(110 days)
No
The description focuses on basic electrical stimulation parameters and hardware components, with no mention of adaptive algorithms, learning, or data processing beyond simple pulse generation and adjustment.
No
Explanation: The "Intended Use / Indications for Use" states the device is "To be used to stimulate healthy muscles in order to improve and facilitate muscle performance," which aligns with a general wellness device rather than treating or diagnosing a disease or condition. While the device delivers electric pulses, its stated purpose is muscle performance improvement, not therapeutic intervention for a medical condition.
No
The "Intended Use / Indications for Use" states that the device is "to be used to stimulate healthy muscles in order to improve and facilitate muscle performance." This describes a therapeutic or performance-enhancing function, not a diagnostic one. Diagnostic devices are used to identify or detect medical conditions.
No
The device description explicitly states that the device is composed of a "host" and "electrode patches" and is "powered by CR2023 battery," indicating physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To be used to stimulate healthy muscles in order to improve and facilitate muscle performance." This describes a physical therapy or fitness application, not a diagnostic test performed on biological samples.
- Device Description: The device delivers electric pulses to the user's skin through electrodes. This is consistent with a muscle stimulator, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device interacts directly with the user's body to stimulate muscles.
- Performance Studies: The performance studies focus on electrical safety, software verification, waveform testing, and electrode patch performance – all relevant to a muscle stimulator, not an IVD.
- Predicate Devices: The predicate devices listed (K142055 and K171803) are also described as electrical stimulators, further supporting that this device falls under that category, not IVD.
In summary, the function and purpose of this device are to stimulate muscles externally, which is not the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Product codes (comma separated list FDA assigned to the subject device)
NGX
Device Description
Muscle Trainer is a product that adopts modern electronic science and technology to delivers electric pulses generated to the user's skin through the electrodes.
Muscle Trainer is mainly composed of the host and electrode patches, as well as it is powered by CR2023 battery. Of which, the electrode patch is cleared in K171381.
Muscle Trainer includes KTR-230 series (KTR-230B, KTR-230W, KTR-230P), KTR-231, KTR-232, KTR-233 and KTR-234 model. All models have three operation modes and one channel, which can give certain electrical pulse through electrode patches on the skin. Their technical parameters are slightly different, but they share the basically same characteristics:
- Electric pulse combination, 0~12 levels can be adjusted and chosen according to personal preference.
- CR2032 Button batteries (DC3V) power supply, easy to use and safe.
The main differences among them are the followings but not affect its intended use:
- Appearance
- The number of control button: KTR-230 series, KTR-231 and KTR-232 have two buttons to control: KTR-233 and KTR-234 have three buttons to control.
- The number of electrode patch used: KTR-230 series, KTR-233 and KTR-234 are equipped with one electrode patch; KTR-231 is equipped with six electrode patches as well as KTR-232 is equipped with two electrode patches.
- Applied parts: KTR-230 series, KTR-233 and KTR-234 apply to abdomen, shoulder, arm, thigh and calf; KTR-231 applies to abdomen in the place where between ribs and hip bones; KTR-232 applies to waist, shoulder, arm, thigh and calf.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen, shoulder, arm, thigh and calf; KTR-231 applies to abdomen in the place where between ribs and hip bones; KTR-232 applies to waist, shoulder, arm, thigh and calf.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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.
-
Biocompatibility Testing
The component of the Muscle Trainer that directly contacting the user is electrode patches and support belt.
Component Name: Electrode patches
Material of Component: EVA foam, Carbon film, conductive hydrogel, PET
Body Contact Category: Surface-contacting skin
Contact Duration: Less than 24hours
The electrode patches are directly purchased from qualified supplier which has obtained FDA clearance with a 510(k) number of K171381 and been legally marketed to U.S. market. -
Electrical and EMC Safety
Electrical safety and EMC safety testing was performed to, and passed, the following standards:
- IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 Medical electrical equipment -Part 1-11: General requirements for basic safety and essential performance -Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-2-10 Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility -Requirements and tests
In addition to the compliance of voluntary standards:
- The software verification has been carries out according to the FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices.
- The waveform test report has also been conducted to verify the output specifications of the subject device according to the FDA Guidance for Powered Muscle Stimulator 510(k)s: Load conditions of 0.5kΩ, 2kΩ and 10kΩ were tested, graphic waveform, output level and maximum charge/current/power calculation is recorded in this report. The outputs of the device models all are biphasic pulsed symmetric waveform, and have the same output design, such as output voltage and current, frequency, pulse duration and so on.
