(28 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 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.
Here's a breakdown of the acceptance criteria and study information for the CoolTone device, based on the provided FDA 510(k) summary:
The document states: "No clinical testing was required for this change." This indicates that a formal clinical study with specific acceptance criteria and performance metrics for the device's indications for use was not performed within this submission.
Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from a clinical study for the CoolTone in relation to its intended use (improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen; strengthening, toning, and firming of buttocks and thighs).
The performance data presented focuses on verifying that changes made to the device (compared to its predicate) do not raise new questions of safety and effectiveness, rather than proving the device meets specific clinical performance acceptance criteria.
However, I can extract information related to the device's technical specifications and how its performance was verified against its predicate:
Acceptance Criteria and Reported Device Performance (Technical Verification - Not Clinical Outcomes)
While no clinical performance acceptance criteria are explicitly stated and met in a human study, the technical performance of the device was verified against its design specifications, particularly concerning the magnetic field intensity when using two applicators simultaneously.
| Acceptance Criteria (Technical) | Reported Device Performance (Technical) |
|---|---|
| Magnetic field intensity for two large applicators (operated separately or simultaneously) within 0.5 – 1.35T +/- 20% | Confirmed: The two applicators, operated separately or simultaneously, performed within the magnetic field intensity of 0.5 – 1.35T +/- 20%. Magnetic Field at applicator center surface measured as 1.43T. |
| Tissue being treated by the device does not present an appreciable rise in temperature at maximum intensity. | Confirmed: 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. |
| Compliance with software requirements, design specifications, and software architecture. | All tests (Integration Tests and System Level Test) were performed successfully and met their acceptance criteria. |
| Biocompatibility of new securement system materials (applicator covers, strap, connection piece) per ISO 10993-5 and -10. | The securement system complies with ISO 10993-5: 2009, and ISO 10993-10: 2010. |
| Electrical safety and electromagnetic compatibility (EMC) per IEC 60601-1 and IEC 60601-1-2. | 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). |
Study Information (Based on the Provided Document)
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable for clinical performance. The document explicitly states, "No clinical testing was required for this change." The "testing" mentioned pertains to technical verification (software, biocompatibility, electrical safety, essential performance of magnetic field). These tests are typically conducted in a lab environment.
- For the technical verifications, specific sample sizes (e.g., number of devices tested, number of material samples for biocompatibility) are not detailed but are assumed to meet relevant standard requirements.
-
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 for clinical ground truth. Since no clinical study was performed for this submission, no expert consensus was established for patient-reported or clinically observed outcomes.
- For technical ground truth (e.g., software functionality, magnetic field strength), the "experts" would be the engineers and technicians involved in performing the verification tests against established technical specifications and compliance standards. Their qualifications are inherent in their professional roles within the device manufacturer and testing labs.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for clinical adjudication. As no clinical study was conducted, there was no need for clinical adjudication.
- For technical tests, the "adjudication" is typically against the pre-defined test protocols, acceptance criteria, and compliance standards. This review is usually performed by quality assurance and regulatory personnel.
-
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 and does not involve "readers" or "cases" in the context of medical imaging or AI assistance for diagnostic tasks. It's a therapeutic device.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable in the usual sense of diagnostic algorithms. The "algorithm" here refers to the device's software control of the magnetic field. Its "standalone performance" is validated through the essential performance testing that confirms the magnetic field intensity and temperature safety without human intervention in the physical operation, once parameters are set.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this submission is based on technical specifications, compliance with recognized voluntary standards (e.g., IEC, ISO), and engineering measurements.
- For example:
- Magnetic field intensity measurements are compared against the specified range (0.5 – 1.35T +/- 20%).
- Temperature rise on tissue is compared against safety thresholds.
- Biocompatibility is assessed against ISO 10993 standards.
- Software functionality is validated against documented software requirements and design specifications.
-
The sample size for the training set:
- Not applicable. This device is a physical therapeutic device, not an AI/ML-driven diagnostic or predictive algorithm that typically uses a "training set." The software controls the device's physical operation.
-
How the ground truth for the training set was established:
- Not applicable. As there is no training set in the context of AI/ML, there's no ground truth established for it.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
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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 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
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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 GmbHJunkersstrasse 989231 Neu-Ulm, GermanyEstablishment Registration: 8010720 |
|---|---|
| CONTACT: | Mrs. Ute HaussManager, Regulatory AffairsPhone: +49-731-9761-216Fax: +49-731-9761-118E-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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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.
| TechnologicalCharacteristics | SUBJECT DEVICEZimmer MedizinSytemeGmbHCoolTone | PREDICATE DEVICEZimmer MedizinSytemeGmbHemFieldPro (K182963) |
|---|---|---|
| Product Code andRegulation | 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 | |
| TechnologicalCharacteristics | Zimmer MedizinSytemeGmbHCoolTone | Zimmer MedizinSytemeGmbHemFieldPro (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 ofApplicator | Securement system | Arm |
| Firmware Controlled | Yes | Yes |
| Type of Energy | Magnetic field | Magnetic field |
| Magnetic FieldIntensity | 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 MagneticCoils 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 Currentin Tissue (mA) | 327 | 251 |
| Type of Operation | Continuous | Continuous |
| Pulse Repetition Rate | 1 - 150 Hz | 1 - 150 Hz |
| Pulse Duration | Large applicator370 us +/- 20% | Small applicator:250us +/- 20%Large applicator:400us +/- 20% |
| SUBJECT DEVICE | PREDICATE DEVICE | |
| TechnologicalCharacteristics | Zimmer MedizinSytemeGmbHCoolTone | Zimmer MedizinSytemeGmbHemFieldPro (K182963) |
| Pulse Amplitude | 0 - 100 % | 0 - 100 % |
| Selection ofparameters (Intensity,Time) | Yes | Yes |
| Treatment Time | Up to 30 min | Up to 60 min |
| Shape of StimulationPulse | Symmetrical Biphasic SineWave | Symmetrical Biphasic SineWave |
| Energy Source | 220-240VAC, 50-60 Hz | 100 - 240 V AC, 50-60 Hz |
| System Dimensions(WxHxD) | 600 x 1100x 600 mm | 501x993x542mm |
| Operating AmbientTemperature | 10°C to 28 °C | 10°C to 30°C |
| EnvironmentalSpecifications | For indoor use only | For indoor use only |
Table 1: Technological Similarities between Proposed and Predicate Device
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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 2,3TechnologicalCharacteristics | SUBJECT DEVICEZimmer MedizinSytemeGmbHCoolTone | PREDICATE DEVICEZimmer MedizinSytemeGmbHemFieldPro (K182963) | Comments |
|---|---|---|---|
| 4. Power Source(s)- Method of LineCurrent Isolation | 60601 compliant | 60601 compliant | |
| - Patient LeakageCurrent | 60601Compliant | ||
| Normal condition | < 1 μΑ | 1 μΑ | |
| Single fault condition | 3.9 μΑ | 3 μΑ | |
| 5. Number of OutputModes | 1 | 1 | |
| 6. Number of OutputChannels- Synchronous orAlternating?- Method of ChannelIsolation | 2SynchronousN/A | 2AlternatingN/A | No electrodes- applicatorsare notconnected topatient |
| Sections 2,3TechnologicalCharacteristics | SUBJECT DEVICEZimmer MedizinSytemeGmbHCoolTone | PREDICATE DEVICEZimmer MedizinSytemeGmbHemFieldPro (K182963) | Comments |
| 7. Regulated Current orRegulated Voltage? | Voltage | Voltage | Controlledvoltage to thecoil |
| 8.Software/Firmware/Microprocessor Control? | Yes | Yes | |
| 9. Automatic OverloadTrip? | N/A | N/A | No electrodes - applicatorsare notconnected topatient |
| 10. Automatic No-LoadTrip? | N/A | N/A | No electrodes - applicatorsare notconnected topatient |
| 11. Automatic Shut Off? | Yes | Yes | Unit shuts offwithspecifiedtimer |
