(424 days)
No reference devices were used in this submission.
No
The description focuses on electrical stimulation parameters and modulation techniques (SimulFAM®) and mentions software verification and validation, but there is no mention of AI or ML algorithms, training data, or performance metrics typically associated with AI/ML.
Yes
The device is explicitly described as a "Powered muscle stimulator" and a "Transcutaneous Electrical Nerve Stimulator (TENS)" with various therapeutic indications, including pain management, muscle strengthening/relaxation, and increasing range of motion.
No
Explanation: The device is described as a powered muscle stimulator and TENS intended for therapeutic purposes like muscle re-education, pain relief, and increasing blood circulation. It does not mention any diagnostic functions such as identifying or detecting diseases or conditions.
No
The device description clearly states it is a non-invasive electrical muscle stimulator/powered muscle stimulator and TENS that stimulates underlying muscle groups through electrical impulses transmitted via electrodes applied on the skin. This involves hardware components (the stimulator unit and electrodes) in addition to the software that controls the parameters.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "Powered muscle stimulator" and "TENS" for therapeutic purposes like muscle relaxation, increasing blood circulation, muscle re-education, range of motion, and pain relief. These are all related to treating the body directly, not analyzing samples taken from the body.
- Device Description: The description details how the device applies electrical impulses to the skin to stimulate underlying muscle groups and nerves. This is a physical interaction with the body, not an in vitro (in glass) test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
In summary, the HiToP® devices are therapeutic medical devices that interact with the body externally, not diagnostic devices that analyze samples outside the body.
N/A
Intended Use / Indications for Use
HiToP®4touch, HiToP®2touch, and HiToP®1touch is intended to be used as 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
Product codes (comma separated list FDA assigned to the subject device)
IPF, GZJ, LIH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities and Hospitals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination.
Sterilization & Shelf-life Testing: Not Applicable- Device is non-sterile.
Biocompatibility Testing: Biocompatibility assessment of conductive rubber electrodes in the subject device was performance with iso 10993-1, "biological evaluation of medical devices - part 1: evaluation and testing within a risk management process" as recognized by FDA. The following endpoints were evaluated for conductive rubber electrodes.
- Cytotoxicity ISO 10993-5
- Skin Irritation ISO 10993-10
- Sensitization ISO 10993-10
NOTE: Nylatex® wraps have not been evaluated for biocompatibility. Precautionary statements and the measures necessary to mitigate the risks in the event of an adverse event associated with the use of the Nylatex® wraps are included within the device labeling.
Electrical safety and electromagnetic compatibility (EMC): The following electrical safety and EMC testing reports were provided: - 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: Software verification and validation testing was provided in accordance with IEC 62304 and FDA guidance documents.
Benchtop Performance Testing: The following benchtop performance testing was provided: - Output waveforms
- Basic unit characteristics
- Output specifications
- Uniform current distribution
Animal Study: Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Human Clinical Performance Testing: Clinical testing was not required to demonstrate the safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 17, 2023
HillTek LLC % Bhoomika Joyappa Medical Device Academy Inc, 345 Lincoln Hill Road Shrewsbury, Vermont 05738
Re: K213655
Trade/Device Name: HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ, LIH Dated: December 19, 2022 Received: December 20, 2022
Dear Bhoomika Joyappa:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (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 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,
Heather L. Dean -S
Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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
2
Indications for Use
510(k) Number (if known) K213655
Device Name
HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)
Indications for Use (Describe) HiToP®4touch, HiToP®2touch, and HiToP®1touch is intended to be used as
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
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY K213655
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
l. SUBMITTER
HillTek LLC 421 S Brookhurst Street; Ste#142 Anaheim, CA 92804, USA +1.206.406.9390 Contact Person: Mohammadali Nezakati Date Prepared: November 18, 2021
II. DEVICE
| Name of Device: | HiToP® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) |
|---|---|
| Classification Name: | Physical Medicine Devices and Neurology |
| Regulation: | 21 CFR §890.5850 |
| Regulatory Class: | Class II |
| Product Classification Code: | IPF, GZJ, LIH |
III. PRIMARY PREDICATE DEVICE
- Predicate Manufacturer: Mettler Electronics Corp.