- The verification report of dispersion and shelf life has been conducted to verify the current dispersion and shelf life of the electrode patch equipped according to the FDA Guidance Shelf Life of Medical Device and ASTM F 1980-07 standard:
- Under the specified conditions, test and record the current dispersion of electrode patch and check the impedance on several places of the active areas of the patch to ensure it is distributing current uniformly, as well as the shelf life and the service life of the electrode patch are judged by comparing the test results. All test results are passed.
- First the data and analysis from Electrode patch dispersion and shelf life testing of KTR-231 and KTR-230 proves that there is no significant difference between the impedances of each point of 6 electrode patches connected to 1 channel, which is the same as 2 electrode patches to 1 channel. That means the current dispersion of each point of 6 electrode patches distributes uniformly. Therefore, 6 patches only differ in area from 2 patches, which are equivalent to 1 large pad made of 6 single same patches together. Second the maximum current density of model KTR-231, decided by the quantity and area of electrode pads, voltage, is less than 0.6(W/cm2). Third KTR-231 complies with the requirements of IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-10. Therefore, the difference does not present different questions of safety.
- Moreover, it is not the specifications about effectiveness, the maximum output voltage and current of model KTR-231 is equivalent to predicate device, thus the difference does not present different questions of effectiveness.
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.
Not Found
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 contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 17, 2018
Shenzhen Kentro Medical Electronics Co., Ltd % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center, Guimiao Road Shenzhen, Cn 518000 Guangdong
Re: K181728
Trade/Device Name: Muscle Trainer Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: July 14, 2018 Received: July 17, 2018
Dear Rain Yip:
We have reviewed vour 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
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181728
Device Name Muscle Trainer
Indications for Use (Describe)
To be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Date: 2018-06-04
I. Submitter
SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD
No.3, Xihu Industry Zone, Xikeng Village, Henggang Town, Longgang District, Shenzhen City, Guangdong Province, China
Tel.: +86 755 3382 5998 Tax: +86 755 3382 5996
Zewu Zhang (Management representative) Tel: +86 134 1043 0929 Email: kentro@kentro.com.cn
II. Device
Type of 510(k): Traditional Common Name: Powered muscle stimulator Trade Name: Muscle Trainer Models: KTR-230 series, KTR-231, KTR-232, KTR-233, KTR-234 Classification Name: Stimulator, Muscle, Powered, For muscle conditioning Review Panel: Physical Medicine Regulatory Class: II Product Code: NGX Regulation Number: 21 CFR 890.5850
III. Predicate Device
| Applicant | Predicate Device | 510(k) Number | Approval Date | ||
|---|---|---|---|---|---|
| Well | |||||
| International Ltd. | Brain | (Primary): | |||
| GYMFORM®ABS & | |||||
| CORE/VDPGYCSET0042 | K142055 | May 11, 2015 | |||
| HIVOX | |||||
| INC. | BIOTEK | HIVOX OTC Electrical | |||
| Stimulator/SEM44 | K171803 | Nov.29, 2017 |
IV. Device Description
Muscle Trainer is a product that adopts modern electronic science and technology to delivers electric pulses generated to the user's skin through the electrodes.
Muscle Trainer is mainly composed of the host and electrode patches, as well as it is powered by CR2023 battery. Of which, the electrode patch is cleared in K171381.
4
Muscle Trainer includes KTR-230 series (KTR-230B, KTR-230W, KTR-230P), KTR-231, KTR-232, KTR-233 and KTR-234 model. All models have three operation modes and one channel, which can give certain electrical pulse through electrode patches on the skin. Their technical parameters are slightly different, but they share the basically same characteristics:
- Electric pulse combination, 0~12 levels can be adjusted and chosen according to personal preference.
- CR2032 Button batteries (DC3V) power supply, easy to use and safe.
The main differences among them are the followings but not affect its intended use:
- Appearance
- The number of control button: KTR-230 series, KTR-231 and KTR-232 have two buttons to control: KTR-233 and KTR-234 have three buttons to control.
- The number of electrode patch used: KTR-230 series, KTR-233 and KTR-234 are equipped with one electrode patch; KTR-231 is equipped with six electrode patches as well as KTR-232 is equipped with two electrode patches.
- Applied parts: KTR-230 series, KTR-233 and KTR-234 apply to abdomen, shoulder, arm, thigh and calf; KTR-231 applies to abdomen in the place where between ribs and hip bones; KTR-232 applies to waist, shoulder, arm, thigh and calf.
V. Indications for Use
To be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
VI. Comparison of Technological Characteristics With the Predicate Devices
The Muscle Trainer is substantially equivalent to the predicated device based on intended use, design, specifications and performance.
