Who is the manufacturer of Katalyst Mark 1 Muscle Stimulation System?

Katalyst, Inc. filed the 510(k) submission for Katalyst Mark 1 Muscle Stimulation System (K171035).

What is the FDA product code for Katalyst Mark 1 Muscle Stimulation System?

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 Katalyst Mark 1 Muscle Stimulation System?

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

What are the predicate devices for Katalyst Mark 1 Muscle Stimulation System?

Compex® Sport Plus (K083140); E-Fit EF-1280 (K133225).

Who can help prepare an FDA 510(k) submission like Katalyst Mark 1 Muscle Stimulation System?

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.

Katalyst Mark 1 Muscle Stimulation System

K171035 · Katalyst, Inc. · NGX · Sep 6, 2017 · Physical Medicine

Device Facts

Record ID	K171035
Device Name	Katalyst Mark 1 Muscle Stimulation System
Applicant	Katalyst, Inc.
Product Code	NGX · Physical Medicine
Decision Date	Sep 6, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.5850
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The Katalyst Mark 1 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated. The Katalyst Mark 1 is Rx only.

Device Story

Katalyst Mark 1 is a powered muscle stimulation system consisting of a compression textile suit with embedded electrodes, a battery-powered Impulse Pack, and a tablet-based control application. The system is operated by a certified professional in a clinic or training environment. The operator configures training programs via the Katalyst Application on a Windows 10 tablet, which communicates wirelessly via Bluetooth Smart to the Impulse Pack. The Impulse Pack delivers regulated electrical impulses to major muscle groups through the suit's electrodes. The device provides localized EMS to improve muscle performance. The operator monitors training duration and intensity levels through the tablet interface. The system includes safety features like automatic overload/no-load trips and a physical emergency shutoff button. The device is intended for healthy muscles only; it is not for rehabilitation or medical treatment.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (ISO 10993-5/10), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), nerve/muscle stimulator performance (IEC 60601-2-10), and battery safety (IEC 62133). Engineering bench testing included oscilloscope waveform verification under various loads and wireless risk mitigation validation.

Technological Characteristics

System comprises a compression suit with embedded electrodes, Impulse Pack, and tablet controller. Uses bipolar square waveforms. Powered by 3.8V Li-Po battery. Connectivity via Bluetooth Smart (BT LE 4.0). Complies with IEC 60601-1, IEC 60601-2-10, and IEC 60601-1-2. Electrodes use 4mm standard SNAP connectors. Software-controlled intensity and training parameters.

Indications for Use

Indicated for healthy individuals 18+ years of age to stimulate muscles to improve or facilitate muscle performance. Contraindicated for individuals with cardiac pacemakers, known heart conditions, history of cardiac arrhythmia, pregnancy, implanted defibrillators, or other implanted metallic/electronic devices.

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

Compex® Sport Plus (K083140)
E-Fit EF-1280 (K133225)

