(162 days)
The FT610-B is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities and lower extremities due to strain from exercise or normal household work activities. It is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication, it also provides a heat function intended to temporarily relieve minor aches and pains.
The subject device is a self-adhesive TENS device with 15 adjustable intensity levels for pain relief. Moreover, it also provides a heat function which can be used alone, or in conjunction with the TENS function simultaneously. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective method of pain relief. It can be used for self-treatment. Any symptoms that could be relieved using TENS must be checked by your general practitioner who will also give you instruction on how to carry out a TENS selftreatment regime.
TENS device works by passing electrical currents over the skin via a set of gel pads. As a transfer medium, the gel pads are subject to natural wear and tear, and must be replaced when they stop providing sufficient contact or the main unit no longer sticks to the skin completely. Failure to replace the gel pad may lead to skin irritation as a result of heightened current density in particular areas.
This device is only compatible with the 50 mm x 56 mm gel pads which are the OTC medical device cleared by FDA under K132588, and come with the device.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device. It does not contain information about acceptance criteria and studies in the context of AI/ML device performance or clinical trials with human readers. Instead, it describes a substantial equivalence determination for a physical medical device (HIVOX OTC Electrical Stimulator, FT610-B) based on non-clinical testing and comparison to predicate devices.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes, data provenance, or number/qualifications of experts for a test set.
- Adjudication methods for a test set.
- MRMC comparative effectiveness studies or human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set or how its ground truth was established.
The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."
Instead, I can provide information based on the non-clinical testing for the physical device:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical Testing):
The document states that "All the test results demonstrate the subject device, HIVOX OTC Electrical Stimulator (FT610-B), meets the requirements of its pre-defined acceptance criteria and intended use". Specific numerical acceptance criteria are not detailed in the provided text, but the device performance was measured against recognized consensus standards and guidance documents.
| Test Category | Applicable Standard(s) / Guidance | Reported Device Performance |
|---|---|---|
| Shelf life | ASTM F1980-16 | Met requirements of pre-defined acceptance criteria |
| Biocompatibility | ISO 10993-1 Edition 4.0, ISO 10993-5 Edition 3.0, ISO 10993-10 Edition 3.0 | Met requirements of pre-defined acceptance criteria |
| Software validation | IEC 62304 Edition 1.1 | Met requirements of pre-defined acceptance criteria |
| Electromagnetic compatibility & electrical safety | ANSI/AAMI ES60601-1:2015/(R)2012, IEC 60601-1-2 Edition 4.0, IEC 60601-1-11 Edition 2.0, IEC 60601-2-10 Edition 2.1 | Met requirements of pre-defined acceptance criteria |
| Function test | Guidance Document for Powered Muscle Stimulator 510(K)s. Document issued on: June 9, 1999 | Met requirements of pre-defined acceptance criteria |
| Usability test | IEC 60601-1-6 Edition 3.1, IEC 62366-1 Edition 1.0 | Met requirements of pre-defined acceptance criteria |
Regarding the other points, the document explicitly states or implies they are not applicable:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of non-clinical device testing for substantial equivalence.
- 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): Not applicable. "Ground truth" in the context of expert consensus for AI/ML performance is not relevant here. Non-clinical tests typically involve engineers and technicians evaluating against technical standards.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical testing.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a physical Transcutaneous Electrical Nerve Stimulator, not an AI/ML diagnostic or assistive tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, "ground truth" is typically defined by the specifications in the standards themselves (e.g., specific electrical output values, temperature limits, material properties).
- 8. The sample size for the training set: Not applicable. This device does not use a "training set" in the context of machine learning.
- 9. How the ground truth for the training set was established: Not applicable.