- Predicate Trade Name: Sys*Stim 240 ●
- . Predicate 510(k): K113017
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
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
4
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.
V. INDICATIONS FOR USE
HiToP®4 touch, HiToP®2 touch, and HiToP®1 touch is intended to be used as 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 ●
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PRIMARY PREDICATE DEVCE
The following characteristics were compared between the predicate device to demonstrate substantial equivalence:
| Device | Subject device Model
HiToP®4 touch | Subject device Model
HiToP®2 touch | Subject device Model
HiToP®1 touch | Primary Predicate
Device
Sys*Stim 240 | SE comparison |
| -------- | --------------------------------------- | --------------------------------------- | --------------------------------------- | --------------------------------------------- | --------------- |
|---|
5
| Submitter | HillTek LLC | HillTek LLC | HillTek LLC | Mettler Electronics
Corp | - | | Interferential Current
Therapy LIH | Interferential Current
Therapy LIH | Interferential Current
Therapy LIH | Interferential Current
Therapy LIH | Same |
|------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K Number | K213655 | K213655 | K213655 | K113017 | - | | NA | NA | NA | Lamp, Infrared,
Therapeutic Heating
ILY | Different:
The subject device is
not a Lamp, Infrared,
Therapeutic Heating
device. Therefore,
product code ILY is not
applicable to the
subject device. This
eliminates the risks
associated with that
function |
| Common or Usual Name | Transcutaneous
Electrical Nerve
Stimulator for pain
relief
Powered Muscle
Stimulator | Transcutaneous
Electrical Nerve
Stimulator for pain
relief
Powered Muscle
Stimulator | Transcutaneous
Electrical Nerve
Stimulator for pain
relief
Powered Muscle
Stimulator | Transcutaneous
Electrical Nerve
Stimulator for pain
relief
Powered Muscle
Stimulator | Same | Regulation Number | 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 890.5850
21 CFR 890.5500 | Similar
21 CFR 890.5500 is
used for Lamp,
Infrared, Therapeutic
Heating device that is
not applicable to the
subject device. This
eliminates the risks
associated with that
function |
| | NA | NA | NA | Infrared lamp | - | Indications for Use | Powered muscle
stimulator
• Relaxation of
muscle spasms
• Increase local
blood circulation
• Muscle re-
education
• Maintaining or
increasing range of
motion
TENS | Powered muscle
stimulator
• Relaxation of
muscle spasms
• Increase local
blood circulation
• Muscle re-
education
• Maintaining or
increasing range
of motion
TENS | Powered muscle
stimulator
• Relaxation of
muscle spasms
• Increase local
blood circulation
• Muscle re-
education
• Maintaining or
increasing range of
motion | Indications for
Medium Frequency
(Russian), Biphasic,
High Volt Pulsed
Current (HVPC),
Interferential (4P) and
Premodulated (2P3)
waveforms:
Relaxation of muscle
spasms
• Prevention or
retardation of
disuse atrophy | Similar:
The indication of use
is identical in both
subject device and
predicate devices. The
additional indications
for use i.e Indications
for DC (Direct Current)
Mode and the laser
and cluster applicators
in the predicate
devices is not
applicable for the |
| Product Code | IPF, LIH, GZJ | IPF, LIH, GZJ | IPF, LIH, GZJ | IPF, ILY, GZJ, LIH | Similar
The subject device is
used for electrical
stimulation. It is not a
Lamp, Infrared,
Therapeutic Heating
device. Therefore,
product code ILY is not
applicable to the
subject device. This
eliminates the risks
associated with that
function | | | | | | |
| Product Classification | Class II | Class II | Class II | Class II | Same | | | | | | |
| Classification Name | Stimulator, nerve,
transcutaneous, for
pain relief (GZJ)
Stimulator, muscle,
powered (IPF) | Stimulator, nerve,
transcutaneous, for
pain relief (GZJ)
Stimulator, muscle,
powered (IPF) | Stimulator, nerve,
transcutaneous, for
pain relief (GZJ)
Stimulator, muscle,
powered (IPF) | Stimulator, nerve,
transcutaneous, for
pain relief (GZJ)
Stimulator, muscle,
powered (IPF) | Same | | | | | | |
6
7
