(271 days)
No
The description focuses on basic electrical stimulation parameters (waveform, frequency, intensity, modes) and safety features. There is no mention of adaptive algorithms, learning from user data, or any other characteristics typically associated with AI/ML in medical devices. The "software-driven" aspect refers to controlling the basic functions, not advanced AI/ML capabilities.
Yes.
The device is intended for the temporary relief of pain associated with sore and aching muscles, which classifies it as a therapeutic use.
No
Explanation: The device is described as an "Electronic Pulse Stimulator" intended for "temporary relief of pain associated with sore and aching muscles." Its function is to apply electrical current for pain relief, not to diagnose any condition.
No
The device description explicitly states it consists of a "controlling host device, output connecting cable and skin electrodes," which are hardware components. While it mentions being "software-driven," it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The MDTS100 Electronic Pulse Stimulator applies electrical current to the skin to relieve pain. It does not analyze any biological samples.
- Intended Use: The intended use is for temporary pain relief, not for diagnosing or monitoring a medical condition through the analysis of biological specimens.
The description clearly indicates that this is a device for external application of electrical stimulation for pain relief, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Electronic Pulse Stimulator MDTS100 is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household and work activities.
Product codes (comma separated list FDA assigned to the subject device)
NUH
Device Description
The MDTS100 Electronic Pulse Stimulator is an electrically powered device intended for over the counter use and used to apply an electrical current to electrodes on a user's skin to relieve pain. The proposed device is intended for at home use in delivering electric pulses to tired and sore muscles.
The proposed device consists of controlling host device, output connecting cable and skin electrodes. The proposed device has many safety measures such as output load detection, timing indication and so on. It is adopted battery as the power supply. The output waveform is adopted "square waveform" as the basic wave. It simulates the various output modes by various frequency combination. The waveform is mainly for single rectangular. The output waveform intensity is continuous adjustable. The working time is controlled automatic.
The MDTS100 is adopted the method that inputting the specific low frequency pulse current into the human body through the human skin to treat the pain.
The MDTS100 Electronic Pulse Stimulator has seven stimulation modes. These stimulation modes can be selected by pressing the MODE button on the front of the unit.
The MDTS100 comes with 2 independent output channels by pressing the CHA button.
Channel A&B are selected by default. Pressing the & buttons will decrease & increase the intensity of stimulation. LCD screen display the left remaining stimulation time in the lower left corner. The default time is 20 minutes.
The proposed device is not for life-supporting or life-sustaining, not for implant.
The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization.
The device is for over the counter use.
The device does not contain drug or biological products.
The device is software-driven and software validation is provided in software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, upper extremities (arm), and lower extremities (leg)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use / at home 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)
Non-clinical tests were performed on the subject matter device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medial device electrical safety, electromagnetic compatibility, and particular requirements for the safety of nerve and muscle stimulator:
EMC and electrical Safety
IEC 60601-1:2005 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2007 Medical electrical equipment-Part1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic compatibility-Requirements and tests.
IEC 60601-1-11: 2010 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: 2012Medical electrical equipment-Part 2-10: Particular requirements for the safety of nerve and muscle stimulator.
Biocompatibility
The electrode pads are the mainly body contacting parts. Electrode pads, as accessories of the subject matter device, are adopted the Self-adhesive Electrode manufactured by Wuxi Jiajian Medical Instrument Co., Ltd. and have been cleared by FDA in June 23, 2009 as K090198. The patient contacting electrodes comply with ISO 10993 and are considered Class A ≤24 hours contact.
Software
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.
Cleaning
The cleaning instructions as described in the Instruction Manual have been tested to be sufficient. The test result was presented in the system test report in Performance Testing.
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.
