Improvement of abdominal tone, strengthening of the abdominal muscles, development for firmer abdomen.
Strengthening, toning and firming of buttocks and thighs.

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.

AI/ML Overview

The provided document (K182963) is a 510(k) premarket notification for the emFieldPro device, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to a predicate device (BTL 799-2 - K180813), rather than presenting a performance study with detailed acceptance criteria and clinical outcome data in the manner typically seen for more complex diagnostic AI/ML devices.

Therefore, much of the requested information regarding acceptance criteria for a study proving the device meets those criteria, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in this document. The document primarily describes the device, its indications for use, and a comparison of its technological characteristics and compliance with general safety and performance standards against a predicate device.

Here's a breakdown of the information that is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present explicit "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, or improvement in specific clinical endpoints) or a study proving the device meets these. Instead, the "acceptance criteria" for this 510(k) revolve around technical specifications and compliance with recognized standards to demonstrate substantial equivalence to a predicate device.

The table below summarizes the comparison of technological characteristics, which serves as the "performance" data for substantial equivalence in this context. The "acceptance" is that these differences do not raise new questions of safety or effectiveness.

Technological Characteristic	Acceptance Criteria (Implied by Equivalence)	Reported Device Performance (emFieldPro)	Discussion on Equivalence (Justification for "Acceptance")
Indications for Use	Must be substantially equivalent to predicate.	Improvement of abdominal tone, strengthening of abdominal muscles, development for firmer abdomen. Strengthening, toning, and firming of buttocks and thighs.	Identical to predicate device.
Primary Function	Muscle stimulation.	Muscle stimulation.	Identical to predicate device.
Principle of Action	Initiating action potential of nerves resulting in muscle contraction.	Initiating action potential of nerves resulting in muscle contraction.	Identical to predicate device.
Electrical Protection	Electrical safety must be covered.	Class I, BF	Electrical safety is covered, with Class I device considered equal to a Class II device for safety purposes.
Touch Screen Size	Usability maintained despite size difference.	7"	Smaller than predicate (15.6"), but "all icons and data are displayed clearly and usability is passed successfully."
Magnetic Field Intensity	Differences within acceptable variability (e.g., 20%); no new safety/effectiveness concerns.	Large applicator: 0.5 - 1.5T +/- 20% Small applicator: 0.5 - 2T	The maximum field intensity for the small applicator (2.0T) is slightly higher than the predicate (1.8T), but this difference "is within 20% of the acceptable variability in field intensity" and does not raise new safety/effectiveness questions.
Total Induced Current in Tissue	Differences do not result in different clinical effect.	251 mA	Less than predicate (285 mA), and therefore "safer with the same effect." The difference (just over 10%) is "not great enough of a variation to produce a different clinical effect."
Pulse Duration	Within typical clinical range (50-500 µs).	Large applicator: 400 µs +/- 20% Small applicator: 250 µs +/- 20%	Differences from predicate (280 +/- 20% µs) are within the typical clinical range of 50 to 500 µs, referencing a paper on nerve fiber size recruitment patterns to support this.
System Dimensions	No influence on safety or effectiveness.	542x501x993mm	Different from predicate (500×1380×580 mm), but "no influence on the safety or effectiveness of the device. The usability is passed successfully."
Operating Ambient Temperature Range	Labeling reflects typical environment.	10°C to 30°C	The allowed operating temperature range is narrower than the predicate (-10°C to +55°C), but the "emFieldPro labeling allows for device usage in an environment that is more typical than the environment stated in the predicate labeling." This implies the device is suitable for its intended use environment, meeting the practical "acceptance" for operational range.
Compliance with Voluntary Standards	Device complies with relevant standards.	IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-10, 62366-1, 62304, 14971.	All listed "required performance tests" were conducted and show "substantial equivalence with the predicate devices."
Magnetic Field Testing	Operate within specifications.	Each applicator operates within specifications.	Confirmed that large and small applicators "operate within the magnetic field intensity specifications."
Tissue Heating Study	No appreciable rise in temperature at max intensity risking the patient.	No appreciable rise in temperature.	Confirmed that "tissue being treated by the device does not present an appreciable rise in temperature at maximum intensity to cause a risk to the patient."

The following information is NOT available in the provided document:

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable / Not provided. The document describes laboratory and engineering tests (e.g., electrical safety, EMC, usability testing, magnetic field measurements, tissue heating studies) to verify technical specifications and compliance with standards. It does not mention a clinical performance "test set" with patient data in the typical sense for AI/ML device validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable / Not provided. Ground truth, in the context of diagnostic AI/ML, refers to a definitive correct answer for a given case. This device is not a diagnostic AI/ML tool. Its "truth" is established by physical measurements and compliance with engineering standards. For usability, implicit "experts" (or trained users) would have assessed the interface, but this is not detailed as "ground truth establishment."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable / Not provided. No such adjudication method is mentioned, as there is no specific "test set" requiring expert consensus for clinical labeling.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable / Not provided. This is not an AI/ML device that assists human readers. It's a non-invasive therapeutic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable / Not provided. This is not an AI algorithm. Its "performance" is its ability to generate an electromagnetic field according to specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable / Not provided. As a therapeutic device, its "ground truth" relates to its physical performance and safety (e.g., measured magnetic field intensity, temperature rise, electrical safety testing results) rather than diagnostic accuracy against a clinical reference standard.

8. The sample size for the training set

Not applicable / Not provided. This device is not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not applicable / Not provided. As there is no training set for an AI/ML model, this question is not relevant.

