(239 days)
Not Found
No
The device description focuses on electromagnetic stimulation controlled by user-adjustable parameters (Frequency, Time, Intensity) via an LCD and rotary knob. There is no mention of AI, ML, or any learning or adaptive capabilities. The performance studies are limited to magnetic field and tissue heating testing, not algorithmic performance.
Yes
The Device Description explicitly states "emFieldPro is a non-invasive therapeutic device."
No
The device description states it is a "non-invasive therapeutic device" and its intended uses are for strengthening and toning muscles, which are therapeutic rather than diagnostic actions. It "produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the emFieldPro helps to strengthen, tone and firm the abdomen, buttocks and thighs," indicating a treatment function. There is no mention of it being used to identify or analyze diseases or conditions.
No
The device description explicitly states it is a "non-invasive therapeutic device" that "produces electromagnetic field" and includes physical components like "device housing," "four wheels," "two applicators," an "LCD," and a "rotary knob." This indicates it is a hardware device with integrated software for control.
Based on the provided information, the emFieldPro device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- emFieldPro's Function: The emFieldPro device is described as a non-invasive therapeutic device that produces an electromagnetic field to stimulate muscles within the human body. Its intended use is for strengthening, toning, and firming specific body parts.
- Lack of Sample Analysis: There is no mention of the emFieldPro device collecting or analyzing any samples from the patient. Its action is directly applied to the body.
Therefore, the emFieldPro falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
emFieldPro is indicated to be used for:
- · Improvement of abdominal tone, strengthening of the abdominal muscles, development for firmer abdomen.
- · Strengthening, toning and firming of buttocks and thighs.
Product codes (comma separated list FDA assigned to the subject device)
NGX
Device Description
emFieldPro is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the emFieldPro helps to strengthen, tone and firm the abdomen, buttocks and thighs.
The device housing protects the patient from electrical shock and mechanical injuries. The device is mobile standalone equipment with four wheels. Two applicators are available for therapy: a large and a small one. The main body of emFieldPro is used to control function of magnetic stimulation. It is operated with parameters such as Frequency, Time and Intensity. These parameters can be controlled by the user on LCD and with the help of a rotary knob at the user control panel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen, buttocks and thighs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Preclinical Testing Results
The following tests were performed on the subject device in addition to the testing listed above:
- Magnetic Field testing
- Tissue Heating study
The testing above confirmed that the large and small applicator each operate within the magnetic field intensity specifications for each applicator and that the tissue being treated by the device does not present an appreciable rise in temperature at maximum intensity to cause a risk to the patient.
Testing has been performed and all components, subassemblies and/or full devices and systems have met the required specifications for the completed tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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
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June 21, 2019
Zimmer MedizinSysteme GmbH % Scott Blood Principal Regulatory Consultant Quality and Regulatory Services 22 Nichols Street #2 Salem, Massachusetts 01970
Re: K182963
Trade/Device Name: emFieldPro Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: May 15, 2019 Received: May 16, 2019
Dear Scott Blood:
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,
for Vivek Pinto, PhD Assistant Director, Acute Injury Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182963
Device Name emFieldPro
Indications for Use (Describe)
emFieldPro is indicated to be used for:
- · Improvement of abdominal tone, strengthening of the abdominal muscles, development for firmer abdomen.
· Strengthening, toning and firming of buttocks and thighs.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The word "zimmer" is in bold, gray font. Underneath the word "zimmer" is the word "MedizinSysteme" in a smaller, gray font.
510(k) Summarv K182963
-
- Basic Information-Submitter:
510(k) Owner:
- Basic Information-Submitter:
Zimmer MedizinSysteme GmbH Junkersstrasse 9 89231 Neu-Ulm Germany Establishment Registration: 8010720
- Official Contact:
Mrs. Ute Hauss Manager Regulatory Affairs Phone: +49-731-9761-216 Fax: +49-731-9761-118 E-mail: u.hauss@zimmer.de
Date Summary Prepared:
14 May 2019
-
- Device Name:
Trade Name: Common Name: Classification Name:
- Device Name:
Regulation Number: Product Code: Classification:
emFieldPro Powered muscle stimulator Stimulator, Muscle, Powered, For Muscle Conditioning 21 CFR 890.5850 NGX Class II
-
- Predicate Devices: BTL 799-2 – K180813
-
- Device Description:
emFieldPro is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the emFieldPro helps to strengthen, tone and firm the abdomen, buttocks and thighs.
The device housing protects the patient from electrical shock and mechanical injuries. The device is mobile standalone equipment with four wheels. Two applicators are available for therapy: a large and a small one. The main body of emFieldPro is used to control function of magnetic stimulation. It is operated with parameters such as Frequency, Time and Intensity. These parameters can be controlled by the user on LCD and with the help of a rotary knob at the user control panel.
4
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-
- Indications for Use Statement:
emFieldPro is indicated to be used for:
- Indications for Use Statement:
-
Improvement of abdominal tone, strengthening of the abdominal muscles, development for ● firmer abdomen.
-
. Strengthening, toning and firming of buttocks and thighs.
-
- Technological Characteristics:
The emFieldPro device has the same indications for use and similar technological characteristics and principles of operation as its predicate device. The emFieldPro device and its predicate are comprised of a system console and applicator. The system console consists of the electromagnetic field generators, computer, and the touch-screen control panel.
The emFieldPro is equipment that generates a magnetic field by applying a strong current to an applicator. The essential technical characteristics of the emFieldPro and its predicate device, particularly the type of energy, type of operation, therapy time and the Magnetic Field Intensity are equivalent.
Compared to the predicate, the emFieldPro device is equipped with an arm which allows adjustment of the applicator right in front of the patient in an optimized position for treatment.
The technological differences between the emFieldPro device and the predicate device do not raise any new types of safety or effectiveness questions.
| Technological
Characteristics | SUBJECT DEVICE
Zimmer MedizinSyteme GmbH
emFieldPro
K182963 | PREDICATE DEVICE
BTL Industries, Inc.
BTL 799-2
K180813 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code and
Regulation | Physical Medicine
21 CFR 890.5850
NGX - Stimulator Muscle,
Powered, Muscle Conditioning | Physical Medicine
21 CFR 890.5850
NGX - Stimulator Muscle,
Powered, Muscle Conditioning |
| Indications for Use | The emFieldPro 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. | BTL 799-2 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. |
| Primary Function | Muscle stimulation | Muscle stimulation |
| Principle of Action | Initiating action potential of nerves | Initiating action potential of nerves |
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| Technological
Characteristics | SUBJECT DEVICE
Zimmer MedizinSyteme GmbH
emFieldPro | PREDICATE DEVICE
BTL Industries, Inc.
BTL 799-2 | |
|--------------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------------------|--|
| | K182963 | K180813 | |
| | results in muscle contraction | results in muscle contraction | |
| Electrical Protection | Class I, BF | Class II, BF | |
| User Interface | Touch screen | Touch screen | |
| Touch screen size | 7" | 15.6" (39.6 cm) | |
| Firmware Controlled | Yes | Yes | |
| Type of Energy | Magnetic field | Magnetic field | |
| Number of outputs | 2 | 2 | |
| Number of Magnetic | 1 | 1 | |
| Coils in the Applicator
Magnetic Field
Intensity | Large applicator 0.5 - 1.5T +/-20%
Small applicator 0.5 - 2T | 0.5-1.8 T | |
| Total Induced Current
in Tissue (mA) | 251 | 285 | |
| Type of Operation | Continuous | Continuous | |
| Pulse Repetition Rate | 1 – 150 Hz | 1 – 150 Hz | |
| Pulse Duration | 400 ps +/- 20% | 280 +/- 20% µs | |
| Pulse Amplitude | 0 - 100 % | 0 - 100 % | |
| Selection of
parameters (Intensity,
Time) | Yes | Yes | |
| Therapy Time | Up to 60 min | Up to 60 min | |
| Shape of Stimulation
Pulse | Symmetrical Biphasic Sine Wave | Symmetrical Biphasic Sine Wave | |
| Energy Source | 100 - 240 VAC, 50/60 Hz | 100 - 240 V AC, 50-60 Hz | |
| System Dimensions
(WxHxD) | 542x501x993mm | 500×1380×580 mm
(20×55×23 in) | |
| Operating Ambient
Temperature | 10°C to 30 °C | -10°C to +55°C | |
| Environmental
Specifications | For indoor use only | For indoor use only | |
The Zimmer MedizinSysteme GmbH emFieldPro has the same technological characteristics as the predicate device except for the following:
| Technological
Characteristic | Characteristic difference
between emFieldPro and
Predicate Device | Discussion on why this difference does not affect
the overall safety and effectiveness of the subject
device when compared to the predicate device |
|---------------------------------|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Protection | Class I versus Class II | Electrical safety is covered as class 1 device equal to a
class 2 device. |
| Touch Screen Size | 7" versus 15.6" (39.6 cm) | Even the size of the touch screen of emFieldPro is
smaller than the predicate device all icons and data are
displayed clearly and usability is passed successfully. |
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| Technological
Characteristic | Characteristic difference
between emFieldPro and
Predicate Device | Discussion on why this difference does not affect
the overall safety and effectiveness of the subject
device when compared to the predicate device |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Magnetic Field
Intnesity | 0.5 - 1.5T +/- 20% for the large
applicator ad 0.5 – 2.0T for the
small applicator versus 0.5 to
1.8T | The maximum field intensity for the emfieldPro's small
applicator is 2.0T as compared to the 1.8T of the
predicate device. This difference is within 20% of the
acceptable variability in field intensity. |
| Total Induced Current
in Tissue (mA) | 251 mA versus 285 mA | The total induced current on the tissue for the
emFieldPro is less than the predicate device and
therefore safer with the same effect. The difference
between the two induced current measurements are
within just over 10%, which is not great enough of a
variation to produce a different clinical effect. |
| Pulse Duration | 400 $\mu$ s +/- 20% for the large
applicator and 250 $\mu$ s +/- 20%
for the small applicator versus
280 +/- 20% $\mu$ s at the predicate
device | The pulse width of the emFieldPro device and the
predicate device are in the typical clinical range of 50 to
500 $\mu$ s
Reference: "the effect of stimulus current pulse width on
nerve fiber size recruitment patterns" by Robert B.
Szlavik and Hubert de Bruin |
| System Dimensions
(WxHxD) | 501x993x542 mm versus
580×1380×580 mm | Different dimensions have no influence on the safety or
effectiveness of the device. The usability is passed
successfully. |
| Operating Ambient
Temperature Range | 10°C to 30 °C versus
-10°C to +55°C | The emFieldPro labeling allows for device usage in an
environment that is more typical than the environment
stated in the predicate labeling |
Any differences in their technological characteristics are explained to demonstrate in this submission that these differences do not raise any new questions of safety and effectiveness.
7. Performance data
The emFieldPro device has been investigated and tested against and complies with the following voluntary standards:
| Standards | Standards
Organization | Standards Title |
|------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 60601-1 | IEC | Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance |
| 60601-1-2 | IEC | Medical electrical equipment – Part 1-2: General requirements
for basic safety and essential performance – Collateral standard:
Electromagnetic disturbances – Requirements and tests |
| 60601-1-6 | IEC | Medical electrical equipment - Part 1-6: General requirements
for basic safety and essential performance - Collateral
standard: Usability |
| 60601-2-10 | IEC | Medical electrical equipment – Part 2–10: Particular
requirements for the Basic Safety and Essential Performance of
Nerve and Muscle Stimulators |
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| Standards | Standards
Organization | Standards Title |
|-----------|---------------------------|---------------------------------------------------------------------------------------------------------------------|
| 62366-1 | IEC | Medical devices – Application of usability engineering to medical
devices |
| 62304 | IEC | Medical devices software -software life cycle processes |
| 14971 | ISO | Medical devices – Application of risk management to medical
devices |
| 10993-1 | ISO | No Biocompatibility testing performed as the applied doesn't get
in contact with the patient
(see section 16) |
The following table shows a comparison of the performance testing in comparison to the predicate devices:
| Standards | SUBJECT DEVICE
Zimmer MedizinSyteme GmbH
emFieldPro
K182963 | PREDICATE DEVICE
BTL Industries, Inc.
BTL 799-2
K180813 |
|---------------|----------------------------------------------------------------------|------------------------------------------------------------------|
| IEC 60601-1 | X | X |
| IEC60601-2-10 | X | X |
| IEC 60601-1-2 | X | X |
| ISO 10993-1 | Not applicable
(no patient-contacting materials) | X |
According to this comparison table all required performance tests were conducted and show substantial equivalence with the predicate devices.
Preclinical Testing Results
The following tests were performed on the subject device in addition to the testing listed above:
- Magnetic Field testing ●
- Tissue Heating study
The testing above confirmed that the large and small applicator each operate within the magnetic field intensity specifications for each applicator and that the tissue being treated by the device does not present an appreciable rise in temperature at maximum intensity to cause a risk to the patient.
Testing has been performed and all components, subassemblies and/or full devices and systems have met the required specifications for the completed tests.
8. 510(k) Summary:
Zimmer MedizinSysteme GmbH has demonstrated that the emFieldPro device is substantially equivalent to the predicate device listed above.