FD TENS 2050 OR SLIDE TENS MODEL FD2050

{0}------------------------------------------------ # NOV - 9 2011 ### 510(k) Summary (per 21 CFR 807.92) E. Device 510(k) number: K111645 #### Applicant Information 1. Date Prepared: Oct 7, 2011 Fuji Dynamics Ltd. Submitter: Unit 1-3, 23/F., Laws Commercial Plaza 788 Cheung Sha Wan Road, Kowloon Hong Kong LEE, Ching Kong Felix Contact Person: (852) 2786 4218 Tel: | Tel: | (852) 2733 7272 | |------|-----------------| | Fax: | (852) 2744 6775 | #### General Device Information 2. | Model Number: | FD2050 | |-----------------|------------------------------------------| | Trade Name: | Slide TENS | | | FD TENS 2050 | | Common Name: | Transcutaneous Electric Nerve Stimulator | | Product Code: | GZJ | | Classification: | Class II | #### 3. Predicate Device Information: SMART TENS [510(k) No.: K091045] #### 4 Device Description # General The FD2050 is a handheld battery powered TENS device. which is used for pain relief. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain. FD2050 has two output channels and five preset programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 20 steps. ### Software The software is built up with different software modules. The software modules are interconnected. One software module can be activated by another software module. The hardware is the physical interface to the user. The hardware passes or receives signal to or from the controller.. # Operation (refer the Functional Block) The microcontroller (MCU) takes request from the key pad (H2). It determines the logic and the parameter setting. It displays the information to the LCD (H1). The output intensity is directly related to the output voltage. The device makes use of a boost converter (H4) such that the controller sends different numbers of pulses to the boost converter build up desired amount of charges. The charges are released through a transistor bridge circuit (H5). The controller manipulates the pulse width, timing and polarity of the pulses in different program modes. {1}------------------------------------------------ When battery gets dry, there is signal from voltage detection chip (H3) and the controller reflects the status on the screen by turning on an icon. The open circuit detect circuitry (H6) can sense if electrode is detached. The controller reflects the status on the screen and turn down the output intensity. # Device Safeguards Software Malfunction – watch dog timer is used to safeguard the malfunction or dead lock of software. The watch dog timer counts down to zero in 546ms. The software in the main loop resets and restarts the timer. If the microcontroller experiences deadlock in subroutine and cannot return to the main loop within 546ms, the device will be turned off and intensity level will be down to zero. Shock Protection - the circuitry has the open circuit detection to prevent user from getting shock. It recognizes 500 to 20k ohm as the present of load and above 200k ohm to be open load. If the electrodes are physical detached from the device, the device will turn down the level to zero. Battery Low - a voltage detection chip is used to monitor the voltage level. If the voltage drops below a threshold, it signals the microcontroller to alert the patient by displaying an icon. #### 5 Intended Use: FD2050 is intended to use as - Symptomatic relief and management of chronic intractable pain . - Adjunctive treatment for the management of post-traumatic or post-surgical . pain. #### Comparison to Predicate Device: 6 ## Similarity ## Engineering FD2050 is developed on the same platform as Smart TENS. On hardware, the schematic and the use of electronics components are the same. The software is cloned from Smart TENS so the basic mechanism, like the basic timing, key scanning and generation of pulse are the same. ## Intended Use FD2050 is intended to be a Transcutaneous Electrical Nerve Stimulator, same as Smart TENS. # Biocompatibility The polymer ABS of the biocompatibility test article is identical to the ABS of the final device in formulation, processing , and cleaning, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.). ## Difference Since the shape of FD2050 is different from Smart TENS, the PC boards are different between two devices. The software basically the same while the parameters for treatment programs are changed so they have different treatment programs. {2}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ # Functional Block Image /page/2/Figure/3 description: The image shows a block diagram of a system with several components. The central component is labeled "MCU", and it is connected to several other components, including "LCD (H1)", "Key Pad (H2)", "Battery Low Detect (H3)", "Voltage Boost (H4)", "Output Circuit (H5)", and "Open Circuit Detect (H6)". Arrows indicate the direction of communication between the components, suggesting a flow of information and control within the system. : {3}------------------------------------------------ ; .