(29 days)
- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance
BEMER therapy system Evo is a noninvasive physical medicine device that can be used as a supportive therapy to increase local blood circulation.
BEMER Therapy System Evo improves local blood distribution via electromagnetic stimulatory principles. The indications for use allow application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance.
The device is noninvasive, fully reusable (no disposable components such as electrodes), and has configurations allowing both patient/home and professional/office use.
This submission is for the redesigned BEMER Therapy System Evo model including all previous applicators plus a new applicator, B.BED Evo.
The device contains firmware that controls the user interface. It also contains the pulse generator, battery charger, audio and pushbutton controller.
This document is a 510(k) Premarket Notification from the FDA regarding the BEMER Therapy System Evo. It addresses the substantial equivalence of the BEMER Therapy System Evo to previously cleared predicate devices (K151834 and K210174).
The document does not describe an AI/ML-driven device or study involving human readers, AI assistance, or expert adjudication for ground truth establishment. Instead, it focuses on the equivalence of a physical medical device (a powered muscle stimulator) based on its technological characteristics, intended use, and non-clinical performance testing.
Therefore, I cannot extract the information required by your prompts (acceptance criteria for AI/ML, sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI, etc.) because these concepts are not relevant to the described device and its regulatory submission.
The document details performance testing for physical device characteristics rather than algorithm performance on data. The "performance testing" mentioned refers to measurements of:
- BEMER signal waveform current output (AC RMS in mA) generated from the console.
- Magnetic flux output (uT) from the applicators at all signal intensity input levels.
These are engineering performance specifications for a physical device, not a study evaluating an AI model with human reading.
In summary, the provided text does not contain the information needed to answer your questions as it pertains to a physical medical device clearance, not an AI/ML device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 8, 2023
BEMER International AG % Prithul Bom Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K231368
Trade/Device Name: BEMER Therapy System Evo Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: May 11, 2023 Received: May 11, 2023
Dear Prithul Bom:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
{1}------------------------------------------------
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tushar Bansal -S
Tushar Bansal, PhD Acting Assistant Director THT5B3: Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K231368
Device Name BEMER Therapy System Evo
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)
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 Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff 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."
{3}------------------------------------------------
| Date Prepared: | 08-Jun-2023 |
|---|---|
| ---------------- | ------------- |
I Submitter
| BEMER International, AG | |
|---|---|
| Austrasse 15 | |
| LIE-9495 Triesen, Liechtenstein | |
| Phone: +423-792-7386 |
| Submitter Contact: | Sandra SchwarzenbergerQuality Director |
|---|---|
| Submission Correspondent: | Paul DrydenProMedic, LLC |
II Device
| Proprietary or Trade Name: | BEMER Therapy Systems Evo |
|---|---|
| Common/Usual Name: | Powered Muscle Stimulator |
| Classification Name: | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Regulation | (21 CFR 890.5850) |
| Product Code: | NGX |
III Predicate Device:
| Common/Usual Name: | BEMER Classic Set and BEMER Pro-Set (K151834) |
|---|---|
| Classification Name: | Powered Muscle Stimulator |
| Regulation | Stimulator, Muscle, Powered, For Muscle Conditioning(21 CFR 890.5850) |
| Product Code: | NGX |
Secondary Predicate Device:
| Common/Usual Name: | BEMER Classic Set and BEMER Pro-Set (K210174)B. Sit and B. Body applicators |
|---|---|
| Classification Name: | Powered Muscle Stimulator |
| Regulation | Stimulator, Muscle, Powered, For Muscle Conditioning(21 CFR 890.5850) |
| Product Code: | NGX |
IV Device Description:
Device Description: IV
BEMER therapy system Evo is a noninvasive physical medicine device that can be used as a supportive therapy to increase local blood circulation.
BEMER Therapy System Evo improves local blood distribution via electromagnetic stimulatory principles. The indications for use allow application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance.