| Symptomatic relief and management of chronic, intractable pain | Symptomatic relief and management of chronic, intractable pain | TENS Symptomatic relief and management of chronic, intractable pain | Increase local blood circulation Muscle re-education Maintaining or increasing range of motion Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Indications for Microcurrent, Interferential (4P3), Premodulated (2P), Biphasic, and TENS waveforms: Symptomatic relief and management of chronic, intractable pain Post-traumatic acute pain Post-surgical acute pain Indications for DC (Direct Current) Mode Relaxation of muscle spasm The laser and cluster | subject device as the subject device is not an Infrared, Therapeutic Heating device and does not work in DC mode |
|---|---|---|---|---|
| ---------------------------------------------------------------- | ---------------------------------------------------------------- | ---------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------ |
8
| Type of Use | Prescription (Rx Only) | Prescription (Rx Only) | Prescription (Rx Only) | Prescription (Rx Only) | Same
Different: | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|---------------------------------------------------|---------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power Source(s) | 100-240V~, 50-60 Hz,
200VA / AC Line | 100-240V~, 50-60 Hz,
120VA / AC Line | 100-240V~, 50-60 Hz,
45VA / AC Line | AC line or optional
battery pack 10.8 V AC
line or optional
battery pack Lithium
Ion | The subject device is
limited to use with AC
line as the power
source. The subject
device does not
include an optional
battery pack like the
predicate device, and
this does not
introduce any new
risks. The subject
device complies with
IEC 60601-1
requirements for
evaluation of safety.
These differences do | |
| Sys*Stim 240 emit infrared energy for:
Temporary increase in local blood circulation Temporary relief of minor muscle and joint aches, pains and stiffness Relaxation of muscles Temporary relief of muscle spasms Temporary relief of minor pain and stiffness associated with arthritis | | | | | | |
| | | | | | question of safety and
effectiveness | |
| Method of Line Current Isolation | 2 MOPP | 2 MOPP | 2 MOPP | Yes, value unknown | Similar:
The subject device has
been tested for
electrical isolation
protection against
electric shock
according to standard
requirement IEC
IEC60601-1. Does not
raise any safety and
effectiveness concerns | |
| Patient leakage current - normal
condition (μΑ) | 4.7 μΑ | 4.7 μΑ | 8.0 μΑ | 78 μΑ (Less than 100 μΑ) | Similar:
The subject device
demonstrated
electrical safety by
passing ANSI AAMI
ES60601-1 and IEC
60601-2-10 tests. The
difference does not
raise the issue of
product's safety and
effectiveness. | |
| Patient leakage current - single
fault condition (μΑ) | 34μΑ
(AC SFC 264V 60 Hz) | 34μΑ
(AC SFC 264V 60 Hz) | 16.0μΑ
(AC SFC 264V 60 Hz) | 78 µA (Less than 500 μΑ) | | |
| Number of Output Channels | 4 | 2 | 1 | 2 | The number of
channels of output
current do not affect
the treatment, and
the design of subject
device comply with
IEC60601-2-10 for
performance
requirement | |
| Number of Output Modes | 2 | 2 | 2 | 9 (one less output) | Similar:
Two output modes of
subject device are
basically like two
outputs of predicate | |
| | | | | | | |
| | | | | | device (Russian and
Interferential). The
minor difference does
not raise different
question of safety and
effectiveness | |
| Synchronous or alternating? | Alternating | Alternating | N/A (1 channel only) | Synchronous | Different:
The subject device will
not raise any safety
concerns of output
current by alternating
stimulation mode, and
the subject device
complies with
IEC60601-2-10 for this
performance
requirement. The
difference does not
raise different
questions of safety
and effectiveness | |
| Method of Channel Isolation | Transformer isolated | Transformer isolated | Transformer isolated | Not Available | - | |
| Regulated Current or Regulated
Voltage? | Regulated Voltage (CV) | Regulated Voltage
(CV) | Regulated Voltage (CV) | Not Available | The subject device
complies with
IEC60601-2-10 for
performance
requirement. So, such
a minor difference
does not raise
different question of
safety and
effectiveness. | |
| Software/Firmware/Microprocesso
r Control? | yes | yes | yes | yes | Same | |
| Automatic Over current Trip?
