(98 days)
AM-100 is indicated to be used for:
- · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- · Strengthening, Toning and Firming of buttocks and thighs.
The AM-100 is a non-invasive therapeutic device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the AM-100 helps to strengthen and firm the abdomen, buttocks and thighs. The AM-100 is equipped with a color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen, buttons and knob on the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
The provided text is a 510(k) summary for the AM-100 device, which is a powered muscle stimulator. The document states that the substantial equivalence determination for the AM-100 is not based on clinical testing. Instead, the device's safety and efficacy were demonstrated by comparison of technical characteristics between the AM-100 and a predicate device (Torc Body K131291).
Therefore, the study design and criteria typically requested for proving a device meets acceptance criteria through clinical or AI-based performance are not applicable in this specific 510(k) submission. The FDA clearance for this device was based on non-clinical testing and a comparison to a predicate device, focusing on technical specifications rather than clinical study outcomes.
For your reference, if this were a clinical study for a device that uses AI or required performance validation, the information you requested would be directly relevant. However, based on the provided document, I cannot extract the information you've asked for because no such clinical study or AI performance evaluation was conducted or presented for this 510(k) submission.
Summary based on the provided document:
- No acceptance criteria related to a clinical study or AI performance were stated in the document, as the submission was based on non-clinical testing and predicate device comparison.
- The document explicitly states: "The substantial equivalence determination for the AM-100 is not based on clinical testing. The device safety and efficacy was demonstrated by comparison of technical characteristics between the AM-100 and the predicate device."
Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details as they pertain to a clinical or AI performance study.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized caduceus-like symbol with three figures in profile, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 16, 2017
BTL Industries, Inc. David Chmel Director 47 Loring Drive Framingham, Massachusetts 01702
Re: K163165
Trade/Device Name: AM-100 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: January 16, 2017 Received: January 17, 2017
Dear Mr. Chmel:
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.
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 and Part 809; medical device reporting (reporting of
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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 and Part 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K163165
Device Name
AM-100
Indications for Use (Describe)
AM-100 is indicated to be used for:
Type of Use (Select one or both, as applicable)
- · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- · Strengthening, Toning and Firming of buttocks and thighs.
Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer
PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Paperwork Reduction Act (PRA) Staff
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Image /page/3/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested squares with the letters "BTL" inside, followed by the text "BTL Industries" in a gray sans-serif font. The squares are blue, and the text is gray.
510(k) Summary
General Information
| Sponsor: | BTL Industries, Inc. |
|---|---|
| 47 Loring Drive | |
| Framingham, MA 01702 | |
| Tel: +1-866-285-1656 | |
| Fax: +1-888-499-2502 | |
| Applicant: | BTL Industries, Inc. |
| 47 Loring Drive | |
| Framingham, MA 01702 | |
| Tel: +1-866-285-1656 | |
| Fax: +1-888-499-2502 | |
| Contact Person: | David Chmel |
| BTL Industries, Inc. | |
| chmel@btlnet.com | |
| Summary PreparationDate: | February 16, 2017 |
Device Name
| Trade/Proprietary Name: | AM-100 |
|---|---|
| Primary Classification Name: | Stimulator, Muscle, Powered |
| Classification Regulation: | 21 CFR 890.5850, Class II |
| Classification Product Code: | NGX |
Legally Marketed Predicate Devices
The AM-100 is a state-of-the-art magnetic device with accessories, and is substantially equivalent to the current product that is already cleared for distribution in the USA under the following 510(k) Premarket Notification number:
- . Torc Body (K131291)
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Image /page/4/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares, each nested inside the other, with the letters "BTL" in white inside the innermost square. To the right of the squares is the text "BTL Industries" in a dark gray sans-serif font. The logo is simple and modern, and the colors are clean and professional.
The HPM-6000 device was used as a reference device to support the determination of substantial equivalence. The HPM-6000 is cleared (K160992) as a PMS device because it elicits a muscle contraction.
Product Description
The AM-100 is a non-invasive therapeutic device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the AM-100 helps to strengthen and firm the abdomen, buttocks and thighs.
The AM-100 is equipped with a color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen, buttons and knob on the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
The AM-100 device has already been cleared by the FDA for muscle stimulation under the device name HPM-6000 (K160992).
Indications for Use
AM-100 is indicated to be used for:
· Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- · Strengthening, Toning and Firming of buttocks and thighs.
Non-clinical Testing
The AM-100 device has been thoroughly evaluated for electrical safety. The device has been found to comply with the following applicable medical device safety standards:
| IEC 60601-1 | Medical electrical equipment – Part 1: General requirements for basicsafety and essential performance |
|---|---|
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements forbasic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests |
| IEC 60601-1-6 | Medical electrical equipment – Part 1-6: General requirements forbasic safety and essential performance – Collateral standard: Usability |
| IEC 60601-2-10 | Medical Electrical Equipment – Part 2-10: Particular Requirements forthe Basic Safety and Essential Performance of Nerve and MuscleStimulators |
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| IEC 62366 | Medical devices - Application of usability engineering to medicaldevices |
|---|---|
| IEC 62304 | Medical device software – Software life cycle processes |
| ISO 14971 | Medical devices - Application of risk management to medical device |
Clinical testing
The substantial equivalence determination for the AM-100 is not based on clinical testing. The device safety and efficacy was demonstrated by comparison of technical characteristics between the AM-100 and the predicate device.
