(262 days)
FD2070 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of chronic post-surgical and post-traumatic acute pain.
As a Transcutanous Electrical Nerve Stimulator (TENS) unit, FD2070 generates patientical pulses and transmit it to the electrodes, which are attached in the skin to the underlying peripheral pulses would then pass his gold then pass through the unders skin to the underlying peripheral nerves no aid in the pass through the skin to the underlying peripheral nerves to aid in the blocking to the traveling to the brain.
Here's an analysis of the provided text regarding the acceptance criteria and study data for the FD2070 Mini TENS device:
Acceptance Criteria and Device Performance Study
The provided 510(k) summary for the FD TENS 2070 (K111654) demonstrates substantial equivalence to its predicate device, FD TENS 2030 (K052813). The acceptance criteria are implicitly defined by the technical specifications of the predicate device, as the new device is seeking to prove it is "as safe and as effective" as the predicate. The study conducted to demonstrate this equivalence is primarily non-clinical testing, with a direct comparison of technical specifications and compliance with relevant safety and EMC standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the specifications of the predicate device (FD TENS 2030, K052813). The reported device performance is that of the FD2070 / Mini TENS (K111654).
| Characteristic | Acceptance Criteria (Predicate: FD TENS 2030, K052813) | Reported Device Performance (FD2070 / Mini TENS, K111654) | Meets Criteria? | Notes |
|---|---|---|---|---|
| Waveform | Asymmetrical Bi-Phasic | Symmetrical Bi-Phasic | No (Different) | The waveform is different, but the submission implicitly argues that symmetrical bi-phasic is still safe and effective for the intended purpose, and within acceptable safety limits as demonstrated by other electrical characteristics and standard compliance. |
| Shape | Rectangular | Rectangular | Yes | |
| Maximum Voltage @500Ω | 31V | 30V | Yes | Lower, indicating potentially safer output. |
| Maximum Voltage @2KΩ | 51V | 37V | Yes | Lower, indicating potentially safer output. |
| Maximum Voltage @10KΩ | 85V | 39V | Yes | Lower, indicating potentially safer output. |
| Max Output Current @500Ω | 63mA | 60mA | Yes | Lower, indicating potentially safer output. |
| Max Output Current @2KΩ | 25 mA | 18mA | Yes | Lower, indicating potentially safer output. |
| Max Output Current @10KΩ | 9 mA | 4mA | Yes | Lower, indicating potentially safer output. |
| Maximum Pulse Width | 250μs | 333 μs | No (Higher) | The maximum pulse width is higher, which could impact comfort or efficacy. However, other parameters (like charge per phase) are similar or lower, suggesting overall safety envelope is maintained. The report includes calculations for charge per pulse/phase/current density/power density to demonstrate safety despite this difference. |
| Maximum Frequency | 200Hz | 120Hz | Yes (Lower) | Lower, which means it operates within the predicate's frequency range. |
| Maximum Net Charge Per Pulse | 5.8μC @500Ω | 0.5μC @500Ω (±0.5μC is neutral charge) | Yes (Lower) | Significantly lower, indicating safer operation (less DC component). The target for net charge is ideally zero for TENS devices to prevent tissue damage. |
| Maximum Output Charge Per Phase | 15.8μC @500Ω | 15.3μC @500Ω | Yes (Similar) | Very close to the predicate device, indicating similar stimulus intensity per phase. |
| Maximum Output RMS Current | 11.0 mA rms @500Ω | 6.0 mA rms @500Ω | Yes (Lower) | Lower, indicating potentially safer output. |
| Max Current Density | 0.1 mA/cm² | 0.074 mA/cm² | Yes (Lower) | Lower, indicating potentially safer output. |
| Max Power Density | 1.82 mW/cm² | 1.12 mW/cm² | Yes (Lower) | Lower, indicating potentially safer output. |
| Standard Compliance (Safety) | (Implied by predicate clearance) | EN60601-1 Safety requirement | Yes | Explicitly stated compliance. |
| Standard Compliance (EMC) | (Implied by predicate clearance) | EN60601-1-2 EMC requirements | Yes | Explicitly stated compliance. |
| Software Verification | (Implied by predicate clearance) | Carried out according to FDA software guidance | Yes | Explicitly stated compliance. |
2. Sample Size and Data Provenance
- Sample Size for the test set: Not applicable – this is a non-clinical, technical comparison of device specifications and compliance testing, not a clinical study involving patients or a test set of data in the traditional sense. The "test set" consists of the physical device being tested against engineering and safety standards.