The device is noninvasive, fully reusable (no disposable components such as electrodes), and has configurations allowing both patient/home and professional/office use.
This submission is for the redesigned BEMER Therapy System Evo model including all previous applicators plus a new applicator, B.BED Evo.
{4}------------------------------------------------
The device contains firmware that controls the user interface. It also contains the pulse generator, battery charger, audio and pushbutton controller.
V 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
Environments of use: OTC (identical to K151834).
VI Comparison of Technological Characteristics and Performance with the Predicate
Table 1 below provides the summarized equivalence comparison of general intended uses/actions, specific indications for use, equivalence of key clinical and technical features between subject and predicate devices, along with a full listing of technical and conformance specifications.
| BEMER Therapy System Evo BEMER Therapy SystemsSubject Device | BEMER Therapy SystemsPredicate DeviceK151834 | BEMER Therapy SystemsApplicator:B.SIT and B.BODYSecondary PredicateK210174 | |
|---|---|---|---|
| ClassificationCode(s) | Primary: Powered MuscleStimulator NGX 890.5850 | Primary: Powered MuscleStimulator NGX 890.5850 | Primary: Powered MuscleStimulator NGX 890.5850 |
| Indications forUse | The BEMER therapySystem Evo is indicated:To temporarily increase localblood circulation in healthyleg muscles.To stimulate healthy muscles | The BEMER therapySystem is indicated:To temporarily increase localblood circulation in healthyleg muscles.To stimulate healthy muscles in | The BEMER therapySystem is indicated:To temporarily increase localblood circulation in healthyleg muscles.To stimulate healthy musclesin order to improve and |
| Primary Mode ofAction | in order to improve andfacilitate muscle performance.Non-invasive tissuestimulation via magnetic fieldinduction | order to improve and facilitatemuscle performance.Non-invasive tissuestimulation via magnetic fieldInduction | facilitate muscle performance.Non-invasive tissuestimulation via magnetic fieldinduction |
| Treat large and/ormultiple regionsSimultaneously | YesB. Spot Evo and B. Pad EvoB. Grip Evo - holds B. SpotB. Sit EvoApplication modules for localtreatments. Local treatment onskeletal muscles. Treatmentarea restricted by applicatorgeometry.B. Body Evo and B. Bed EvoLower extremities and uppertorso. Local treatment onskeletal muscles.Treatment area restricted by | YesB. Spot and B. PadB. Grip - holds B. SpotApplication modules for localtreatments. Local treatment onskeletal muscles. Treatmentarea restricted by applicatorgeometry. | YesB. SitApplication module for localtreatments. Local treatmenton skeletal muscles.Treatment area restricted byapplicator geometry.B. Body - Lower extremitiesand upper torso. Localtreatment on skeletal musclesTreatment area restricted byapplicator geometry |
Table 1: Comparison of Subject vs. Predicate
{5}------------------------------------------------
510(k) Summary Page 3 of 5
| BEMER Therapy System EvoSubject Device | BEMER Therapy SystemsPredicate DeviceK151834 | BEMER Therapy SystemsApplicator:B.SIT and B.BODYSecondary PredicateK210174 | |
|---|---|---|---|
| applicator geometry. | |||
| MultipleApplicators | B. Spot EvoB. Pad EvoB. Grip EvoB. Sit EvoB. Body EvoB. Bed Evo (new) | B. SpotB. PadB. Grip | B. SitB. Body |
| Average Fluxdensity(Applicator) | $\approx$ 35 μΤ το 50 μΤ (max. level)B. Body Evo and B. Bed Evo | $\approx$ 35 μΤ to 50 µT (max. level)B. Body | |
| $\approx$ 100 to 150 μΤ (max. level)B. Sit Evo, B. Pad Evo, B.Grip Evo and B.Spot Evo | $\approx$ 100 to 150 μΤ (max. level)B. Pad, B. Grip and B.Spot | $\approx$ 100 to 150 μΤ (max. level)B. Sit | |
| PowerConsumption(System) | 30 Watt max. | 30 Watt max. | 30 Watt max. |
| Number of outputmodes (System) | 1 | 1 | 1 |
| Number of outputchannels and ports(System) | 2 for each | 2 for each | 2 for each |
| Voltage / CurrentLevel | 1-3 intensity indicator | 1-10 intensity indicator | 1-10 intensity indicator |
| Timer Range | 8-20 minutes | 8-20 minutes | 8-20 minutes |
