(217 days)
EasyStim TN28 OTC is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
EasyStim TN28 OTC is a portable, battery powered T.E.N.S. device for pain relief intended for over-the-counter use.
There are totally eight (8) modes that are intended for application to the following areas: Shoulder/ Arm, Lower Back and Leg/Foot.
The accessories include electrode cable and electrodes pads which are placed on the specific body part. Generally, the electrodes are connected to the device through electrode cable. The device produces either a fixed or modulated electrical signal through electrodes normally placed on a patient's skin over the area of pain.
Since the device is battery powered, there is no connection to AC mains supply.
The provided document is a 510(k) Summary for the EasyStim TN28 OTC device, a Transcutaneous Electrical Nerve Stimulator (T.E.N.S.). It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of diagnostic or treatment performance.
Here's an analysis based on the information provided, addressing the questions as best as possible within the scope of the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for diagnosis or treatment effectiveness, as would be common for AI/ML-based medical devices or novel therapies. Instead, the substantial equivalence hinges on meeting electrical safety, electromagnetic compatibility, usability, risk management standards, and having similar technical characteristics and indications for use as predicate devices.
The "device performance" reported is primarily a comparison of its technical specifications to those of legally marketed predicate devices.
| Attribute | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (EasyStim TN28 OTC) |
|---|---|---|
| Indications for Use | Same as predicate devices | Relief of pain associated with sore or aching muscles of lower back, arms, or legs due to strain from exercise or normal household and work activities. |
| Product Code | NUH (or similar, like GZJ) | NUH |
| Regulation No. | 21 CFR 882.5890 | 21 CFR 882.5890 |
| Prescriptive or OTC | OTC | OTC |
| Environment of use | Clinics, hospital and home environments | Clinics, hospital and home environments |
| Maximum Phase charge (500 ohm) | < 25µC (based on predicate comparison) | 20.02μC |
| Maximum Average Power Density (500 ohm) | < 0.25W/cm² (based on predicate comparison) | 0.00752W/cm² |
| Frequency (Hz) | Within range of predicate devices (e.g., 1-150Hz) | From 1Hz to 150Hz |
| Compliance Standards | AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-1-6, IEC 62304, ISO 14971, IEC 60601-2-10 | 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 60601-1:2005, Mod). (General I (QS/RM)); IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Safety-Collateral Standard: Electromagnetic Compatibility- Requirements and Tests(Ed.3) (General); IEC 60601-1-11 (Edition1.0 2010-04), 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 [Including: Technical Corrigendum 1(2011)]. (General I (QS/RM)); IEC 60601-1-6 Medical Electrical Equipment-Part 1-6: General Requirements for Basic Safety and Essential Performance- Collateral Standard: Usability: 2010; IEC 62304 ED.1.0, Medical devices software life cycle processes (Software/ Informatics); ISO 14971: Medical devices-Application of risk management to medical devices. (General); IEC 60601-2-10 Edition 2.0 2012-06, Medical Electrical Equipment -- Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators. (Neurology) |
| Usability | Users able to use the device correctly and safely | Usability study conducted and showed users were able to use the device correctly and safely. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions a "usability study" but does not provide any details on the sample size for the test set, data provenance (country, retrospective/prospective), or methodology beyond stating that it "showed that users were able to use the device correctly and safety."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For a T.E.N.S. device, "ground truth" might relate to observed pain relief or proper device operation, but the document does not elaborate on how these were established or by whom. The "experts" for the usability study are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. The usability study details are minimal.
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
No MRMC study was performed or is mentioned. This device is a Transcutaneous Electrical Nerve Stimulator, not an AI-assisted diagnostic or interpretation system that would typically involve human "readers." The focus is on the device's electrical characteristics and safety, not on improving human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable in the context of this device. The EasyStim TN28 OTC is a physical medical device (T.E.N.S. unit) that operates to deliver electrical stimulation, not a standalone algorithm. Its performance is inherent in its electrical output and user interface, with human interaction being fundamental to its application.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not specify a type of "ground truth" in the context of clinical effectiveness or diagnostic accuracy. The usability study would likely rely on direct observation of user interaction and safety, which is a form of observational data. The "performance tests" relate to compliance with electrical and safety standards, not clinical outcomes.
