Katalyst Training System

K190966 · Katalyst, Inc. · NGX · Feb 3, 2020 · Physical Medicine

Device Facts

• Record ID: K190966
• Device Name: Katalyst Training System
• Applicant: Katalyst, Inc.
• Product Code: NGX · Physical Medicine
• Decision Date: Feb 3, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Katalyst Training System is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. The Katalyst Training System 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 Training System's electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons 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 can be imposed on the stimulated muscles.

Device Story

Katalyst Training System is a battery-powered neuromuscular electrical stimulation (NMES) device for muscle conditioning. System consists of an Impulse Pack and a wearable suit with integrated electrodes. User operates device via Katalyst Application on a user-supplied iOS device, communicating via Bluetooth 4.2. Device delivers electrical impulses to trigger action potentials on motoneurons, inducing muscle fiber contraction. Parameters (pulse frequency, contraction/rest duration) are adjustable to impose different types of muscle work. Used by adults in non-clinical settings for fitness/performance improvement. Output allows users to recruit more muscle fibers during training. Device includes safety features like automatic overload/no-load trips and patient override. Healthcare providers do not operate the device; it is for consumer self-use.

Clinical Evidence

No clinical data submitted. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993-5/10), electrical safety (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), wireless coexistence, and software verification/validation.

Technological Characteristics

Battery-powered (7.4V Li-Po) NMES device. 13 output channels using multi-channel high-voltage analog switches. Symmetrical biphasic rectangular waveforms. Regulated current output. Connectivity via Bluetooth 4.2 to iOS application. Materials: plastic injection molded housing. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62133, ISO 14971, ISO 10993, IEC 62304.

Indications for Use

Indicated for healthy adults to stimulate muscles to improve or facilitate muscle performance. Contraindicated for use on injured or ailing muscles or in conjunction with therapy/treatment of medical diseases or 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 Wireless USA (K170903)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right 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.

February 3, 2020

Katalyst Inc. Bjoern Woltermann Chief Executive Officer 316 Occidental Ave. South Suite B300 Seattle, WA 98104

Re: K190966

Trade/Device Name: Katalyst Training System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: January 30, 2020 Received: January 31, 2020

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.

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

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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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Vivek Pinto, Ph.D. Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K190966

Device Name Katalyst Training System

#### Indications for Use (Describe)

The Katalyst Training System is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.

The Katalyst Training System 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 Training System's electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons 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 can be imposed on the stimulated muscles.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
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# 510(k) Summary

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

## Submitted by:

Katalyst Inc. 1201 3rd Avenue Suite 2200 Seattle WA, 98101

#### Contact Person:

Bjoern Woltermann - Chief Executive Officer, Katalyst Inc. Tel: [phone] Email: [e-mail]

#### Date Summary Prepared

April 3, 2019

Trade/Proprietary Name

Katalyst Training System

#### Common Name

Powered Muscle Stimulator for Muscle Conditioning

#### Classification Name

Powered Muscle Stimulator

## Product Code:

Powered Muscle Stimulator, For Muscle Conditioning - 21 CFR 890.5850 Product Code NGX Review Panel: 89, Physical Medicine

Regulatory Class Class II

Predicate Devices Compex Wireless USA (K170903)

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#### Device Description

The Katalyst Training System is a battery powered muscle stimulator that uses electrical muscle stimulation (EMS) technology to stimulate your muscles and help to improve muscle performance. Specifically, it uses neuromuscular electrical stimulation (NMES) to stimulate motor nerves, creating a muscle contraction to recruit more muscle fibers while training.

It is designed to be used with the Katalyst Application, which is the interface between the user and the Impulse Pack and runs on a user supplied iOS device communicates wirelessly with the Impulse Pack using Bluetooth 4.2.

# Indications for Use

The Katalyst Training System is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.

The Katalyst Training System 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 Training System's electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons 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 can be imposed on the stimulated muscles.

