FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The High Tone Power therapy (HiToP®) is a non-invasive electrical muscle stimulator/ powered muscle stimulator and Transcutaneous Electrical Nerve Stimulator (TENS). The device is designed for pain management, muscle strengthening, training, muscle relaxation, and re-education. The device stimulates the underlying muscle groups through electrical impulses transmitted via electrodes applied on the skin. The device can deliver medium frequency sinusoidal electrical waves with different programmable parameters such as frequency, duration of rest, and total session duration to underlying muscle groups. In High Tone power therapy, the amplitude and the frequency are modulated simultaneously.
The High Tone Power Therapy devices (HiToP®) provide a therapy with medium frequency sine current waves ranging from 4096 – 32768 Hz. The amplitude (A) and frequency (f) of Sine waves can be simultaneously modulated, so this method is called SimulFAM® which stands for Simultaneous Frequency Amplitude Modulation.
SimulFAM®X
A frequency scan of three octaves is realized. The frequency scan is realized with different speed (0.1 - 200 Hz).
There are three models of HiToP®, which are HiToP® touch, HiToP® 1 touch. Each model's intended use, working principle, product structure, and significant parameters are the slight difference in product appearance and number of programs. HiToP®4 touch, HiToP®2 touch, HiToP®1 touch is used at healthcare facilities and hospitals.
The device's parameters are controlled by the driver (control knob), and the user can select the desired therapy using a graphical user interface.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for the HiTop® series of powered muscle stimulators. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against acceptance criteria for a novel AI/software function.

Therefore, most of the requested information (related to AI model performance, test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not applicable to this document as it does not describe an AI medical device or a clinical performance study using a test set against predefined acceptance criteria for such a device. This submission is for a traditional powered muscle stimulator.

However, I can extract the information that is relevant from the provided text:

1. A table of acceptance criteria and the reported device performance:

This document describes a comparison to a predicate device (Sys*Stim 240, K113017) to demonstrate substantial equivalence, not performance against specific acceptance criteria for a new AI algorithm. The "acceptance criteria" here are implicitly that the new device is as safe and effective as the predicate, and that any differences do not raise new questions of safety and effectiveness.

The document provides a detailed comparison table of technical characteristics and output specifications. Below is an excerpt of key comparisons, presented as a "performance" summary in the context of demonstrating substantial equivalence. The "Acceptance Criteria" column would effectively be "Similar to Predicate" or "Does not raise new safety/effectiveness concerns."

