(297 days)
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.
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.
This document (K190966 summary for Katalyst Training System) does not provide acceptance criteria and detailed study results in the typical format for assessing devices based on performance metrics (e.g., accuracy, sensitivity, specificity). Instead, it focuses on demonstrating substantial equivalence to a predicate device through comparison of characteristics and adherence to recognized standards.
Here's an analysis based on the provided text, addressing the requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present performance against explicit acceptance criteria in quantifiable terms such as accuracy, sensitivity, or specificity for a specific clinical task. The "acceptance criteria" can be inferred from the standards the device complies with, and the "reported device performance" is essentially the successful completion of tests demonstrating compliance with these standards and equivalence to the predicate device.
| Acceptance Criteria (Inferred from Standards & Predicate Equivalence) | Reported Device Performance |
|---|---|
| Safety and Essential Performance: Adherence to medical electrical equipment standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10). | Electrical Safety and Electromagnetic Compatibility: Tested to AAMI/ANSI ES60601-1, IEC 60601-1-2, and IEC 60601-2-10, demonstrating compliance. |
| Software Functionality: Software verification and validation in accordance with FDA guidance. | Software Verification and Validation: Impulse Pack firmware and Katalyst Application verified; all software requirement specifications were met. |
| Biocompatibility: Meet standards for skin contact (e.g., ISO 10993-5, ISO 10993-10). | Biocompatibility Testing: Skin contacting Base Layers tested to ISO 10993-5 and ISO 10993-10 standard under GLP. |
| Battery Safety: Compliance with battery safety standards (e.g., IEC 62133). | Battery Testing: Lithium-Polymer battery tested for compliance with IEC 62133. |
| Wireless Coexistence: Proper function in environments with other wireless devices. | Wireless Coexistence Testing: Evaluated in environment with other Katalyst Training Systems and 2.4 GHz wireless devices (Bluetooth and Wi-Fi); device met all specified requirements. |
| Output Specifications: Comparable electrical output parameters to predicate. | Output Specifications: Similar waveforms, shapes, net charge, and maximum power density. Differences in maximum voltage, maximum current, pulse width range, and some frequencies were noted, but deemed to not raise safety and effectiveness concerns. |
| Indications for Use: Consistent with predicate for muscle stimulation. | Indications for Use: Identical to predicate in intent to stimulate healthy muscles for performance improvement, for adults only, and no intent for therapy or treatment of medical diseases. Differences noted in TENS functionality (Katalyst does not include TENS). |
2. Sample Size Used for the Test Set and the Data Provenance
No test set with human or patient data is mentioned in this submission. The "test set" here refers to the physical device itself or its components undergoing engineering and safety tests. Thus, the concept of sample size for a "test set" in a clinical or statistical sense is not applicable in this context. The provenance of such data would be internal lab testing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This submission is for a powered muscle stimulator for general healthy muscle performance, not a diagnostic or prognostic device that relies on expert interpretation of complex data (e.g., medical images) to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. There was no expert-based ground truth establishment process or clinical study that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-assisted diagnostic or prognostic tool, and no MRMC study was performed or required.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an algorithm-only device. The device itself is the primary component. Software verification and validation was performed for the device's firmware and application, which is a form of standalone testing for the software components.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the established scientific and engineering principles, and the specifications of the predicate device. Compliance with these standards and comparability to the predicate device's established safe and effective parameters serve as the basis for the safety and effectiveness determination.
8. The Sample Size for the Training Set
Not applicable. This device, as described, does not utilize machine learning or AI models that would require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model.
Summary of the Study (as described in the 510(k) Summary):
The documentation describes a series of non-clinical tests to establish the substantial equivalence of the Katalyst Training System to its predicate device, the Compex Wireless USA. The study primarily consisted of:
- Biocompatibility Testing: Tested the skin-contacting components to ISO 10993-5 and ISO 10993-10 standards.
- Software Verification and Validation: Verified the Impulse Pack firmware and Katalyst Application according to FDA guidance, ensuring all software requirements were met.
- Battery Testing: Demonstrated compliance of the Lithium-Polymer battery with IEC 62133.
- Engineering Bench Testing: Included specific tests recommended by FDA's "Guidance Document for Powered Muscle Stimulator 510(k)s."
- Electrical Safety and Electromagnetic Compatibility: Tested to AAMI/ANSI ES60601-1, IEC 60601-1-2, and IEC 60601-2-10 to ensure electrical safety and EMC compliance.
