Who is the manufacturer of Katalyst Mark 1 Muscle Stimulation System Model 2?

Katalyst, Inc. filed the 510(k) submission for Katalyst Mark 1 Muscle Stimulation System Model 2 (K181199).

What is the FDA product code for Katalyst Mark 1 Muscle Stimulation System Model 2?

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 Model 2?

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

What are the predicate devices for Katalyst Mark 1 Muscle Stimulation System Model 2?

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 Model 2?

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 Model 2

K181199 · Katalyst, Inc. · NGX · Sep 20, 2018 · Physical Medicine

Device Facts

Record ID	K181199
Device Name	Katalyst Mark 1 Muscle Stimulation System Model 2
Applicant	Katalyst, Inc.
Product Code	NGX · Physical Medicine
Decision Date	Sep 20, 2018
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 textile suit with integrated electrode pads, a battery-powered Impulse Pack, and a Windows 10-based Training Station. The system is operated by a trained professional in a clinical or training setting. The operator configures training parameters via the Training Station, which communicates wirelessly (Bluetooth LE 4.0) with the Impulse Pack. The Impulse Pack delivers localized electrical muscle stimulation (EMS) impulses to major muscle groups through the suit's electrodes. The operator monitors and adjusts channel intensities using rotary encoders. The device is intended to improve muscle performance in healthy users; it does not target medical conditions. The system includes safety features like an automatic overload trip and physical shutoff buttons.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing (ISO 10993-5/10), electrical safety and EMC testing (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2), battery safety (IEC 62133), and software verification/validation. Engineering bench testing confirmed output waveforms under various loads (500 Ω, 2 kΩ, 10 kΩ) per FDA guidance.

Technological Characteristics

Powered muscle stimulator; 10 channels; symmetrical biphasic rectangular waveform; 85Hz frequency; 175µs pulse width. Components: textile suit with SNAP connectors, Impulse Pack (Li-Po battery, 3.8V, 2050mAh), and Windows 10 Training Station. Connectivity: Bluetooth LE 4.0. Complies with IEC 60601-1, IEC 60601-2-10, and IEC 60601-1-2. Sterilization: N/A (textile base layer).

Indications for Use

Indicated for healthy individuals to improve or facilitate muscle performance. Contraindicated for use on injured or ailing muscles or in conjunction with therapy/treatment of medical conditions.