- Data Provenance: The technical specifications and test results are generated from the manufacturing and testing activities of Fuji Dynamics Ltd. in Hong Kong. The data are from the prospective design, manufacturing, and electrical testing of the FD2070 device.
3. Number of Experts and Qualifications for Ground Truth
- Number of experts: Not applicable. Ground truth for device specifications and standard compliance is established via objective physical measurements and adherence to recognized international standards (e.g., EN60601-1). This does not involve expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the test set
- Adjudication method: Not applicable. The "test set" involves physical measurements and compliance verification against standards, not subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC study: No. This device is a Transcutaneous Electrical Nerve Stimulator (TENS), not an imaging or diagnostic device that would typically involve human readers interpreting cases. Therefore, a MRMC study is not relevant for this 510(k) submission.
6. Standalone (Algorithm Only) Performance
- Standalone performance: Not applicable. The device is a physical electronic medical device (TENS unit), not a software algorithm or AI model that would have a "standalone" or "human-in-the-loop" performance. Its performance is its physical output characteristics.
7. Type of Ground Truth Used
- Type of ground truth: Objective Technical Specifications and International Standards. The key ground truths are:
- The published technical specifications of the predicate device (FD TENS 2030).
- The requirements of EN60601-1 Safety requirement and EN60601-1-2 EMC requirements.
- The principles of FDA software guidance for software verification.
- The concept of electrical safety which dictates limits on parameters like net charge, current density, and power density to prevent tissue damage.
8. Sample Size for the Training Set
- Sample size for training set: Not applicable. This is not an AI/ML device where a "training set" in the machine learning sense would be used. The device design is based on established engineering principles and the predicate device's design.
9. How the Ground Truth for the Training Set Was Established
- How ground truth for training set was established: Not applicable. As there is no training set for a machine learning model, this question is not relevant. The "ground truth" for the device's design and functionality is derived from engineering principles, safety standards, and the performance characteristics of previously cleared predicate devices.
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MAR - 1 2012
E. 510(k) Summary (per 21 CFR 807.92)
Device 510(k) number: K111654
Applicant Information 1.
| Date: | Feb 8, 2012 |
|---|---|
| Submitter: | Fuji Dynamics Ltd.Unit 1-3, 23/F., Laws Commercial Plaza788 Cheung Sha Wan Road, KowloonHong Kong |
| Contact Person: | NG, Kam TimProduct Development Manager |
| Tel:Fax : | (852) 2786 4218(852) 2744 6775 |
2. General Device Information
| Model No.: | FD2070 |
|---|---|
| Trade Name: | Mini TENS |
| FD TENS 2070 | |
| Common Name: | Transcutaneous Electric Nerve Stimulator (TENS) |
| Product Code: | GZJ |
| Classification: | Class II |
3. Predicate Device Information:
FD2070 is substantially equivalent to FD TENS 2030 (K052813) which is also
manufactured by Fuji Dynamics. manufactured by Fuji Dynamics.
4. Device Description
As a Transcutanous Electrical Nerve Stimulator (TENS) unit, FD2070 generates
patientical pulses and transmit it to the electrodes, within clectical pulses and transmit it to the electrodes, which are attached in the skin to the underlying peripheral pulses would then pass his gold then pass through the unders
skin to the underlying peripheral nerves no aid in the pass through the skin to the underlying peripheral nerves to aid in the blocking to the traveling to the brain.
Intended Use: 5
FD2070 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of chronic
post-surgical and post-traumatic acute nain post-surgical and post-traumatic acute pain.
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Comparison to Predicate Device: (
Similarity
Engineering
Both FD2070 and FD TENS 2030 are developed by Fuji with the similar
platform and technology platform and technology.
Although the microcontrollers used are both devices are different, the software flow, the software logic and the modules are similar.
On hardware, the basic mechanisms generating the pulses are the same.
