(372 days)
No
The device description details a simple TENS/EMS device with pre-programmed modes, manual intensity adjustment, and fixed time settings. There is no mention of adaptive algorithms, learning capabilities, or any technology that would typically be associated with AI or ML. The performance studies focus on electrical safety, biocompatibility, and software validation against specifications, not on the performance of an AI/ML model.
Yes
The intended uses, such as "temporary relief of pain associated with sore and aching muscles" and "symptomatic relief and management of chronic, intractable pain associated with Arthritis," indicate a therapeutic purpose. Additionally, the device uses TENS and EMS technology, which are established therapeutic modalities.
No
The device is indicated for temporary pain relief and muscle stimulation, not for diagnosing medical conditions.
No
The device description clearly outlines hardware components including a main unit, electrode cables, electrode pads, batteries, knobs, buttons, and indicator lights. While software is mentioned as being tested, it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the temporary relief of pain associated with sore and aching muscles and for the symptomatic relief and management of chronic pain. It also mentions stimulating healthy muscles. These are all therapeutic applications, not diagnostic ones.
- Device Description: The device is described as a TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation) device. These types of devices deliver electrical impulses to the body for therapeutic purposes, not to analyze samples from the body.
- No mention of biological samples: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. There is no mention of the device interacting with or analyzing any biological samples.
Therefore, the Pain Therapy System, Model PTS-II, as described, is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities (Choose Mode A, B, or C)
To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (Arms) due to strain from exercise or normal household work activities (Choose Mode A, B or C)
To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (Legs) due to strain from exercise or normal household work activities (Choose Mode A., B or C)
To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with Arthritis (Choose Mode A)
To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode B)
Product codes
NUH, NYN, NGX, GZJ
Device Description
The Pain Therapy System, Model PTS-II is a selectable dual channel TENS and EMS device operated by DC 3.0V (AAA*2 batteries). It is made up of one main unit, two electrode cables, and two pairs of electrode pads.
There are 3 selectable, pre-programmed output waveforms (modes) to choose from. The two channels share one knob to adjust, the intensity are adjustable from 0 to 5. Running time can be selected among 10, 20 or 40min and recycled. There is a dial with on/off on the side that enables the device to be turned on or off, and it can be used to adjust the output intensity level, turn clockwise to increase intensity and turn anticlockwise to decrease the intensity. In the front of the device, there are 2 buttons and 6 indicator lights, in which one button is the mode selection button, and the other is for time selection. There are three modes A. B. C. respectively indicated by three indicator lights, which are on the right of the mode selection button. The device has 3 timing levels, namely 10, 20, 40 min, and indicated by three indicator lights, which are on the right of the timing selection button.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower back, upper extremities (Arms), lower extremities (Legs)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinics, Hospitals and home environments
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 testing was performed in order to validate the design according to the company's specified design requirements, and to assure conformance with the following voluntary design standards:
a. EMC and electrical safety
ANSI/AAMI ES60601-1:2005+Corr.1(2006)+Corr.2(2007) general requirements for basic safety and essential performance
IEC 60601-2-10 Edition 2.0 2012-06 basic safety and essential performance of nerve and muscle stimulators. (Neurology)
IEC 60601-1-2 Edition 3:2007-03 medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic disturbances - requirements and tests. (General II (ES/EMC))
b. Biocompatibility
The electrode pads are the only body contacting parts. They have been FDA cleared under K132588.
c. Software
Based upon the test results it was concluded that the software performs within specifications and is safe to the stated intended use. Since a permanent hazard analysis is implemented in the software development process, and due to the clear software architecture, it is believed that the test protocol sufficiently verifies the software's main functional operation.
