(275 days)
Not Found
No
The summary describes a standard TENS device with different waveforms and does not mention any AI or ML capabilities.
Yes
The device is described as a Transcutaneous Electrical Nerve Stimulation (TENS) device used for symptomatic relief and management of pain, which aligns with the definition of a therapeutic device.
No
The device is described as a Transcutaneous Electrical Nerve Stimulation (TENS) device used for symptomatic relief and management of pain, not for diagnosing conditions.
No
The device description explicitly states it is a "hand held low frequency neuromodulation Transcutaneous Electrical Nerve Stimulation (TENS) device" and mentions waveforms, electrical safety, and electromagnetic compatibility testing, all indicative of a hardware device.
Based on the provided information, the STIMPOD NMS460 Nerve Stimulator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a Transcutaneous Electrical Nerve Stimulation (TENS) device used for pain relief and management. This is a therapeutic application, not a diagnostic one performed on samples taken from the body.
- Device Description: The description reinforces its function as a nerve stimulator for pain management, focusing on the electrical waveforms delivered to the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The STIMPOD NMS460's function is to deliver electrical stimulation to the body for pain relief, which falls under the category of therapeutic devices.
N/A
Intended Use / Indications for Use
The STIMPOD NMS460 Nerve Stimulator is a Transcutaneous Electrical Nerve Stimulation (TENS) device used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment of post-surgical pain, post traumatic acute pain problems, as well as an adjunct for pain control due to rehabilitation.
Product codes
GZJ
Device Description
The STIMPOD NMS460 Nerve Stimulator is a hand held low frequency neuromodulation Transcutaneous Electrical Nerve Stimulation (TENS) device, used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical pain, post traumatic acute pain, as well as an adjunct for pain control due to rehabilitation exercises.
The STIMPOD NMS460 Nerve Stimulator offers two types of waveforms for the management of pain. The first is a Monophasic Square Wave, which is typical of normal TENS machines. The second waveform is a Hybrid RF waveform which consists of a Monophasic Square Wave with a superimposed Radio Frequency waveform. This waveform is proprietary and is unique to STIMPOD NMS460 Nerve Stimulator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 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).
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 18, 2017
Xavant Technology (PTY) Ltd Roche Janse van Rensberg Chairman Unit 102 The Tannery Industrial Park 309 Derdepoort Road Silverton, ZA 0184 Gauteng
Re: K161091
Trade/Device Name: STIMPOD NMS460 Nerve Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: December 2, 2016 Received: December 2, 2016
Dear Roche van Rensberg:
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,
| William J. | Digitally signed by William J. Heetderks -A |
|---|---|
| DN: c=US, o=U.S. Government, ou=HHS, | |
| ou=NIH, ou=People, | |
| 0.9.2342.19200300.100.1.1=0010149848, | |
| Heetderks -A | cn=William J. Heetderks -A |
| Date: 2017.01.18 16:51:40 -05'00' |
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) K161091
Device Name STIMPOD NMS460 Nerve Stimulator
Indications for Use (Describe)
The STIMPOD NMS460 Nerve Stimulator is a Transcutaneous Electrical Nerve Stimulation (TENS) device used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment of post-surgical pain, post traumatic acute pain problems, as well as an adjunct for pain control due to rehabilitation.
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) |
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3
This 501(k) summary is prepared in accordance with the requirements of 21 CFR 807.92 K161091
Date this Summary was Prepared [21CFR807.92(a)(1)]
Date Prepared: February 2016
Submitter's Information [21CFR807.92(a)(1)]
| Company Name: | XAVANT TECHNOLOGY (PTY) LTD |
|---|---|
| Street Address: | Unit 102 The Tannery Industrial Park |
| 309 Derdepoort Road | |
| Silverton | |
| City: | Pretoria |
| State/Province: | Gauteng |
| Country: | South Africa |
| Telephone: | +27(0) 12 743 5959 |
| Facsimile: | +27(0) 86 547 0026 |
| Contact Person: | R. Janse van Rensburg |
| Contact Title: | Chairman |
| Contact Email: | roche@xavant.com |
Trade Name, Common Name, Classification [21CFR807.92(a)(2)]
Trade Name: STIMPOD NMS460 Nerve Stimulator Common Name: TENS (Transcutaneous Electronic Nerve Stimulator) device Device Class: Class II Product Code: GZJ (Stimulator, nerve, transcutaneous)
Identification of Predicate Device(s) [21CFR807.92(a)(3)[
| PREDICATE DEVICES |
|---|
| The STIMPOD NMS460 Nerve Stimulator is similar to the following predicate device as |
| a TENS device under classification GZJ: |
| Acticare (K081835), Bioinduction Ltd |
| The STIMPOD NMS460 Nerve Stimulator mapping probe is similar to the following |
| predicate device |
| under classification BXN: |
| STIMPOD NMS400 (K093591), Xavant Technology |
4
Description of the Device [21CFR807.92(a)(4)]
The STIMPOD NMS460 Nerve Stimulator is a hand held low frequency neuromodulation Transcutaneous Electrical Nerve Stimulation (TENS) device, used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical pain, post traumatic acute pain, as well as an adjunct for pain control due to rehabilitation exercises.
