(30 days)
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.
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.
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.
This document is a 510(k) Premarket Notification for the CoolTone device. It states that the device is substantially equivalent to a previously cleared predicate device (K192940). As such, the purpose of this submission is not to prove new efficacy or safety but rather to demonstrate that modifications made to the device do not change its substantial equivalence to the predicate. Therefore, this document does not contain a new clinical study from which to extract acceptance criteria and performance data in the typical sense of a de novo device or a device with new indications.
The relevant sections to address your request will derive from the comparison to the predicate device and the performance testing conducted to show the current device continues to meet the predicate's performance.
Based on the provided text, here's an attempt to answer your questions, but many points will indicate that a new study to prove the device meets acceptance criteria was not required for this 510(k) submission, as it's establishing substantial equivalence to an existing cleared device with minor modifications.
Here's the analysis of the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" for a new clinical study. Instead, it demonstrates that the modified device maintains the same performance characteristics as the predicate device (CoolTone K192940). The performance data section primarily focuses on compliance with voluntary standards and the effects of the engineering changes.
| Acceptance Criterion (Implicitly referring to predicate device performance) | Reported Device Performance (Subject CoolTone) |
|---|---|
| Magnetic Field Intensity: 0.5-1.35T ± 20% | 0.5 – 1.35T +/- 20% The System Level Testing confirmed that the two applicators, either operated separately or simultaneously, performed within this range. |
| Tissue Temperature Rise: No appreciable rise in temperature at maximum intensity to cause patient risk. | The System Level Testing confirmed 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." |
| Electrical Safety: Compliance with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R)2012 | Complies The system (control unit and applicator) underwent electrical and mechanical safety performance testing and complies with this standard. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2:2014 (Edition 4.0) | Complies The control unit underwent electromagnetic compatibility testing and complies with this standard. The applicator did not require additional EMC testing because the changes did not affect its electromagnetic compatibility. |
| Software Verification & Validation: Meeting requirements as per FDA guidance | Met all acceptance criteria. 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 and System Level Test, were performed successfully and met their acceptance criteria. |
| Biocompatibility: No changes to patient-contacting materials, thus maintaining previous biocompatibility. | No changes There were no changes to patient-contacting materials in comparison with the previously cleared predicate device, implying continued biocompatibility. |
| Cybersecurity: No impact on cybersecurity from software changes. | No impact. Cybersecurity risk management was performed. The changes made to the predicate's system software have no impact on cybersecurity. |
| Therapy Time: Up to 30 min | Same as predicate. |
| Pulse Repetition Rate: 1 - 150 Hz | Same as predicate. |
| Pulse Duration: 370 µs ± 20% | Same as predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not applicable for a clinical test set from this document. The "test set" here refers to engineering and performance verification tests of the device itself (e.g., electrical safety, EMC, software). Specific numbers are not provided for electrical and mechanical safety performance testing or EMC testing, but it states these were "undergone." The system level testing mentioned refers to device performance parameters (magnetic field, temperature) and not a patient-based clinical study.
- Data Provenance: Not applicable for a clinical test set. The testing is for the device's technical specifications.
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)
This 510(k) submission is for modifications to a physical therapeutic device, not an AI/imaging device requiring expert interpretation of outputs. Therefore, there are no "experts" establishing ground truth in the sense of medical image annotation or diagnosis. The "ground truth" for the device's performance is its technical specifications and compliance with established engineering and safety standards (e.g., IEC, ANSI AAMI).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an image-based or diagnostic study requiring adjudication of expert interpretations.
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. This device is a powered muscle stimulator, not an AI or imaging device, and no clinical MRMC study was conducted or required for this 510(k) submission (as stated in Section VII: "No clinical testing was required for these changes.").