Intended Use
FD2070 is intended to be a Transcutaneous Electrical Nerve Stimulator, same as
FD TENS 2030. FD TENS 2030.
Biocompatibility
The polymer ABS of the biocompatibility test article is identical to the ABS of the predicate device (FD TENS 2030, K052813) 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 FD2070 is single channel but FD TENS 2030 is two channels, the electronics hardware are different. The treatment programs are also different.
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| Characteristic | FD2070 / Mini TENSK111654 | FD TENS 2030K052813 (Predicate Device) |
|---|---|---|
| Waveform | Symmetrical Bi-Phasic | Asymmetrical Bi-Phasic |
| Shape | Rectangular | Rectangular |
| Maximum Voltage(peak voltage) | 30V @500Ω37V @2KΩ39V @10KΩ | 31V @500Ω51V @2KΩ85V @10KΩ |
| Max Output Current(peak current) | 60mA @500Ω18mA @2KΩ4mA @10KΩ | 63mA @500Ω25 mA @2KΩ9 mA @10KΩ |
| Maximum Pulse Width | 333 μs | 250μs |
| Maximum Frequency | 120Hz | 200Hz |
| Maximum Net ChargePer Pulse | * 0.5μC @500Ω | 5.8μC @500Ω |
| Maximum OutputCharge Per Phase | * 15.3μC @500Ω | 15.8μC @500Ω |
| Maximum OutputRMS Current | ** 6.0 mA rms @500Ω | 11.0 mA rms @500Ω |
| Max Current Density | ** 0.074 mA/cm² | 0.1 mA/cm² |
| Max Power Density | ** 1.12 mW/cm² | 1.82 mW/cm² |
| BURST 1 | Burst 1 (Step 1)80Hz240pulses/burst, 1 burst/6sec3 sec duration, 50% duty cycleBurst 1 (Step 2)60Hz240pulses/burst, 1 burst/8sec4 sec duration, 50% duty cycleBurst 1 (Step 3)100Hz300pulses/burst, 1 burst/6sec3 sec duration, 50% duty cycle | BURST I80HzSelectable pulse width between25us and 250us80pulses/burst, 1 burst/2sec1 sec duration, 50% duty cycleSelectable pulse width |
| BURST 2 | Burst 2 (Step 1)60Hz180pulses/burst, 1 burst/6sec3 sec duration, 50% duty cycleBurst 2 (Step 2)80Hz80pulses/burst, 1 burst/2sec1 sec duration, 50% duty cycleBurst 2 (Step 3)100Hz100pulses/burst, 1 burst/2sec1 sec duration, 50% duty cycle | BURST II28HzSelectable pulse width between25us and 250us7pulses/burst, 2 burst/sec1 sec duration, 50% duty cycle |
| BURST 3 | Burst 3 (Step 1)4Hz96pulses/burst, 1 burst/28sec24 sec duration, 85.7% duty cycleBurst 3 (Step 2)60Hz120pulses/burst, 1 burst/2.5sec2 sec duration, 80% duty cycleBurst 3 (Step 3)80Hz, 250usAmplitude Modulation 2.5Hz, 50%On 40sec, Off 4sec |
E. 510(k) Summary (per 21 CFR 807.92)
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| Continuous Mode | Not available | Selectable 1Hz to 200HzSelectable 25μs to 100μs |
|---|---|---|
| Pulse Width Modulation | Not available | Selectable 1Hz to 200 Hz25μs to 250μs in 8 sec250μs to 15μs in 8sec, repeat |
| Frequency Modulation | Not available | Selectable 25μs to 250μs100Hz to 20 Hz in 8 sec,20Hz to 100Hz in 8sec, repeat |
| MODUL 1(Modulation 1) | Modulation 1 (Step 1)100Hz, 200μs0.5Hz, 50%On 42sec, Off 6secModulation 1 (Step 2)80Hz, 250μs2Hz, 30%On 4sec, Off 4secModulation 1 (Step 3)60Hz, 333μs1.25Hz, 30%On 4sec, Off4sec | |
| MODUL 2(Modulation 2) | Modulation 2 (Step 1)100Hz, 200μs0.5Hz, 50%On 38sec, Off 4secModulation 2 (Step 2)80Hz, 250μs1.25Hz, 40%On 8sec, Off 4secModulation 2 (Step 3)120Hz, 167μs1.25Hz, 40%On 8sec, Off 4sec | |
| MODUL 3(Modulation 3) | Modulation 3 (Step 1)120Hz, 167μs0.5Hz, 50%On 40sec, Off 4secModulation 3 (Step 2)100Hz, 120μs0.25Hz, 50%On 36sec, Off 4secModulation 3 (Step 3)80Hz, 250μs0.125Hz, 50% |
E. 510(k) Summary (per 21 CFR 807.92)
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* Sample Calculation – using Burst 3 (Step 1)
Image /page/4/Figure/2 description: The image shows two graphs, one for a positive pulse and one for a negative pulse, along with calculations related to charge and time constants. The positive pulse graph shows voltage over time, with labels V1, V2, t1, and t2. Calculations determine ( \tau_+ ) as 139 ( \mu s ), ( Q_+ ) as 7.88 ( \mu C ), ( \tau_- ) as 142 ( \mu s ), and ( Q_- ) as 7.41 ( \mu C ). The maximum charge per phase is calculated as 15.3 ( \mu C ), and the maximum net charge per phase is 0.5 ( \mu C ).