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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 21, 2016
Beijing Choice Electronic Technololgy Co., Ltd. Lei Chen Quality Director No.9 Shuangyuan Road, Badach Hi-tech Zone Shijingshan District Beijing, 100041 CN
Re: K160508
Trade/Device Name: Electronic Pulse Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: February 22, 2016 Received: February 24, 2016
Dear Lei Chen:
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. H |
|---|---|
| Heetderks -A |
| DN: | c=US, o=U.S. Government |
|---|---|
| ou= | People, |
| 0.9.2342.19200300.100.1.1=00 | |
| cn= | William J. Heetderks -A |
| Date: | 2016.11.21 21:22:10 -05" |
| 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
Section II Indications for Use Statement
Indications for Use
510(k) Number (if known): Device Name: Electronic Pulse Stimulator Model:
Indications for Use:
The Electronic Pulse Stimulator MDTS100 is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household and work activities.
| Prescription Use | |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | V |
|---|---|
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) Summary
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.
3.1 Submitter Information
Manufacturer Name:
Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. Room 4104,No.A12 Yuquan Road Haidian District 100143 Beijing, P.R.China
Contact Person:
Mr.Lei Chen Beijing Choice Electronic Technology Co., Ltd. North Building 3F, No. 9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing China 100041 Phone: +86-10-88798300 Ext 6020 Fax:215-4052545 Email: cc@choicemmed.com Date prepared: October 31, 2016
3.2 Proposed Device Information
Device Common Name: Transcutaneous Electrical Nerve Stimulator, OTC
Device Trade/Proprietary Name: Electronic Pulse Stimulator
Model: MDTS100
Classification Name: Transcutaneous Electrical Nerve Stimulator for pain relief
Regulation Number: 21 CFR 882.5890
Product Code: NUH
Class: II
Use: Over -The-Counter Use
4
Panel: Neurology
3.3 Predicate Device
510(k) Number: K122744
Common Name: Transcutaneous electrical nerve stimulator OTC
Device Trade/Proprietary Name: Prospera OTC TENSE Electronic Pulse Massager
Model: PL029
Classification Name: Transcutaneous Electrical Nerve Stimulator for pain relief
Product Code: NUH, NGX
Regulation Number: 21 CFR 882.5890
Device Class: II
Panel: Neurology
Use: Over-The-Counter Use
Manufacturer: Prospera Corporation
Intended Use:
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm), and lower extremities(leg) due to strain from exercise or normal household work activities.
3.4 Device Description
The MDTS100 Electronic Pulse Stimulator is an electrically powered device intended for over the counter use and used to apply an electrical current to electrodes on a user's skin to relieve pain. The proposed device is intended for at home use in delivering electric pulses to tired and sore muscles.
The proposed device consists of controlling host device, output connecting cable and skin electrodes. The proposed device has many safety measures such as output load detection, timing indication and so on. It is adopted battery as the power supply. The output waveform is adopted "square waveform" as the basic wave. It simulates the various output modes by various frequency combination. The waveform is mainly for single rectangular. The output waveform intensity is continuous adjustable. The working time is controlled automatic.
The MDTS100 is adopted the method that inputting the specific low frequency pulse
5
Premarket Notification 510(k) Submission-510(k) Summary
current into the human body through the human skin to treat the pain.
The MDTS100 Electronic Pulse Stimulator has seven stimulation modes. These stimulation modes can be selected by pressing the MODE button on the front of the unit.
The MDTS100 comes with 2 independent output channels by pressing the CHA button.
Channel A&B are selected by default. Pressing the & buttons will decrease & increase the intensity of stimulation. LCD screen display the left remaining stimulation time in the lower left corner. The default time is 20 minutes.
The proposed device is not for life-supporting or life-sustaining, not for implant.
The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization.
The device is for over the counter use.
The device does not contain drug or biological products.
The device is software-driven and software validation is provided in software.
3.5 Indication for Use
The Electronic Pulse Stimulator MDTS100 is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household and work activities.