d. Cleaning
The cleaning instructions as described the Instruction Manual have been tested to be sufficient. Testing involved validation of the manual cleaning method as per the instructions. All testing concluded that the Pain Therapy System can be cleaned by the use of the methods described in the Instruction Manual.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
Counter Scientific Development (gz) Ltd % Guenter Ginsberg President Media Trade Corporation 11820 Red Hibiscus Drive Bonita Springs, Florida 34135
Re: K150277
Trade/Device Name: Pain Therapy System, Model PTS-II Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH, NYN, NGX, GZJ Dated: January 8. 2016 Received: January 11, 2016
Dear Guenter Ginsberg:
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
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (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 -A
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) K150277
Device Name
Pain Therapy System, Model PTS-II
Indications for Use (Describe)
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities (Choose Mode A, B, or C)
To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (Arms) due to strain from exercise or normal household work activities (Choose Mode A, B or C)
To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (Legs) due to strain from exercise or normal household work activities (Choose Mode A, B or C)
To be used for symptomatic relief and management of chronic, intractable pain associated with Arthritis (Choose Mode A)
To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode B)
| 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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3
510(k) SUMMARY
Date of Summary Prepared: 02/11/2016
| 1. Submitter's Name: | Counter Scientific Development (GZ) Ltd
2nd and 3rd Floor, Bldg 6, DaPian Industrial Zone
Tangxia Road, Tianhe District, Guangzhou 510665, China | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact person: | Jiang Eagle
Tel: +86-20 -8328 9980
Fax: +86-20-38339500 | |
E-mail: Counter csd(@yahoo.com.cn & csd.counter(@gmail.com
2. Proposed New Device:
Trade Name: Pain Therapy System, Model PTS-II Classification Name: TENS/EMS Device Regulation Number: 882.5890 & 882.5850 Product Code: NUH, NGX, NYN, GZJ Device Class: II
3. Predicate (cleared) Device:
OTC TENS, Model T1040 aka Aurawave 510(k) Number: K124055 Manufacturer: Endurance Therapeutics
4
4. Description of Proposed Device:
The Pain Therapy System, Model PTS-II is a selectable dual channel TENS and EMS device operated by DC 3.0V (AAA*2 batteries). It is made up of one main unit, two electrode cables, and two pairs of electrode pads.
There are 3 selectable, pre-programmed output waveforms (modes) to choose from. The two channels share one knob to adjust, the intensity are adjustable from 0 to 5. Running time can be selected among 10, 20 or 40min and recycled. There is a dial with on/off on the side that enables the device to be turned on or off, and it can be used to adjust the output intensity level, turn clockwise to increase intensity and turn anticlockwise to decrease the intensity. In the front of the device, there are 2 buttons and 6 indicator lights, in which one button is the mode selection button, and the other is for time selection. There are three modes A. B. C. respectively indicated by three indicator lights, which are on the right of the mode selection button. The device has 3 timing levels, namely 10, 20, 40 min, and indicated by three indicator lights, which are on the right of the timing selection button.
The device has been tested to and meets the requirements of the following recognized consensus standards:
ANSI/AAMI ES60601-1:2005+Corr.1(2006)+Corr.2(2007) general requirements for basic safety and essential performance
IEC 60601-2-10 Edition 2.0 2012-06 basic safety and essential performance of nerve and muscle stimulators. (Neurology)
IEC 60601-1-2 Edition 3:2007-03 medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic disturbances - requirements and tests. (General II (ES/EMC))
5. Indication for Use:
This Pain Therapy System, Model PTS-II is:
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities (Choose Mode A. B. or C)
To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (Arms) due to strain from exercise or normal household work activities (Choose Mode A. B or C)
To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (Legs) due to strain from exercise or normal household work activities (Choose Mode A., B or C)
5
To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with Arthritis (Choose Mode A)
To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose ModeB)
6. Environment of Use:
Clinics, Hospitals and home environments
7. Contraindications:
Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electrical shock, burns, electrical interference, or death.
Do not use this device together with a life-supporting medical electronic device such as an artificial heart or lung.
Do not use this device together with a body-worn medical electronic device such as an ECG.