#### Comparison to the Predicate Device

The similarities and differences between the technology and specifications of the subject device and its predicate devices are reflected below:

| Characteristic | New Device | Predicate Device | Comparison |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Manufacturer | Katalyst Inc. | DJO LLC | N/A |
| Device name, model | Katalyst Training System<br>Model 1 | Compex Wireless USA | N/A |
| Classification name | Powered muscle stimulator | Powered muscle stimulator | Similar |
| Product code | NGX | NGX | Similar |
| Regulation number | 21 CFR 890.5850 | 21 CFR 890.5850 | Similar |
| Panel | Physical Medicine | Physical Medicine | Similar |
| Class | Class II | Class II | Similar |
| 510(k) number | - | K170903 | N/A |
| Prescription/OTC | OTC | OTC | Similar |
| Indications for use | The Katalyst Training System is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. The Katalyst Training | The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. The Compex Wireless USA | The Katalyst Training System does not include TENS |
| | | | |
| System is not intended to be | is not intended for | | |
| used in conjunction with | adjunctive therapy in the | | |
| therapy or treatment of | treatment of medical | | |
| medical diseases or medical | diseases and conditions of | | |
| conditions of any kind. None | any kind. None of the | | |
| of the training programs or | Compex Wireless USA | | |
| operational parameters are | stimulation programs are | | |
| designed to target injured or | designed for injured or | | |
| ailing muscles and its use on | disease afflicted muscles. Its | | |
| such muscles is | use on such muscles is | | |
| contraindicated. | contraindicated. The work | | |
| The Katalyst Training | imposed on the muscles by | | |
| System's electrical impulses | the Compex Wireless USA | | |
| allow the triggering of action | programs is definitely not | | |
| potentials on motoneurons of | suitable for rehabilitation | | |
| motor nerves (excitations). | and physiotherapy. The | | |
| These excitations of | Compex Wireless USA | | |
| motoneurons are transmitted | electrical impulses allow the | | |
| to the muscle fibers via the | triggering of action | | |
| motor endplate where they | potentials on motoneurons | | |
| generate mechanical muscle | of motor nerves | | |
| fiber responses that | (excitations). These | | |
| correspond to muscle work. | excitations of motoneurons | | |
| Depending on the parameters | are transmitted to the muscle | | |
| of the electrical impulses | fibers via the motor endplate | | |
| (pulse frequency, duration of | where they generate | | |
| contraction, duration of rest, | mechanical muscle fiber | | |
| total session duration), | responses that correspond to | | |
| different types of muscle | muscle work. Depending on | | |
| work can be imposed on the | the parameters of the | | |
| stimulated muscles. | 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<br>Compex Wireless USA may | | |
| | therefore be considered a | | |
| | technique of muscle training. | | |
| | The Compex Wireless USA | | |
| | TENS is used for: | | |
| | • temporary relief of pain | | |
| | associated with sore and | | |
| | aching muscles due to strain | | |
| | from exercise or normal | | |
| | household and work | | |
| | activities. | | |
| | • the symptomatic relief and | | |
| | management of chronic, | | |
| | intractable pain and relief of | | |