| 12. Patient OverrideControl? | No | No | Treatment isdelivered byhealth careprovider |
| 13. Indicator Display:- On/Off Status?- Low Battery?- Voltage/CurrentLevel? | YesN/ANo | YesN/ANo | |
| 14. Timer Range(minutes) | Up to 30 Min | Up to 60 Min | |
| 15. Compliance withVoluntary Standards? | N/A | N/A | |
| 16. Compliance* with21 CFR 898? ( *Becomesmandatory beginningMay 9, 2000) | Yes | Yes | |
| 17. Weight | 80 Kg | 60 Kg | |
| Sections 2,3TechnologicalCharacteristics | SUBJECT DEVICEZimmer MedizinSytemeGmbHCoolTone | PREDICATE DEVICEZimmer MedizinSytemeGmbHemFieldPro (K182963) | Comments |
| 19. Housing Materialsand Construction | Steel and Injection MoldedPlastics | Steel and InjectionMolded Plastics | |
| Waveform (e.g., pulsedmonophasic, biphasic) | Biphasic | Biphasic | |
| Shape (e.g., rectangular,spike, rectifiedsinusoidal) | Sinusoidal | Sinusoidal | |
| Maximum OutputVoltage (specify units) | N/A | N/A | No electrodes- applicatorsare notconnected topatient |
| Maximum OutputCurrent (specify units) | N/A | N/A | No electrodes- applicatorsare notconnected topatient |
| Pulse Width (specifyunits) | 370 $ μ$ s +/- 20% | 250-400 $ μ$ s +/- 20% | |
| Frequency (Hz) | 1-150 Hz | 1-150 Hz | |
| For interferentialmodes only: - BeatFrequency (Hz) | N/A | N/A | |
| For multiphasicwaveforms only: -Symmetrical phases? | Yes | Yes | Biphasic |
| Phase Duration (includeunits) (state range, ifapplicable) (bothphases, if asymmetrical) | 370 $ μ$ s +/- 20% | 250-400 $ μ$ s +/- 20% | |
| Net Charge (mC perpulse) (If zero, statemethod of achievingzero net charge.) | N/A | N/A | No electrodes- applicatorsnotconnected tothe patient |
| Maximum PhaseCharge, (mC) | N/A | N/A | No electrodes- applicatorsnot |
| Sections 2,3TechnologicalCharacteristics | SUBJECT DEVICEZimmer MedizinSytemeGmbHCoolTone | PREDICATE DEVICEZimmer MedizinSytemeGmbHemFieldPro (K182963) | Comments |
| Maximum CurrentDensity, (mA/cm²) | N/A | N/A | connected tothe patientNo electrodes- applicatorsnotconnected tothe patient -see SARreport |
| Maximum PowerDensity, (W/cm²)(usingsmallest electrodeconductive surfacearea) | N/A | N/A | No electrodes- applicatorsnotconnected tothe patient |
| Burst Mode7 (i.e., pulsetrains) a. Pulses perburst b. Bursts persecond c. Burst duration(seconds) d. Duty Cycle[Line (b) x Line (c)] | N/A | N/A | N/A |
| ON Time (seconds) | N/A | N/A | N/A |
| OFF Time (seconds) | N/A | N/A | N/A |
| Additional Features (ifapplicable) | N/A | N/A | N/A |
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Substantial Equivalence Determination
- a. Intended Use: There is no change to the indications for use for this submission between the Proposed and Predicate devices
- b. Technological Characteristics
The CoolTone has the same technological characteristics as the predicate device (K182963) except for the following:
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| TechnologicalCharacteristics | Characteristicdifference betweenCoolTone andPredicate Device | Discussion on why this differencedoes not affect the overall safetyand effectiveness of the subjectdevice when compared to thepredicate device |
|---|---|---|
| Touch Screen Size | 12" versus 7" | The size of the touch screen does notimpact the icons and data visiblydisplayed on the screen. |
| Positioning of theapplicator | Securement systemversus arm | The securement system ensuresapplicator position during treatment.Biocompatibility testing wasperformed on the securement systemsince it may have patient contact.Please refer to Section 13. |
| Pulse Duration | 370 $ \mu $ s +/- 20% versus400 $ \mu $ s +/- 20% | No impact. The pulse width of theCoolTone device and the predicatedevice are in the typical clinical rangeof 50 to 500 $ \mu $ s.Reference: "The effect of stimuluscurrent pulse width on nerve fiber sizerecruitment patterns" by Robert B.Szlavik and Hubert de Bruin |