| 510(k) Number | K150277 | K124055 |
|---|---|---|
| Device Name and Model | PAIN THERAPY | |
| SYSTEM | T1040 aka AUrawave | |
| Manufacturer | Counter | |
| Scientific | Endurance Therapeutics | |
| Power Source | 3.0 v (2*1.5vAAA) | 4.5 v ( 3*1.5vAAA batteries ) |
| Method of Line Current Isolation | Use resistance to isolate | Use transformer to isolate |
| Patient Leakage Current | N/A | N/A |
| Normal Condition (μΑ) | N/A | N/A |
| Single Fault Condition (μA) | N/A | N/A |
| Average DC current | ||
| through electrodes when device | ||
| is on but | 0μA | 0μA |
| Numbers of Output Modes | 3 modes (A,B,C) | 10modes |
| (Mode1, Mode2, Mode3, | ||
| Mode4, Mode5, Mode6, | ||
| AUTO1, AUTO2, AUTO3, | ||
| AUTO4) |
8. Technological Characteristics Compared to the Predicate Device
6
| Number of
Output
Channels | Synchronous
or
Method of
Channel | 2 Synchronous | 1 Synchronous |
|--------------------------------------------|-------------------------------------------|---------------------|-------------------|
| | | Parallel connection | N/A |
| Regulated current or
regulated voltage? | | Regulated voltage | Regulated voltage |
| Parameter | Subject Device K150277 | Predicate Device K124055 |
|---|---|---|
| Mode or Program Name | PAIN THERAPY SYSTEM, | ELECTRO THERAPY PAIN RELIEF, T1040 |
| Waveform (e.g. positive-going, reverse, biphasic ) | Positive-going, Reverse and | Positive-going, Reverse and Biphasic |
| Shape(e.g., spike, rectangular, square wave) | square wave | square wave |
| Maximum Output Voltage ( Volts ) (+/-15%) | 88vp @500Ω (Mode B has max) | |
| 102vp @2kΩ | ||
| 106vp @10kΩ | 40.7vp @500Ω | |
| 105.1vp @2kΩ | ||
| 154.1vp @10kΩ | ||
| Maximum Output Current (+/-15%) | 176mA @500Ω (Mode B has max) | |
| 51.0mA @2kΩ | ||
| 10.6mA @10kΩ | 81.4mA @500Ω | |
| 52.5.0mA @2kΩ | ||
| 15.4mA @10kΩ | ||
| Duration of primary phase | 0 | 0 |
| Pulse Duration | 170 μs | 200 μs |
| Frequency | 1-136 Hz | 1-250 Hz |
| For multiphase waveforms only: | Symmetrical phases | |
| Pulse Duration | ||
| N/A | N/A | |
| Net charge (micro coulombs μC) per pulse) (If zero, state method of achieving zero net charge.) | 1.63μC @500Ω | 1.9μC @500Ω |
| Maximum Phase Charge (μC) | 29.9μC @500Ω | 16.9μC @500Ω |
| Maximum Current Density (mA/cm2, r.m.s.) | 8.31mA/cm² @500Ω | 3.84mA/cm² @500Ω |
| Maximum Average Current (average absolute value), mA | 2.22mA | 1.28mA |
| Maximum Average Power Density (using smallest electrode conductive surface area) | $0.115mW/cm^2 @500\Omega$ | $0.039mW/cm^2 @500\Omega$ |
7
9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:
Counter did not conduct, nor rely upon, clinical tests to determine substantial equivalence of the Pain Therapy System Model PTS-II vs. the predicate. Non-clinical testing was performed in order to validate the design according to the company's specified design requirements, and to assure conformance with the following voluntary design standards:
a. EMC and electrical safety
ANSI/AAMI ES60601-1:2005+Corr.1(2006)+Corr.2(2007) general requirements for basic safety and essential performance
IEC 60601-2-10 Edition 2.0 2012-06 basic safety and essential performance of nerve and muscle stimulators. (Neurology)
IEC 60601-1-2 Edition 3:2007-03 medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic disturbances - requirements and tests. (General II (ES/EMC))
b. Biocompatibility
The electrode pads are the only body contacting parts. They have been FDA cleared under K132588.
c. Software
Based upon the test results it was concluded that the software performs within specifications and is safe to the stated intended use. Since a permanent hazard analysis is implemented in the software development process, and due to the clear software architecture, it is believed that the test protocol sufficiently verifies the software's main functional operation.
d. Cleaning
The cleaning instructions as described the Instruction Manual have been tested to be sufficient. Testing involved validation of the manual cleaning method as per the instructions. All testing concluded that the Pain Therapy System can be cleaned by the use of the methods described in the Instruction Manual.
8. Conclusions:
The Counter Pain Therapy System, Model PTS-II has the same intended use and 5 | Page
8
technological characteristics as the predicate device. Moreover, bench testing and safety report documentation demonstrate that the submitted device could maintain the same safety and effectiveness as that of predicate device. In the other words, the differences do not affect the intended use and do not raise any new questions of safety or effectiveness or alter the fundamental scientific technology of the device. Thus, the Counter Pain Therapy System, Model PTS-II is substantially equivalent to the predicate device.