The Muscle Trainer does not raise different questions of safety and effectiveness as compared to the predicate devices.
Information for predicate device was obtained from publicly available sources, including the 510(k) Summary and device instruction manual. A technical comparison to the predicate is provided below:
5
| Comparison
Elements | Subject Device | Primary Predicate Device
K142055 | Predicate Device 1
K171803 | | |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------|
| 510(k) number | K181728 | K142055 | K171803 | / | |
| Trade name | Muscle
Trainer/KTR-230series,
KTR-231, KTR-232, KTR-233,
KTR-234 | GYMFORM®
VDPGYCSET0042 | HIVOX OTC Electrical
Stimulator/SEM44 | / | |
| Product code | NGX | NGX | NUH
NGX | / | |
| Indication
for
use/Intended use | To be used to stimulate healthy
muscles in order to improve and
facilitate muscle performance. | GYMFORM®ABS& CORE is
intended to stimulate healthy
muscles in order to improve or
facilitate muscle performance. The
ABS& CORE may be considered a
technique or method for muscle
training. 2-area belt is intended for
use on the muscles in abdomen or
lower back separately. Mini belt is
intended for use on the muscles in
arms, legs, thighs or buttocks areas
separately | "HIVOX OTC Electrical Stimulator,
SEM44 –
TENS: The device is designed to be
used for temporary relief of pain
associated with sore and aching
muscles in the shoulder, waist, back,
neck, upper extremities (arm), lower
extremities (leg), abdomen and
bottom due to strain from exercise o
normal household work activities.
EMS: The device is designed to be
used for stimulate healthy muscles in
order to improve and facilitate
muscle performance" | SE
NOTE 4 | |
| Location for use | OTC | OTC | OTC | SE | |
| BASIC UNIT SPECIFICATIOSN | | | | | |
| Power supply | 2032 Button battery (DC3V) | 2 ×1.5V AAA batteries | 4.5V (batteries, 3×1.5V AAA) | SE | |
| Comparison
Elements | Subject Device | Primary Predicate Device
K142055 | Predicate Device 1
K171803 | | |
| | | | | NOTE 1 | |
| Number of output
modes | | 3 | 6 | TENS: 15
EMS: 35 | SE
NOTE 1 |
| | Channel
Number | 1 | 2 | 2 | SE
NOTE 1 |
| Number
of output
channels | Synchro
nous or
Alternat
ing? | N/A | Alternating | Synchronous | SE |
| | Method
of
Channel
Isolation | N/A | Press MODE button for 3 seconds | By electrical circuit and software | SE |
| Regulated Current
or Voltage? | | Regulated Voltage | Regulated Voltage | Regulated Voltage | SE |
| Software/Firmware
/Microprocessor
Control? | | Yes | Yes | Yes | SE |
| Automatic overload
trip voltage level? | | No | No | Yes | SE |
| Automatic no-load
trip? | | Yes | Yes | Yes | SE |
| Automatic shut off | | Yes | Yes | Yes | SE |
| Comparison
Elements | Subject Device | Primary Predicate Device
K142055 | Predicate Device 1
K171803 | | |
| Patient override
control? | Yes | Yes | Yes | SE | |
| Indicator
Display | On/Off
Status? | Yes | Yes | Yes | SE |
| | Low
Battery? | Yes | Yes | Yes | SE |
| | Voltage/
Current
Level? | N/A | Yes | Yes | SE |
| Timer range | | Default 15-minute | Default 10-minute | 5-100 minutes | SE |
| Compliance
with
voluntary standards | | ■ IEC60601-1-2
■ IEC60601-1
■ IEC60601-1-11
■ IEC60601-2-10 | ■ IEC60601-1-2
■ IEC60601-1
■ IEC60601-2-10 | ■ IEC60601-1-2
■ IEC60601-1
■ IEC60601-2-10 | SE |
| Compliance
with
21CFR 898 | | Yes | Yes | Yes | SE |
| Dimensions
(LWH) | | (Host)
KTR-230 series: φ51×13.5mm
KTR-231: φ51×13.5mm
KTR-232: φ51×13.5mm
KRT-233: 53.4×47.5×11.8mm
KTR-234: 49×49×12.6mm | 100mm×68mm×24.5mm | 132mm×63mm×29.5mm (including
belt clip) | SE
NOTE 2 |
| Weight | | (Host)
KTR-230 series: 0.6oz
KTR-231: 0.6oz
KTR-232: 0.6oz
