emField

K203488 · Zimmer Medizinsysteme GmbH · IPF · Feb 19, 2021 · Physical Medicine

Device Facts

• Record ID: K203488
• Device Name: emField
• Applicant: Zimmer Medizinsysteme GmbH
• Product Code: IPF · Physical Medicine
• Decision Date: Feb 19, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

emField is a mobile, standalone, non-invasive powered muscle stimulator; used in clinical settings by healthcare providers. Device generates magnetic fields via applicators (large/small) to induce action potentials in nerves, resulting in muscle contraction. User controls parameters (frequency, time, intensity) via touch-screen interface and rotary knob. Device provides bulk muscle excitation in arms or legs for rehabilitation. Benefits include improved circulation, muscle re-education, and prevention of atrophy/thrombosis. Clinical decision-making is supported by user-defined therapy parameters tailored to patient rehabilitation needs.

Clinical Evidence

Bench testing only. Testing included magnetic field intensity verification, tissue heating studies, and usability testing. Device complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10, IEC 62366-1, IEC 62304, and ISO 14971. Tissue heating study confirmed no appreciable temperature rise at maximum intensity.

Technological Characteristics

Mobile standalone system; console with electromagnetic field generators and touch-screen. Two applicators (large/small) with single magnetic coil each. Energy source: 100-240V AC. Output: Symmetrical Biphasic Sine Wave; 1-150 Hz frequency; 0.5-2.0 T intensity. Electrical safety: Class I, BF. Software life cycle per IEC 62304. No patient-contacting materials.

Indications for Use

Indicated for patients requiring muscle stimulation for relaxation of spasms, prevention of disuse atrophy, increased local blood circulation, muscle re-education, post-surgical calf muscle stimulation to prevent venous thrombosis, and maintenance or increase of range of motion.

Regulatory Classification

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.

Predicate Devices

• HPM-6000 (K160992)

Reference Devices

• emFieldPro (K182963)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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<br>Junkersstrasse 9<br>89231 Neu-Ulm<br>Germany<br>Establishment Registration: 8010720 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Mrs. Ute Hauss<br>Manager Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| 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 |

4. Device Description:

Company Name:

2.

3.

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

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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<br>Zimmer<br>MedizinSysteme GmbH<br>emField<br>This Submission | PREDICATE DEVICE<br>BTL Industries, Inc.<br>HPM-6000<br>K160992 | REFERENCE DEVICE<br>Zimmer<br>MedizinSysteme GmbH<br>emFieldPro<br>K182963 |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Physical Medicine<br>21 CFR 890.5850<br>IPF - Stimulator, Muscle, Powered<br>The emField is indicated to be used for:<br>• Relaxation of muscle spasms;<br>• Prevention or retardation of disuse atrophy;<br>• Increasing local blood circulation;<br>• Muscle re-education;<br>• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and<br>• Maintaining or increasing range of motion. | Physical Medicine<br>21 CFR 890.5850<br>IPF - Stimulator, Muscle, Powered<br>The HPM-6000 is indicated to be used for:<br>• Relaxation of muscle spasms;<br>• Prevention or retardation of disuse atrophy;<br>• Increasing local blood circulation;<br>• Muscle re-education;<br>• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and<br>• Maintaining or increasing range of motion. | Physical Medicine<br>21 CFR 890.5850<br>NGX- Stimulator, Muscle, Powered, For Muscle Conditioning<br>The emFieldPro is indicated to be used for:<br>• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.<br>• 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.