Yes/no | yes | yes | yes | yes | Same | |
| Automatic Overload Trip? Yes/no | yes | yes | yes | yes | Same | |
| Automatic No-Load Trip? Yes/no | yes | yes | yes | yes | Same | |
| Automatic Shut Off? Yes/no | | yes | yes | yes | yes | Same |
| Patient Override Control? Yes/no | | yes | yes | yes | yes | Same |
| Patient Override Control method | | Removal of patient
connector at the
device. | Removal of patient
connector at the
device. | Removal of patient
connector at the
device. | Patient interrupt
switch | Different:
The subject device
does not have a
patient interrupt
switch like the
predicate device. The
subject device has an
automatic shutdown
function and an
overload protection
function that can
monitor the
unintended change in
the intensity of
current that can
prevent the patient
from unexpected
conditions. the
difference would not
affect the safety and
effectiveness of the
subject device. |
| Indicator
Display | On/Off Status?
Yes/ No | Yes | Yes | Yes | Same | |
| | Low Battery
Yes/No | No | No | No | Different:
The subject device
does not use battery
for its operation. This
eliminates the risks
associated with that
function. Therefore,
the subject device will
not have any safety or
effectiveness concerns | |
| | Voltage/Current
Level? | Yes | Yes | Yes | associated with this
function | |
| Timer Range | | 1 – 90 min | 1 – 90 min | 1 – 90 min | 0-60 min | Similar:
The timer range in the
subject device is
within the range or
slightly above the
range of the predicate
device. The design of
the timer range is
based on the intended
use. the operating
time is adjustable by
the operator
according to
physician's direction.
So, the difference in
timer setting range
would not impact its
safety and
effectiveness
compared to the
predicate devices |
| Compliance with 21 CFR 898? | | Yes | Yes | Yes | yes | Same |
| Compliance with voluntary
standards
• IEC60601-1
• IEC60601-1-2
• IEC60601-2-10
• ISO14971
• IEC62304
• IEC62366 | | Yes | Yes | Yes | Information not
available | Same |
| Weight (lbs., oz,) | | 24.2508 lbs. without
accessories | 24.2508 lbs. without
accessories | 5.5 lbs. without
accessories | 4.5 lb. | Different
There are minor
differences between |
| | | | | | | |
| Dimensions (in.) [W x H x D] | 13.77" x 11.41" x 13.77" | 13.77" x 11.41" x
13.77" | 10.6" x 9.64" x 2.36" | 8" x 8" x13" | the subject device and
the predicate devices
in device weight. But
the subject device
complies with
IEC60601-1, and
IEC60601-2-10
Standard
requirement. Different
design criteria will
have no effect on its
function and does not
raise safety and
performance concerns
Different
There are minor
differences between
the subject device and
the predicate devices
in device weight. But
the subject device
complies with
IEC60601-1, and
IEC60601-2-10
Standard
requirement. Different
dimensions will have
no effect on its
function and does not
raise safety and
performance concerns | |
| Environment of use | Healthcare facilities and
Hospitals | Healthcare facilities
and Hospitals | Healthcare facilities
and Hospitals | Information not
available | Same | |
| Electrode shape (square, round,
rectangular, oval) in cm² | Rectangular
12, 48, 96,200 | Rectangular
12, 48, 96,200 | Rectangular
12, 48, 96,200. | Not Available | - | |
| Housing Material and Construction | Aluminum | Aluminum | Aluminum | ABS Plastic | Different
There are minor
differences between | |
| | | | | | the subject device and
the predicate devices
in device weight. But
the subject device
complies with
IEC60601-1, and
IEC60601-2-10
Standard
requirement. Different
materials will have no
effect on its function
and does not raise
safety and
performance concern | |
9
10
11
12
13
14
OUTPUT SPECIFICATIONS -Comparison of Subject Device Models with Predicate Rx Device
| | Subject device Model
HiToP4 touch | Subject device Model
HiToP2 touch | Subject device Model
HiToP1 touch | Predicate Device
Sys*Stim 240 | SE Comparison |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Waveform (e.g., pulsed
monophasic, biphasic) | Biphasic | Biphasic | Biphasic | 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 (±20%) | 100mA@500 Ω load
38mA@2 k Ω
7.6mA@10 k Ω | 100mA@500 Ω load
38mA@2 k Ω
7.6mA@10 k Ω | 100mA@500 Ω load
38mA@2 k Ω
7.6mA@10 k Ω | Not Available | The output
current of the
subject
device |
| | | | | | |
| Maximum output voltage (±20%) | 76V per channel
@500 Ω 76V per
channel @2k Ω
76V per channel
@10k Ω | 76V per channel @500
Ω 76V per channel @2k
Ω
76V per channel @10k
Ω | 76V per channel @500
Ω 76V per channel @2k
Ω
76V per channel @10k
Ω | Not Available | complies with
standard
requirement
of IEC60601-
2-10.