The STIMPOD NMS460 Nerve Stimulator offers two types of waveforms for the management of pain. The first is a Monophasic Square Wave, which is typical of normal TENS machines. The second waveform is a Hybrid RF waveform which consists of a Monophasic Square Wave with a superimposed Radio Frequency waveform. This waveform is proprietary and is unique to STIMPOD NMS460 Nerve Stimulator.
| Parameters | STIMPOD NMS460 Nerve
Stimulator (Subject device) | Acticare (Predicate device)
K081835 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The STIMPOD NMS460
Nerve Stimulator is a low
frequency neuromodulation
Transcutaneous Electrical
Nerve Stimulation device,
used for symptomatic relief
and management of chronic
intractable pain and/or as an
adjunctive treatment in the
management of post-surgical
pain, post traumatic acute
pain, as well as and adjunct
for pain control due to
rehabilitation exercises | As a transcutaneous
electronic nerve
stimulation(tens) device for:
the symptomatic relief of
chronic intractable pain, and
as an adjunctive treatment in
the management of post-
surgical or post traumatic
pain.
As a neuromuscular
electrostimulation (nmes)
device for: the relaxation of
muscle spasm, prevention of
retardation of disuse atrophy,
increasing local blood
circulation, muscle re-
education, immediate post-
surgical stimulation of the
calf muscles to prevent
venous thrombosis and to
maintain or increase the
range of motion. |
| Number of Output Modes | 1 | 5 (Normal, Powerful, Long
Pulse, Burst Mode 1 and 2) |
| Number of Waveforms | 2 (Monophasic, Biphasic
with offset) | 3 (Monophasic, Biphasic,
Twin Peak) |
| Number of Output
Channels | 1 | 1 |
| Method of Channel
Isolation | N/A | N/A |
| Current/Voltage Source | Current source | Voltage source |
| Automatic Overload | Yes | N/A |
Indications for Use and Substantial Equivalence [21 CFR807.92(a)(5)]
5
| Detection | ||
|---|---|---|
| Automatic No-Load | ||
| Detection | Yes | Yes |
| Automatic Shut Off | Yes | |
| User Override Control | Yes | Yes |
| Housing Materials and | ||
| Construction | ABS Plastic | ABS Plastic |
| Current Range | 0-30mA | 20mA |
| Pulse width options | 0.1ms, 0.2ms | 0.005ms to 0.1ms |
| Maximum stimulation | ||
| voltage | 220V | 250V |
| Maximum output current | 43.7mA | 127mA |
| Net charge | $6.06\mu C$ | $14.88\mu C$ |
| Maximum Current Density | $93.28\mu A/mm^2$ @500Ohm | $232.62\mu A/mm^2$ @500Ohm |
| Maximum Average Power | ||
| Density | $71.5\mu W/mm^2$ @500Ohm | $378.575\mu W/mm^2$ @500Ohm |
| Waveform | Monophasic square | |
| wave/Hybrid RF wave | Biphasic, Monophasic, Twin | |
| Peak | ||
| Stimulation Frequency | 1Hz, 2Hz, 5Hz, 10Hz +5% | 1Hz to 500kHz |
| Load Impedance | 7kOhm | 12.5kOhm |
| Treatment Timer | ||
| Maximum | 99 minutes | 180 minutes |
| Device Classification | Class IIa, Type BF | Class IIa, Type BF |
| Power Supply | 4 x AAA alkaline batteries | 4 x AA alkaline batteries |
Technological Characteristics [21CFR807.92(a)(6)]
The STIMPPOD NMS460 Nerve Stimulator is very similar to the predicate device and has technology characteristics that are substantially equivalent to the predicate device.
The STIMPOD NMS460 and the Acticare predicate device transmit electrical pulses through the skin. The range of amplitudes, pulse widths, frequencies and polarities delivered by the STIMPOD NMS460 Nerve Stimulator is within the ranges delivered by the predicate device.
The STIMPOD NMS460 Nerve Stimulator and the predicate device can be used in clinical environments.
