(597 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on electromagnetic stimulation and standard performance testing.
Yes
The 'Intended Use / Indications for Use' section explicitly states the device is indicated for purposes such as "To temporarily increase local blood circulation in healthy leg muscles" and "To stimulate healthy muscles in order to improve and facilitate muscle performance," which are therapeutic applications. Additionally, the 'Device Description' refers to it as a "noninvasive physical medicine device that can be used as a supportive therapy."
No
The device description and intended use state that the BEMER therapy systems are used to increase local blood circulation and stimulate healthy muscles for performance improvement, not to diagnose or identify medical conditions.
No
The device description explicitly states that the BEMER therapy systems consist of hardware components including a B.BOX console, signal applicators, power pack, B.SCAN indicator, and accessories.
Based on the provided information, the BEMER therapy system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used to temporarily increase local blood circulation and stimulate healthy muscles in the body. This is a therapeutic or physical medicine application, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a noninvasive physical medicine device that uses electromagnetic stimulation. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The BEMER system's function is to directly interact with the body for therapeutic benefit.
N/A
Intended Use / Indications for Use
- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance
Product codes
NGX
Device Description
BEMER therapy systems are a family of noninvasive physical medicine devices that can be used as a supportive therapy to increase local blood circulation. BEMER therapy is offered in two system options-Classic and Professional. Both systems consist of a B.BOX console, a set of BEMER signal applicators, power pack, B.SCAN indicator and accessories for attachment. The B.PAD and B.SPOT applicators have been cleared for use in this submission.
BEMER systems improve local blood distribution via electromagnetic stimulatory principles. The resulting increase in local blood distribution can broadly benefit patients. The indications for use allow the application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance.
BEMER therapy systems are substantially equivalent to other legally marketed over-the-counter devices within physical medicine classifications NGX (Powered Muscle stimulator). Generally, these are non-invasive and reusable muscle conditioning devices that stimulate muscle contractile properties, force output and/or fatigue resistance. These devices also improve local blood circulation in muscle tissue. These devices create electric stimulation either via direct application of electric current or via induction of electrical stimulation within the tissue by application of magnetic flux. All are used for therapy regimes lasting days to weeks with one or more individual treatments per day lasting generally less than an hour. All are designed for patient-managed self-use in a home setting.
BEMER Therapy Systems utilize induction of microcurrents to tissue. Like the reference device, this non-invasive electromagnetic stimulation improves muscle activity induced by electromagnetic stimulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
healthy leg muscles (implied from "To temporarily increase local blood circulation in healthy leg muscles")
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patient-managed self-use in a home setting.
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A Usability study was conducted to proof that the intended users can identify the key functions of the device and to assess, that they can operate the device in a safe and effective manner based on their knowledge and following the directions for use in the device label.
The BEMER Therapy Systems usability study design follows FDA's human factors guidance for industry entitled, Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016). In summary, BEMER Therapy Systems, as labeled, are safe and effective in use by lay and professional users and therefore it is suitable for Over-The-Counter (OTC) use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 representation of three human profiles facing to the right, stacked one behind the other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2017
Sven Bieler, PhD Regulatory Affairs BEMER Int. AG Austrasse 15 Triesen, 9495 Liechtenstein
Re: K151834
Trade/Device Name: BEMER Classic Set, BEMER Pro-Set Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: January 23, 2017 Received: January 23, 2017
Dear Dr. Bieler:
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 medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
1
as set 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.
If vou 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 yours,
Michael J. Hoffmann -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151834
Device Name BEMER Classic Set and BEMER Pro-Set
Indications for Use (Describe)
-
To temporarily increase local blood circulation in healthy leg muscles
-
To stimulate healthy muscles in order to improve and facilitate muscle performance
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
6. 510(K) SUMMARY
The following information is provided as required by 21 CFR 807.92 for BEMER International, AG's BEMER Therapy Systems 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.