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)
Katalyst Mark 1 Muscle Stimulation System (K171035)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. September 20, 2018 Katalyst Inc. Bjoern Woltermann Chief Executive Officer, Katalyst Inc 316 Occidental Ave. South Suite B300 Seattle, Washington 98104 Re: K181199 Trade/Device Name: Katalyst Mark 1 Muscle Stimulation System Model 2 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: June 22, 2018 Received: June 26, 2018 Dear Bjoern Woltermann: 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). 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) K181199 Device Name Katalyst Mark 1 Muscle Stimulation System Model 2 #### 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) | | |--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> 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}------------------------------------------------ # 510(k) Summary This summary is being submitted in accordance with the requirements of 21 CFR 807.92. #### 1. Submitter Katalyst Inc. 316 Occidental Avenue S. Suite B300 Seattle, WA 98104 Contact: Bjoern Woltermann - Chief Executive Officer, Katalyst Inc. Tel: (206) 488-3939 Email: bjoern@katalyst-fitness.com Previously Cleared Devices: K171035 Katalyst Mark 1 Muscle Stimulation System #### 2. Date Prepared September 20, 2018 #### 3. Device Name and Classification Information: Trade/Proprietary Name: Katalyst Mark 1 Muscle Stimulation System Model 2 Model Number: 2 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 #### 4. Predicate Devices Primary Predicate: Compex® Sport Plus (K083140) Secondary Predicate: E-Fit EF-1280 (K133225) #### 5. Device Description The Katalyst Mark 1 Muscle Stimulation System Model 2, commonly referred to as Katalyst Mark 1, consists of the following three main components: {4}------------------------------------------------ | Katalyst Suit | Worn by the client, the Katalyst Suit consists of a base layer textile (client contacting), a cable harness, and an outer layer for the cable harness to snap into corresponding electrode pads for major muscle groups. When connected to the Impulse Pack, it provides localized EMS impulses to major muscle groups at controlled intensities. | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Impulse Pack | A powered muscle stimulation device specifically designed to mate with the Katalyst Suit through a single port connector. It delivers EMS impulses through a battery powered regulated booster. The Impulse Pack receives commands over Bluetooth from the Katalyst Training Station which is controlled by the operator. | | Katalyst Training Station | The Katalyst Training Station is based on an MSI computer running Windows 10. It is paired with a touch screen and rotary encoders which are used to configure and run a training via the Katalyst Application. The adjustment of independent intensities for each muscle group are done using 10 smaller knobs to adjust channel intensities and 1 larger knob to control the overall master intensity. | Table 014- 1 Katalyst Mark 1 Component Overview Accessories included: Cable Harnesses for connecting Impulse packs and Katalyst Suits, Impulse Pack Charging Adaptors and Katalyst Training Station Power Cords. # 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. # 7. 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, Model 2 | Compex Sport Plus (currently marketed as Compex Sport Elite) | E-Fit EF-1280 | K083140 - Different K133225 - Different | {5}------------------------------------------------ | Manufacturer | Katalyst Inc. | DJO LLC | FIT-PRO KFT LTD. | K083140 -Different K133225 -Different | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------| | 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 motor endplate where they | 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 | K083140 -Similar K133225 -Similar | {6}------------------------------------------------ | | 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 | diseases or medical conditions of any kind. None 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, | |--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {7}------------------------------------------------ | | | | | | | | | is via SNAP connectors directly onto the outer vest and leg straps. | | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. | | Power Source(s) | Li-Po Battery 3.8V, 7.79Wh (2050mAh) IEC 62133: 2012 (2nd Edition) | Rechargeable Ni-Mh Battery 4.6V (4 cells AA=R6) | Lead Acid Battery 12V, 3400mAH | K083140 -Different K133225 - Different Difference does not adversely affect the safety and effectivene ss of the device | | | | | 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. | | 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 effectivene ss of the device | | Connection of device to electrodes | The Katalyst Impulse Pack is connected to the electrodes via a cable harness. The connection to the Impulse Pack is via a standard MDR connector, and snapping onto the electrodes using standard SNAP connectors integrated in the electrodes themselves. | 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. | 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 is via a plastic 12pin waterproof ip68 Connector and the connection to the electrodes | K083140 - Similar K133225 - Similar | Waveform | Bipolar Square | Bipolar Square | Bipolar Square | K083140 - Similar K133225 - Similar | | Channels | 10 | 4 | 12 | K083140 - Different K133225 - Similar | | | | | | | Operation Modes | 1 | 9 | 5+5 | K083140 - Different K133225 - Different | | | | | | {8}------------------------------------------------ {9}------------------------------------------------ | | | | | See section 1.10 Differences below for justificatio n of differences | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | Charging Isolation | Yes | Yes | Yes | K083140 - Similar K133225 - Similar | | Rechargeable Integrated Battery | Yes | Yes | Yes | K083140 - Similar K133225 - Similar | | Display / Control Interface | Yes; LCD Display on Katalyst Training Station | Yes, Integrated (LCD) | LCD 2x40 character LCD display with LED backlight. The rotary encoder allows for a quick setup and ease of use | K083140 - Different K133225 - Similar | | Per Channel Control | Yes. Using rotary encoder knobs for each channel. | Yes, Using integrated buttons. | Yes. Using rotary encoder knobs for each channel. | K083140 - Similar K133225 - Similar | | Electrode Placement | Placed into outer layer, appropriately 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/altere d. | K083140 - Different K133225 - Similar | | Electrode Leads | 21 CFR 898 compliant. | 21 CFR 898 compliant. | 21 CFR 898 compliant. | K083140 - Similar K133225 - Similar | | Electrode Interface | 4mm Standard SNAP Connector. | 4mm Standard SNAP Connector. | 4mm Standard SNAP Connector. | K083140 - Similar | | | | | | K133225 - Similar K083140 - Similar K133225 - Similar | | Electrodes | 2 per channel; Max 20. | 2 per channel; Max 8. | 2 per channel; Max 24. | | | Transthoracic stimulation | Yes | No | Yes | K083140 - Different K133225 - Similar electrode placement and safety mitigations as K133225 | | Wireless Communication with Control Interface | Yes. Utilizing Bluetooth Smart (BT LE 4.0). | No | No | K083140 - Different K133225 - Different See section 1.10 Differences below for justificatio n of differences | | Mobile / Form Factor | Portable with difficulty, no mobile device, its intended use requires a Katalyst certified operator. | Yes (pocket device with travel case) | Portable with difficulty, no mobile device, its intended use requires the qualified and trained operator. | K083140 - Different K133225 - Similar | | Channel Control Interface | Using rotary encoder knobs for each channel and master rotary encoder for all channels. | Physical Buttons and Display on unit. | Using rotary encoder knobs for each channel and master rotary | K083140 - Different K133225 - Similar | | | | | encoder for all channels. | | | 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? | No | Yes | Yes | K083140 - Different K133225 - Different See section 1.10 Differences below for justification of differences | | Automatic Shutoff? | On/Off Switch | On/Off Switch | On/Off Switch | K083140 - Similar K133225 - Similar | | Patient Override Control? | No | Yes | Yes | K083140 - Different K133225 - Different See section 1.10 Differences below for justification of differences | | Interface Indicators | On/Off - Yes (on Impulse Pack via LED | On/Off - yes | On/Off - yes | K083140 - Similar | | and the Katalyst application). Low Battery - Yes (on Impulse Pack). Voltage/Current Level - Yes (in the Katalyst application). Charging - yes (on Impulse Pack). Duration of training- yes (in the Katalyst application) | Voltage/Current Level - yes Charging - yes Duration of training training- yes. | Low Battery - yes Voltage/Current Level - yes Charging - yes Duration of training training- yes. | K133225 - Similar | | | Duration in minutes | 20 | 55 | 30 minutes | K083140 - Similar K133225 - Similar | | Rx Only or OTC | Rx Only | OTC | Rx Only | K083140 - Different K133225 - Similar | {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ Table 014- 2 Device Characteristic Comparisons # 8. 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 | | | | | | | | 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 | K133225 - Similar 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 | 175µs symmetrical | 200 μs to 400 μs | 100µs to 500µs | K083140 - Different K133225 - Similar | | Negative Pulse Width | 175µs symmetrical | 200 μs to 400 μs | 100µs to 500µs | K083140 - Different K133225 - Similar | | Frequency | 85Hz | 1 to 120Hz | 5 to 120Hz | K083140 - Similar K133225 - Different | | For interferential modes only: | No | No | No | K083140 - Similar K133225 - Similar | | -Beat Frequency | No | No | No | K083140 - Similar K133225 - Similar | | For multiphasic waveforms only: | Yes | Yes | Yes | K083140 - Similar K133225 - Similar | | - Symmetrical phases? | Yes | Yes | Yes | K083140 - Similar K133225 - Similar | | - Phase Duration (include units) (state range, if applicable) (both phases, if asymmetrical) | 175µs Symmetrical | 200-400μs Symmetrical | 100 - 500μs Symmetrical | K083140 - Different K133225 - Similar | | Net Charge | $0.5 [\mu C] @ 500\Omega$ 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 | $21\mu C @ 500 \Omega$ | $48\mu C @ 500\Omega$ | $36\mu C @ 500 \Omega$ | K083140 - Similar K133225 - Similar | | Maximum Current (RMS) Density | $0.788mA/cm^2 @500\Omega$ | $1.49mA/cm2 @ 500\Omega$ | $0.85mA/cm2 @ 500\Omega$ | K083140 - Different K133225 - Similar | | Maximum Power Density | $8.16mW/cm^2 @ 500 \Omega$ | $27.6mW/cm2 @500\Omega$ | $6.3mW/cm2 @ 500 \Omega$ | K083140 - Different K133225 - Similar | | Burst Mode (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 | Unknown | Unknown | K083140 -Unknown K133225 - Unknown | | ON Time | 4 second intervals | Not Adjustable | 0.1 to 60 seconds, 0.1 second intervals (adjustable within range) | K083140 - Different K133225 - Similar | | OFF Time | 4 second intervals | Not Adjustable | 0.1 to 60 seconds, 0.1 second intervals (adjustable within range) | K083140 - Different K133225 - Similar | | Treatment Training Time | 20 minutes | Not Adjustable | 1-30 minutes, 1-minute intervals (adjustable within range) | K083140 - Different K133225 - Similar | | Ramp up time per impulse | 300 ms | Not Adjustable | 0 ms - 5000 ms, 100ms | K083140 - Different | | | | intervals (adjustable within range) | K133225 - Similar | | | | | | | | {13}------------------------------------------------ {14}------------------------------------------------ {15}------------------------------------------------ Table 014- 3 Output Specification Comparisons ## 9. Differences When comparing the core design, output specifications, operating behavior, intended use and general modes of operation it can conclude there is little difference between the Compex Sport Plus, EF-1280, and the Katalyst Mark 1 Muscle Stimulation System. 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 | |-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The Katalyst Mark 1 has only 1 operation mode compared to many modes of the predicate devices | In order to provide a consistent and predictable training experience, the Katalyst Mark 1 only provide a single mode of operation. | | 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. This is similar to the PowerDot Pd-01 Muscle Stimulator (with PowerDot Mobile Application) (K150078) | | Patient Override Control | The Katalyst Mark 1 is always operated by an Katalyst operator for a patient, and as such the operator can immediately turn off the device. | | Automatic No-Load Trip | The Katalyst Mark 1 is always operated by an Katalyst operator for a patient. The Operator's Guide outlines proper no load procedures. | Table 014- 4 Justification of differences with predicate devices # 10.Non-Clinical Tests The following non-clinical testing was provided in this 510(k): # 10.1. Biocompatibility Testing Skin contacting Katalyst Suit Base Layers have been tested to ISO 10993-10:2009 and ISO 10993-5:2009 standard under GLP. {16}------------------------------------------------ # 10.2. 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. ### 10.3. 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 - Collateral standard: Electromagnetic Disturbances. Edition 4.0 #### 10.4. Battery Testing The Lithium-Polymer battery used in the Impulse Pack was tested by the battery manufacturer for compliance with IEC 62133 Edition 2.0. #### 10.5. Engineering Bench Testing In addition to the full system validation testing, the 510(k) also included testing in accordance with the recommendations of FDA's "Guidance Document for Powered Muscle Stimulator 510(k)s" issued on June 9, 1999. Oscilloscope tracings were obtained of the device output waveforms under maximum supported voltage and pulse widths under loads of 500 Ω, 2 kΩ and 10 kΩ. Also, several 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. #### 11.Conclusion Test results demonstrate the Katalyst Mark 1 Muscle Stimulation System is substantially equivalent to the predicate devices.

Katalyst Mark 1 Muscle Stimulation System Model 2

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Katalyst Mark 1 Muscle Stimulation System Model 2

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps