(30 days)
No
The description focuses on the physical device, its electromagnetic field generation, and user-controlled parameters. There is no mention of AI, ML, or any learning/adaptive capabilities. The "pre-set treatment options" are fixed choices, not indicative of AI/ML.
Yes
The device description explicitly states, "The CoolTone system is a non-invasive, therapeutic device."
No
The device description and intended use clearly state that CoolTone is a therapeutic device designed for muscle stimulation, strengthening, toning, and firming. There is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly outlines physical hardware components including a mobile unit, control unit housing, applicators, and a touch screen, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for improving muscle tone, strengthening, and firming of the abdomen, buttocks, and thighs. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device description focuses on generating an electromagnetic field to stimulate muscles. It does not mention analyzing biological samples (like blood, urine, or tissue) which is characteristic of IVDs.
- Lack of IVD-related information: The document does not mention any of the typical elements associated with IVDs, such as:
- Analysis of biological specimens.
- Detection or measurement of analytes.
- Diagnostic claims.
- Performance metrics like sensitivity, specificity, etc., which are crucial for evaluating diagnostic accuracy.
The device is described as a non-invasive therapeutic device that interacts with the human body to achieve physical changes. This aligns with the definition of a medical device used for treatment, not for diagnosing a condition.
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 system 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 the abdomen, buttocks and thighs.
The device is a mobile, standalone unit with four wheels and the control unit housing protects the patient from electrical shock and mechanical injury. These features are unchanged.
Two large applicators are connected to the control unit and can be used simultaneously depending on the treatment. CoolTone is a medical device that generates a magnetic field by applying a strong current to an applicator. It is equipped with the securement system, designed to maintain the position of the applicator 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 variable parameters such as frequency, time and intensity. Three, pre-set treatment options are available for users to choose from: Abdomen, buttocks and thighs. These features are unchanged.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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 CoolTone System is the same as the previously cleared predicate device (K192940). It has been tested/assessed against and fully complies with the following voluntary standards:
ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R)2012
IEC 60601-1-2:2014 (Edition 4.0)
IEC 60601-1-6:2013 (Edition 3.1)
IEC 60601-2-10:2016 (Edition 2.1)
IEC 62366-1:2015 (Edition 1.0)
ISO 62304:2015 (Edition 1.1)
ISO 14971:2012
ISO 10993-1: 2018
ISO 10993-5: 2009
ISO 10993-10: 2010
Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Software verification was performed in three steps: verification of the software requirements, verification of the design specifications and verification of the software architecture. All tests, including Integration Tests (Tests of the System Architecture and the Design Specification) and the System Level Test (Test of functional requirements that were evaluated in the software requirements verification) were performed successfully and met their acceptance criteria.
Cybersecurity risk management for the device was performed as part of the overall risk management process for the medical device and follows the guidance in the FDA document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". The changes made to the predicate's (K192940) system software have no impact on cybersecurity.
There were no changes to patient-contacting materials in comparison with the previously cleared predicate device.
The CoolTone system (control unit and applicator) has undergone electrical and mechanical safety performance testing as a result of the changes referenced. Additionally, the control unit underwent electromagnetic compatibility testing. The applicator did not require additional electromagnetic compatibility testing because the changes did not affect its electromagnetic compatibility.
The system complies with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R)2012), and IEC 60601-1-2:2014 (Fourth Edition).
The proposed CoolTone system performance is the same as the previously cleared predicate device.
The System Level Testing 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 is not subjected to an appreciable rise in temperature at maximum intensity to cause a risk to the patient.
No clinical testing was required for these changes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CoolTone (K192940)
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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April 1, 2022
Zimmer MedizinSysteme GmbH % Scott Blood Principal Consultant Quality and Regulatory Services 151 Glensondale Road Stow, Massachusetts 01775
Re: K220601
Trade/Device Name: CoolTone Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: March 1, 2022 Received: March 2, 2022
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.
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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 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.
Heather Dean, PhD Assistant Director THT5B3: Acute Injury Devices 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) K220601
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 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.
6. 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.
| I. SUBMITTER: | Zimmer MedizinSysteme GmbH |
|---|---|
| Junkersstrasse 9 | |
| 89231 Neu-Ulm, Germany | |
| Establishment Registration: 8010720 | |
| Ms. Julia Kredler | |
| Manager, Regulatory Affairs | |
| Phone: +49-731-9761-625 | |
| Fax: +49-731-9761-118 | |
| E-mail: j.kredler@zimmer.de | |
| CONTACT: | Scott Blood |
| Principal Consultant | |
| Phone: 978-729-5978 | |
| Fax: +49-731-9761-118 | |
| Email: scottqara@gmail.com | |
| DATE PREPARED: | March 31, 2022 |
| 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: | CoolTone (K192940) |
IV. DEVICE DESCRIPTION:
The CoolTone system 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 the abdomen, buttocks and thighs.