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the device's functional performance tests (e.g., magnetic field output, temperature control) as described under "Performance Testing" and compliance with engineering standards. It is a standalone device in that its primary function is to directly stimulate muscles, not provide algorithmic analysis to a human. The document confirms that the device's physical performance characteristics (e.g., magnetic field intensity, temperature rise) were tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" here is based on:
- Engineering Specifications and Standards: The device's technical parameters (e.g., magnetic field intensity, pulse duration, frequency) were verified against its design specifications and relevant international standards (e.g., ANSI AAMI ES 60601-1, IEC 60601-1-2, ISO 62304).
- Predicate Device Performance: The primary "ground truth" for substantial equivalence is that the modified device performs identically or equivalently to the predicate device (CoolTone K192940) for its intended use.
- Safety and Biocompatibility Standards: Compliance with standards like ISO 10993 for biocompatibility and IEC 60601 series for electrical safety.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device with a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device and submission.
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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.
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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;
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- . 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 DeviceCoolTone K192940 | SubjectDeviceCoolTone |
|---|---|---|
| Company Name | Zimmer MedizinSysteme GmbH | Same |
| Product Code andRegulation | Physical Medicine 21 CFR 890.5850NGX-Stimulator, Muscle, Powered, MuscleConditioning | 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 inmuscle 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 atsame time | Same |
| Applicator Connection | Detachable from the control unit | Same |
| Total Induced Current inTissue (mA) | 327 | Same |
| Type of Operation | Continuous | Same |
| Number of Magnetic Coilsin 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 DeviceCoolTone K192940 | SubjectDeviceCoolTone |
|---|---|---|
| Selection of parameters(Intensity, Time) | Yes | Same |
| Therapy Time | Up to 30 min | Same |
| Shape of StimulationPulse | Symmetrical Biphasic SineWave | Same |
| Energy Source | 220-240V, 50/60 Hz | Same |
| System Dimensions(WxHxD) | 600x1100x600 mm | Same |
| Operating AmbientTemperature | 10°C – 28 °C | Same |
| EnvironmentalSpecifications | 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)
| TechnologicalCharacteristics | Predicate DeviceCoolTone K192940 | Subject DeviceCoolTone | Comments |
|---|---|---|---|
| Power Source(s)- Method of LineCurrent Isolation- Patient LeakageCurrentNormal conditionSingle fault condition | 60601 compliant< 1 μΑ3.9 μΑ | Same | 60601 Compliant |
| Number of OutputModes | 1 | Same | |
| Number of OutputChannels- Synchronous orAlternating?- Method of ChannelIsolation | SynchronousN/A | Same | No electrodes -applicators arenot connected topatient |
| Regulated Current orRegulated Voltage? | Voltage | Same | Controlledvoltage to the coil |
| Software/Firmware/Microprocessor Control? | Yes | Same | |
| Automatic OverloadTrip? | N/A | N/A | No electrodes -applicators arenot connected topatient |
| Automatic No-LoadTrip? | N/A | N/A | No electrodes -applicators arenot connected topatient |
| TechnologicalCharacteristics | Predicate DeviceCoolTone K192940 | Subject DeviceCoolTone | Comments |
| Automatic Shut Off? | Yes | Same | Unit shuts offwith specifiedtimer |
| Patient OverrideControl? | No | Same | Treatment isdelivered byhealthcareprovider |
| Indicator Display:- On/Off Status?- Low Battery?- Voltage/Current Level? | YesN/ANo | Same | |
| Timer Range(minutes) | Up to 30 min | Same | |
| Compliance withVoluntary Standards? | Yes | Same | Refer toperformance datafor details |
| Compliance* with21 CFR 898? (*Becomesmandatory beginningMay 9, 2000) | Yes | Same | |
| Weight | 80 Kg | Same | |
| Housing Materialsand Construction | Steel and InjectionMolded Plastics | Same | |
| Waveform (e.g., pulsedmonophasic, biphasic) | Symmetrical BiphasicSineWave | Same | |