Summary of detailed comparison between the Stimpod NMS460 and Acticare devices for the listed worst-case scenarios:
| Device | Calculation/Result | Mode | Load/s |
|---|---|---|---|
| Maximum output Voltage | |||
| NMS460 | 228V | Monophasic Square Wave | 10 kOhm |
| Acticare | 62.4V | Monophasic Square Wave | 5 kOhm |
| Maximum output Current | |||
| NMS460 | 43.7mA (Peak) | Hybrid RF Mode | 500 Ohm |
| Acticare | 127mA (Peak) | Monophasic Square Wave | 500 Ohm |
| Maximum Average Current (Over primary phase) | |||
| NMS460 | 29.85mA | Monophasic Square Wave | 500 Ohm |
6
| Acticare | 74.44mA | Monophasic Square Wave | 500 Ohm |
|---|---|---|---|
| Duration of primary phase | |||
| NMS460 | 206us | Hybrid RF Mode | 10 kOhm |
| Acticare | 200.4us | Monophasic Square Wave | 5 kOhm |
| Pulse Duration | |||
| NMS460 | 206us | Hybrid RF Mode | 10 kOhm |
| Acticare | 200.4us | Monophasic Square Wave | 5 kOhm |
| Net Charge | |||
| NMS460 | 6.06 uC | Hybrid RF Mode | 500 Ohm |
| Acticare | 14.88 uC | Monophasic Square Wave | 500 Ohm |
| Maximum Average Phase Charge | |||
| NMS460 | 6.06 uC | Hybrid RF Mode | 500 Ohm |
| Acticare | 14.88 uC | Monophasic Square Wave | 500 Ohm |
| Maximum Current Density | |||
| NMS460 | $93.281 x 10^{-6} \frac{A}{mm^2}$ | Hybrid RF Mode | 500 Ohm |
| Acticare | $232.619 x 10^{-6} \frac{A}{mm^2}$ | Monophasic Square Wave | 500 Ohm |
| Maximum Average Power Density | |||
| NMS460 | $591.783 x 10^{-6} \frac{W}{mm^2}$ | Hybrid RF Mode | 5 kOhm |
| Acticare | $378.575 x 10^{-6} \frac{W}{mm^2}$ | Monophasic Square Wave | 500 Ohm |
As indicated above the Acticare can deliver up to three times as much peak current and more than twice the average phase current compared to the NMS460. For the selected pulse width of 200us, both units performed within 5% of the pulse width setting. With regards to the net charge and maximum average phase charge and maximum current density, the Acticare again has significantly higher values than the Stimpod NMS460 Nerve Stimulator.
Considering these factors, it is reasonable to conclude that the Stimpod NMS460 Nerve Stimulator is substantially equivalent regarding safety to the Acticare.
Comparison of RF component of Hybrid RF Waveform of Stimpod NMS460 Nerve Stimulator with Burst Modes in the RF range of the Acticare:
| RF Stimulating Options | ||
|---|---|---|
| Articare TSE (refer to Appendix B for detail) | Stimpod NMS460 Nerve Stimulator | |
| Waveform Options | Biphasic, Monophasic, Twin Peak | Biphasic, with a DC offset, decaying |
| Pulse Width Options | $10\u03bcs$ – 2s | $100\u03bcs$ , $200\u03bcs$ |
| Pulse Repetition Rate Options | 0.25Hz – 2kHz | 1,2,5,10 Hz |
| RF Frequency Options | 5kHz - 500kHz | 160kHz fixed |
As indicated above the RF parameters offered by the Stimpod NMS460 Nerve Stimulator are well within the range of RF parameters offered by the Articare TSE as far as frequency of stimulation, pulse widths, pulse repetition rates and current amplitude are concerned.
7
Based on the fact that the Stimpod NMS450 Nerve Stimulator is designed as a current source and delivers according to its specification for loads up to 5 kOhm, it is reasonable to conclude that the NMS460 is substantially equivalent to the Acticare regarding effectiveness.
Contra-indications
Known neurological disorders.
Biocompatibility
Materials used in the manufacture of the STIMPOD NMS460 Nerve Stimulator are safe and pose no threat or danger if they come into contact with human skin. Both the stainless steel (316L) used in the construction of the probe and the ABS plastic used in the manufacture of the enclosure have previously been used in the manufacture of medical and surgical instruments. The materials, referring to the stainless steel and ABS plastic, have also been previously used in FDA approved medical devices (K093591).
The material used and the physical properties of the materials that come into contact with the patient are equivalent with the comparative devices and pose no danger to the patient.
Software level of concern
Software level of concern: Moderate
Non-clinical Testing [21CFR807.92(b)(1)]
Electrical Safety
The STIMPOD NMS460 Nerve Stimulator was tested for patient safety in accordance with the following standards:
IEC 60601-1: 2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
Test results indicated that the STIMPOD NMS460 Nerve Stimulator complies with the applicable Standards.
Electromagnetic Compatibility
The STIMPOD NMS460 Nerve Stimulator was tested for EMC in accordance with the following standard:
IEC 60601-1-2: 2007, Medical Electrical Equipment, Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility-Requirements and Tests.
Test results indicated that the STIMPOD NMS460 Nerve Stimulator complies with the applicable Standard.
Safety of Nerve and Muscle Stimulators
The STIMPOD NMS460 Nerve Stimulator was tested for the requirements for safety of nerve and muscle stimulators:
IEC 60601-2-10: 2015. Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
Test results indicated that the STIMPOD NMS460 Nerve Stimulator complies with the applicable Standard.
8
Conclusion [21CFR807.92(b)(3)]
The STIMPOD NMS460 and the Acticare predicate device have the same intended use and similar technical characteristics, performances and applications. The information supplied in the full 510(k) application illustrates that the device does not pose any new question of safety or effectiveness. STIMPOD NMS460 is substantially equivalent to the predicate device.