(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.
§ 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).