Therefore,
the
difference
would not
affect safety
and
effectiveness
of the subject
device.
Note: As the
device
operates in
voltage-
controlled
mode, it is
normal that
with higher
resistances
the current
goes down.
the output
voltage of the
subject
device
complies with
standard
requirement
of IEC60601-
2-10.
Therefore,
the
difference
would not |
| | | | | | affect safety
and
effectiveness
of the subject
device. |
| Frequency | 4096 – 32768 Hz | 4096 – 32768 Hz | 4096 – 32768 Hz | Not Available | The device |
| Pulse Width | 1 s – 120 s | 1 s – 120 s | 1.5 s – 120 s | Not Available | complies with |
| Maximum Current Density,
(mA/cm²) | 100mA @ 500 Ω
/12cm² = 8.3 | 100mA @ 500 Ω /12cm²
= 8.3 | 100mA @ 500 Ω
/12cm² = 8.3 | Not Available | IEC60601-1,
andIEC60601- |
| Maximum Power Density,
(W/CM²), (using smallest
electrode conductive surface
area) | 5W / 12cm²=0.42 | 5W / 12cm²=0.42 | 5W / 12cm²=0.42 | Not Available | 2- 10 for
safety
evaluation |
15
16
The following performance data were provided in support of the substantial equivalence determination.
Sterilization & Shelf-life Testing
Not Applicable- Device is non-sterile.
Biocompatibility Testing
Biocompatibility assessment of conductive rubber electrodes in the subject device was performance with iso 10993-1, "biological evaluation of medical devices - part 1: evaluation and testing within a risk management process" as recognized by FDA. The following endpoints were evaluated for conductive rubber electrodes.
- · Cytotoxicity ISO 10993-5
- Skin Irritation ISO 10993-10
- · Sensitization ISO 10993-10
NOTE:
Nylatex® wraps have not been evaluated for biocompatibility. Precautionary statements and the measures necessary to mitigate the risks in the event of an adverse event associated with the use of the Nylatex® wraps are included within the device labeling.
Electrical safety and electromagnetic compatibility (EMC)
The following electrical safety and EMC testing reports were provided:
- Electrical Safety Testing IEC 60601-1 .
- EMC Testing IEC 60601-1-2 .
17
- Home Use Environment IEC 60601-1-11 ●
- Nerve and Muscle Stimulators IEC 60601-2-10
Software Verification and Validation Testing
Software verification and validation testing was provided in accordance with IEC 62304 and FDA guidance documents.
Benchtop Performance Testing
The following benchtop performance testing was provided:
- . Output waveforms
- Basic unit characteristics .
- Output specifications .
- . Uniform current distribution
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Human Clinical Performance Testing
Clinical testing was not required to demonstrate the safety and effectiveness of the device.
VII. CONCLUSIONS
Based on the comparison to the predicate device and on the outcome of non-clinical performance that the subject device is 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. Thus, the HiToP® models are substantially equivalent to the predicate device.