KTR-233: 0.6oz | 50g (Without batteries) | 89g (including belt clip, without
batteries)
123g (including belt clip and
batteries) | SE
NOTE 2 |
| Comparison
Elements | Subject Device | Primary Predicate Device
K142055 | Predicate Device 1
K171803 | | |
| | KTR-234: 0.56oz | | | | |
| Housing
material
and construction | ABS | ABS | ABS | SE | |
| OUTPUT SPECIFICATIOSNS | | | | | |
| Waveform | Mode 1: Pulsed symmetric, biphasic,
square wave
Mode 2: Pulsed symmetric, biphasic,
square wave
Mode 3: Pulsed symmetric, biphasic,
square wave | Symmetrical, rectangular | Biphasic, square | SE | |
| Maximum
output
voltage | Mode 1:
(±10%)Vp
36.5V @500Ω
58.5V @2kΩ
93 V @10kΩ
Mode 2:
(±10%)Vp
36.5V @500Ω
58.5V @2kΩ
93 V @10kΩ
Mode 3:
(±10%)Vp
36.5V @500Ω
58.5V @2kΩ
93 V @10kΩ | (±10%)Vp
66V @ 500 Ω
69V @ 2k Ω
70V @ 10k Ω | (±10%)Vp
50V @ 500 Ω
60V @ 2k Ω
125V @ 10k Ω | SE
NOTE 3 | |
| Maximum
output | Mode 1:
(±10%) Ip | (±10%)Ip
132mA @ 500 Ω | (±10%)Ip
100mA @ 500 Ω | SE
NOTE 3 | |
| Comparison
Elements | Subject Device | Primary Predicate Device
K142055 | Predicate Device 1
K171803 | | |
| current | 73mA @ 500 Ω
29.25mA @ 2k Ω
9.3mA @ 10k Ω
Mode 2:
(±10%) Ip
73mA @ 500 Ω
29.25mA @ 2k Ω
9.3mA @ 10k Ω
Mode 3:
(±10%) Ip
73mA @ 500 Ω
29.25mA @ 2k Ω
9.3mA @ 10k Ω | 34.5mA @ 2k Ω
7mA @ 10k Ω | 45mA @ 2k Ω
12.5mA @ 10k Ω | | |
| Net charge (per
pulse) | @500Ω
Mode 1: 0
Mode 2: 0
Mode 3: 0 | 19.2μC @ 500 Ω | 0.001μC @ 500 Ω | SE | |
| Maximum phase
charge @500Ω | Mode 1: 6.85μC@500 Ω
Mode 2: 10.11µC@500 Ω
Mode 3: 10.11µC@500 Ω | 16.4µC @ 500 Ω | 0.045μC @ 500 Ω | SE
NOTE 3 | |
| Maximum average
current @500Ω | Mode 1: 3.6mA@500 Ω
Mode 2: 1.1mA@500 Ω
Mode 3: 5.4mA@500 Ω | 2.304mA@500 Ω | 13.5mA @ 500 Ω | SE
NOTE 3 | |
| Maximum current
density @500Ω | Mode 1:
KTR-230series: 0.175mA/cm²@500 Ω
KTR-231: 0.050mA/cm²@500 Ω
KTR-232: 0.073mA/cm²@500 Ω | 0.082mA/ cm²@ 500 Ω | 0.667mA/ cm²@ 500 Ω | SE
NOTE 3 | |
| Comparison
Elements | Subject Device | Primary Predicate Device
K142055 | Predicate Device 1
K171803 | | |
| Maximum
power
density @500Ω | KTR-233: 0.169mA/cm²@500 Ω
KTR-234: 0.172mA/cm²@500 Ω
Mode 2:
KTR-230series: 0.053mA/cm²@500 Ω
KTR-231: 0.015mA/cm²@500 Ω
KTR-232: 0.022mA/cm²@500 Ω
KTR-233:0.052mA/cm²@500 Ω
KTR-234: 0.053mA/cm²@500 Ω
Mode 3:
KTR-230series: 0.263mA/cm²@500 Ω
KTR-231: 0.076mA/cm²@500 Ω
KTR-232: 0.109mA/cm²@500 Ω
KTR-233: 0.254mA/cm²@500 Ω
KTR-234: 0.258mA/cm²@500 Ω
Mode 1:
KTR-230series: 0.0003W/cm²@500 Ω
KTR-231: 0.00009W/cm²@500Ω
KTR-232: 0.0001W/cm²@500Ω
KTR-233: 0.0003W/cm²@500Ω
KTR-234: 0.0003W/cm²@500Ω
Mode 2:
KTR-230series:
0.00003W/cm²@500 Ω
KTR-231: 0.000008W/cm²@500Ω | 94.8μW/cm² @ 500 Ω | 0.0046μW/cm² @ 500 Ω (average) | SE
NOTE 3 | |
| Comparison
Elements | Subject Device | Primary Predicate Device
K142055 | Predicate Device 1
K171803 | | |
| | KTR-232: 0.00001W/cm2@500Ω
KTR-233: 0.00003W/cm2@500Ω
KTR-234: 0.00003W/cm2@500Ω | | | | |
| | Mode 3:
KTR-230series: 0.0007W/cm2@500Ω
KTR-231: 0.0002W/cm2@500Ω
KTR-232: 0.0003W/cm2@500Ω
KTR-233: 0.0007W/cm2@500Ω
KTR-234: 0.0007W/cm2@500Ω | | | | |
| Pulse frequency | Mode 1: 1-120Hz
Mode 2: 1-120Hz
Mode 3: 1-120Hz | 2Hz, 10Hz, 50Hz, 90Hz, 120Hz | 1-150Hz | SE
NOTE 3 | |
| | | | | | |
| Pulse duration | Mode 1: 50-200μs
Mode 2: 50-200μs
Mode 3: 50-200μs | 108μs/124μs | 50-450μs | SE
NOTE 3 | |
| | | | | | |
| | Pulses
per burst | Mode 1: N/A
Mode 2: N/A
Mode 3: N/A | 1397 | 3 | SE |1 | 2/60Hz | SE |
| | | | | | |
| | | | | | |
| Burst
Mode | Bursts
per
second | Mode 1: N/A
Mode 2: N/A
Mode 3: N/A | 0.125
| | | | | | |
| | | | | | |
| | Burst
duration
(seconds) | Mode 1: N/A
Mode 2: N/A
Mode 3: N/A | 1~8 | 36ms | SE |
| | | | | | |
| | | | | | |
| | Duty
Cycle | Mode 1: N/A
