvement.
6. 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, so "standalone performance" in the context of AI is not relevant. The device requires human application and use.
7. The Type of Ground Truth Used
- Not Applicable: For the claims of "improvement of abdominal muscle tone, for strengthening of abdominal muscles and for the development of a firmer abdomen," no clinical ground truth (e.g., physiological measurements, expert assessment, outcomes data) is described in the provided document. The regulatory pathway here relies on substantial equivalence to a previously cleared device for the stated indications, rather than new clinical efficacy data for these specific claims.
8. The Sample Size for the Training Set
- Not Applicable: This device is not an AI/ML algorithm that would typically have a "training set." The engineering and safety testing performed would not involve such a concept.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As above, this device does not utilize a training set in the context of AI/ML.
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JOL X 6 2007
SPORT-ELEC.
PREMARKET NOTIFICATION 510(K) SUBMISSION
Kova1914
CT5
| 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 / Christian Lamy | |
| Phone number : (+33) 2 32 96 50 50Fax number : (+33) 2 32 96 50 59 | ||
| Preparation date | Jan 30th 2007 | |
| 2 | Device name | CT5 |
| Trade Name | SPORT-ELEC® | |
| Common Name | Muscle stimulator | |
| Code product and classificationname | Stimulator, muscle, powered for muscle conditioning (NGX)21 CFR Section 890.5850Powered Muscle Stimulator | |
| 3 | Predicate devices | SLENDERTONE FLEX ABDOMINAL Training System, TY, manufactured byBIO-MEDICAL RESEARCH, LTD., K030708, cleared June 25, 2003 |
| 4 | Description | CT5 is a 2 channel battery operated muscle stimulation system specificallydesigned to exercise the abdominal muscles. It comprises namely anelectronic stimulator module which generates the required stimulationsignals. |
| CT5 comprises belt with integral electrodes, which connects the signals fromthe stimulator to the skin. The built-in electrodes are located on the innersurface of the belt, which take the place of the lead wires. | ||
| The product is supplied with the cream VC 57B/53 -148, a User's Guide anda carry case. | ||
| Explanation of how the deviceoperates | Power is derived from 4 batteries located in a compartment protected by aremovable battery cover. | |
| The electrodes are integrated in the inner surface of the belt. The garment isworn as belt, and waist secured by hooks and loops fastening patches. | ||
| There is no current passed from side to side. The user cannot access thewiring or connectors within the belt. | ||
| Intended use | The CT5 is intended for use by healthy persons to apply trans-coetaneouselectrical muscle stimulation (EMS) through skin contact electrodes for thefollowing purposes: | |
| 5 | Performance data | Testing was carried out to assure compliance with recognized electrical safety 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.Performance data were also verified versus the requirements of the FDAGuidances for Pre Market Submissions and for Software contained in Medical Devices. |
| 6 | Substantial equivalence summary | The technological characteristics, features, specifications, materials, mode of operation, and intended use of the CT5 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 CT5 Device.The CT5 is the same as the Slendertone FLEX Abdominal training system 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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- Improvement of muscle tone of the muscles in the abdomen
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CT5
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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 a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three parallel lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lamy Christian Project Leader SPORT-ELEC S.A. Route De Rouen BP 35 27520 Bourgtheroulde Infreville, France 91400
Re: K061914
Trade/Device Name: Sport-Elec CT5 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulators Regulatory Class: Class II Product Code: NGX Dated: July 10, 2007 Received: July 13, 2007
Dear Mr. Christian:
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
JUL 26 2007
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Page 2 - Mr. Lamy Christian
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
sincerely yours,
Mark M. Mikkelsen
Mark N. Melkerson. M.S 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. The logo is in black and white and features the words "SPORT-ELEC" in large, bold letters. Below the main logo, the words "ELECTRO-MUSCULATION" are written in smaller letters. The logo has a registered trademark symbol on the upper right.
CATIONS 4. INDICATIONS FOR USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
510(k) Number (if known):
CT5
Device Name:
Indications for Use: CT5 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles and for the development of a firmer abdomen
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)
Mark A. Milliman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061914
§ 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).