8. The sample size for the training set
This information is not applicable / not provided. This device is not an AI/ML system that undergoes a "training set" for model development.
9. How the ground truth for the training set was established
This information is not applicable / not provided for the same reason as point 8.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a stylized emblem. The emblem features three human profiles facing right, layered to create a sense of depth and unity. The profiles are rendered in a simple, elegant style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2014
Easymed Instruments Co., Ltd Mr. Jeffery Wu (Wu Tingjie) General Manager 5/F - 6/F, Block A, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Daliang, 528300 Shunde, Foshan, Guangdong, CHINA
Re: K140168
Trade/Device Name: EasyStim TN28 OTC Regulation Number: 21 CFR 882.5890 Regulation Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter Regulatory Class: Class II Product Code: NUH Dated: May 22, 2014 Received: June 02, 2014
Dear Mr. Tingjie Wu:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{1}------------------------------------------------
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aguel -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) K140168
Device Name EasyStim TN28 OTC
Indications for Use (Describe)
EasyStim TN28 OTC is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Date: 2014.08.28 17:19:10 -04'00'
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Easymed. The logo is in blue and has a registered trademark symbol. Below the logo is the text "Easy for the relief of your suffering".
510(k) Summary
Date of submission prepared: 5th December 2013
| Submitter: | EasyMed Instruments Co., Ltd. |
|---|---|
| Address: | 5/F – 6/F, Block A, Gupo Gongmao Building, Fengxin Road,Fengxiang Industrial District, Daliang, 528300 Shunde, Foshan,Guangdong, CHINA |
| Tel : | +86 757 2809 1300 |
| Fax : | +86 757 2772 7868 |
| E-Mail : | jeffery@easymed.com.cn |
- Official Contact: Jeffery Wu (Wu Tingjie)
Address of the manufacturing facility: The same as above
SUBMITTED DEVICE:
| Generic Name: | Transcutaneous Electrical Nerve Stimulator (T.E.N.S.) |
|---|---|
| Proprietary or Trade Name: | EasyStim TN28_OTC |
| Common/Usual Name: | Stimulator, nerve, transcutaneous, over-the-counter |
| Classification Name: | Stimulator, nerve, transcutaneous, over-the-counter21 CFR 882.5890 |
| Product Code: | NUH |
| Device Panel: | Neurology |
| Device Classification: | Class II |
PREDICATE DEVICES:
| Device Name: | Model PM3030 |
|---|---|
| Manufacturer: | Omron Healthcare, Inc. |
| 510(k) Number: | K110068 |
| Product Code: | NUH |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image features the word "Easymed" in a large, blue, sans-serif font. A thin black line is located directly underneath the word. Below the line, the phrase "Easy for the relief of your suffering" is written in a smaller, blue font.
Device Name: EasyMed TN-28C T.E.N.S. Unit EasyMed Instrument Co., Ltd Manufacturer: 510(k) Number: K040253 GZJ Product Code:
INDICATIONS FOR USE:
This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
DEVICE DESCRIPTION:
EasyStim TN28 OTC is a portable, battery powered T.E.N.S. device for pain relief intended for over-the-counter use.
There are totally eight (8) modes that are intended for application to the following areas: Shoulder/ Arm, Lower Back and Leg/Foot.
The accessories include electrode cable and electrodes pads which are placed on the specific body part. Generally, the electrodes are connected to the device through electrode cable. The device produces either a fixed or modulated electrical signal through electrodes normally placed on a patient's skin over the area of pain.
Since the device is battery powered, there is no connection to AC mains supply.
ENVIRONMENT OF USE: Clinics, hospital and home environments
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the brand name "Easymed" in a large, bold, blue font. A thin black line is placed directly underneath the brand name. Below the line, the text "Easy for the relief of your suffering" is written in a smaller, blue font.
SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Attribute | New Device | Predicate Device (1) | Predicate Device (2) |
|---|---|---|---|
| Product Name | EasyStim TN28_OTC | Model PM3030 | EasyMed TN-28CT.E.N.S. Unit |
| 510(K) number | (to be assigned) | K110068 | K040253 |
| Product Code | NUH | NUH | GZJ |
| Regulation No. | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 |
| Indications for Use | This device is intendedfor the relief of painassociated with sore oraching muscles of thelower back, arms, or legsdue to strain fromexercise or normalhousehold and workactivities. | This device isintended for the reliefof pain associatedwith sore or achingmuscles of the lowerback, arms, or legsdue to strain fromexercise or normalhousehold and workactivities. | This T.E.N.S. system isused to providesymptomatic pain relieffor chronic, acute or postoperative pain. |
| Patient Population | Adult | Adult | Not specified |
| Prescriptive or OTC | OTC | OTC | Prescription |
| Environment of use | Clinics, hospital andhome environments | Clinics, hospital andhome environments | Not specified |
| Number of outputmodes | 8 | 3 | 5 |
| Number of outputchannels | 2 | 1 | 2 |
| Waveform | Biphasic rectangularMonophasic rectangular | Biphasic rectangularMonophasicrectangular | Symmetrical Bi-phasicrectangularAsymmetrical Bi-phasicrectangularMonophasic rectangular |
| Maximum OutputVoltage(max)500 ohm2k ohm10k ohm | 68V102V110V | 35.6V46.4V50.4V | 74.4V109V116V |
| Maximum OutputCurrent(max)500 ohm2k ohm | 133mA51mA11mA | 69.8mA23.2mA | 145mA54.5mA11.6mA |
| 10k ohm | 5.04mA | ||
| Maximum Phase charge (500 ohm) | 20.02μC | 7.12μC | 21.62μC |
| Maximum Average Current (500 ohm) | 3.0375mA | 0.528mA | 3.243mA |
| Maximum Current Density (500 ohm) | 0.188mA/cm² | 0.0084mA/cm² | 0.20mA/cm² |
| Maximum Average Power Density (500 ohm) | 7.52mW/ cm² | 0.202mW/cm² | 8.764mW/cm² |
| Frequency (Hz) | From 1Hz to 150Hz | From 1Hz to 110 Hz | From 1Hz to 150Hz |
| Pulse Duration (μs) | 50-250μs, in steps of 50μs | 1-100μs | 50-250μs, in steps of 50μs |
| Burst Mode | Yes | None | Yes |
| Timer range(min) | 20min, 25min, 30min, 40min depending on preset program | 15 minutes for all programs | Continuous, 15min, 30min, 45min, 60min, 90min selectable |
| Indication display | |||
| -On/Off status | Yes | Yes | Yes |
| -Low battery | Yes | No | Yes |
| -Voltage/Current level | Yes | Yes | Yes |
| -Output mode | Yes | Yes | Yes |
| -Time to cut-off | Yes | No | Yes |
| Power Source | 2 Alkaline AA 1.5V (LR6) Batteries | 2 AAA Batteries | 2 Alkaline AA 1.5V (LR6) Batteries |
| Dimensions (mm) | 66×136×30.7 | 55 x95 x 19 | 66×136×30.7 |
| Weight | 146.5 grams | 60 grams | 146.5 grams |
| Housing material | ABS | ABS | ABS |
| Microprocessor control | Yes | Yes | Yes |
| Automatic Overload trip | Yes | Yes | Yes |
| Automatic no-load trip | Yes | Yes | Yes |
| Automatic shut-off | Yes | Yes | Yes |
| User override control | Yes | Power On/Off button | Yes |
| Electrode compliance with 21 CFR 898 | Yes | Yes | Yes |
| Electrode cable | Yes | Yes | Yes |
Add: 5/F-6/F, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Da Liang, 528300 ShunDe, GuangDong, China 86-757-28091300
б
{6}------------------------------------------------
EasyMed Instruments Co., Ltd
Easy for the relief of your suffering
Add: 5/F-6/F, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Da Liang, 528300 ShunDe, GuangDong, China Tel: 86-757-28091300 Fax: 86-757-27727868
7
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the word "Easymed" in blue font with a black line underneath. The word is written in a sans-serif font, and the "y" extends below the line. There is a registered trademark symbol in the upper right corner of the image.