4
The device is a mobile, standalone unit with four wheels and the control unit housing protects the patient from electrical shock and mechanical injury.. These features are unchanged.
Two large applicators are connected to the control unit and can be used simultaneously depending on the treatment. CoolTone is a medical device that generates a magnetic field by applying a strong current to an applicator. It is equipped with the securement system, designed to maintain the position of the applicator 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 variable parameters such as frequency, time and intensity. Three, pre-set treatment options are available for users to choose from: Abdomen, buttocks and thighs. These features are unchanged.
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 principles associated with the treatment remain unchanged from the predicate device. The subject device is identical to the primary predicate device, the CoolTone system, as cleared under K192940.
In comparison with the predicate device, the following changes have been made on the subject device:
Hardware: Control unit:
- A compressor cooler was added to the cooling circuit to enhance cooling ● performance;
- . The single diode was replaced by a double diode on the capacitor stage to reduce the potential for treatment interruption;
- . Foam tape was added to the compressor module to reduce noise;
Applicator:
- . Design and manufacture process improvement was made to the applicator to prevent cracking and the leaking of coolant fluid;
Software:
- . Modified to allow customers limited access to a device check and an advanced customer screen to facilitate troubleshooting;
5
- . Implemented a treatment protocol that was within the previously cleared range of software specification;
- Adjusted the coolant flow, implemented relax-sequences and extended cooldown to reduce the potential interruption of treatment incurred by applicator warmth;
- Optimized pulsing sequence to reduce noise;
Labeling:
- The user's manual was updated to capture information obtained in post-market . surveillance activity.
The technological characteristics of the subject device, as outlined in the comparison table below, remain the same as those of the predicate device.
| Device Name | Predicate Device
CoolTone K192940 | Subject
Device
CoolTone |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Company Name | Zimmer MedizinSysteme GmbH | Same |
| Product Code and
Regulation | Physical Medicine 21 CFR 890.5850
NGX-Stimulator, Muscle, Powered, Muscle
Conditioning | Same |
| Intended Use | Improvement of abdominal tone,
•
strengthening of the abdominal muscles,
development of firmer abdomen.
Strengthening, Toning and Firming of
•
buttocks and thighs. | Same |
| Principle of Action | Initiating action potential of nerves results in
muscle contraction | Same |
| Clinical Use | Prescription use | Same |
| Electrical Protection | Class I, BF | Same |
| User Interface | Touch screen, 12" | Same |
| Firmware Controlled | Yes | Same |
| Type of Energy | Magnetic field | Same |
| Number of outputs | 2 | Same |
| Number of Applicators | Up to two applicators can be operational at
same time | Same |
| Applicator Connection | Detachable from the control unit | Same |
| Total Induced Current in
Tissue (mA) | 327 | Same |
| Type of Operation | Continuous | Same |
| Number of Magnetic Coils
in the Applicator | 1 | Same |
| Positioning of Applicator | Securement system | Same |
| Magnetic Field Intensity | 0.5-1.35T ± 20% | Same |
| Pulse Repetition Rate | 1 - 150 Hz | Same |
| Pulse Duration | 370 µs ± 20% | Same |
| Pulse Amplitude | 0 - 100% | Same |
Table 6.1: Technological Characteristics between Subject and Predicate Device
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| Device Name | Predicate Device
CoolTone K192940 | Subject
Device
CoolTone |
|----------------------------------------------|--------------------------------------|-------------------------------|
| Selection of parameters
(Intensity, Time) | Yes | Same |
| Therapy Time | Up to 30 min | Same |
| Shape of Stimulation
Pulse | Symmetrical Biphasic Sine
Wave | Same |
| Energy Source | 220-240V, 50/60 Hz | Same |
| System Dimensions
(WxHxD) | 600x1100x600 mm | Same |
| Operating Ambient
Temperature | 10°C – 28 °C | Same |
| Environmental
Specifications | For indoor use only | Same |
Table 6.2: Technological Similarities between Proposed and Predicate Device per FDA Guidance for Industry for Powered Muscle Stimulators for 510(k)s (June 9, 1999)
| Technological
Characteristics | Predicate Device
CoolTone K192940 | Subject Device
CoolTone | Comments |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|----------------------------|-------------------------------------------------------------------|
| Power Source(s)
- Method of Line
Current Isolation - Patient Leakage
Current
Normal condition
Single fault condition | 60601 compliant