Who is the manufacturer of CoolTone?

Zimmer Medizinsysteme GmbH filed the 510(k) submission for CoolTone (K192940).

What is the FDA product code for CoolTone?

NGX. It is classified under 21 CFR 890.5850 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for CoolTone?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like CoolTone?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CoolTone

K192940 · Zimmer Medizinsysteme GmbH · NGX · Nov 15, 2019 · Physical Medicine

Device Facts

Record ID	K192940
Device Name	CoolTone
Applicant	Zimmer Medizinsysteme GmbH
Product Code	NGX · Physical Medicine
Decision Date	Nov 15, 2019
Decision	SESE
Submission Type	Special
Regulation	21 CFR 890.5850
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

CoolTone is a non-invasive, mobile, powered muscle stimulator used in clinical settings by healthcare providers. It generates a magnetic field via applicators placed on the patient's abdomen, buttocks, or thighs. The device induces action potentials in nerves, resulting in muscle contraction. It features a 12-inch color touch screen for selecting treatment parameters (frequency, time, intensity) and body regions. The system supports simultaneous operation of two large applicators, secured to the patient via a strap system. The device guides the user through treatment steps; output parameters are controlled by the operator. By stimulating muscles, the device aims to improve tone and strength. It includes an automatic shut-off timer and is designed for continuous operation.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing of the magnetic field intensity and tissue temperature rise. Biocompatibility testing (ISO 10993-5, 10993-10) was performed on the new applicator securement system.

Technological Characteristics

Powered muscle stimulator using electromagnetic field technology. Energy source: 220-240VAC, 50-60 Hz. Output: Symmetrical Biphasic Sine Wave, 1-150 Hz frequency, 370 µs pulse duration. Magnetic field intensity: 0.5–1.35T. Class I, BF electrical protection. Housing: Steel and injection-molded plastics. Connectivity: Standalone with 12-inch touch screen interface. Software-controlled with firmware for parameter management and dual-applicator synchronization. Sterilization: Not applicable (non-invasive).

Indications for Use

Indicated for improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen, and strengthening, toning, and firming of buttocks and thighs in adult patients.

Regulatory Classification

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.

Predicate Devices

emFieldPro (K182963)

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Submission Summary (Full Text)