| Number ofapplicators | Up to two largeapplicators can beoperational at sametime versus oneapplicator at a time | The performance testing confirmedthat the two applicators, eitheroperated separately orsimultaneously, performed within themagnetic field intensity of 0.5 – 1.35T+/- 20% and that the tissue beingtreated by the device does not presentan appreciable rise in temperature atmaximum intensity to cause a risk tothe patient. Please refer to Section 13. |
| Applicatorconnection | Detachable versusfixed | No impact. Each applicator can bedetached from the control unit by aconnector, for ease of service.Performance testing shows that theconnector does not influenceeffectiveness of the treatmentparameters. |
| Treatment time | Up to 30 minutes(CoolTone) versus 60minutes (emField Pro) | No impact. A typical treatment sessionis 20 – 30 minutes. |
| System Dimensions(WxHxD) | 600 x 1100 x 600 mmversus 501 x 993 x542mm | Different dimensions have noinfluence on the safety or effectivenessof the device. |
| Energy Source | 220-240VAC, 50-60 Hzversus 100 – 240 V AC,50-60 Hz | No impact. The energy source issufficient to operate the device undernormal operating conditions. |
| Maximum MagneticField Intensity atApplicator CenterSurface | Up to two Largeapplicators with 0.5 –$1.35T +/- 20%$versus one largeapplicator with 0.5 –$1.5T +/- 20%$ and onesmall applicator 0.5 –$2.0T$ . | EMF is measured as 1.43T. Theperformance testing confirmed thatthe two applicators, either operatedseparately or simultaneously,performed within the magnetic fieldintensity of 0.5 – 1.35T +/- 20% andthat the tissue being treated by thedevice does not present anappreciable rise in temperature atmaximum intensity to cause a risk tothe patient. |
| Operating AmbientTemperature | $10°C$ to $28 °C$ versus$10°C$ to $30°C$ | Lower ambient temperatures ispreferred to facilitate applicatorcooling. No impact is expected as atypical medical office sets roomtemperature to no higher than $27°C$(80°F) |
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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. The CoolTone is substantially equivalent to the predicate K182963.
VII. PERFORMANCE DATA:
The CoolTone has been investigated and tested against and complies with the following voluntary standards:
| Standards | StandardsOrganization | Standards Title |
|---|---|---|
| 60601-1:2005 +CORR: 1:2006 +CORR. 2:2007 +A1:2012 (Edition 3.1) | ANSI AAMI | Medical electrical equipment – Part 1: Generalrequirements for basic safety and essentialperformance |
| 60601-1-2:2014(Edition 4.0) | IEC | Medical electrical equipment – Part 1-2: Generalrequirements for basic safety and essentialperformance – Collateral standard: Electromagneticdisturbances – Requirements and tests |
| 60601-2-10:2016(Edition 2.1) | IEC | Medical electrical equipment – Part 2-10: Particularrequirements for the Basic Safety and EssentialPerformance of Nerve and Muscle Stimulators |
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| Standards | StandardsOrganization | Standards Title |
|---|---|---|
| 62366-1:2015(Edition 1.0) | IEC | Medical devices – Application of usabilityengineering to medical devices |
| 62304:2015 (Edition1.1) | IEC | Medical devices software –software life cycleprocesses |
| 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 |
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).
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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.
VIII. CONCLUSION:
The Indication for Use for the CoolTone is the same as the device cleared in K182963. The changes that have been made to the system's hardware and software, along with the new feature to use two large applicators simultaneously as an option, do not affect the intended use, performance or risk profile of the device. The CoolTone system is 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).