- 5. 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<br>Characteristic | SUBJECT DEVICE<br>Zimmer<br>MedizinSysteme GmbH<br>emField<br>This Submission | PREDICATE DEVCIE<br>BTL Industries, Inc.<br>HPM-6000<br>K160992 | REFERENCE DEVICE<br>Zimmer<br>MedizinSysteme GmbH<br>emFieldPro<br>K182963 |
|-----------------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Primary<br>Function | Muscle stimulation | Muscle stimulation | Muscle stimulation |
| Principle of<br>Action | Initiating action potential<br>of nerves results in<br>muscle contraction | Initiating action potential<br>of nerves results in<br>muscle contraction | Initiating action potential<br>of nerves results in<br>muscle contraction |
| Electrical<br>Protection | Class I, BF | Class II, BF | Class I, BF |
| User Interface | Touch screen | Touch screen | Touch screen |
| Touch screen<br>size | 7" | 8.4" | 7" |
| Type of Energy | Magnetic field | Magnetic field | Magnetic field |
| Number of<br>Applicators | 2 | 2 | 2 |
| Number of<br>Magnetic Coils<br>in the<br>Applicator | 1 | 1 | 1 |
| Magnetic Field<br>Intensity | Large applicator:<br>0.5 – 1.5 T +/-20%<br>Small applicator: | 299-1 applicator:<br>0.5 – 1.8 T<br>299-2 applicator: | Large applicator:<br>0.5 – 1.5 T +/-20%<br>Small applicator: |
| | 0.5 – 2.0 T +/-20% | 0.7 – 2.5 T | 0.5 – 2.0 T +/-20% |
| Total Induced<br>Current in<br>Tissue (mA) | 251 | unknown | 251 |
| Type of<br>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<br>Characteristic | SUBJECT DEVICE<br>Zimmer<br>MedizinSysteme GmbH<br>emField<br>This Submission | PREDICATE DEVCIE<br>BTL Industries, Inc.<br>HPM-6000<br>K160992 | REFERENCE DEVICE<br>Zimmer<br>MedizinSysteme GmbH<br>emFieldPro<br>K182963 |
|----------------------------------------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------|
| Pulse<br>Repetition Rate | 1 - 150 Hz | 1 - 150 Hz | 1 - 150 Hz |
| Pulse Duration | Large applicator:<br>400 µs +/- 20%<br>Small applicator:<br>250 µs +/- 20% | 280 +/- 20% µs | Large applicator:<br>400 µs +/- 20%<br>Small applicator:<br>250 µs +/- 20% |
| Pulse<br>Amplitude | 0 - 100 % | 0 - 100 % | 0 - 100 % |
| Selection of<br>parameters<br>(Intensity.<br>Time) | Yes | unknown | Yes |
| Therapy Time | Up to 60 min | Up to 60 min | Up to 60 min |
| Shape of<br>Stimulation<br>Pulse | Symmetrical Biphasic<br>Sine Wave | Sine, biphasic | Symmetrical Biphasic<br>Sine Wave |
| Energy Source | 100-240 V AC, 50-60<br>Hz, max 12.5 A | 100-240 V AC, 50-60<br>Hz, max. 14 A | 100-240 V AC, 50-60<br>Hz, max 12.5 A |
| System<br>Dimensions<br>(WxHxD) | 542 x 501 x 993 mm | 500 × 970 × 580 mm<br>(20×38×23 in) | 542 x 501 x 993 mm |
| Operating<br>Ambient<br>Temperature | 10° C to 30° C | 10° C to 30° C | 10° C to 30° C |
| Operating<br>Ambient<br>Humidity | 30-85% | 30-75% | 30-85% |
| Weight | Approx. 60 kg | 33 kg | Approx. 60 kg |
| Environmental<br>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<br>Organization | Standards Title |
|----------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 60601-1 | IEC | Medical electrical equipment – Part 1: General<br>requirements for basic safety and essential performance |
| 60601-1-2 | IEC | Medical electrical equipment – Part 1-2: General<br>requirements for basic safety and essential performance –<br>Collateral standard: Electromagnetic disturbances –<br>Requirements and tests |
| 60601-1-6 | IEC | Medical electrical equipment – Part 1-6: General<br>requirements for basic safety and essential performance -<br>Collateral standard: Usability |
| 60601-2-<br>10 | IEC | Medical electrical equipment – Part 2-10: Particular<br>requirements for the Basic Safety and Essential<br>Performance of Nerve and Muscle Stimulators |
| 62366-1 | IEC | Medical devices – Application of usability engineering to<br>medical devices |
| 62304 | IEC | Medical devices software –software life cycle processes |
| 14971 | ISO | Medical devices – Application of risk management to<br>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<br>MedizinSyteme<br>GmbH | BTL Industries,<br>Inc. | Zimmer<br>MedizinSyteme GmbH |
| | emField<br>This Submission | HPM-6000<br>K160992 | emFieldPro<br>K182963 |
| IEC 60601-1 | X | X | X |
| IEC 60601-1-<br>2 | X | X | X |
| IEC 60601-2-<br>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<br>MedizinSyteme<br>GmbH<br><br>emField<br>This Submission | BTL Industries,<br>Inc.<br><br>HPM-6000<br>K160992 | Zimmer<br>MedizinSyteme GmbH<br><br>emFieldPro<br>K182963 |
| ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | Not applicable<br>(no patient-contacting<br>materials) | X | Not applicable<br>(no patient-contacting<br>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.

7. 510(k) Summary:

Zimmer MedizinSysteme GmbH has demonstrated that the emField device is substantially equivalent to the predicate device and reference device.