Summary of Clinical and Non-clinical testing
Nonclinical test have been conducted to evaluate the AM-100 performance, and results confirm that the device performs as intended and in a similar manner compared to the predicate. Thus, the AM-100 is substantially equivalent to the predicate devices.
| 510(k) number | Not Assigned | K131291 | Significant Difference |
|---|---|---|---|
| Device name | AM-100 | Torc Body | |
| Company name | BTL Industries, Inc. | Johari Digital HealthCare Ltd. | |
| Product Codeand Regulation | Physical Medicine21 CFR 890.5850NGX - Stimulator, Muscle,Powered, MuscleConditioning | Physical Medicine21 CFR 890.5850NGX - Stimulator, Muscle,Powered, MuscleConditioning | None |
| 510(k) numberDevice name | Not AssignedAM-100 | K131291Torc Body | SignificantDifference |
| Company name | BTL Industries, Inc. | Johari Digital HealthCareLtd. | |
| Indications forUse | AM-100 is indicated to beused for:• Improvement ofabdominal tone,strengthening of theabdominal muscles,development of firmerabdomen.• Strengthening, Toningand Firming of buttocksand thighs. | TORC BODY is indicated tobe used for:• Improvement of abdominaltone, for strengthening ofthe abdominal muscles,for development of firmerabdomen.• Strengthening, Toning andFirming of buttocks andthighs. | None |
| Primary Function | Muscle stimulation | Muscle stimulation | None |
| Principle ofAction | Initiating action potential ofnerves results in musclecontraction | Initiating action potential ofnerves results in musclecontraction | None |
| Clinical Use | Prescription use | Home use | NotSignificantlydifferent |
| ElectricalProtection | Class II, BF | Class II, BF | None |
| User Interface | Touch screen | Touch screen | None |
| FirmwareControlled | Yes | Yes | None |
| Type of Energy | Magnetic field | Electrical | NotSignificantlydifferent |
| Magnetic FieldIntensity | Applicator 299-1: 0.5–1.8 TApplicator 299-2: 0.7–2.5 T | N/A | N/A |
| Type of Operation | Continuous | Continuous | None |
| Pulse RepetitionRate | 1 – 150 Hz | 1 – 200 Hz | Notsignificantlydifferent |
| 510(k) numberDevice nameCompany name | Not AssignedAM-100BTL Industries, Inc. | K131291Torc BodyJohari Digital HealthCareLtd. | SignificantDifference |
| Pulse Duration | $280 \pm 20%$ µs | 290 µs | None |
| Pulse Amplitude | 0 – 100% | 0 - 100% | None |
| Current Strength | N/A | Up to 102 mA | N/A |
| Induced Currentin the Tissue | 28-30 mA | 28 mA | Notsignificantlydifferent |
| Selection ofparameters(Intensity, Time) | Yes | Yes | None |
| Therapy Time | Up to 60 min | 1 – 60 min | None |
| Shape ofStimulation Pulse | Symmetrical Biphasic SineWave | Symmetrical BiphasicSquare Wave | Notsignificantlydifferent |
| Energy Source | 100 - 240 V AC, 50-60 Hz | 24 V DC Battery pack andAdaptor: 100 – 240 V AC,50-60 Hz | Notsignificantlydifferent |
| SystemDimensions(W×H×D) | 500×970×580 mm(20×38×23 in) | 152x102x203 mm(6×4×8 in) | Notsignificantlydifferent |
| AmbientTemperature | -10°C to +55°C | 0°C to +44°C | Notsignificantlydifferent |
| EnvironmentalSpecifications | For indoor use only | For indoor use only | None |
Comparison with the Predicate Device
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Substantial Equivalence
The AM-100 device has the same indications for use and similar technological characteristics and principles of operation as its predicate device.
One of the technological differences between the subject and the predicate device includes type of energy used. However, the mechanism of action of the electrical stimulator and this
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kind of magnetic device is the same. Further, the predicate device is intended for a home use, while the subject device is intended for prescription use only. There are devices with a similar technology that are already cleared by the FDA as a prescription use devices. The AM-100 device and its predicate device differ in the shape of stimulation pulse, however that feature does not influence the muscle contraction stimulation. The last technological difference between the subject and the predicate device is pulse repetition rate. The pulse repetition rate of the subject device is within the range of the commonly used ones for devices intended for muscle stimulation.
The energies coming out of the devices can not be directly compared due to the fact the predicate device is a contact one while the subject device is the non-contact device. Comparable are electrical currents induced directly in the targeted tissue.
The current induced by the magnetic field (subject device) is almost identical compared to the predicate device.
The technological differences between the AM-100 and the predicate device do not raise new types of safety or effectiveness questions.
Conclusion
Based upon the intended use and known technical information provided in this pre-market notification, the AM-100 device has been shown to be substantially equivalent to currently marketed predicate device.
§ 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).