- Sponsor: BEMER International, AG Austrasse 15 LIE-9495 Triesen, Liechtenstein Phone: +423-399-3999 Fax: +423-399-3998 Registration Number: 30039102830
- Contact: BEMER International AG Sven Bieler, Fred Harms Austrasse 15 LIE-9495 Triesen, Liechtenstein Phone: +423 399 3999 Fax: +423 399 3998
| Date of Submission: | February 22, 2017 |
|---|---|
| Proprietary Name(s): | BEMER Classic Set and BEMER Pro-Set |
| Common Name: | Powered Muscle Stimulator, Powered Muscle Stimulator for |
| Muscle Conditioning | |
| Regulatory Class: | II |
| Regulation: | 21 CFR 890.5850 |
| Panel: | Physical Medicine |
| Product Codes: | NGX |
| Predicate Device: | K143207, Revitive IX (OTC) |
| Reference Device: | K973929, Neotonus Model 1000 Muscle Stimulator System |
4
Device Description:
BEMER therapy systems are a family of noninvasive physical medicine devices that can be used as a supportive therapy to increase local blood circulation. BEMER therapy is offered in two system options-Classic and Professional. Both systems consist of a B.BOX console, a set of BEMER signal applicators, power pack, B.SCAN indicator and accessories for attachment. The B.PAD and B.SPOT applicators have been cleared for use in this submission.
BEMER systems improve local blood distribution via electromagnetic stimulatory principles. The resulting increase in local blood distribution can broadly benefit patients. The indications for use allow the application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance.
BEMER therapy systems are substantially equivalent to other legally marketed over-thecounter devices within physical medicine classifications NGX (Powered Muscle stimulator). Generally, these are non-invasive and reusable muscle conditioning devices that stimulate muscle contractile properties, force output and/or fatigue resistance. These devices also improve local blood circulation in muscle tissue. These devices create electric stimulation either via direct application of electric current or via induction of electrical stimulation within the tissue by application of magnetic flux. All are used for therapy regimes lasting days to weeks with one or more individual treatments per day lasting generally less than an hour. All are designed for patient-managed self-use in a home setting.
BEMER Therapy Systems utilize induction of microcurrents to tissue. Like the reference device, this non-invasive electromagnetic stimulation improves muscle activity induced by electromagnetic stimulation.
Intended Use:
BEMER therapy systems (BEMER Classic Set, BEMER Pro-Set) are indicated for:
- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance
5
Performance Testing:
BEMER therapy systems are compliant with the following standards and have outputs that are within the same range as the predicate devices:
| STANDARD | DESCRIPTION |
|---|---|
| 510(k) Declaration of Conformity Standards | |
| IEC/EN 60601-1:2007 | Medical Electrical Equipment, Part 1, |
| General Requirements for Safety | |
| IEC 60601-1-2:2014 | Medical Electrical Equipment, Part 1-2, General Requirement for |
| Safety. Electromagnetic Compatibility | |
| IEC/EN 60601-1-4:2001 | Medical Electrical Equipment, Part 1-4, Collateral Standard: |
| Programmable electrical medical systems. | |
| IEC/EN 60601-1-6: 3rd | Medical Electrical Equipment, Part 1-6, Usability |
| IEC/EN 60601-1-11: 2010 | Medical Electrical Equipment, Part 1-11, |
| General requirements for basic safety and essential performance | |
| – | |
| Collateral Standard: Requirements for medical electrical | |
| equipment and medical electrical systems used in the home | |
| healthcare environment | |
| IEC/EN 62366 | Medical devices - Application of usability engineering to medical |
| devices | |
| EN ISO 10993-1:2009 | Biological Evaluation of Medical Devices Part 1: Evaluation and |
| Testing | |
| (Overall plan and requirements established internally, specific | |
| tests conducted by 3rd party, see Section 16) | |
| General Compliance Standards | |
| EN ISO 13485:2012 | Medical Devices, Quality Management Systems, Requirements |
| for Regulatory Purposes | |
| EN ISO 14971 | Application of risk management to medical products |
| IEC/EN 62304 | Software life cycle processes |
Technical and Performance Comparison:
The subject and predicate devices are all non-invasive, reusable, and used as therapies for wide-ranging conditions resulting in pain, atrophy, and reduced circulation (loss of vascular and muscle tone). All employ the same general principles of tissue and cellular stimulation; some stimulate via direct electrical stimulation, while others induce electrical stimulation within the tissue by the application of magnetic flux.