{0}------------------------------------------------ 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. {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) K192940 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) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 | < 1 μΑ | 1 μΑ | | | Single fault condition | 3.9 μΑ | 3 μΑ | | | 5. Number of Output Modes | 1 | 1 | | | 6. Number of Output Channels - Synchronous or Alternating? - Method of Channel Isolation | 2 Synchronous N/A | 2 Alternating N/A | No electrodes - applicators are not connected to patient | | Sections 2,3 Technological Characteristics | SUBJECT DEVICE Zimmer MedizinSyteme GmbH CoolTone | PREDICATE DEVICE Zimmer MedizinSyteme GmbH emFieldPro (K182963) | Comments | | 7. Regulated Current or Regulated Voltage? | Voltage | Voltage | Controlled voltage to the coil | | 8. Software/Firmware/Mi croprocessor Control? | Yes | Yes | | | 9. Automatic Overload Trip? | N/A | N/A | No electrodes - applicators are not connected to patient | | 10. Automatic No-Load Trip? | N/A | N/A | No electrodes - applicators are not connected to patient | | 11. Automatic Shut Off? | Yes | Yes | Unit shuts off with specified timer | | 12. Patient Override Control? | No | No | Treatment is delivered by health care provider | | 13. Indicator Display: - On/Off Status? - Low Battery? - Voltage/Current Level? | Yes N/A No | Yes N/A No | | | 14. Timer Range (minutes) | Up to 30 Min | Up to 60 Min | | | 15. Compliance with Voluntary Standards? | N/A | N/A | | | 16. Compliance* with 21 CFR 898? ( *Becomes mandatory beginning May 9, 2000) | Yes | Yes | | | 17. Weight | 80 Kg | 60 Kg | | | Sections 2,3 Technological Characteristics | SUBJECT DEVICE Zimmer MedizinSyteme GmbH CoolTone | PREDICATE DEVICE Zimmer MedizinSyteme GmbH emFieldPro (K182963) | Comments | | 19. Housing Materials and Construction | Steel and Injection Molded Plastics | Steel and Injection Molded Plastics | | | Waveform (e.g., pulsed monophasic, biphasic) | Biphasic | Biphasic | | | Shape (e.g., rectangular, spike, rectified sinusoidal) | Sinusoidal | Sinusoidal | | | Maximum Output Voltage (specify units) | N/A | N/A | No electrodes - applicators are not connected to patient | | Maximum Output Current (specify units) | N/A | N/A | No electrodes - applicators are not connected to patient | | Pulse Width (specify units) | 370 $ μ$ s +/- 20% | 250-400 $ μ$ s +/- 20% | | | Frequency (Hz) | 1-150 Hz | 1-150 Hz | | | For interferential modes only: - Beat Frequency (Hz) | N/A | N/A | | | For multiphasic waveforms only: - Symmetrical phases? | Yes | Yes | Biphasic | | Phase Duration (include units) (state range, if applicable) (both phases, if asymmetrical) | 370 $ μ$ s +/- 20% | 250-400 $ μ$ s +/- 20% | | | Net Charge (mC per pulse) (If zero, state method of achieving zero net charge.) | N/A | N/A | No electrodes - applicators not connected to the patient | | Maximum Phase Charge, (mC) | N/A | N/A | No electrodes - applicators not | | Sections 2,3 Technological Characteristics | SUBJECT DEVICE Zimmer MedizinSyteme GmbH CoolTone | PREDICATE DEVICE Zimmer MedizinSyteme GmbH emFieldPro (K182963) | Comments | | Maximum Current Density, (mA/cm²) | N/A | N/A | connected to the patient No electrodes - applicators not connected to the patient - see SAR report | | Maximum Power Density, (W/cm²)(using smallest electrode conductive surface area) | N/A | N/A | No electrodes - applicators not connected to the patient | | Burst Mode7 (i.e., pulse trains) a. Pulses per burst b. Bursts per second 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 (if applicable) | N/A | N/A | N/A | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with the word "MedizinSysteme" in a smaller font size underneath. The text is in a dark color, likely black or a dark gray, against a white background. {8}------------------------------------------------ ## Zimmer {9}------------------------------------------------ ## 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: {10}------------------------------------------------ # Zimmer | Technological Characteristics | Characteristic difference between CoolTone and Predicate Device | Discussion on why this difference does not affect the overall safety and effectiveness of the subject device when compared to the predicate device | |------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Touch Screen Size | 12" versus 7" | The size of the touch screen does not impact the icons and data visibly displayed on the screen. | | Positioning of the applicator | Securement system versus arm | The securement system ensures applicator position during treatment. Biocompatibility testing was performed on the securement system since it may have patient contact. Please refer to Section 13. | | Pulse Duration | 370 $ \mu $ s +/- 20% versus 400 $ \mu $ s +/- 20% | No impact. The pulse width of the CoolTone device and the predicate device are in the typical clinical range of 50 to 500 $ \mu $ s. Reference: "The effect of stimulus current pulse width on nerve fiber size recruitment patterns" by Robert B. Szlavik and Hubert de Bruin | | Number of applicators | Up to two large applicators can be operational at same time versus one applicator at a time | The performance 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 does not present an appreciable rise in temperature at maximum intensity to cause a risk to the patient. Please refer to Section 13. | | Applicator connection | Detachable versus fixed | No impact. Each applicator can be detached from the control unit by a connector, for ease of service. Performance testing shows that the connector does not influence effectiveness of the treatment parameters. | | Treatment time | Up to 30 minutes (CoolTone) versus 60 minutes (emField Pro) | No impact. A typical treatment session is 20 – 30 minutes. | | System Dimensions (WxHxD) | 600 x 1100 x 600 mm versus 501 x 993 x 542mm | Different dimensions have no influence on the safety or effectiveness of the device. | | Energy Source | 220-240VAC, 50-60 Hz versus 100 – 240 V AC, 50-60 Hz | No impact. The energy source is sufficient to operate the device under normal operating conditions. | | Maximum Magnetic Field Intensity at Applicator Center Surface | Up to two Large applicators with 0.5 – $1.35T +/- 20%$ versus one large applicator with 0.5 – $1.5T +/- 20%$ and one small applicator 0.5 – $2.0T$ . | EMF is measured as 1.43T. The performance 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 does not present an appreciable rise in temperature at maximum intensity to cause a risk to the patient. | | Operating Ambient Temperature | $10°C$ to $28 °C$ versus $10°C$ to $30°C$ | Lower ambient temperatures is preferred to facilitate applicator cooling. No impact is expected as a typical medical office sets room temperature to no higher than $27°C$ (80°F) | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo is in a sans-serif font and is in black and white. The word "zimmer" is in a larger font than the words "MedizinSysteme". The logo is simple and modern. 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 | Standards Organization | Standards Title | |-----------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 60601-1:2005 + CORR: 1:2006 + CORR. 2:2007 + A1:2012 (Edition 3.1) | ANSI AAMI | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance | | 60601-1-2:2014 (Edition 4.0) | IEC | 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) | IEC | Medical electrical equipment – Part 2-10: Particular requirements for the Basic Safety and Essential Performance of Nerve and Muscle Stimulators | {12}------------------------------------------------ | Standards | Standards Organization | Standards Title | |-------------------------------|---------------------------|----------------------------------------------------------------------------------------------------| | 62366-1:2015 (Edition 1.0) | IEC | Medical devices – Application of usability engineering to medical devices | | 62304:2015 (Edition 1.1) | IEC | Medical devices software –software life cycle processes | | 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). {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The word "zimmer" is in bold, dark gray letters. Below that, in a smaller font, are the words "MedizinSysteme" in a lighter gray color. ## 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.