In summary, this 510(k) focuses on demonstrating substantial equivalence through comparison of technical specifications and compliance with performance standards, rather than clinical trial data with defined acceptance criteria for AI/ML performance. The "study" referenced in the document primarily consists of various engineering and safety tests outlined in the standards listed, such as IEC 60601-1 (general medical electrical equipment safety), IEC 60601-2-10 (particular requirements for nerve and muscle stimulators), and ISO 14971 (risk management).

Summary

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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

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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 (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

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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

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:

14 May 2019

1. Device Name:
  Trade Name: Common Name: Classification Name:

Regulation Number: Product Code: Classification:

emFieldPro Powered muscle stimulator Stimulator, Muscle, Powered, For Muscle Conditioning 21 CFR 890.5850 NGX Class II

1. Predicate Devices: BTL 799-2 – K180813
1. Device Description:

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.

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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 grayscale.

1. Indications for Use Statement:
  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.
1. 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.

TechnologicalCharacteristics	SUBJECT DEVICEZimmer MedizinSyteme GmbHemFieldProK182963	PREDICATE DEVICEBTL Industries, Inc.BTL 799-2K180813
Product Code andRegulation	Physical Medicine21 CFR 890.5850NGX - Stimulator Muscle,Powered, Muscle Conditioning	Physical Medicine21 CFR 890.5850NGX - Stimulator Muscle,Powered, Muscle Conditioning
Indications for Use	The emFieldPro is indicated to beused for:• Improvement of abdominaltone, strengthening of theabdominal muscles,development of firmerabdomen.• Strengthening, Toning andFirming of buttocks and thighs.	BTL 799-2 is indicated to be usedfor:• Improvement of abdominaltone, strengthening of theabdominal muscles,development of firmerabdomen.• Strengthening, Toning andFirming 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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TechnologicalCharacteristics	SUBJECT DEVICEZimmer MedizinSyteme GmbHemFieldPro	PREDICATE DEVICEBTL 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 ApplicatorMagnetic FieldIntensity	Large applicator 0.5 - 1.5T +/-20%Small applicator 0.5 - 2T	0.5-1.8 T
Total Induced Currentin 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 ofparameters (Intensity,Time)	Yes	Yes
Therapy Time	Up to 60 min	Up to 60 min
Shape of StimulationPulse	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 AmbientTemperature	10°C to 30 °C	-10°C to +55°C
EnvironmentalSpecifications	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:

TechnologicalCharacteristic	Characteristic differencebetween emFieldPro andPredicate Device	Discussion on why this difference does not affectthe overall safety and effectiveness of the subjectdevice when compared to the predicate device
Electrical Protection	Class I versus Class II	Electrical safety is covered as class 1 device equal to aclass 2 device.
Touch Screen Size	7" versus 15.6" (39.6 cm)	Even the size of the touch screen of emFieldPro issmaller than the predicate device all icons and data aredisplayed clearly and usability is passed successfully.

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TechnologicalCharacteristic	Characteristic differencebetween emFieldPro andPredicate Device	Discussion on why this difference does not affectthe overall safety and effectiveness of the subjectdevice when compared to the predicate device
Magnetic FieldIntnesity	0.5 - 1.5T +/- 20% for the largeapplicator ad 0.5 – 2.0T for thesmall applicator versus 0.5 to1.8T	The maximum field intensity for the emfieldPro's smallapplicator is 2.0T as compared to the 1.8T of thepredicate device. This difference is within 20% of theacceptable variability in field intensity.
Total Induced Currentin Tissue (mA)	251 mA versus 285 mA	The total induced current on the tissue for theemFieldPro is less than the predicate device andtherefore safer with the same effect. The differencebetween the two induced current measurements arewithin just over 10%, which is not great enough of avariation to produce a different clinical effect.
Pulse Duration	400 $\mu$ s +/- 20% for the largeapplicator and 250 $\mu$ s +/- 20%for the small applicator versus280 +/- 20% $\mu$ s at the predicatedevice	The pulse width of the emFieldPro device and thepredicate device are in the typical clinical range of 50 to500 $\mu$ sReference: "the effect of stimulus current pulse width onnerve fiber size recruitment patterns" by Robert B.Szlavik and Hubert de Bruin
System Dimensions(WxHxD)	501x993x542 mm versus580×1380×580 mm	Different dimensions have no influence on the safety oreffectiveness of the device. The usability is passedsuccessfully.
Operating AmbientTemperature Range	10°C to 30 °C versus-10°C to +55°C	The emFieldPro labeling allows for device usage in anenvironment that is more typical than the environmentstated 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	StandardsOrganization	Standards Title
60601-1	IEC	Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance
60601-1-2	IEC	Medical electrical equipment – Part 1-2: General requirementsfor basic safety and essential performance – Collateral standard:Electromagnetic disturbances – Requirements and tests
60601-1-6	IEC	Medical electrical equipment - Part 1-6: General requirementsfor basic safety and essential performance - Collateralstandard: Usability
60601-2-10	IEC	Medical electrical equipment – Part 2–10: Particularrequirements for the Basic Safety and Essential Performance ofNerve and Muscle Stimulators

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Standards	StandardsOrganization	Standards Title
62366-1	IEC	Medical devices – Application of usability engineering to medicaldevices
62304	IEC	Medical devices software -software life cycle processes
14971	ISO	Medical devices – Application of risk management to medicaldevices
10993-1	ISO	No Biocompatibility testing performed as the applied doesn't getin 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 DEVICEZimmer MedizinSyteme GmbHemFieldProK182963	PREDICATE DEVICEBTL Industries, Inc.BTL 799-2K180813
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.

Regulation Number and Section

§ 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).