Mode 2: N/A | 0.02%~1.28% | 36ms/390ms | SE |
| | | | | | |
| Comparison
Elements | Subject Device | Primary Predicate Device
K142055 | Predicate Device 1
K171803 | | |
| [Line (b)
x Line (c)] | Mode 3: N/A | | | | |
| ON Time (seconds) | 1s | 0.5s | 2s | SE | |
| OFF Time
(seconds) | IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-11 Medical electrical equipment -Part 1-11: General requirements for basic safety and essential performance -Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
14
-
IEC 60601-2-10 Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
-
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility -Requirements and tests
In addition to the compliance of voluntary standards:
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The software verification has been carries out according to the FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices.
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The waveform test report has also been conducted to verify the output specifications of the subject device according to the FDA Guidance for Powered Muscle Stimulator 510(k)s: Load conditions of 0.5kΩ, 2kΩ and 10kΩ were tested, graphic waveform, output level and maximum charge/current/power calculation is recorded in this report. The outputs of the device models all are biphasic pulsed symmetric waveform, and have the same output design, such as output voltage and current, frequency, pulse duration and so on.
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The verification report of dispersion and shelf life has been conducted to verify the current dispersion and shelf life of the electrode patch equipped according to the FDA Guidance Shelf Life of Medical Device and ASTM F 1980-07 standard:
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- Under the specified conditions, test and record the current dispersion of electrode patch and check the impedance on several places of the active areas of the patch to ensure it is distributing current uniformly, as well as the shelf life and the service life of the electrode patch are judged by comparing the test results. All test results are passed.
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- First the data and analysis from Electrode patch dispersion and shelf life testing of KTR-231 and KTR-230 proves that there is no significant difference between the impedances of each point of 6 electrode patches connected to 1 channel, which is the same as 2 electrode patches to 1 channel. That means the current dispersion of each point of 6 electrode patches distributes uniformly. Therefore, 6 patches only differ in area from 2 patches, which are equivalent to 1 large pad made of 6 single same patches together. Second the maximum current density of model KTR-231, decided by the quantity and area of electrode pads, voltage, is less than 0.6(W/cm2). Third KTR-231 complies with the requirements of IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-10. Therefore, the difference does not present different questions of safety.
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- Moreover, it is not the specifications about effectiveness, the maximum output voltage and current of model KTR-231 is equivalent to predicate device, thus the difference does not present different questions of effectiveness.
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Summary
Based on the above performance as documented in this application. Muscle Trainer was found to have a safety and effectiveness profile that is similar to the predicate device.
VIII. Conclusions
The subject device Muscle Trainer is to be concluded substantial equivalent to its predicate devices.