| Shape (e.g., rectangular,spike, rectifiedsinusoidal) | Sinusoidal | Same | |
| Maximum OutputVoltage (specify units) | N/A | N/A | No electrodes -applicators arenot connected topatient |
| Maximum OutputCurrent (specify units) | N/A | N/A | No electrodes -applicators arenot connected topatient |
| Frequency (Hz) | 1-150 Hz | Same | |
| For interferentialmodes only: - BeatFrequency (Hz) | N/A | N/A | |
| For multiphasicwaveforms only: -Symmetrical phases? | Yes | Same | Biphasic |
| Phase Duration(include units) (staterange, if applicable) | 370 $\mu$ s +/- 20% | Same | |
| TechnologicalCharacteristics | Predicate DeviceCoolTone K192940 | Subject DeviceCoolTone | Comments |
| (both phases, ifasymmetrical) | N/A | N/A | |
| Net Charge (mC perpulse) (If zero, statemethod of achievingzero net charge.) | N/A | N/A | No electrodes -applicators arenot connected topatient |
| Maximum PhaseCharge, (mC) | N/A | N/A | No electrodes -applicators arenot connected topatient |
| Maximum CurrentDensity, (mA/cm²) | N/A | N/A | No electrodes -applicators arenot connected topatient |
| Maximum PowerDensity, (W/cm²)(using smallestelectrode conductivesurface area) | N/A | N/A | No electrodes -applicators arenot connected topatient |
| Burst Mode7 (i.e., pulsetrains) a. Pulses perburst b. Bursts persecond c. Burstduration (seconds) d.Duty Cycle[Line (b) x Line (c)] | N/A | N/A | |
| ON Time (seconds) | N/A | N/A | |
| OFF Time (seconds) | N/A | N/A | |
| Additional Features (ifapplicable) | N/A | N/A |
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VII. PERFORMANCE DATA:
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:
| Table 6.3: Compliance with Voluntary Standards | |
|---|---|
| ------------------------------------------------ | -- |
| Standards | StandardsOrganization | Standards Title |
|---|---|---|
| ANSI AAMI ES60601-1:2005/(R)2012and A1:2012,C1:2009/(R) 2012 andA2:2010/(R)2012 | ANSIAAMI | Medical electrical equipment – Part 1: Generalrequirements for basic safety and essentialperformance |
| Standards | StandardsOrganization | Standards Title |
| 60601-1-2:2014(Edition 4.0) | IEC | Medical electrical equipment – Part 1-2: Generalrequirements for basic safety and essentialperformance – Collateral standard:Electromagnetic disturbances - Requirementsand tests |
| 60601-1-6:2013(Edition 3.1) | IEC | Medical electrical equipment – Part 1-6: Generalrequirements for basic safety and essentialperformance - Collateral standard: Usability |
| 60601-2-10:2016(Edition 2.1) | IEC | Medical electrical equipment - Part 2-10:Particular requirements for the Basic Safety andEssential Performance of Nerve and MuscleStimulators |
| 62366-1:2015(Edition 1.0) | IEC | Medical devices - Application of usabilityengineering to medical devices |
| 62304:2015(Edition 1.1) | ISO | Medical devices software –software life cycleprocesses |
| 14971:2012 | ISO | Medical devices - Application of risk managementto medical devices |
| 10993-1: 2018 | ISO | Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess |
| 10993-5: 2009 | ISO | Biological evaluation of medical devices - Part 5:Tests for in vitro cytotoxicity |
| 10993-10: 2010 | ISO | Biological evaluation of medical devices - Part 10:Tests for irritation and skin sensitization |
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Software Verification and Validation Testing
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
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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
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.
Biocompatibility Testing
There were no changes to patient-contacting materials in comparison with the previously cleared predicate device.
Electrical safety and electromagnetic compatibility (EMC)
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).
Performance Testing
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.
Clinical Study
No clinical testing was required for these changes.
VIII. CONCLUSION:
The Indication for Use for the subject CoolTone system is the same as the predicate device cleared in K192940. The changes that have been made to the system's hardware and software do not affect the intended use, performance or risk profile of the device. The subject CoolTone system is therefore substantially equivalent to the predicate device.
§ 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).