(28 days)
Not Found
No
The document does not mention AI, ML, or any related concepts like deep learning, neural networks, or algorithms that learn from data. The device description focuses on electromagnetic stimulation and pre-set treatment options.
Yes
The device description explicitly states, "The CoolTone is a non-invasive therapeutic device." Additionally, its intended use for muscle strengthening, toning, and firming falls under the general definition of therapeutic applications.
No
The device description indicates it is a therapeutic device that stimulates muscles to strengthen, tone, and firm the abdomen, buttocks, and thighs. Its intended uses are for improvement of abdominal tone, muscle strengthening, and firming. It does not perform any diagnostic functions or provide information about a patient's health status.
No
The device description clearly outlines a physical, non-invasive therapeutic device that produces an electromagnetic field using hardware components like a control unit, applicators, and a securement system. Performance studies also include testing of hardware aspects like biocompatibility, electrical safety, and essential performance related to the magnetic field.
Based on the provided information, the CoolTone device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- CoolTone's Function: The CoolTone device is described as a non-invasive therapeutic device that produces an electromagnetic field to stimulate muscles for strengthening, toning, and firming. It interacts directly with the body externally.
- Lack of Specimen Analysis: There is no mention of the CoolTone device analyzing any biological specimens. Its function is based on applying energy to the body.
Therefore, the CoolTone device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CoolTone 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
NGX
Device Description
The CoolTone is a non-invasive therapeutic device. The device produces an electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the CoolTone helps to strengthen, tone and firm abdomen, buttocks and thighs.
The device housing protects the patient from electrical shock and mechanical injuries. The device is a mobile standalone equipment with four wheels.
Two large applicators are connected to the control unit and can be used simultaneously depending on the treatment. The device is a medical equipment that generates a magnetic field by applying a strong current to an applicator. The CoolTone is equipped with the securement system which is designed to maintain applicator position throughout treatment.
A large color touch screen facilitates the use of the device. The on-screen information guides the user step-by-step through the entire treatment process. The treatment is operated through parameters such as frequency, time and intensity. Three pre-set treatment options are available for users to choose from: Abdomen, buttocks and thighs.
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
health care provider
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
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Summary of Performance Studies
The CoolTone has been investigated and tested against and complies with the following voluntary standards:
- 60601-1:2005 + CORR: 1:2006 + CORR. 2:2007 + A1:2012 (Edition 3.1) - Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- 60601-1-2:2014 (Edition 4.0) - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests
- 60601-2-10:2016 (Edition 2.1) - Medical electrical equipment – Part 2-10: Particular requirements for the Basic Safety and Essential Performance of Nerve and Muscle Stimulators
- 62366-1:2015 (Edition 1.0) - Medical devices – Application of usability engineering to medical devices
- 62304:2015 (Edition 1.1) - Medical devices software –software life cycle processes
- 10993-5: 2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- 10993-10: 2010 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Software Verification and Validation Testing: The software for the CoolTone has been updated, which includes an updated system and software architecture. The update allows CoolTone the ability to treat patients with up to two applicators simultaneously. The updated software also includes improved graphical user interface that sets treatment parameters by body region with an improved user flow.
The verification of the software requirements was performed in three steps: the verification of the software requirements, the verification of the design specifications and the verification of the software architecture. All the tests including Integration Tests (Tests of the System Architecture and the Design Specification) and the System Level Test (Test of functional requirements, that were tested in the software requirements verification) were performed successfully and met their acceptance criteria.
Biocompatibility Testing: The CoolTone includes a new securement system which is used to maintain applicator position throughout the treatment. The securement system is composed of two applicator covers, a strap, and a connection piece. The materials for these components have undergone biocompatibility testing. The system complies with ISO 10993-5: 2009, and ISO 10993-10: 2010.
Electrical safety and electromagnetic compatibility (EMC): The device has undergone electrical and mechanical safety performance testing and electromagnetic compatibility testing as a result of the changes referenced. The system complies with IEC 60601-1:2005 + CORR: 1:2006 + CORR. 2:2007 + A1:2012 (Edition 3.1), and IEC 60601-1-2:2014 (Fourth Edition).
Essential Performance Testing: The testing above confirmed that the two applicators, either operated separately or simultaneously, performed within the magnetic field intensity of 0.5 – 1.35T +/- 20% 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.
Clinical Study: No clinical testing was required for this change.
Key Metrics
Not Found
Predicate Device(s)
emFieldPro (K182963)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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November 15, 2019
Zimmer MedizinSysteme GmbH % Scott Blood Principal Consultant Quality and Regulatory Services 151 Glensondale Road Stow, Massachusetts 01775
Re: K192940
Trade/Device Name: CoolTone Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 17, 2019 Received: October 18, 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.
1
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 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 mediation-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, Ph.D. 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
2
Indications for Use
510(k) Number (if known)
Device Name CoolTone
Indications for Use (Describe)
CoolTone 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) | |
|---|---|
| ☑ 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 contains the logo for Zimmer MedizinSysteme. The word "zimmer" is in bold, dark gray font. Below that, the words "MedizinSysteme" are in a lighter gray font. The logo is simple and professional.