| Biocompatibility | Surface Contact, Intact skin,permanent duration of use (>30 days)ISO 10993-5:2009ISO 10993-10:2010 | Surface Contact, Intact skin,permanent duration of use (>30 days) | Surface Contact, Intact skin,permanent duration of use (>30 days) |
| Compliance withvoluntary standards | IEC 60601-1 | IEC60601-1 | IEC60601-1 |
| IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | |
| EN 60601-1-6 | EN 60601-1-6 | EN 60601-1-6 | |
| EN 62366EN 60601-1-11 | EN 62366EN 60601-1-11 | EN 62366EN 60601-1-11 |
VII Substantial Equivalence
Intended Use/ Indications for Use
The BEMER Therapy System Evo and its applicators have indications for use as the predicates, K151834 and K210174.
Technological Characteristics
The technology of the coils is identical to that of the predicate applicators. The coils of the B.Body Evo and B.Bed Evo have been redesigned but treat the same regions with the identical power out as the predicates, K151834 and K210174. Specific to the B.Bed Evo applicator has the same power outputs, average flux density, as the cleared B. Body Evo, K210174. It provides local stimulation of more superficial muscles to temporarily increase local blood flow while the other applicators are used for applications for deeper penetration and therefore are intended for a more targeted therapy.
{6}------------------------------------------------
Principles of Operation
The principle of operation is identical to the predicate, K151834.
Non-clinical Testing
Performance testing demonstrated that the subject applicators performed equivalent to the predicate applicators. Testing included:
Performance testing involved multiple measurements of:
- BEMER signal waveform current output (AC RMS in mA) generated from B.BOX Evo . console as input to the applicators
- Magnetic flux output (uT) generated from B.BODY Evo, B.SPOT Evo, B.SIT Evi, B.BED ● Evo and B.PAD Evo applicators at all signal intensity input levels
Software
-
. Validation and Verification performed.
Electrical / EMC -
IEC 60601-1 - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
-
IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements For . Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
-
EN 60601-1-11 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
-
EN 60601-1-6 Medical Electrical Equipment Part 1-6: General Requirements For ● Basic Safety And Essential Performance - Collateral Standard: Usability
-
EN 62366 Medical devices Part 1: Application of usability engineering to medical . devices
Biocompatibilitv
- Surface Contact, Intact Skin, Permanent duration of use. Evaluated with ISO 10993-5 2009 ● - Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity and ISO 10993-10 - 2010 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
Discussion of Differences
The differences between the proposed and predicate device are:
- Updating the console, B.Box Evo to a new look ●
- . Change in coil design for the B. Body Evo from a 6 coil configuration. Output is the same as the predicate B. Body, K210174
- . Adding B. Bed Evo applicator which is a larger configuration of B. Body with the same 16 coil configuration and outputs.
- . Limiting the intensity settings to 3 vs. 10 as in the predicate
{7}------------------------------------------------
510(k) Summary Page 5 of 5
These changes do not alter the indications for use, patient population, environments of use, technological characteristics, contraindications, or performance specifications. The differences do not raise different concerns of safety or effectiveness.
Substantial Equivalence Conclusion
The changes to this device do not alter the indications for use, patient population, environments of use, technological characteristics, contraindications, or performance specifications. The differences do not raise different concerns of safety or effectiveness.
BEMER International, AG has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device does not raise different safety concerns compared to the predicates, and is therefore substantially equivalent to the predicate devices.
§ 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).