Reference Devices

PowerDot Pd-01 Muscle Stimulator (K150078)
Compex Sport (K011880)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or a stream. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 6, 2017 Katalyst Inc. Amish Patel Chief Product Officer 316 Occidental Avenue South B300 Seattle, Washington 98104 Re: K171035 Trade/Device Name: Katalyst Mark 1 Muscle Stimulation System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: August 1, 2017 Received: August 3, 2017 Dear Mr. Patel: 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # Vivek J. Pinto -S for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K171035 Device Name Katalyst Mark 1 Muscle Stimulation System #### Indications for Use (Describe) The Katalyst Mark 1 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated. The Katalyst Mark 1 is Rx only. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div> X Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> □ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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}------------------------------------------------ # 510(K) SUMMARY This summary is being submitted in accordance with the requirements of 21 CFR 807.92. ## 1.1 Submitter Katalyst Inc. 316 Occidental Avenue S. B300 Seattle, WA 98104 Contact: Amish Patel, Chief Product Officer Tel: 406-616-3671 Email: devices@katalyst-fitness.com ## 1.2 Date Prepared September 6, 2017 ### 1.3 Device Name and Classification Information: Trade/Proprietary Name: Katalyst Mark 1 Muscle Stimulation System Common Name: Powered Muscle Stimulator for Muscle Conditioning Classification Name: Powered Muscle Stimulator Classification: 21 CFR 890.5850, Class II Product Code: NGX Panel: 89, Physical Medicine #### 1.4 Predicate Devices Primary Predicate: Compex® Sport Plus (K083140) Secondary Predicate: E-Fit EF-1280 (K133225) ## 1.5 Device Description The Katalyst Mark 1 Muscle Stimulation System consists of the following three main components: | Katalyst Suit | Worn by the client, the Katalyst Suit is a compression textile with embedded electrodes connected by a cable harness. When connected to the Impulse Pack it provides localized EMS impulses to major muscle groups at controllable intensities. | |---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {4}------------------------------------------------ | Impulse Pack | A powered muscle stimulation device specifically designed to mate with the Katalyst Suit through a single port connector. It delivers electrical impulses through a battery powered regulated booster. The Impulse Pack is operator controlled wirelessly via the Katalyst Application over Bluetooth. | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Katalyst Application | Controlled by the Operator, the Katalyst Application is run on a Microsoft Surface Pro 3 running Windows 10 Professional. It is used to configure and run a Katalyst training, including the setting of independent intensities for each muscle group channel. | Accessories included: cable harnesses and an Impulse Pack charging cable. ### 1.6 Indications for Use: The Katalyst Mark 1 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated. The Katalyst Mark 1 is Rx only. #### 1.7 Contraindications The Katalyst Mark 1 should only be operated by a certified Katalyst Operator. Trainings should not be used by anyone under 18 years of age, with a cardiac pacemaker, with known heart conditions, with a history of cardiac arrhythmia, who is pregnant, with an implanted defibrillator, or with other implanted metallic or electronic device. Such use could cause cardiac arrhythmia, electric shock, burns, electrical interference, or death. Other contraindications are provided in the operator guide. #### 1.8 Basic Device Characteristics - Comparison with Predicate Devices | Characteristic | New Device (Katalyst Mark 1 Muscle Stimulation System) | Primary Predicate Compex Sport Plus (K083140) | Secondary Predicate: E-Fit EF-1280 (K133225) | Similar/ Different | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------| | Device Name, Model | Katalyst Mark 1 Muscle Stimulation System | Compex Sport Plus (currently marketed) | E-Fit EF-1280 | K083140 - Different | | Manufacturer | | as Compex Sport Elite) | | K133225 - Different K083140 - Different | | | Katalyst Inc. | DJO LLC | FIT PRO, LLC | K133225 - Different K083140 - Similar K133225 - Similar | | Indications for Use | The Katalyst Mark 1 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated. The Katalyst Mark 1 is Rx only. | The Compex® Sport Plus is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Compex® Sport Plus is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Compex® Sport Plus training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Compex® Sport Plus electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the | E-fit EF-1280 is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes. The E-Fit EF-1280 intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The E-Fit EF-1280 is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None | | {5}------------------------------------------------ {6}------------------------------------------------ | | motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that the Compex® Sport Plus can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Compex® Sport Plus may therefore be considered a technique of muscle training | of the E-Fit EF- 1280 training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The E-Fit EF- 1280 electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work | |--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {7}------------------------------------------------ | Connection of device to electrodes | The Katalyst Impulse Pack unit is connected to the electrodes via a cable electrode harness. The connection to the Impulse Pack is via a ROHS compliant standard DB-25 Female connector, and snapping onto the electrodes using standard 4mm SNAP connectors integrated in the electrodes themselves. The SNAP headers are combined and over molded in the lead cables. | With 6-pole cables including female custom SNAP plugged on the custom Compex female SNAP assembled in the electrode. Entire electronic circuit for four (4) Stimulation Channels and User Interface is combined into same casing, connected to the electrodes with 6-pole cables. | on the stimulated muscles. The various types of muscle work that the E- Fit EF-1280 can impose on the stimulated muscles are able to improve or facilitate muscle performance. The E-Fit EF- 1280 may therefore be considered a technique of muscle training. The EF-1280 unit is connected to the electrodes via a cable electrode harness which is connected to the EMS device with a physical connection. The connection to the EMS device 1s via a plastic 12pin waterproof ip68 Connector and the connection to the electrodes is via SNAP connectors directly onto the outer vest and | K083140 - Similar K133225 - Similar | | | | LED backlight. The rotary encoder allows for a quick setup and ease of use | Different See section 1.10 Differences below for justification of differences | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------| | Power Source(s) | Li-Po Battery 3.8V, 7.79Wh | Rechargeable Ni-Mh Battery 4.6V (4 cells | leg straps. Lead Acid Battery | K083140 - Different | Per Channel Control | Yes. Using Windows 10 control application | Yes, Using integrated buttons. | Yes. Using rotary encoder knobs for each channel. | K083140 - Similar K133225 - Similar | | | (2050mAh) | AA=R6) | | K133225 - | Electrode Placement | Integrated into wearable body suit and positioned over corresponding muscle group positions. Cannot be modified/altered. | Not defined. Placement of electrodes is dictated by the operator. | Placed into outer layer, appropriately positioned over corresponding muscle group positions. Cannot be modified/altered. | K083140 - Different K133225 - Similar | | | IEC 62133: 2012 (2nd Edition) | | 12V, 3400mAH | Different | Electrode Leads | 21 CFR 898 compliant. | 21 CFR 898 compliant. | 21 CFR 898 compliant. | K083140 - Similar K133225 - Similar | | Charging System | AC/DC wall plug in, distributed directly to the device. 18.0[v], 1.33[A] | AC/DC 9[v] 0.4[A] Distributed directly to the device | AC/DC wall plug in, distributed directly to the device. | K083140 - Different K133225 - Different Difference does not adversely affect the safety and effectivenes s of the device | Electrode Interface | 4mm Standard SNAP Connector. | 4mm Standard SNAP Connector. | 4mm Standard SNAP Connector. | K083140 - Similar K133225 - Similar | | Waveform | Bipolar Square | Bipolar Square | Bipolar Square | K083140 - Similar K133225 - Similar | Electrodes | Only 2 per channel; Max 20. | 2 per channel; Max 8. | 2 per channel; Max 24. | K083140 - Similar K133225 - Similar | | Channels | 10 | 4 | 12 | K083140 - Different K133225 - Similar | Transthoracic stimulation | Yes | No | Yes | K083140 - Different K133225 - Similar electrode placement and safety mitigations as K133225 | | Operation Modes | 3 | 9 | 5+5 | K083140 - Similar K133225 - Different | | | | | | | Charging Isolation | Yes | Yes | Yes | K083140 - Similar K133225 - Similar | | | | | | | Rechargeable Integrated Battery | Yes | Yes | Yes | K083140 - Similar K133225 - Similar | | | | | | | Display / Control | Yes; (LCD Display on Microsoft Surface Pro 3 | Yes, Integrated (LCD) | LCD 2x40 character LCD | K083140 - Different | | | | | | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ | Communication with Control Interface | Bluetooth Smart (BT LE 4.0). | | | Different K133225 - Different See section 1.10 Differences below for justification of differences | |--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | Mobile / Form Factor | Yes (tablet, handheld device and wearable suit). | Yes (pocket device with travel case) | Portable with difficulty, no mobile device, its intended