- Wireless Coexistence Testing: Evaluated device performance in a wireless environment to confirm reliability.
The "study" here is a collection of engineering and compliance tests. The conclusion states that these test results demonstrate the Katalyst Training System is substantially equivalent to the predicate device, implying that it meets the safety and effectiveness criteria inferred from the predicate and relevant standards. No clinical studies were submitted to support this premarket notification.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
|---|---|
| X |
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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: (206) 488-3939 Email: bjoern@katalyst-fitness.com
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 SystemModel 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. TheCompex 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) | DifferentThe Katalyst Training System does not include TENS |
| Number of output channels | 13 | 4 | DifferentCompex Wireless USA Electrodes can be applied to multiple anatomical sites. Katalyst Training |
| Synchronous oralternating? | Synchronous, but never 2channels activated at thesame time | Synchronous, but never 2channels activated at thesame time | Systemelectrodes arefixed in the suitonly allowingstimulation topredefinedareas of thebody |
| Method ofchannel isolation | Multi-Channel High VoltageAnalog Switches. Exceptduring channel activation,each channel is always inhigh Z state | Each channel is the middleof a H- Bridge. Except whenit is activated, each channelis always in high impedancestate | Similar |
| Regulated current orregulated voltage? | Regulated current (allchannels) | Regulated current (allchannels) | Similar |
| Software/firmware/microprocessorcontrol? | Yes | Yes | Similar |
| Automatic overloadtrip? | Yes | Yes | Similar |
| Automatic no-loadtrip? | Yes | Yes | Similar |
| Automatic shut off? | "On/Off" switch | "On/Off" switch | Similar |
| Patient overridecontrol? | Yes | Yes, push on On/Off buttondirectly pause the program | Similar |
| Indicator display- on/off status? | Yes | Yes | Similar |
| - Low battery? | Yes | Yes | Similar |
| - Voltage/currentlevel? | Yes | Yes, unit = [Energy] | Similar |
| Timer range(minutes) | Maximum program: 60minutes | Not publicly available | Cannotdetermine |
| Compliance withvoluntary standards? | YesIEC 60601-1IEC 60601-1-2IEC 60601-2-10 | YesIEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-10 | SimilarThe KatalystTrainingSystem is notintended foruse in a homecareenvironment |
| Compliance with 21cfr 898? | Yes | Yes | Similar |
| Weight | Impulse Pack - 248 g | Remote: 110 [g]StimulationModule:2x60 [g]Docking Station 800 [g] | Similar |
| Dimensions | Impulse Pack | Not publicly available | Cannot |
| Impulse Pack- 148x78 mmConnector 1- 65x32mmConnector 2- 56x32mm | determine | ||
| Housing material andconstruction | Plastic injection molding | Not publicly available | Cannotdetermine |
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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 SystemModel 1 | Compex Wireless USA | N/A | |
| Waveform | Endurance:Symmetrical Biphasic | -Endurance:Symmetrical Biphasic | SimilarThe KatalystTrainingSystem doesnot includeTENS | |
| Resistance:Symmetrical Biphasic | -Resistance:Symmetrical Biphasic | |||
| Strength:Symmetrical Biphasic | -Strength:Symmetrical Biphasic | |||
| Explosive Strength:Symmetrical Biphasic | -Explosive Strength:Symmetrical Biphasic | |||
| Potentiation:Symmetrical Biphasic | -Potentiation: SymmetricalBiphasic | |||
| Training Recovery :Symmetrical Biphasic | -Training Recovery (same asActive Recovery):Symmetrical Biphasic | |||
| Competition Recovery:Symmetrical Biphasic | -Competition Recovery(same as Recovery Plus):Symmetrical Biphasic | |||
| Warmup:Symmetrical Biphasic | -Pre-Warmup Program:Symmetrical Biphasic | |||
| Muscle Relaxation:Symmetrical Biphasic | -Muscle Relaxation (same asMassage): SymmetricalBiphasic | |||
| -Pain relief TENS (same asFM): Balanced,asymmetrical Biphasic | ||||
| Shape | Endurance:Rectangular | -Endurance:Rectangular | ||
| Resistance: | - Resistance: | Training | ||
| Rectangular | Rectangular | System doesnot includeTENS | ||
| Strength: | -Strength: | |||
| Rectangular | Rectangular | |||
| Explosive Strength: | -Explosive Strength: | |||
| Rectangular | Rectangular | |||
| Potentiation: | -Potentiation: | |||
| Rectangular | Rectangular | |||
| Training Recovery : | -Training Recovery: | |||
| Rectangular | Rectangular | |||
| Competition Recovery: | -Competition Recovery: | |||
| Rectangular | Rectangular | |||
| Warmup: | -Pre-Warmup: | |||
| Rectangular | Rectangular | |||
| Muscle Relaxation: | -Muscle Relaxation: | |||
| Rectangular | Rectangular | |||
| -Pain relief TENS (same asFM): | ||||
| Maximum outputvoltage (+/- 10%) | Endurance: | Endurance: | Different | |
| 60 V @ 500 Ω100 V @ 2 kΩ100 V @ 10 kΩ | 60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | |||
| Resistance: | Resistance: | The KatalystTrainingSystem's maxvoltage is lessthan that of thepredicatedevice | ||
| 60 V @ 500 Ω100 V @ 2 kΩ100 V @ 10 kΩ | 60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | |||
| Strength: | Strength: | |||
| 60 V @ 500 Ω100 V @ 2 kΩ100 V @ 10 kΩ | 60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | The KatalystTrainingSystem doesnot includeTENS | ||
| Explosive Strength: | Explosive Strength: | |||
| 60 V @ 500 Ω100 V @ 2 kΩ100 V @ 10 kΩ | 60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | |||
| Potentiation: | Potentiation: | |||
| 60 V @ 500 Ω100 V @ 2 kΩ100 V @ 10 kΩ | 60 V @ 500 Ω152 V @ 2 kΩ136 V @ 10 kΩ | |||
| Training Recovery : | Training Recovery: | |||
| 60 V @ 500 Ω | 60 V @ 500 Ω | |||
| 100 V @ 2 kΩ | 165 V @ 2 kΩ | |||
| 100 V @ 10 kΩ | 165 V @ 10 kΩ | |||
| Competition Recovery: | Competition Recovery: | |||
| 60 V @ 500 Ω | 60 V @ 500 Ω | |||
| 100 V @ 2 kΩ | 165 V @ 2 kΩ | |||
| 100 V @ 10 kΩ | 165 V @ 10 kΩ | |||
| Warmup: | Pre Warmup: | |||
| 60 V @ 500 Ω | 60 V @ 500 Ω | |||
| 100 V @ 2 kΩ | 165 V @ 2 kΩ | |||
| 100 V @ 10 kΩ | 165 V @ 10 kΩ | |||
| Muscle Relaxation: | Muscle Relaxation: | |||
| 60 V @ 500 Ω | 60 V @ 500 Ω | |||
| 100 V @ 2 kΩ | 165 V @ 2 kΩ | |||
| 100 V @ 10 kΩ | 165 V @ 10 kΩ | |||
| Pain Relief TENS: | ||||
| 180[V] peak on 10[kΩ] | ||||
| 170[V] peak on 2[kΩ] 58[V] | ||||
| peak on 500[Ω] | ||||
| Maximum outputcurrent (+/- 10%) | Endurance: | Endurance: | Different | |
| 120 mA @ 500 Ω | 116 mA @ 500 Ω | |||
| 50 mA @ 2 kΩ | 80 mA @ 2 kΩ | The Katalyst | ||
| 10 mA @ 10 kΩ | 15 mA @ 10 kΩ | TrainingSystem's maxcurrent is | ||
| Resistance: | Resistance: | |||
| 120 mA @ 500 Ω | 116 mA @ 500 Ω | similar, but | ||
| 50 mA @ 2 kΩ | 80 mA @ 2 kΩ | currents at 2kΩ and 10 kΩ | ||
| 10 mA @ 10 kΩ | 17 mA @ 10 kΩ | load resistancesare less than | ||
| Strength: | Strength: | that of the | ||
| 120 mA @ 500 Ω | 113 mA @ 500 Ω | predicate | ||
| 50 mA @ 2 kΩ | 80 mA @ 2 kΩ | device | ||
| 10 mA @ 10 kΩ | 15 mA @ 10 kΩ | |||
| Explosive Strength: | Explosive Strength: | The Katalyst | ||
| 120 mA @ 500 Ω | 81 mA @ 500 Ω | Training | ||
| 50 mA @ 2 kΩ | 81 mA @ 2 kΩ | System does | ||
| 10 mA @ 10 kΩ | 15 mA @ 10 kΩ | not includeTENS | ||
| Potentiation: | Potentiation: | |||
| 120 mA @ 500 Ω | 117 mA @ 500 Ω | |||
| 50 mA @ 2 kΩ | 80 mA @ 2 kΩ | |||
| 10 mA @ 10 kΩ | 16 mA @ 10 kΩ | |||
| Training Recovery : | Training Recovery: | |||
| 120 mA @ 500 Ω | 116 mA @ 500 Ω | |||
| 50 mA @ 2 kΩ10 mA @ 10 kΩ | 81mA @ 2 kΩ16 mA @ 10 kΩ | |||
| Competition Recovery:120 mA @ 500 Ω50 mA @ 2 kΩ10 mA @ 10 kΩ | Competition Recovery:116 mA @ 500 Ω81 mA @ 2 kΩ16 mA @ 10 kΩ | |||
| Warmup:120 mA @ 500 Ω50 mA @ 2 kΩ10 mA @ 10 kΩ | Pre Warmup:116 mA @ 500 Ω81 mA @ 2 kΩ15 mA @ 10 kΩ | |||
| Muscle Relaxation:120 mA @ 500 Ω50 mA @ 2 kΩ10 mA @ 10 kΩ | Muscle Relaxation:116 mA @ 500 Ω81 mA @ 2 kΩ16 mA @ 10 kΩPain Relief TENS:18[mA] peak @10[kΩ]86[mA] peak@2[kΩ]116[mA] peak@500[Ω] | |||
| Pulse width | Potentiation:250 to 375 μsEndurance:250 to 375 μsResistance:250 to 375 μsStrength:250 to 375 μsExplosive Strength:250 to 375 μsTraining Recovery :250 to 375 μsCompetition Recovery:250 to 375 μsWarmup:250 to 375 μsMuscle Relaxation:250 to 375 μs | Endurance:200 to 400 [μs]Resistance:200 to 400 [μs]Strength:200 to 400 [μs]Explosive Strength:200 to 400 [μs]Potentiation:200 to 400 [μs]Training Recovery:200 to 400 [μs]Competition Recovery:200 to 400 [μs]Pre Warmup:200 to 400 [μs]Muscle Relaxation:200 to 400 [μs]Pain Relief TENS:70 to 300[μs] (measured at | SimilarThe KatalystTrainingsystem's pulsewidth range isa subset of thatof the predicatedevice's.The KatalystTrainingSystem doesnot includeTENS. | |
| 50% of positive pulse) | ||||
| Frequency | Endurance:10 Hz | Endurance:10 [Hz] | Similar | |
| Resistance:50 Hz | Resistance:50 [Hz] | The KatalystTrainingSystem doesnot includeTENS | ||
| Strength:75 Hz | Strength:75 [Hz] | |||
| Explosive Strength:105 Hz | Explosive Strength:100 [Hz] | |||
| Potentiation:1 to 75 Hz | Potentiation:From 1 to 75 [Hz] | |||
| Training Recovery :1 to 9 Hz | Training Recovery:10 [Hz] | |||
| Competition Recovery:1 to 6 Hz | Competition Recovery:0.5 [Hz] | |||
| Warmup:5 Hz | Pre Warmup:4 [Hz] | |||
| Muscle Relaxation:1 Hz | Muscle Relaxation:1 [Hz] | |||
| Pain Relief TENS:5 to 122[Hz]Not publicly available | ||||
| Phase duration | 250 to 375 µs | Not publicly available | Cannotdetermine | |
| Net charge | Endurance:0 µC @ 500 Ω | Endurance:0 [µC] @ 500ΩExcitation pulse fullycompensated | Similar | |
| Resistance:0 µC @ 500 Ω | Resistance:0 [µC] @ 500Ω Excitationpulse fully compensated | KatalystTrainingSystem doesnot includeTENS | ||
| Strength:0 µC @ 500 Ω | Strength:0 [µC] @ 500Ω Excitationpulse fully compensated | |||
| Explosive Strength:0 µC @ 500 Ω | Explosive Strength:0 [µC] @ 500Ω Excitationpulse fully compensated | |||
| Potentiation: | Potentiation:0 [µC] @ 500Ω Excitation | |||
| 0 μC @ 500 Ω | pulse fully compensated | |||
| Training Recovery :0 μC @ 500 Ω | Training Recovery:0 [μC] @ 500Ω Excitationpulse fully compensated | |||
| Competition Recovery:0 μC @ 500 Ω | Competition Recovery:0 [μC] @ 500Ω Excitationpulse fully compensated | |||
| Warmup:0 μC @ 500 Ω | Pre Warmup:0 [μC] @ 500Ω Excitationpulse fully compensated | |||
| Muscle Relaxation:0 μC @ 500 Ω | Muscle Relaxation:0 [μC] @ 500Ω Excitationpulse compensated | |||
| Pain Relief TENS: 0 [µC] @500Ω Excitation pulse fullycompensated | ||||
| Maximum phasecharge | 45 μC @ 500 Ω | 48 [μC] @ 500Ω | Similar | |
| Maximum current(rms) density | 1.15 mA/cm2 @ 500 Ω | 4.8 [mA/cm2] @ 500Ω | DifferentThe KatalystTrainingSystemMaximumCurrent (RMS)Density islower than thatof the predicatedevice | |
| Maximum PowerDensity (usingsmallest electrodeconductive surfacearea) | 22.68 mW/cm2 @ 500Ω | 27.6 [mW/cm2] @ 500Ω | Similar | |
| Pulses per burst | 4 - 420 | Not publicly available | Cannotdetermine | |
| Bursts per second | 0.125 | Not publicly available | Cannotdetermine | |
| Burst duration(seconds) | 4 | Not publicly available | Cannotdetermine | |
| Duty Cycle | 50% | Not publicly available | Cannotdetermine | |
| determine | ||||
| OFF time (seconds) | 4 | Not publicly available | Cannot determine |
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Although there are minor differences observed between the Katalyst Training System and the predicate device, no difference found raised any question safety and effectiveness of the new device.
Standards
The Katalyst Training System is designed and manufactured in accordance with the following standards:
- AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And ● A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1, Mod.)
- IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements and Tests
- . IEC 60601-2-10 Edition 2.1 2016-04 Medical Electrical Equipment - Part 2-10: Particular Requirements for The Basic Safety and Essential Performance of Nerve and Muscle Stimulators
- IEC 62133 Edition 2.0 2012-12 Secondary Cells and Batteries Containing Alkaline or Other Non-● Acid Electrolytes - Safety Requirements for Portable Sealed Secondary Cells, And for Batteries Made from Them, For Use in Portable Applications [Including: Corrigendum 1 (2013)]
- ISO 14971 Second Edition 2007-03-01 Medical Devices - Application of Risk Management to Medical Devices
- ISO 10993-5 Third Edition 2009-06-01 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10 Third Edition 2010-08-01 Biological Evaluation of Medical Devices Part 10: Tests . for Irritation and Skin Sensitization
- AAMI /ANSI /IEC 62304:2006/A1:2016 Medical Device Software - Software Life Cycle Processes [Including Amendment 1 (2016)]
Non-Clinical Testing
The Katalyst Training System was subjected to testing in accordance with the appropriate standards and the results are provided in this 510(k). The non-clinical tests performed are as follows:
- . Biocompatibility Testing
- The Skin contacting Base Layers have been tested to ISO 10993-5 and ISO 10993-10 O standard under GLP.
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- Software Verification and Validation ●
- The Impulse Pack firmware and Katalyst Application were verified in accordance with the O requirements of FDA's guidance document: General Principles of Software Validation. This testing proves that all software requirement specifications were met.
- Battery Testing
- The Lithium-Polymer battery used in the Impulse Pack was tested by the battery o manufacturer for compliance with IEC 62133
- Engineering Bench Testing
- In addition to the full system validation testing, the 510(k) also included testing in accordance o with the recommendations of FDA's "Guidance Document for Powered Muscle Stimulator 510(k)s" issued on June 9, 1999.
- . Electrical Safety and Electromagnetic Compatibility:
- The Katalyst Training System has been tested to AAMI/ANSI ES60601-1, IEC 60601-1-2, o and IEC 60601-2-10.
- Wireless Coexistence Testing:
- The performance of the Katalyst Training System was evaluated in an environment with other o Katalyst Training Systems and with other types of 2.4 GHz wireless devices (Bluetooth and Wi-Fi). The device met all specified requirements.
Clinical Testing
No clinical studies are submitted to support this premarket notification submission.
Conclusion
Test results demonstrate the Katalyst Training System is substantially equivalent to the predicate device.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).