Easy for the relief of vour sufferin
DIFFERENCES BETWEEN NEW DEVICE AND PREDICATE DEVICES
The technical characteristics of EasyStim TN28 OTC are similar to those of the predicate devices in design, energy source, intended use and function. Like the predicate device Model PM3030 (K110068) and EasyMed TN-28C T.E.N.S. Unit (K040253), the EasyStim TN28 OTC is a device used to apply an electrical current to electrodes on a patient's skin to relieve pain.
The stimulation parameters of new device EasyStim TN28_OTC are all in the same range of those of predicate device TN-28C(K040253) and similar to those of Model PM3030 (K110068). Furthermore, the designed circuitry of new device EasyStim TN28 OTC is very similar to the marketed device TN-28C (K040253), they are of similar circuit diagrams, similar working principle, and same plastic housing.
Some output characteristics of EasyStim TN28 OTC are different from those of Model PM3030 (K110068). However, the maximum phase charge (the charge delivered per pulse) of EasyStim TN28 OTC is 20.02µC, which is less than 25µC. On the other hand, the maximum average power density of EasyStim TN28 OTC is 0.00752W/cm², which is also less than 0.25W/cm². Furthermore, the frequency range of EasyStim TN28 OTC is from 1Hz to 150Hz, which is same as TN-28C(K040253) but different from Model PM3030 (K110068). But it needs 20 steps to reach up to the maximum output frequency (150Hz). Therefore, the differences between EasyStim TN28 OTC and Model PM3030 (K110068) are insignificant in terms of safety.
The EasyStim TN28 OTC is viewed as substantially equivalent to the predicate devices because: the electrical stimulation provided by the EasyStim TN28_OTC is substantially equivalent to that commonly employed by TENS devices that have been cleared for marketing without prescription labeling, i.e. for OTC use. The waveform combinations are restricted in amplitude and duration to values consistent with other cleared devices.
Technological characteristics, features, specifications, materials and intended uses of the EasyStim TN28 OTC are substantially equivalent to the predicate devices. The differences that exist between EasyStim TN28_OTC and predicate devices are insignificant in the terms of safety or effectiveness.
PERFORMANCE TESTS:
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 60601-1:2005, Mod). (General I (QS/RM))
IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Safety-Collateral Standard: Electromagnetic Compatibility- Requirements and Tests(Ed.3) (General)
Add: 5/F-6/F, Gupo Gongmao Building, Fengxin Road, Fengxiang Industrial District, Da Liang, 528300 ShunDe, GuangDong, China
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the word "Easymed" in a blue, sans-serif font. The word is underlined with a thin, black line. There is a small, circled "R" symbol in the upper right corner of the image, indicating that the word is a registered trademark. The background of the image is white.
Easy for the relief of vour sufferir
EasyMed Instruments Co., Ltd
IEC 60601-1-11 (Edition1.0 2010-04), 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 [Including: Technical Corrigendum 1(2011)]. (General I (QS/RM))
IEC 60601-1-6 Medical Electrical Equipment-Part 1-6: General Requirements for Basic Safety and Essential Performance- Collateral Standard: Usability: 2010
IEC 62304 ED.1.0, Medical devices software life cycle processes (Software/ Informatics)
ISO 14971: Medical devices-Application of risk management to medical devices. (General)
IEC 60601-2-10 Edition 2.0 2012-06, Medical Electrical Equipment -- Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators. (Neurology)
USABILITY STUDY:
A usability study was conducted and showed that users were able to use the device correctly and safety.
CONCLUSION:
The new device EasyStim TN28 OTC has the same indications for use and similar technological characteristics as the predicate devices Model PM3030 (K110068) and TN-28C (K040253). The stimulation parameters of new device EasyStim TN28 OTC are all in the same range of those of predicate devices. Thus, the new device EasyStim TN28 OTC is substantially equivalent to the predicate devices and any differences between the devices do not pose any new questions of safety and effectiveness.
9
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).