use requires the qualified and trained operator. | K083140 - Similar K133225 - Similar | | Channel Control Interface | Touch User Interface provided by Katalyst Application on Surface Pro 3 PC | Physical Buttons and Display on unit. | Using rotary encoder knobs for each channel and master rotary encoder for all channels. | K083140 - Different K133225 - Different See section 1.10 Differences below for justification of differences | | Instant Shutoff | Physical Button | Physical Button | Physical Button | K083140 - Similar K133225 - Similar | | Microprocessor Controlled? | Yes | Yes | Yes | K083140 - Similar K133225 - Similar | | Automatic overload trip? | Yes | Yes | Yes | K083140 - Similar K133225 - Similar | | Automatic No- Load Trip? | Yes | Yes | Yes | K083140 - Similar K133225 - Similar | | Automatic Shutoff? | On/Off Switch | On/Off Switch | On/Off Switch | K083140 - Similar K133225 - Similar | | Patient Override Control? | Yes | Yes | Yes | K083140 - Similar K133225 - Similar | | Interface Indicators | On/Off - Yes (on Impulse Pack via LED and in application) Low Battery - Yes (on Impulse Pack) Voltage/Current Level - Yes (in application). Charging - yes on Impulse Pack. Duration of training- yes (in application) | On/Off - yes Low Battery - yes Voltage/Current Level - yes Charging - yes Duration of training training- yes. | On/Off - yes Low Battery - yes Voltage/Current Level - yes Charging - yes Duration of training training- yes. | K083140 - Similar K133225 - Similar | | Duration in minutes | 40 (shown on display) | 55 | 30 minutes | K083140 - Similar K133225 - Similar | {11}------------------------------------------------ Table 10: Device Characteristic Comparisons # 1.9 Output Specification - Comparison with Predicate Devices | Characteristic | New Device (Katalyst Mark 1 Muscle Stimulation System) | Primary Predicate: Compex Sport Plus (K083140) | Secondary Predicate: E- Fit EF-1280 (K133225) | Similar/ Different | |-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | Waveform | Symmetrical Biphasic | Symmetrical Biphasic | Symmetrical Biphasic | K083140 - Similar K133225 - | | | | | | Similar | | Shape | Rectangular | Rectangular | Rectangular | K083140 - Similar K133225 - Similar | | Maximum Output Voltage (+/- 10%) | 60 V @ 500 Ω 96 V @ 2 kΩ 114.2 V @ 10 kΩ | 60 V @ 500 Ω 165 V @ 2 kΩ 165 V @ 10 kΩ | 36 V @ 500 Ω | K083140 - Similar K133225 - Different | | Maximum Output Current (+/- 10%) | 120 mA @ 500 Ω 48 mA @ 2 kΩ 11 mA @ 10 kΩ | 120 mA @ 500 Ω 82 mA @ 2 kΩ 16 mA @ 10 kΩ | 72 mA @ 500 Ω | K083140 - Similar K133225 - Different | | Positive Pulse Width | 75µs or 175µs | 200 µs to 400 µs | 100µs to 500µs | K083140 - Different K133225 - Different Difference does not adversely affect the safety and effectiveness of the device | | Negative Pulse Width | 75µs or 175µs | 200 µs to 400 µs | 100µs to 500µs | K083140 - Different K133225 - Different Difference does not adversely affect the safety and effectiveness of the device | | Frequency | 85Hz or 100Hz | 1 to 120Hz | 5 to 120Hz | K083140 - Similar K133225 - Different | | For interferential modes only: | No | No | No | K083140 - Similar K133225 - Similar | | | | | | | | For multiphasic waveforms only: | Yes | Yes | Yes | Similar K133225 - Similar | | - Symmetrical phases? | Yes | Yes | Yes | K083140 - Similar K133225 - Similar | | - Phase Duration (include units) (state range, if applicable) (both phases, if asymmetrical) | 75µs Symmetrical or 175uSec Symmetrical | 70-200µs Symmetrical | 100 - 500µs Symmetrical | K083140 - Similar K133225 - Different | | Net Charge [µC/pulse] | $0.5 [\mu C] @ 500\Omega$ Excitation pulse fully compensated | $0 [\mu C] @ 500\Omega$ Excitation pulse fully compensated | $0 [\mu C] @ 500\Omega$ Excitation pulse fully compensated | K083140 - Similar K133225 - Similar | | Maximum Phase Charge [µC] | $21\mu C @ 500 \Omega$ | $48\mu C @ 500\Omega$ | $36\mu C @ 500 \Omega$ | K083140 - Similar K133225 - Similar | | Maximum Current (RMS) Density [mA/cm2] | $2.4mA/cm^2 @500\Omega$ | $1.49mA/cm^2 @ 500\Omega$ | $0.85mA/cm^2 @ 500\Omega$ | K083140 - Different K133225 - Different See section 1.10 Differences below for justification of differences | | Maximum Power Density [mW/cm2] | $5.04mW/cm^2 @ 500 \Omega$ | $27.6mW/cm^2 @500\Omega$ | $6.3mW/cm^2 @ 500 \Omega$ | K083140 - Similar K133225 - Similar | | Burst Mode (i.e., pulse trains) | N/A | Unknown | Unknown | K083140 - Unknown K133225 - | | c. Burst duration (seconds) | | | | | | d. Duty Cycle [Line (b) x Line (c)] | | | | | | ON Time (seconds) | 1 or 4, 1 second intervals (software adjustable modes) | Not Adjustable | 0.1 to 60 seconds, 0.1 second intervals (adjustable within range) | K083140 - Different K133225 - Different Difference does not adversely affect the safety and effectiveness of the device | | OFF Time (seconds) | 1 or 4, 1 second intervals (software adjustable modes) | Not Adjustable | 0.1 to 60 seconds, 0.1 second intervals (adjustable within range) | K083140 - Different K133225 - Different Difference does not adversely affect the safety and effectiveness of the device | | Treatment Training Time | 1-40 minutes, 1- minute intervals (software adjustable within range) | Not Adjustable | 1-30 minutes, 1-minute intervals (adjustable within range) | K083140 - Different K133225 - Similar Difference does not adversely affect the safety and effectiveness of the device | | Ramp up time per impulse | 0 seconds or 300ms (software adjustable within range) | Not Adjustable | 0 ms - 5000 ms, 100ms intervals (adjustable within range) | K083140 - Different K133225 - Different Difference does not adversely affect the safety and effectiveness of the device | | | | | | does not adversely affect the safety and effectiveness of the device | {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------ {15}------------------------------------------------ Table 11: Output Specification Comparisons #### 1.10 Differences Fundamentally, when we compare the core design, output specifications, operating behavior, intended use and general modes of operation we can conclude there is little difference between the Compex Sport Plus, EF-1280, and the Katalyst Mark 1 Muscle Stimulator. The following table outlines the essential differences with justifications for how the differences do not adversely impact the safety and effectiveness of the subject device. | Difference | Additional Details | Justification for how the difference does not adversely impact safety and effectiveness | |----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Katalyst Mark 1's use of wireless communication between the controller device and the impulse generator. | In order to better utilize modern interfaces alongside with strong and robust platforms. Katalyst utilizes a Bluetooth Smart connection between its interface controller and the impulse pack. | System validation testing scenarios covering mitigation of wireless risks in accordance with FDA's “Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff” were added to our full system testing protocol to ensure safe and effective use In addition, this is similar to the PowerDot Pd-01 Muscle Stimulator (with PowerDot Mobile Application) (K150078) | | Using a tablet / touch interface to control channel impulse intensities. | The touch application is used to control the impulse intensities wirelessly via Bluetooth. | Impulse Pack firmware and Katalyst Application software documentation, consistent with a Moderate level of concern, is provided with this 510(k). System Validation Testing proves that all software requirement specifications were met and all software hazards were mitigated to Accepted risk level In addition, this is similar to the PowerDot Pd-01 Muscle Stimulator (with PowerDot Mobile Application) (K150078) | | The Katalyst Mark 1 has a current density (RMS) greater than 2mA/cm² | As outlined in IEC 60601-2-10 additional warnings and guidance are included in the Operator's Guide to properly advice operators on proper procedures to increase to intensities. | The Katalyst Mark 1 has been tested and conformed to the IEC 60601-2-10:2012 "Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators." Edition 2.0 standard. Furthermore, the subject device has complied with the recommendations set forth in FDA's "Guidance Document for Powered Muscle Stimulator 510(k)s" | | | issued on June 9, 1999 In addition, Compex Sport (K011880) has a current density of 3.84mA/cm² which includes similar warnings and guidance. | | {16}------------------------------------------------ {17}------------------------------------------------ #### 1.11 Non-Clinical Tests The following non-clinical testing was provided in this 510(k): #### Biocompatibility Testing Skin contacting electrodes pads have been tested to ISO 10993-10:2009 and ISO 10993-5:2009 standard under GLP. #### Software Verification and Validation Impulse Pack firmware and Katalyst Application software documentation, consistent with a Moderate level of concern, is provided with this 510(k). System Validation Testing proves that all software requirement specifications were met and all software hazards were mitigated to Accepted risk level. #### Electrical Safety and Electromagnetic Compatibility Testing The Katalyst Suit and the Impulse Pack have been designed to comply and tested for compatibility with the applicable clauses of the following FDA-recognized standards: - . IEC/EN 60601-1:2005 "Medical Electrical Equipment - Part 1: General Requirements for Safety" Edition 3.1 - . IEC 60601-2-10:2012 "Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators." Edition 2.0 - . IEC/EN 60601-1-2:2014 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collater…

Katalyst Mark 1 Muscle Stimulation System

Device Facts

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Katalyst Mark 1 Muscle Stimulation System

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