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . く ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ # Output Specification Comparison - | Parameter | FD2050 / Slide TENS<br>K111645 | SMART TENS<br>K091045 (Predicate Device) | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | Waveform | Asymmetrical Bi-Phasic<br>Rectangular Waveform | Asymmetrical Bi-Phasic<br>Rectangular Waveform | | Maximum Voltage<br>(0 to peak voltage) | 60V @500Ω<br>75V @2kΩ<br>83V @10kΩ | 61V @500Ω<br>76V @2kΩ<br>90V @10kΩ | | Max Output Current | 120 mA @500Ω<br>37 mA @2kΩ<br>8 mA @10kΩ | 122 mA @500Ω<br>38 mA @2kΩ<br>9 mA @10kΩ | | Maximum Pulse Width | 250 μs | 250 μs | | Maximum Frequency | 150Hz | 100Hz | | Maximum Output<br>Charge Per Phase | * 23.0μC @500Ω<br>17.1μC @1kΩ<br>11.9μC @2kΩ<br>3.4μC @10kΩ | 28.4μC @500Ω<br>21.3μC @1kΩ<br>13.9μC @2kΩ<br>3.9μC @10kΩ | | Maximum Output<br>Net Charge Per Phase | * 11.9μC @500Ω<br>6.2μC @1kΩ<br>2.9μC @2kΩ<br>0.4μC @10kΩ | 14.4μC @500Ω<br>6.5μC @1kΩ<br>2.9μC @2kΩ<br>0.4μC @10kΩ | | Maximum Output<br>RMS Current | * 13.1 mArms @500Ω<br>8.4 mArms @1kΩ<br>5.3 mArms @2kΩ<br>1.4 mArms @10kΩ | 14.4 mArms @500Ω<br>10.0 mArms @1kΩ<br>6.3 mArms @2kΩ<br>1.7 mArms @10kΩ | | Max Current Density | * 0.22mA/cm2 @500Ω | 0.11 mA/cm2 @500Ω | | Max Power Density | * 5.3mW/cm2 @500Ω | 4.2 mW/cm2 @500Ω | | Treatment Timer | 5 selectable timer<br>Continuous 15 minutes<br>30 minutes 45 minutes<br>60 minutes | 5 selectable timer<br>Continuous 15 minutes<br>30 minutes 45 minutes<br>60 minutes | | Continuous Stimulation<br>(CONTS) | 150µs<br>Selectable 1Hz to 150Hz | 100Hz<br>Selectable 20µs to 250µs | | Burst<br>(BURST 1<br>BURST 2) | Burst 1<br>28Hz, 150µs, 2 bursts/sec, 7<br>pulses/burst<br>Burst 2<br>80Hz, 150µs, 1 burst/2sec, 80<br>pulses/burst | 32Hz, selectable 20µs to 250µs<br>2 burst/sec, 7 pulses/burst | | Pulse Width Modulation<br>(MODUL 1) | 50µs -> 250µs in 6sec<br>250µs -> 50µs in 6sec<br>repeat | 20µs -> max pulse width in 5 sec<br>max pulse width ->20µs in 5sec<br>repeat | | | 42 selectable pulse rate<br>between 1Hz and 150Hz | 23 selectable max pulse width<br>between 20µs and 250µs | | Frequency Modulation<br>(MODUL 2) | Pulse width 150µs<br>20Hz -> 100Hz in 6sec<br>100Hz -> 20Hz in 6sec<br>Then repeat | Not Available | {4}------------------------------------------------ K11645 # * Sample Calculation Image /page/4/Figure/3 description: This image contains a graph and several equations related to electrical charge and current density. The graph shows voltage over time, with labels such as V1, V2, t1, and t2. Several equations are presented, including formulas for V(t), τ, and Q, along with calculations for Q+ and Q- which are 17.44 μC and 5.51 μC, respectively. The image also includes calculations for MaxCharge, NetCharge, and CurrentDensity, with the final current density calculated as 0.22mA/cm². $I_{rms}^2 = \frac{1}{T} \int_{t_i}^{t_f} \left(\frac{\mathbf{V}_1}{R_L} \mathbf{e}^{-\left(\mathbf{t} - \mathbf{t}_i\right)/\tau}\right)^2 dt = \frac{\tau}{2T} \left(\frac{\mathbf{V}_1}{R_L}\right)^2 \left(\mathbf{l} \cdot \mathbf{e}^{-\epsilon_s/\tau}\right)$ $I_{rms}^{2} = \frac{208\mu s}{2(1/150Hz)} \left(\frac{60V}{500\Omega}\right)^{2} (1 - e^{-250\mu s / 208\mu s}) = 0.157 lmA^{2}$ $+ve Pulse I_{rms}^{2} = 0.1571mA^{2}$ $-ve Pulse I_{rms}^{2} = 0.0132mA^{2}$ $I_{rms} = \sqrt{0.1571mA^{2} + 0.0132mA^{2}} = 13.1mA$ $MaxPowerDensity = \frac{Effective Power}{Area of Electrode} = \frac{\sum (I_{rms}^{2} \cdot R_{L})}{A}$ $= \frac{(0.1571 + 0.0132)mA^{2} \cdot 500\Omega}{4cm \cdot 4cm} = 5.3 mW/cm^{2}$ {5}------------------------------------------------ ### E. 510(k) Summary (per 21 CFR 807.92) #### 7 Non-clinical Testing: FD2050 complies with the following standard. EN60601-1 Safety requirement EN60601-1-2 EMC requirements The design control follows the FDA quality system requirement and the software verification has been carried out according to the FDA software guidance. #### 8 Clinical Testing None #### 9 Conclusions: FD2050 has the same intended use and the same technical characteristics as the predicate device, SMART TENS [510(k) No.: K091045]. FD2050 is as safe and as effective as the predicate device. Therefore, the FD2050 is substantially equivalent to the predicate device. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Fuji Dynamics, Ltd. c/o Mr. Ching Kong Lee Product Developer Manager Unit 1-3, 23/F, Laws Commercial Plaza 788 Cheung Sha Wan Road Kowloon, Hong Kong NOV - 9 2011 Re: K111645 Trade/Device Name: Slide TENS FD TENS 2050 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: October 11, 2011 Received: October 12, 2011 Dear Mr. Lee: 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. {7}------------------------------------------------ Page 2 - Mr. Ching Kong (Felix) Lee 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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Sincerely yours. Kesia Alexander Image /page/7/Picture/7 description: The image shows the handwritten word "for" in cursive script. The letter 'f' has a large, looping descender that extends below the baseline, and the 'o' and 'r' are connected with a smooth, flowing line. The writing style appears elegant and fluid. Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ K111645 . · 510(k) Number (if known): FD2050 Model No.: FD TENS 2050 Device Name: Slide TENS Indications For Use: The FD2050 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain. Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Dan L. Kaufman, M.A. (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K111645