(90 days)
The Butterfly Toner is indicated for the improvement of abdominal muscle tone, strengthening of the abdominal muscles, and development of a firmer abdomen.
The Butterfly Toner is a single channel, battery operated muscle stimulation system for exercising the abdominal muscles. The Butterfly Toner has two electrodes fixed at a distance of 28 mm.
This 510(k) submission (K093368) for the "Butterfly Toner" muscle stimulator does not include a study with acceptance criteria and device performance results. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (Slendertone 512, K010335).
Here's a breakdown of why the requested information cannot be provided from the given document:
- No Clinical Tests: The document explicitly states under "Clinical tests submitted or relied upon:": "None." This means no clinical study was conducted by the applicant for this device to prove it meets specific acceptance criteria.
- Substantial Equivalence: The basis for clearance is "The Butterfly Toner is substantially equivalent to the Slendertone 512 because they use equivalent technology and have the same intended use." In 510(k) submissions, substantial equivalence means demonstrating that the new device is as safe and effective as a legally marketed predicate device and does not raise new questions of safety or effectiveness. This often involves comparing technological characteristics and intended use, rather than conducting new clinical trials with specific performance metrics and acceptance criteria.
- Non-Clinical Tests: Only "Waveforms as provided" are mentioned as non-clinical tests, which are typically electrical performance and safety tests, not outcomes-based clinical performance.
Therefore, the questions regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, adjudication, and MRMC studies cannot be answered as they are not present in this 510(k) submission.
In summary, for medical devices cleared through the 510(k) pathway based on substantial equivalence, especially for devices like muscle stimulators that are well-understood, extensive clinical trials with pre-defined acceptance criteria are often not required if a suitable predicate device exists.
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'JAN_2' 7 2010
510(k) Summary
| Date prepared: | |||
|---|---|---|---|
| Applicant: | Global Marketing Partners dba Gymmax USA3488 Rockhaven CircleAtlanta, GA 30324 | ||
| Contact person: | Nicolaas C. Besseling, ConsultantBesTech Consulting Services28711 Jaeger DriveLaguna Niguel, CA 92677949.466.7472bestechconsulting@cox.net | ||
| Trade name: | Butterfly Toner | ||
| Common name: | Muscle stimulator | Class: | 2 |
| Classification name: | Powered muscle stimulator | Product code: | NGX |
| Predicate device: | Slendertone 512, K010335 | ||
| Device description: | The Butterfly Toner is a single channel, battery operatedmuscle stimulation system for exercising the abdominalmuscles. The Butterfly Toner has two electrodes fixed at adistance of 28 mm. | ||
| Intended use: | The Butterfly Toner is indicated for the improvement of ab-dominal muscle tone, strengthening of the abdominal mus-cles, and development of a firmer abdomen. | ||
| Technological characteristics: | The device has an electronic stimulation controller thatconnects directly with "press-studs" to the electrodes, thusavoiding the need for an electrode cable. The device offersa selection of programs and voltages to suit individualneeds. The user has no access to the wiring or the connec-tors, and cannot change the programming of the units. | ||
| Non-clinical tests submitted orrelied upon: | Waveforms as provided | ||
| Clinical tests submitted or re-lied upon: | None. | ||
| Substantial equivalence con-clusion: | The Butterfly Toner is substantially equivalent to theSlendertone 512 because they use equivalent technologyand have the same intended use. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Globus Marketing Partners dbs Gymmax USA % BesTech Consulting Services Mr. Nicolaas C. Besseling 28711 Jaeger Drive Laguna Niguel, California 92677
JAN 2 7 2010
Re: K093368
Trade/Device Name: Butterfly Toner Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: NGX Dated: October 23, 2009 Received: October 29, 2009
Dear Mr. Besseling:
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, Orug, 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 A c + 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 contractly and warranties.
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 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.
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Page 2 - Dr. Kelly J. Baker
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Mallery
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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Indications for use
510(k) number (if known:
Device name:
...
Butterfly Toner
Indications for use:
The Butterfly Toner is indicated for the improvement of abdominal muscle tone, strengthening of the abdominal muscles, and development of a firmer abdomen.
Prescription use( Over-The-Counter use and/or V (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
FOR M. MELKERSON
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093368
§ 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).