6
3.6 Comparison list of technical characteristics
| Parameter | Proposed Device | Predicate Device |
|---|---|---|
| 510(k) number | (to be assigned) | K122744 |
| Device Name and Model | MDTS100 | PL029 |
| Manufacturer | Beijing Choice Electronic Technology Co., Ltd. | Prospera |
| Power Source | DC 3V, 2 AAA batteries | 3V Battery |
| -Method of Line Current Isolation | N/A for DC current | Battery Supply N/A |
| -patient Leakage Current | -- | -- |
| -Normal Condition( $\mu$ A) | ≤10 $\mu$ A | 2.0 $\mu$ A |
| -Single Fault Condition( $\mu$ A) | ≤50 $\mu$ A | 3.0 $\mu$ A |
| Average DC current through electrodes when device is on but no pulses are being applied( $\mu$ A) | ≤10 $\mu$ A | 0 $\mu$ A |
| Number of Output Modes | 7 | 8 |
| Number of Synchronous or Output Alternating? | Alternating | Alternating |
| Channels Method of Channel Isolation | No | By software |
| Regulated Current or Regulated Voltage? | Regulated Voltage | Voltage control |
| Software/Firmware/Microprocessor Control? | Yes | Yes |
Table 3-1 Basic Unit Characteristics Comparison Table between the Proposed Device (MDTS100) and Predicate Device
7
Premarket Notification 510(k) Submission—510(k) Summary
Maximum Output Current (specify units) (+/- 20
%)
| Automatic Overload Trip? | No | No | |
|---|---|---|---|
| Automatic No-Load Trip? | Yes | No | |
| Automatic Shut Off? | Yes | Yes | |
| User Override Control? | Yes | Yes | |
| Display: | On/OFF Status? | Yes | Yes |
| Low Battery? | Yes | No | |
| Voltage/Current Level? | Yes | No | |
| Timer Range (minutes) | 20 minutes | 5minutes, 10 minutes | |
| Compliance with Voluntary Standards? | Yes | Yes | |
| Compliance with 21 CFR 898? | Yes | Yes | |
| Weight (lbs., oz.) | 0 lb., 2.2 oz. ( Battery Excluded ) | 0 lb, 8.21oz. | |
| Dimensions (in.) [W x H x D] | 2.17x 5.12x0.87 | 2.24x7.87x0.83 | |
| Housing Materials and Construction | Enclosure: ABS | Enclosure: ABS | |
| Table 3-2 Output Specification Comparison Table between the Proposed Device (MDTS100) and Predicate Device | |||
| Parameter | Proposed Device | Predicate Device | |
| Device Name and Model | MDTS100 | PL029 | |
| Waveform | pulsed monophasic | Monophasic | |
| Shape | Rectangular | Rectangular | |
| Maximum Output Voltage (volts) (+/- 20 %) | 150V@500 Ω | ||
| 160V @2kΩ | |||
| 165V@10kΩ | 49.6V@500 Ω | ||
| 99.2V@2kΩ | |||
| 114V @10k Ω | |||
| 16.5mA @10k Ω | 0.6mA @10k Ω | ||
| Duration of primary (depolarizing) phase (µsec) | 0µsec | 40msec | |
| Pulse Duration (µsec) | 50~140µsec | 120~6800µsec | |
| Frequency (Hz) [or Rate (pps)] | 0.9Hz~82Hz | 0.5~86Hz | |
| Net Charge (microcoulombs (µC) per pulse) @500Ω | 42µC | 18000µC | |
| Maximum Phase Charge, (µC) @500Ω | 42µC | 23µC | |
| Maximum Current Density, (mA/cm2, r.m.s.) | 3.3mA/cm2@1.57"×1.57"Electrode | ||
| Pad | 1.4mA/cm2 | ||
| Maximum Average Current (average absolute value), mA | 2.8mA | --- | |
| Maximum Average Power Density, (W/cm2), | |||
| (using smallest electrode conductive surface rate) | 0.02W/cm2@1.57"×1.57"Electrode | ||
| Pad | 0.23 W/cm2 | ||
| Burst Mode | (a) Pulses per burst | 197 | 1 |
| (b) Burst per second | 0.185 | 0-7 | |
| (c) Burst duration (seconds) | 2.4s | 1 | |
| (d) Duty Cycle: Line(b) x Line(c) | 0.44 | 7 | |
| ON TIME (seconds) |