6
| | BEMER Therapy
Systems | Revitive IX
(K143207) | Neotonus MS-101
Magnetic Muscle
Stim. System
(K973929)
Reference Device | Comments |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SUBJECT DEVICE | Predicate Device | | |
| Classification
Code(s) | Primary: Powered
Muscle Stimulator
NGX 890.5850 | Primary: Powered
Muscle Stimulator
NGX 890.5850 | Powered Muscle
Stimulator
IPF 890.5850 | |
| | | Secondary:
Transcutaneous
Nerve Stimulator
NUH 882.5890 | | |
| Indications for
Use | [Pending] The
BEMER therapy is
indicated:
To temporarily
increase local
blood circulation in
healthy leg
muscles.
-
To stimulate
healthy
muscles in
order to
improve and
facilitate
muscle
performance. | To temporarily
increase local
blood circulation in
healthy leg
muscles. -
To stimulate
healthy
muscles in
order to
improve and
facilitate
muscle
performance. -
For temporary
relief of pain
associated
with sore and
aching
muscles in the
shoulder,
waist, back,
upper
extremities
(arms) and
lower
extremities
(legs) due to
strain from
exercise or
normal
household
duties. | The Neotonus MS-
101 Magnetic
Muscle Stimulator
System is intended
to be used under
medical
supervision for
adjunctive therapy
for the treatment of
medical diseases
and conditions.
The Neotonus MS-
101 is indicated for
use in stimulating
neuromuscular
tissues for bulk
muscle excitation
in the legs or arms
for rehabilitative
purposes.
Indications for Use
for Muscle
Stimulators:
Relaxation of
muscle spasms,
prevention or
retardation of
disuse atrophy,
increasing local
blood circulation,
muscle re-
education,
immediate post-
surgical stimulation
of calf muscles to
prevent venous
thrombosis,
maintaining or | |
| | BEMER | Revitive IX
(K143207) | Neotonus
(K973929) | |
| PRIMARY MODE OF ACTION | Non-invasive tissue stimulation via magnetic field induction | Non-invasive tissue stimulation via skin electrodes | Non-invasive tissue stimulation via magnetic field induction | |
| Waveform | Pulsed asymmetric, constant amplitude during treatment | Pulsed symmetrical, constant amplitude during treatment | Unknown | Minor difference, no impact on safety and effectiveness. |
| Shape | Sinusoidal, monopolar | Rectangular, bipolar | Unknown | Minor difference, no impact on safety and effectiveness |
| Pulse repetition rate | All accessories: 10-30Hz | Foot: 20-53Hz
Body: 35-46Hz | 1-55Hz | Minor difference, no impact on safety and effectiveness |
| Single pulse duration | All accessories: 10 - 33μS | Foot:0.4 - 7.5µS
Body: 1.4 - 33.6µS | 18-1000µS | Minor difference, no impact on safety and effectiveness |
| Maximum Power density applied:: | All accessories: 35 - 100μT | Foot:
0.023 mA/cm2
Body:
0.082 mA/cm2 | 1-100% | Minor difference, no impact on safety and effectiveness |
| Maximum output voltage | N/A | @500Ω: 20-32V
@2kΩ: 95-118V
@10kΩ: 138-169V | Unknown | Safety: The subject device does not directly apply voltage to the human body. Therefore, no new hazards were identified. |
| Maximum Output Current | Current directly applied to the patient's body
All accessories: