(84 days)
HPM-6000 – K160992
emFieldPro – K182963
No
The description focuses on user-controlled parameters (Frequency, Time, Intensity) and standard electrical/magnetic safety testing, with no mention of AI/ML terms or functionalities.
Yes
The device description explicitly states, "emField is a non-invasive therapeutic device." Additionally, its intended uses, such as relaxation of muscle spasms and prevention of disuse atrophy, are therapeutic in nature.
No
The device description and intended uses clearly state that the emField is a therapeutic device designed for muscle stimulation and various rehabilitation purposes, not for diagnosing conditions or diseases.
No
The device description explicitly details physical hardware components such as a device housing, wheels, applicators, an LCD screen, and a rotary knob, indicating it is a hardware device with integrated software for control.
Based on the provided information, the emField device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended uses listed are all related to therapeutic applications on the human body (muscle relaxation, preventing atrophy, increasing circulation, muscle re-education, preventing thrombosis, increasing range of motion). These are not diagnostic purposes.
- Device Description: The description clearly states it's a "non-invasive therapeutic device" that produces a magnetic field to interact with tissues for "muscle stimulation" and "rehabilitative purposes."
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information.
- Performance Studies: The performance studies mentioned focus on safety and compliance with standards for medical devices, as well as preclinical testing related to the device's physical effects (magnetic field, tissue heating, usability). There are no studies related to diagnostic accuracy or performance.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The emField device's function and intended use fall squarely within the realm of therapeutic medical devices, not IVDs.
N/A
Intended Use / Indications for Use
The emField is indicated to be used for:
*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; and
*Maintaining or increasing range of motion.
Product codes (comma separated list FDA assigned to the subject device)
IPF
Device Description
emField is a non-invasive therapeutic device. The device produces a magnetic field that interacts with the tissues of the human body. By muscle stimulation, the emField is indicated for bulk muscle excitation in the legs or arms for rehabilitative purposes.
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 emField 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
legs or arms (for bulk muscle excitation)
calf muscles (for prevention of venous thrombosis)
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)
The emField device has been investigated and tested against and complies with the following voluntary standards:
- 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
- IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-2-10 Medical electrical equipment – Part 2-10: Particular requirements for the Basic Safety and Essential Performance of Nerve and Muscle Stimulators
- IEC 62366-1 Medical devices – Application of usability engineering to medical devices
- IEC 62304 Medical devices software –software life cycle processes
- ISO 14971 Medical devices – Application of risk management to medical devices
Comparison of performance testing:
- IEC 60601-1: Subject Device (X), Predicate Device (X), Reference Device (X)
- IEC 60601-1-2: Subject Device (X), Predicate Device (X), Reference Device (X)
- IEC 60601-2-10: Subject Device (X), Predicate Device (X), Reference Device (X)
- ISO 10993-1, ISO 10993-5, ISO 10993-10: Subject Device (Not applicable - no patient-contacting materials), Predicate Device (X), Reference Device (Not applicable - no patient-contacting materials)
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
- Usability testing
Key results:
The testing 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.
HPM-6000 – K160992
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.
emFieldPro – K182963
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).
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February 19, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
Zimmer MedizinSysteme GmbH % Scott Blood Principal Regulatory Consultant Quality and Regulatory Services 151 Gleasondale Road Stow, Massachusetts 01775
Re: K203488
Trade/Device Name: emField Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: November 24, 2020 Received: November 27, 2020
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,
Patrick Antkowiak, PhD Assistant Director (acting) 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
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Indications for Use
510(k) Number (if known) K203488
Device Name emField
Indications for Use (Describe) The emField is indicated to be used for:
*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; and
*Maintaining or increasing range of motion.
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 letters. Below that, in smaller gray letters, is the word "MedizinSysteme."
510(k) Summary emField
1. Basic Information-Submitter:
| 510(k) Owner: | 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: | November 24, 2020 |
| Device Name: | |
| Trade Name: | emField |
| Common Name: | Powered Muscle Stimulator |
| Classification Name: | Stimulator, Muscle, Powered |
| Regulation Number: | 21 CFR 890.5850 |
| Product Code: | IPF |
| Classification: | Class II |
| Predciate Device: | HPM-6000 – K160992 |
| Company Name: | BTL Industries, Inc. |
| Reference Device: | emFieldPro – K182963 |
- Device Description:
Company Name:
emField is a non-invasive therapeutic device. The device produces a magnetic field that interacts with the tissues of the human body. By muscle stimulation, the emField is indicated for bulk muscle excitation in the legs or arms for rehabilitative purposes.
Zimmer MedizinSysteme GmbH
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 emField is used to control function of magnetic stimulation. It is operated with parameters such as
4
Image /page/4/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, sans-serif font. The logo is in gray color.
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.
Indications for Use Statement:
emField is indicated to be used for:
- 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; . and
- Maintaining or increasing range of motion.
| ATTRIBUTE | SUBJECT DEVICE
Zimmer
MedizinSysteme GmbH
emField
This Submission | PREDICATE DEVICE
BTL Industries, Inc.
HPM-6000
K160992 | REFERENCE DEVICE
Zimmer
MedizinSysteme GmbH
emFieldPro
K182963 |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Physical Medicine
21 CFR 890.5850
IPF - Stimulator, Muscle, Powered
The emField is indicated to be used for:
• 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; and
• Maintaining or increasing range of motion. | Physical Medicine
21 CFR 890.5850
IPF - Stimulator, Muscle, Powered
The HPM-6000 is indicated to be used for:
• 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; and
• Maintaining or increasing range of motion. | Physical Medicine
21 CFR 890.5850
NGX- Stimulator, Muscle, Powered, For Muscle Conditioning
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. |
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Image /page/5/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo is in black and white. The word "zimmer" is in a bold, sans-serif font, and the words "MedizinSysteme" are in a smaller, sans-serif font below the word "zimmer."
The Indications for Use statement for emField is identical to the predicate device. The Indications for Use is not the same for the reference device, however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for conditioning and stimulation of muscles.
-
- Technological Characteristics:
The emField device has the equivalent technology and principles of operation as its predicate device. The emField device and its predicate are comprised of a system console and applicators. The system console consists of the electromagnetic field generators, computer, and the touch-screen control panel. The emField is equipment that generates a magnetic field by applying a strong current to an applicator. The technical characteristics of the emField and its predicate device, are equivalent.
- Technological Characteristics:
| Technological
Characteristic | SUBJECT DEVICE
Zimmer
MedizinSysteme GmbH
emField
This Submission | PREDICATE DEVCIE
BTL Industries, Inc.
HPM-6000
K160992 | REFERENCE DEVICE
Zimmer
MedizinSysteme GmbH
emFieldPro
K182963 |
|-----------------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Primary
Function | Muscle stimulation | Muscle stimulation | Muscle stimulation |
| Principle of
Action | Initiating action potential
of nerves results in
muscle contraction | Initiating action potential
of nerves results in
muscle contraction | Initiating action potential
of nerves results in
muscle contraction |
| Electrical
Protection | Class I, BF | Class II, BF | Class I, BF |
| User Interface | Touch screen | Touch screen | Touch screen |
| Touch screen
size | 7" | 8.4" | 7" |
| Type of Energy | Magnetic field | Magnetic field | Magnetic field |
| Number of
Applicators | 2 | 2 | 2 |
| Number of
Magnetic Coils
in the
Applicator | 1 | 1 | 1 |
| Magnetic Field
Intensity | Large applicator:
0.5 – 1.5 T +/-20%
Small applicator: | 299-1 applicator:
0.5 – 1.8 T
299-2 applicator: | Large applicator:
0.5 – 1.5 T +/-20%
Small applicator: |
| | 0.5 – 2.0 T +/-20% | 0.7 – 2.5 T | 0.5 – 2.0 T +/-20% |
| Total Induced
Current in
Tissue (mA) | 251 | unknown | 251 |
| Type of
Operation | Continuous | Continuous | Continuous |
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Image /page/6/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The word "zimmer" is in bold, gray letters. Underneath the word "zimmer" is the phrase "MedizinSysteme" in a smaller, lighter gray font.
| Technological
Characteristic | SUBJECT DEVICE
Zimmer
MedizinSysteme GmbH
emField
This Submission | PREDICATE DEVCIE
BTL Industries, Inc.
HPM-6000
K160992 | REFERENCE DEVICE
Zimmer
MedizinSysteme GmbH
emFieldPro
K182963 |
|----------------------------------------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------|
| Pulse
Repetition Rate | 1 - 150 Hz | 1 - 150 Hz | 1 - 150 Hz |
| Pulse Duration | Large applicator:
400 µs +/- 20%
Small applicator:
250 µs +/- 20% | 280 +/- 20% µs | Large applicator:
400 µs +/- 20%
Small applicator:
250 µs +/- 20% |
| Pulse
Amplitude | 0 - 100 % | 0 - 100 % | 0 - 100 % |
| Selection of
parameters
(Intensity.
Time) | Yes | unknown | Yes |
| Therapy Time | Up to 60 min | Up to 60 min | Up to 60 min |
| Shape of
Stimulation
Pulse | Symmetrical Biphasic
Sine Wave | Sine, biphasic | Symmetrical Biphasic
Sine Wave |
| Energy Source | 100-240 V AC, 50-60
Hz, max 12.5 A | 100-240 V AC, 50-60
Hz, max. 14 A | 100-240 V AC, 50-60
Hz, max 12.5 A |
| System
Dimensions
(WxHxD) | 542 x 501 x 993 mm | 500 × 970 × 580 mm
(20×38×23 in) | 542 x 501 x 993 mm |
| Operating
Ambient
Temperature | 10° C to 30° C | 10° C to 30° C | 10° C to 30° C |
| Operating
Ambient
Humidity | 30-85% | 30-75% | 30-85% |
| Weight | Approx. 60 kg | 33 kg | Approx. 60 kg |
| Environmental
Specifications | For indoor use only | For indoor use only | For indoor use only |
There are no technological differences between the emField device and the reference device, as they are the same device. There are few differences between the technological differences of the subject device and those of the predicate device. Those differences have been discussed and do not affect device safety or performance. The subject device has all features of the predicate device. emField does not raise any new types of safety or effectiveness questions.
The Zimmer MedizinSysteme GmbH emField has the same technological characteristics as the predicate device.
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Image /page/7/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The word "zimmer" is in bold, sans-serif font. Below that, in a smaller font, are the words "MedizinSysteme".
6. Performance data
The emField 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 |
| 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 |
The following table shows a comparison of the performance testing in comparison to the predicate devices:
| Standards | SUBJECT DEVICE | PREDCIATE DEVICE | REFERENCE DEVICE |
|---|---|---|---|
| Zimmer | |||
| MedizinSyteme | |||
| GmbH | BTL Industries, | ||
| Inc. | Zimmer | ||
| MedizinSyteme GmbH | |||
| emField | |||
| This Submission | HPM-6000 | ||
| K160992 | emFieldPro | ||
| K182963 | |||
| IEC 60601-1 | X | X | X |
| IEC 60601-1- | |||
| 2 | X | X | X |
| IEC 60601-2- | |||
| 10 | X | X | X |
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Image /page/8/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z" and "i". Below the word "zimmer" is the phrase "MedizinSysteme" in a smaller, sans-serif font. The logo is simple and modern, and the use of a bold font makes it easily recognizable.
| SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE | |
|---|---|---|---|
| Standards | Zimmer | ||
| MedizinSyteme | |||
| GmbH |
emField
This Submission | BTL Industries,
Inc.
HPM-6000
K160992 | Zimmer
MedizinSyteme GmbH
emFieldPro
K182963 |
| ISO 10993-1
ISO 10993-5
ISO 10993-10 | Not applicable
(no patient-contacting
materials) | X | Not applicable
(no patient-contacting
materials) |
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
- Usability testing
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.
- 510(k) Summary:
Zimmer MedizinSysteme GmbH has demonstrated that the emField device is substantially equivalent to the predicate device and reference device.