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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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 15, 2021
Hivox Biotek Inc. Ruby Lu Regulatory Affairs Specialist SF., No. 123, Xingde Road, Sanchong District New Taipei City, 241 Taiwan
Re: K211403
Trade/Device Name: HIVOX OTC Electrical Stimulator, FT610-B Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: July 16, 2021 Received: July 19, 2021
Dear Ruby Lu:
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
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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,
For Pamela Scott Assistant Director 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
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Indications for Use
510(k) Number (if known) K211403
Device Name HIVOX OTC Electrical Stimulator (FT610-B)
Indications for Use (Describe)
The FT610-B is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities and lower extremities due to strain from exercise or normal household work activities. It is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication, it also provides a heat function intended to temporarily relieve minor aches and pains.
| 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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510(k) SUMMARY
1. Type of Submission Traditional
| 2. Date of Summary | October 15, 2021 |
|---|---|
| 3. Submitter | HIVOX BIOTEK INC. |
| Address: | 5F., No. 123, Xingde Rd., Sanchong Dist.,New Taipei City 24158, Taiwan, R.O.C. |
| Phone: | +886-2-8511-2668 |
| Fax: | +886-2-8511-2669 |
| Contact: | Ruby Lu(Ruby.Lu@hivox-biotek.com) |
4. Identification of the Subject Device
| Proprietary Name: | HIVOX OTC Electrical Stimulator |
|---|---|
| Model: | FT610-B |
| Regulation Description: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NUH |
| Regulation Number: | 21 CFR 882.5890 |
| Device Class: | II |
5. Identification of the Predicate Device #1
| 510(k) Number: | K162517 |
|---|---|
| Manufacturer: | JKH Health Co., Ltd. |
| Proprietary Name: | Electronic Pulse Stimulator |
| Model: | PL-029K13 |
| Regulatory Description: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NUH, NGX, NYN, IRT |
| Regulatory Number: | 21 CFR 882.5890 |
| Device Class: | II |
6. Identification of the Reference Device
| 510(k) Number: | K183110 |
|---|---|
| Manufacturer: | LifeCare Ltd. |
| Proprietary Name: | LIVIA |
| Regulatory Description: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NUH |
| Regulatory Number: | 21 CFR 882.5890 |
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Device Class: II
7. Device Description
The subject device is a self-adhesive TENS device with 15 adjustable intensity levels for pain relief. Moreover, it also provides a heat function which can be used alone, or in conjunction with the TENS function simultaneously. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective method of pain relief. It can be used for self-treatment. Any symptoms that could be relieved using TENS must be checked by your general practitioner who will also give you instruction on how to carry out a TENS selftreatment regime.
TENS device works by passing electrical currents over the skin via a set of gel pads. As a transfer medium, the gel pads are subject to natural wear and tear, and must be replaced when they stop providing sufficient contact or the main unit no longer sticks to the skin completely. Failure to replace the gel pad may lead to skin irritation as a result of heightened current density in particular areas.
This device is only compatible with the 50 mm x 56 mm gel pads which are the OTC medical device cleared by FDA under K132588, and come with the device.
8. Intended Use / Indications for Use of the Device
The subject device is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities and lower extremities due to strain from exercise or normal household work activities. It is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-thecounter pain medication. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.
9. Non-clinical Testing
A series of safety and performance tests, as follows, were conducted on the subject device in accordance with FDA recognized consensus standards and/or guidance:
- Shelf life (ASTM F1980-16)
- Biocompatibility (ISO 10993-1 Edition 4.0, ISO 10993-5 Edition 3.0 and ISO 10993-10 Edition 3.0)
- Software validation (IEC 62304 Edition 1.1)
- Electromagnetic compatibility and electrical safety (ANSI/AAMI ES60601-1:2015/(R)2012, IEC 60601-1-2 Edition 4.0, IEC 60601-1-11 Edition 2.0 and IEC 60601-2-10 Edition 2.1)
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- Function test (Guidance Document for Powered Muscle Stimulator 510(K)s. Document issued on: June 9, 1999)
- Usability test (IEC 60601-1-6 Edition 3.1 and IEC 62366-1 Edition 1.0)
All the test results demonstrate the subject device, HIVOX OTC Electrical Stimulator (FT610-B), meets the requirements of its pre-defined acceptance criteria and intended use, and its substantially equivalent to the predicate device.
10. Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
11. Substantial Equivalence Comparison
The subject device, HIVOX OTC Electrical Stimulator (FT610-B), was compared to the predicate and reference devices in the tables below:
| Comparison item | Subject device | Primary Predicate | Reference Device | SubstantialEquivalenceDetermination | |
|---|---|---|---|---|---|
| 510(k) Number | To be assigned | K162517 | K183110 | ||
| Device Name | HIVOX OTCElectrical Stimulator | Electronic PulseStimulator | LIVIA | N/A | |
| Model | FT610-B | PL-029K13 | |||
| Manufacturer | HIVOX BIOTEKINC. | JKH Health Co., Ltd | LifeCare Ltd. | ||
| Intended use | The FT610-B isdesigned forsymptomatic relief andmanagement of chronicpain, and for temporaryrelief of pain associatedwith sore and achingmuscles in the shoulder,waist, back, neck, upperextremities and lowerextremities due to strainfrom exercise or normalhousehold work | TENS ModeTo be used fortemporary relief ofpain associated withsore and achingmuscles in theshoulder, waist, back,arm and leg due tostrain from exercise ornormal household andwork activities.It is also intended forsymptomatic relief andmanagement of | The Livia is designedfor symptomatic reliefand management ofchronic pain, and fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back,neck, upper extremities(arm) and lowerextremities (leg) due tostrain from exercise ornormal household workactivities. The Livia is | Subject device hasthe sametechnologicalfeatures as theprimary predicate(TENS + heating)excluding PMS.Subject devicecombines the heatoutput parameteron primarypredicate deviceand thestimulation output | |
| indicated for temporaryrelief of pain associatedwith dysmenorrhea(menstrual cramps)when used with over-the-counter painmedication. In addition,it also provides a heatfunction intended fortemporary relief ofminor aches and pains. | chronic, intractablepain and relief of painassociated witharthritis.PMS modeTo stimulate healthymuscles in order toimprove and facilitatemuscle performance.To be used for theimprovement ofmuscle tone andfirmness, and forstrengthening musclesin the arm, abdomen,legs, and buttocks. Notintended for use in anytherapy or for thetreatment of anymedical condition ordisease.It is also intended totemporarily increaselocal blood circulationin the healthy musclesof lower extremities.Heating ModeTemporary relief ofminor aches and pains. | also indicated fortemporary relief of painassociated withdysmenorrhea(menstrual cramps)when used with over-the-counter painmedication. | parameter onreference device,which contain theindication for useon dysmenorrhea. | ||
| FDA Product Code | NUH | NUH, NGX, NYN,IRT | NUH | Identical toreference device | |
| Prescription or OTC | OTC | OTC | OTC | Identical toprimary predicateand reference | |
| device | |||||
| Power Source(s) | Rechargeable battery | Rechargeable battery | Rechargeable battery | Identical toprimary predicatedevice andreference device | |
| Function and Design | Electrical stimulationand heat | Electrical stimulationand heat | Electrical stimulation | Identical toprimary predicatedevice | |
| Heating setting | Nonadjustable | Low and high | N/A | No different insafety oreffectiveness fromprimary predicatedevice | |
| Maximum TemperatureSetting (°C) | 43 | 43 | N/A | Identical toprimary predicatedevice | |
| Output Pattern of theHeating | Delivers electricalstimulation and heatsimultaneously | Delivers electricalstimulation and heatsimultaneously | N/A | Identical toprimary predicatedevice | |
| MaximumOutputVoltage(Vp-p) | @ 500 Ω | 72 ±10% | Mode 1: This modecycles the followingmodesMode 2: 31.2 ±20%Mode 3: 46.0 ±20%Mode 4: 42.0 ±20%Mode 5: 27.6 ±20%Mode 6: 27.6 ±20%Mode 7: 40.8 ±20%Mode 8: 23.2 ±20% | 65.6 ±10% | No different insafety oreffectiveness fromreference device |
| @ 2 kΩ | 112 ±10% | Mode 1: This modecycles the followingmodesMode 2: 68.0 ±20%Mode 3: 90.4 ±20%Mode 4: 68.8 ±20%Mode 5: 60.0 ±20% | 115 ±10% | ||
| Mode 6: 60.0 ±20% | |||||
| Mode 7: 84.0 ±20% | |||||
| Mode 8: 50.4 ±20% | |||||
| Mode 1: This modecycles the following | 121 ±10% | ||||
| 120 ±10% | modes | ||||
| Mode 2: 118 ±20% | |||||
| Mode 3: 124 ±20% | |||||
| @ 10 kΩ | Mode 4: 78.4 ±20% | ||||
| Mode 5: 115 ±20% | |||||
| Mode 6: 115 ±20% | |||||
| Mode 7: 124 ±20% | |||||
| Mode 8: 99.2 ±20% | |||||
| Mode 1: This modecycles the following | |||||
| 144 ±10% | modes | 130.4 ±10% | |||
| Mode 2: 62.4 ±20% | |||||
| @ 500 Ω | Mode 3: 92.0 ±20% | ||||
| Mode 4: 84.0 ±20% | |||||
| Mode 5: 55.2 ±20% | |||||
| Mode 6: 55.2 ±20% | |||||
| Mode 7: 81.6 ±20% | |||||
| Mode 8: 46.4 ±20% | |||||
| MaximumOutputCurrent(mAp-p) | Mode 1: This modecycles the following | ||||
| 56 ±10% | modes | 57.5 ±10% | |||
| @ 2 kΩ | Mode 2: 34.0 ±20% | ||||
| Mode 3: 45.2 ±20% | |||||
| Mode 4: 34.4 ±20% | |||||
| Mode 5: 30.0 ±20% | |||||
| Mode 6: 30.0 ±20% | |||||
| Mode 7: 42.0 ±20% | |||||
| Mode 8: 25.2 ±20% | |||||
| 12 ±10% | Mode 1: This modecycles the following | 12.1 ±10% | |||
| @ 10 kΩ | modes | ||||
| Mode 2: 11.8 ±20% | |||||
| Mode 3: 12.4 ±20%Mode 4: 7.84 ±20%Mode 5: 11.5 ±20%Mode 6: 11.5 ±20%Mode 7: 12.4 ±20%Mode 8: 9.92 ±20% | |||||
| Pulse Width (μs) | 100 | 5.6~806 | 100 | Identical to reference device | |
| Frequency (Hz) | 100 | Mode 1: This mode cycles the following modesMode 2: 73.5Mode 3: 13.7~59.5Mode 4: 1.24Mode 5: 104.1Mode 6: 104.1Mode 7: 20.8Mode 8: 178.5 | 100 | Identical to reference device | |
| Maximum Phase Charge (μC @ 500Ω) | 7.2 | Mode 1: This mode cycles the following modesMode 2: 11.5Mode 3: 16.9Mode 4: 15.5Mode 5: 10.2Mode 6: 10.2Mode 7: 15.0Mode 8: 8.54 | 6.56 | No different in safety or effectiveness from reference device | |
| Maximum Current Density (mA/cm² @ 500Ω) | 0.364 | Mode 1: This mode cycles the following modesMode 2: 2.23Mode 3: 3.29Mode 4: 3.00Mode 5: 1.97Mode 6: 1.97 | 0.492 |
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| Mode 7: 2.91 | |||
|---|---|---|---|
| Mode 8: 1.66 | |||
| Maximum PowerDensity (W/cm² @500Ω) | 0.00185 | Mode 1: This modecycles the followingmodes | 0.00228 |
| Mode 2: 0.94 | |||
| Mode 3: 0.38~1.65 | |||
| Mode 4: 0.03 | |||
| Mode 5: 1.04 | |||
| Mode 6: 1.04 | |||
| Mode 7: 0.46 | |||
| Mode 8: 1.26 |
12. Similarity and Difference
Based on the comparison information in our submission, both subject device and primary predicate device have the same indication for use on TENS mode and heat mode, which relieve the pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities, and lower extremities due to strain from exercise or normal household work activities, and temporarily relieve the minor aches and pain. Primary predicate device has more indication for use on PMS mode, but subject device does not have a PMS mode.
Besides, the subject device added an indication for use on temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication as all of the TENS stimulation output parameters were based on reference device.
There is no difference in safety or effectiveness of the heat output parameters between subject device and primary predicate device. There is no difference in safety or effectiveness of TENS output parameters between subject device and reference device.
13. Conclusion
After a series of non-clinical tests to ensure our design outputs met the specified design inputs and needs of the user, we believe that the subject device, HIVOX OTC Electrical Stimulator (FT610-B), is substantially equivalent to the predicate device in safety and effectiveness.
§ 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).