#### Basic Device Characteristics - Comparison with Predicate Devices

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| | | pain associated with arthritis. | |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Target population | It is to be used by adults only. | It is to be used by adults only. | Similar |
| Connection of device to electrodes | The Impulse Pack connects to the Suit through output cables that terminate with pogo pin connectors. The Suit contains an embedded cable harness which makes connection with the built-in electrodes. Neither the cable harness or the electrodes are removable. The Suit also features leads with snap connectors for connecting to the arm electrodes | Lead wires Stimulation Module is directly connected to the custom Compex female SNAP assembled in the electrode. User Interface (LCD and buttons) is physically separated (Remote Control) and communicates wirelessly with up to four (4) Stimulation Modules. Stimulation safety remains fully managed by Stimulation Module electronic circuit itself. | Different |
| Power source(s) | Lithium Polymer (Li-Po) rechargeable battery 7.4V, 2,050 mAh | Remote: Lithium Polymer (LiPo) rechargeable 3.7[V] / ≥ 1500[mAh Stimulation Modules: Lithium Polymer (LiPo) rechargeable 3.7[V] / ≥ 450[mAh] | Similar |
| Method of line current isolation | N/A (battery operated device) | N/A (battery operated device) | Similar |
| Patient leakage current | N/A (battery operated device) | N/A (battery operated device) | Similar |
| Normal condition | N/A (battery operated device) | N/A (battery operated device) | Similar |
| Single fault condition | N/A (battery operated device) | N/A (battery operated device) | Similar |
| Number of output modes | One (NMES) | Two (NMES/TENS) | Different<br>The Katalyst Training System does not include TENS |
| Number of output channels | 13 | 4 | Different<br>Compex Wireless USA Electrodes can be applied to multiple anatomical sites. Katalyst Training |
| Synchronous or<br>alternating? | Synchronous, but never 2<br>channels activated at the<br>same time | Synchronous, but never 2<br>channels activated at the<br>same time | System<br>electrodes are<br>fixed in the suit<br>only allowing<br>stimulation to<br>predefined<br>areas of the<br>body |
| Method of<br>channel isolation | Multi-Channel High Voltage<br>Analog Switches. Except<br>during channel activation,<br>each channel is always in<br>high Z state | Each channel is the middle<br>of a H- Bridge. Except when<br>it is activated, each channel<br>is always in high impedance<br>state | Similar |
| Regulated current or<br>regulated voltage? | Regulated current (all<br>channels) | Regulated current (all<br>channels) | Similar |
| Software/firmware/m<br>icroprocessor<br>control? | Yes | Yes | Similar |
| Automatic overload<br>trip? | Yes | Yes | Similar |
| Automatic no-load<br>trip? | Yes | Yes | Similar |
| Automatic shut off? | "On/Off" switch | "On/Off" switch | Similar |
| Patient override<br>control? | Yes | Yes, push on On/Off button<br>directly pause the program | Similar |
| Indicator display<br>- on/off status? | Yes | Yes | Similar |
| - Low battery? | Yes | Yes | Similar |
| - Voltage/current<br>level? | Yes | Yes, unit = [Energy] | Similar |
| Timer range<br>(minutes) | Maximum program: 60<br>minutes | Not publicly available | Cannot<br>determine |
| Compliance with<br>voluntary standards? | Yes<br>IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | Yes<br>IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-10 | Similar<br>The Katalyst<br>Training<br>System is not<br>intended for<br>use in a home<br>care<br>environment |
| Compliance with 21<br>cfr 898? | Yes | Yes | Similar |
| Weight | Impulse Pack - 248 g | Remote: 110 [g]<br>Stimulation<br>Module:2x60 [g]<br>Docking Station 800 [g] | Similar |
| Dimensions | Impulse Pack | Not publicly available | Cannot |
| | Impulse Pack<br>- 148x78 mm<br>Connector 1<br>- 65x32mm<br>Connector 2<br>- 56x32mm | | determine |
| Housing material and<br>construction | Plastic injection molding | Not publicly available | Cannot<br>determine |

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| Output Specification - Comparison with Predicate Devices | | | |
|----------------------------------------------------------|--|--|--|
| | | | |

| Characteristic | New Device | Predicate Device | Comparison | |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Katalyst Inc. | DJO LLC | N/A | |
| Device name, model | Katalyst Training System<br>Model 1 | Compex Wireless USA | N/A | |
| Waveform | Endurance:<br>Symmetrical Biphasic | -Endurance:<br>Symmetrical Biphasic | Similar<br>The Katalyst<br>Training<br>System does<br>not include<br>TENS | |
| | Resistance:<br>Symmetrical Biphasic | -Resistance:<br>Symmetrical Biphasic | | |
| | Strength:<br>Symmetrical Biphasic | -Strength:<br>Symmetrical Biphasic | | |
| | Explosive Strength:<br>Symmetrical Biphasic | -Explosive Strength:<br>Symmetrical Biphasic | | |
| | Potentiation:<br>Symmetrical Biphasic | -Potentiation: Symmetrical<br>Biphasic | | |
| | Training Recovery :<br>Symmetrical Biphasic | -Training Recovery (same as<br>Active Recovery):<br>Symmetrical Biphasic | | |
| | Competition Recovery:<br>Symmetrical Biphasic…