Characteristic	HiToP® (Subject Devices) Performance	Predicate Device (Sys*Stim 240) Performance	SE Comparison (Outcome vs. Implicit Acceptance Criteria)
Indications for Use	Powered muscle stimulator: Relaxation of muscle spasms, Increase local blood circulation, Muscle re-education, Maintaining or increasing range of motion. TENS: Symptomatic relief and management of chronic, intractable pain.	Powered muscle stimulator: Relaxation of muscle spasms, Prevention or retardation of disuse atrophy, Increase local blood circulation, Muscle re-education, Maintaining or increasing range of motion. TENS: Symptomatic relief and management of chronic, intractable pain, Post-traumatic acute pain, Post-surgical acute pain. Also includes DC Mode, laser, and cluster applicators.	Similar: The indications are identical, with the predicate having additional indications and functionalities (DC mode, laser) that are not applicable to the subject device, thus not introducing new risks for the subject device.
Product Code	IPF, LIH, GZJ	IPF, ILY, GZJ, LIH	Similar: Subject device does not include Product Code ILY (Infrared Lamp), which eliminates risks associated with that function.
Regulation Number	21 CFR 890.5850	21 CFR 890.5850, 21 CFR 890.5500	Similar: 21 CFR 890.5500 (Infrared Lamp) is not applicable to the subject device, eliminating associated risks.
Patient Leakage Current (Normal Condition)	HiToP®4touch: 4.7 µA, HiToP®2touch: 4.7 µA, HiToP®1touch: 8.0 µA	78 µA (Less than 100 µA)	Similar: Subject device demonstrated electrical safety by passing ANSI AAMI ES60601-1 and IEC 60601-2-10 tests. Difference does not raise safety/effectiveness concerns.
Patient Leakage Current (Single Fault Condition)	HiToP®4touch: 34 µA, HiToP®2touch: 34 µA, HiToP®1touch: 16.0 µA (all AC SFC 264V 60 Hz)	78 µA (Less than 500 µA)	Similar: Subject device demonstrated electrical safety by passing ANSI AAMI ES60601-1 and IEC 60601-2-10 tests. Difference does not raise safety/effectiveness concerns.
Number of Output Modes	2	9 (one less output, implying 10 total)	Similar: Two output modes are like two outputs of predicate (Russian and Interferential). Minor difference does not raise different safety/effectiveness questions.
Synchronous or Alternating?	Alternating (N/A for 1 channel model)	Synchronous	Different but acceptable: Alternating mode does not raise safety concerns and complies with IEC60601-2-10. Does not raise different questions of safety and effectiveness.
Power Source	100-240V~, 50-60 Hz, AC Line only	AC line or optional battery pack 10.8 V Lithium Ion	Different but acceptable: Subject device is AC line only, no battery pack, which does not introduce new risks and complies with IEC 60601-1. _
Patient Override Control Method	Removal of patient connector at the device.	Patient interrupt switch	Different but acceptable: Subject device has automatic shutdown and overload protection functions to prevent unexpected conditions. The difference does not affect safety and effectiveness.
Low Battery Indicator?	No	Yes	Different but acceptable: Subject device does not use battery, eliminating associated risks. No safety or effectiveness concerns.
Timer Range	1 – 90 min (HiToP®4touch, HiToP®2touch), 1.5 – 120 s (HiToP®1touch)	0-60 min	Similar: Timer range is within or slightly above predicate. Adjustable based on physician's direction; differences in setting range do not impact safety and effectiveness.
Housing Material	Aluminum	ABS Plastic	Different but acceptable: Complies with IEC60601-1 and IEC60601-2-10. Different materials have no effect on function and do not raise safety/performance concerns.
Waveform	Biphasic (medium frequency sine wave)	Medium Frequency (Russian), Biphasic, High Volt Pulsed Current (HVPC), Interferential (4P) and Pre-modulated (2P3)	Same: Subject device has medium frequency sine waveform same as Russian and interferential output in predicate device.
Maximum Output Current	100mA@500 Ω load, 38mA@2 k Ω, 7.6mA@10 k Ω	Not Available (but implied to be comparable given SE determination)	Complies with Standards: Output current complies with IEC60601-2-10. Difference would not affect safety and effectiveness.
Maximum Output Voltage	76V per channel @ all tested loads	Not Available (but implied to be comparable given SE determination)	Complies with Standards: Output voltage complies with IEC60601-2-10. Difference would not affect safety and effectiveness.

2. Sample sized used for the test set and the data provenance:

Not applicable. This submission relies on "non-clinical performance" (bench testing and adherence to standards) and comparison to a predicate device, rather than a clinical performance study with a test set of patient data.
Benchtop Performance Testing: This included testing of output waveforms, basic unit characteristics, output specifications, and uniform current distribution. The "sample size" here refers to test procedures performed on the device itself, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No test set of patient data requiring expert ground truth or review was used for this submission. The "ground truth" for demonstrating substantial equivalence is the safety and effectiveness profile of the predicate device, demonstrated through adherence to recognized standards and comparison of technical characteristics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set of patient data requiring adjudication was used.

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 a physical muscle stimulator and TENS unit, not an AI-powered diagnostic or assistive device that would involve human readers.

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. Its function is to deliver electrical impulses directly.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. The "ground truth" in this context is established by the well-understood principles of electrical muscle stimulation and TENS, and the regulatory history and safety profile of the predicate device. Compliance with recognized electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) serves as the basis for proving performance and safety.

8. The sample size for the training set:

Not applicable. This device does not use an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. No training set was used.

Summary of relevant data provided in the document:

Sterilization & Shelf-life Testing: Not Applicable (Device is non-sterile).
Biocompatibility Testing: Performed with ISO 10993-1, evaluating Cytotoxicity (ISO 10993-5), Skin Irritation (ISO 10993-10), and Sensitization (ISO 10993-10) for conductive rubber electrodes. (Note: Nylatex® wraps not evaluated for biocompatibility).
Electrical safety and electromagnetic compatibility (EMC):
- Electrical Safety Testing: IEC 60601-1
- EMC Testing: IEC 60601-1-2
- Home Use Environment: IEC 60601-1-11
- Nerve and Muscle Stimulators: IEC 60601-2-10
Software Verification and Validation Testing: Performed in accordance with IEC 62304 and FDA guidance documents.
Benchtop Performance Testing: Conducted for Output waveforms, Basic unit characteristics, Output specifications, and Uniform current distribution.
Animal Study: Not required.
Human Clinical Performance Testing: Not required.

The core of this 510(k) submission is the demonstration, through bench testing and comparison to an existing legally marketed device, that the HiToP® devices are "as safe, as effective, and performs as well as the legally marketed predicate devices and any differences between the devices do not pose any new questions of safety and effectiveness."

Summary

Regulation Number and Section

§ 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).