(217 days)
The AD-2129A TENS device is intended for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The AD-2129A Transcutaneous Electrical Nerve Stimulator(TENS) is transcutaneous electrical nerve stimulator for relief of muscular pain and sold without prescription. The device consists of a microprocessor, buttons, electrical pads, and display. Keys can control the device to choose the operation modes, adjust pulse output strength, then the channel that effectively transfers your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle stimulation. The LCD display can show user the mode and strength chosen and other information like date and time Self-adhesive electrodes are used in this devices, and they are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. The electrodes is for OTC use, and mainly consists of substrate and wire.
The provided document is a 510(k) Premarket Notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device, AD-2129A. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria and proving performance against them through a clinical study.
Therefore, the document does not report on acceptance criteria or a study designed to prove the device meets these criteria in the way one would for a novel AI/ML medical device or a device requiring clinical performance validation against specific metrics.
Instead, the document details:
- Regulatory Substantial Equivalence: The primary goal is to show that the AD-2129A TENS device is substantially equivalent to legally marketed predicate TENS devices (Smart Relief K131159 and EasyStim TN28_OTC K140168).
- Safety and Performance to Standards: The "Performance Summary" and "Non-clinical Testing Summary" sections confirm that the device conforms to relevant electrical safety, electromagnetic compatibility (EMC), and biocompatibility standards (e.g., IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, ISO 10993). These are general safety and performance standards for the device type, not specific outcome-based acceptance criteria for a novel technology.
- Comparison Table: A detailed comparison table highlights similarities and differences between the subject device and the predicates regarding product name, regulatory information, intended use, physical characteristics, and electrical parameters.
To directly answer your request based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The document does not present acceptance criteria in a quantitative, outcome-based manner for clinical efficacy or diagnostic accuracy, as would be expected for an AI/ML device. Instead, "acceptance criteria" are implied by adherence to recognized electrical, EMC, and biological safety standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1 (Electrical Safety) | "the device meet all the applicable requirements." |
| Compliance with IEC 60601-2-10 (Nerve & Muscle Stimulators Safety) | "particular safety test has been performed... and the device meet all the applicable requirements." |
| Compliance with IEC 60601-1-2 (Electromagnetic Compatibility) | "the test result show that, the device meet all the applicable requirements." |
| Compliance with ISO 10993-5 (In vitro cytotoxicity - Biocompatibility) | "the result shows it meet the applicable requirements." |
| Compliance with ISO 10993-10 (Irritation & skin sensitization - Biocompatibility) | "the result shows it meet the applicable requirements." |
| Substantial Equivalence to Predicate Devices | "The new device AD-2129A TENS has the same intended use, design, technological characteristics as the predicate device K131159 and K140168." |
2. Sample size used for the test set and the data provenance:
- The document describes non-clinical bench testing (electrical safety, EMC, biocompatibility) rather than a clinical "test set" of patient data. Therefore, concepts like sample size for a test set and data provenance (country, retrospective/prospective) are not applicable in this context. The "sample" tested would be the physical device units and their components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically understood for medical imaging or diagnostic AI (e.g., expert consensus on clinical findings) is not established here. The "ground truth" for the non-clinical tests is adherence to engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no expert adjudication process described, as clinical interpretation is not being evaluated.
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. This is a TENS device, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant to this submission type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance evaluation against standards is defined by the technical specifications and limits set by the referenced IEC and ISO standards for electrical safety, EMC, and biocompatibility.
8. The sample size for the training set:
- Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the left side of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 14, 2015
Andon Health Co., Ltd. Liu Yi President No. 3, Jin Ping Street, Ya An Road, Nankai District Tianjin, CN 300190
Re: K150043
Trade/Device Name: AD-2129A Transcutaneous Electrical Nerve Stimulators (TENS) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH, NYN Dated: July 14, 2015 Received: July 16, 2015
Dear Liu Yi:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (OS) 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" (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 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,
Michael J. Hoffmann -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) K150043
Device Name
AD-2129A Transcutaneous Electrical Nerve Stimulators (TENS)
Indications for Use (Describe)
The AD-2129A TENS device is intended for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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}------------------------------------------------
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.
1.0 submitter's information
| Name: | Andon Health Co., Ltd. |
|---|---|
| Address: | No 3, Jinping Street Ya An Road, Nankai District, Tianjin,P.R. China |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 1/7/2015 |
2.0 Device name
Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter Device name: Transcutaneous Electrical Nerve Stimulators (TENS) Model: AD-2129A
3.0 Classification
Production code: NUH, NYN Regulation number: 21 CFR 882.5890 Classification: II Panel: Neurology
4.0 Predicate device information
| Information | Predicate 1 | Predicate 2 |
|---|---|---|
| 510(k) number: | K131159 | K140168 |
| Manufacturer | Chattem, Inc. | EasyMed Instruments |
{4}------------------------------------------------
| Co., Ltd. | ||
|---|---|---|
| Trade/Proprietary Name | Smart Relief | EasyStim TN28_OTC |
| Classification Name | Transcutaneous NerveStimulator. | Transcutaneous NerveStimulator. |
| Regulation number | 882.5890 | 21 CFR 882.5890 |
| Classification | Class II | Class II |
| Product Code | NUH, NYN | NUH |
5.0 Intended use
The AD-2129A TENS device is intended for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities, It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
6.0 Device description
The AD-2129A Transcutaneous Electrical Nerve Stimulator(TENS) is transcutaneous electrical nerve stimulator for relief of muscular pain and sold without prescription.
The device consists of a microprocessor, buttons, electrical pads, and display. Keys can control the device to choose the operation modes, adjust pulse output strength, then the channel that effectively transfers your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle stimulation. The LCD display can show user the mode and strength chosen and other information like date and time
Self-adhesive electrodes are used in this devices, and they are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. The electrodes is for OTC use, and mainly consists of substrate and wire.
7.0 Performance summary
TENS conforms to the following standards:
{5}------------------------------------------------
- · IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 2005.
- · IEC 60601-2-10, Medical electrical equipment Part 2: 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 Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, 2007.
- · ISO 10993: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
- · ISO 10993: Biological evaluation of medical devices Part 5: Test for in vitro cytotoxicity.
- · ISO 10993: Biological evaluation of medical devices Part 10: Test for irritation and skin sensitization.
8.0 Non-clinical Testing Summary
The following testing was performed on the TENS devices in accordance with the requirements of the design control regulations and established quality assurance procedures.
(1) Biocompatibility of materials
When use the TENS device, one side of the electrode will contact the user, and the materials used on this side is tested according to ISO 10993-5 and ISO 10993-10, and the result shows it meet the applicable requirements.
(2) Electromagnetic Compatibility
Electromagnetic Compatibility test has been performed on the TENS devices according to the identical standard of IEC 60601-1-2, and the test result show that, the device meet all the applicable requirements.
(3) Electrical Safety Testing
Electrical Safety Test has been performed according to IEC 60601-1, and the test result shows that, the device meet all the applicable requirements. Also,
{6}------------------------------------------------
particular safety test has been performed according to IEC 60601-2-10.
9.0 Comparison to the predicate device and the conclusion
The applicant device TENS is substantially equivalent to Smart Relief (K131159) and EasyStim TN28_OTC(K140168).
| Similarities and differences comparison | |||
|---|---|---|---|
| Characteristics | Subject device | Predicate device(1) | Predicate device(2) |
| Product name | AD-2129A TENS device | Smart Relief | EasyStim TN28_OTC |
| 510(K)number | To be assigned | K131159 | K140168 |
| Product code | NUH, NYN | NUH, NYN | NUH |
| Regulation No. | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 |
| Intended use | The device is intendedfor temporary relief of painassociated with sore andaching muscles due tostrain from exercise ornormal household andwork activities, It is alsointended for symptomaticrelief and management ofchronic, intractable painand relief of painassociated with arthritis. | To be used for temporaryrelief of pain associated withsore and aching musclesdue to strain from exerciseor normal household andwork activities.To be used for symptomaticrelief and management ofchronic, intractable pain andrelief of pain associated witharthritis. | This device is intended forthe relief of pain associatedwith sore or aching musclesof the lower back, arms, orlegs due to strain fromexercise or normalhousehold and workactivities. |
| Presentation orOTC | OTC | OTC | OTC |
| Environment ofuse | Home use | Not specified | Clinics, hospital and homeenvironments |
| Number ofOutputs mode | 8 | 1 | 8 |
| Number ofOutputs | 2 | 1 | 2 |
| Waveform | Monophasic rectangular | Asymmetrical Biphasicrectangular | Biphasic rectangularMonophasic rectangular |
| Maximumoutputvoltage(max)500 Ω, 2 kΩ,and 10 kΩ | 500 Ω: 48V2 kΩ: 91.2V10 kΩ: 46V | Not specified | 500 Ω: 68V2 kΩ: 102V10 kΩ: 110V |
| Maximum | 500 Ω: 96mA | 500 Ω: 133mA | |
| OutputCurrent 500 Ω,2 kΩ, and 10kΩ | 2KΩ: 4.33mA10 kΩ:0.44 mA | Not specified | 2KΩ: 51mA10 kΩ:11 mA |
| MaximumPhase Charge,(μC) @ 500 Ω | 11.92uC | Not specified | 20.02uC |
| MaximumAverageCurrent(500ohm) | 8.64mA | Not specified | 3.0375mA |
| MaximumCurrent Density,(mA/cm² @ 500 Ω) | 0.38mA/cm² | Not specified | 0.188mA/cm² |
| MaximumAverage PowerDensity, (W/cm²@ 500 Ω | 1.62mW/cm² | Not specified | 7.52mW/cm² |
| Frequency(Hz) | 2-125HZ | 1-100 Hz | 1-150Hz |
| PulseDuration(us) | 60-125 | Not specified | 10-250us, in steps of 50us |
| Burst Mode | None | None | Yes |
| Timerrange(min) | 15 minutes for allprograms | Not specified | 20min, 25min, 30min, 40mindepending on presetprogram |
| Indicationdisplay: | -On/Off status-Output strength-Output mode-Time to cut-off | Not specified | -On/Off status-Low battery-Voltage/Current level-Output mode-Time to cut-off |
| Power Source | 4×1.5 size AAA | 3 V lithium battery | 2 Alkaline AA 1.5V (LR6)Batteries |
| Dimension | 140mm×63mm×30mm | 64mmX38mmX13mm | 66mm×136mm×30.7mm |
| Weight | 88g (exclude battery) | 20g | 146.5 grams |
| HousingMaterials | ABS | ABS | ABS |
| Microprocessorcontrol | Yes | Yes | Yes |
| AutomaticOverload trip | No | Not specified | Yes |
| Automaticno-load trip | Yes | Not specified | Yes |
| Automaticshut-off | Yes | Not specified | Yes |
| User overridecontrol | No | Not specified | Yes |
| Electrodecompliancewith 21 CFR898 | Yes | Yes | Yes |
| Electrode cable | Yes | No | Yes |
{7}------------------------------------------------
{8}------------------------------------------------
The new device AD-2129A TENS has the same intended use, design, technological characteristics as the predicate device K131159 and K140168. Only pulse frequency, pulse strength and the appearance are different, but the Electrical Safety test and the EMC test in this submission provides demonstrated that these small differences do not raise any new questions of safety and effectiveness to the new devices.
§ 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).