5. 510(K) SUMMARY
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| SUBMITTER: | Zimmer MedizinSysteme GmbH
Junkersstrasse 9
89231 Neu-Ulm, Germany
Establishment Registration: 8010720 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Mrs. Ute Hauss
Manager, Regulatory Affairs
Phone: +49-731-9761-216
Fax: +49-731-9761-118
E-mail: u.hauss@zimmer.de |
| DATE PREPARED: | October 17, 2019 |
| II. DEVICE: | |
| TRADE NAME: | CoolTone |
| COMMON NAME: | Powered Muscle Stimulator |
| CLASSIFICATION NAME: | Stimulator, Muscle, Powered, For Muscle Conditioning |
| DEVICE CLASSIFICATION: | Class II, 21 CFR §890.5850 |
| PRODUCT CODE: | NGX |
| III. PREDICATE DEVICE: | emFieldPro (K182963) |
IV. DEVICE DESCRIPTION:
The CoolTone is a non-invasive therapeutic device. The device produces an electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the CoolTone helps to strengthen, tone and firm abdomen, buttocks and thighs.
The device housing protects the patient from electrical shock and mechanical injuries. The device is a mobile standalone equipment with four wheels.
Two large applicators are connected to the control unit and can be used simultaneously depending on the treatment. The device is a medical equipment that generates a magnetic
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Image /page/4/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The word "zimmer" is in bold, gray font. Below that, the words "MedizinSysteme" are in a smaller, gray font.
field by applying a strong current to an applicator. The CoolTone is equipped with the securement system which is designed to maintain applicator position throughout treatment.
A large color touch screen facilitates the use of the device. The on-screen information guides the user step-by-step through the entire treatment process. The treatment is operated through parameters such as frequency, time and intensity. Three pre-set treatment options are available for users to choose from: Abdomen, buttocks and thighs.
V: INDICATION FOR USE:
CoolTone 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
The technological characteristics and operating principal associated with the treatment remain unchanged from the predicate device. The device produces electromagnetic field that interacts with the tissues of the human body.
Changes were made to the predicate's (K182963) system hardware and the software to allow the modified system to be able to use up to two large applicators at the same time. The applicator design, size and shape are unchanged. The applicator connection to the control unit is now detachable.
The technological similarities and differences between the subject device and the predicate device are described below in the comparison table. The differences do not raise any new types of safety or effectiveness questions.
| Technological
Characteristics | SUBJECT DEVICE
Zimmer MedizinSyteme
GmbH
CoolTone | PREDICATE DEVICE
Zimmer MedizinSyteme
GmbH
emFieldPro (K182963) |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code and
Regulation | Physical Medicine | Physical Medicine |
| | 21 CFR 890.5850 | 21 CFR 890.5850 |
| | NGX – Stimulator Muscle, | NGX – Stimulator Muscle, |
| | Powered, Muscle | Powered, Muscle |
| | Conditioning | Conditioning |
| | SUBJECT DEVICE | PREDICATE DEVICE |
| Technological
Characteristics | Zimmer MedizinSyteme
GmbH
CoolTone | Zimmer MedizinSyteme
GmbH
emFieldPro (K182963) |
| Indications for Use | The CoolTone 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. | 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. |
| Primary Function | 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 |
| Electrical Protection | Class I, BF | Class I, BF |
| User Interface | Touch screen | Touch screen |
| Touch screen size | 12" | 7" |
| Positioning of
Applicator | Securement system | Arm |
| Firmware Controlled | Yes | Yes |
| Type of Energy | Magnetic field | Magnetic field |
| Magnetic Field
Intensity | Large applicator 0.5 – 1.35T +/- 20% | Large applicator 0.5 – 1.5T +/- 20%
Small applicator 0.5 – 2.0T+/- 20% |
| Number of outputs | 2 | 2 |
| Number of Magnetic
Coils in the Applicator | 1 | 1 |
| Number of applicators | Up to two large applicators can be operational at same time | One large and one small applicator, operational one applicator at a time |
| Applicator connection | Detachable from the control unit | Fixed to the control unit |
| Total Induced Current
in Tissue (mA) | 327 | 251 |
| Type of Operation | Continuous | Continuous |
| Pulse Repetition Rate | 1 - 150 Hz | 1 - 150 Hz |
| Pulse Duration | Large applicator
370 us +/- 20% | Small applicator:
250us +/- 20%
Large applicator:
400us +/- 20% |
| | SUBJECT DEVICE | PREDICATE DEVICE |
| Technological
Characteristics | Zimmer MedizinSyteme
GmbH
CoolTone | Zimmer MedizinSyteme
GmbH
emFieldPro (K182963) |
| Pulse Amplitude | 0 - 100 % | 0 - 100 % |
| Selection of
parameters (Intensity,
Time) | Yes | Yes |
| Treatment Time | Up to 30 min | Up to 60 min |
| Shape of Stimulation
Pulse | Symmetrical Biphasic Sine
Wave | Symmetrical Biphasic Sine
Wave |
| Energy Source | 220-240VAC, 50-60 Hz | 100 - 240 V AC, 50-60 Hz |
| System Dimensions
(WxHxD) | 600 x 1100x 600 mm | 501x993x542mm |
| Operating Ambient
Temperature | 10°C to 28 °C | 10°C to 30°C |
| Environmental
Specifications | For indoor use only | For indoor use only |
Table 1: Technological Similarities between Proposed and Predicate Device
5
Zin mmer
MedizinSysteme
6
Table 2: Technological Similarities between Proposed and Predicate Device per FDA Guidance for Industry for Powered Muscle Stimulators for 510(k)s (June 9, 1999)
| Sections 2,3
Technological
Characteristics | SUBJECT DEVICE
Zimmer MedizinSyteme
GmbH
CoolTone | PREDICATE DEVICE
Zimmer MedizinSyteme
GmbH
emFieldPro (K182963) | Comments |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| 4. Power Source(s)
- Method of Line
Current Isolation | 60601 compliant | 60601 compliant | |
| - Patient Leakage
Current | | | 60601
Compliant |
| Normal condition |