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** Sample Calculation – using Burst 1 (Step 3)
$$\left[\boldsymbol{I}\right]{rms}^{2} = \frac{1}{T} \int{t_{\parallel}}^{t_{\perp}} \left(\frac{\dot{\boldsymbol{V}}{1}}{\boldsymbol{R}{L}} \cdot \mathbf{e}^{-\left(\boldsymbol{l} - \boldsymbol{t}{\perp}\right)/\tau}\right)^{2} d\boldsymbol{t} = \frac{\pi}{2T} \left(\frac{\mathbf{V}{1}}{\boldsymbol{R}{L}}\right)^{2} \left(\boldsymbol{l} - \boldsymbol{e}^{-t{\perp}/\tau}\right) \dots \text{(iii)}$$
From equation (3), (4) and (iii) above
Positive Pulse $-202 \mu s$ $\tau_{+}$ $=123\mu s$ Equation (3) 6.0V ln 31.2V
Equation (4)
$\frac{31.2V \cdot 123\mu s}{}$ [ $Q_{+} =$ $- e^{-202 \mu s / 123 \mu s}$ ] = 6.18$\mu C$ $Q_{-} = 5.66 \mu C$ 500$\Omega$ 123$\mu s$ $I_{rms}^{2} =$ 31.2V $e^{-202 \mu s / 123 \mu s}$ Equation (iii) 2(1/100Hz) 500Ω $I_{rms}^2 = 0.0165mA^2$ = 0.0193$mA^2$
Negative Pulse
$τ$ = 120$\mu s$
$$I_{rms} = \sqrt{0.0193mA^{2} + 0.0165nA^{2}} = 6.0mA$$
$$CurrentDensity = \frac{Q_{+} + Q_{-}}{period \cdot area} = \frac{11.8\mu C}{(1/100Hz) \cdot (4cm \times 4cm)} = 0.074mA/cm^{2}$$
$$\frac{Effective \ Power}{Area \ of \ Electrode} = \frac{\sum (I_{rms}^{2} \cdot R_{L})}{A} = \frac{(0.0193 + 0.0165)mA^{2} \cdot 500\Omega}{4cm \cdot 4cm} = 1.12 \ mW/cm^{2}$$
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E. 510(k) Summary (per 21 CFR 807.92)
7 Non-clinical Testing:
FD2070 is compliànce 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:
FD2070 has the same intended use and the same technical characteristics as the predicate device FD TENS 2030 (K052813).
FD2070 is as safe and as effective as the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 1 2012
Fuji Dynamics Ltd c/o Mr. Tim Ng Product Development Manager Unit 1-3, 23/F., Laws Commercial Plaza 788 Cheung Sha Wan Road Hong Kong, China
Re: K111654
Trade/Device Name: FD TENS 2070 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: February 8, 2012 Received: February 23, 2012
Dear Mr. Ng:
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.
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Page 2 - Mr. Tim Ng
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
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
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Indication For Use D.
510(k) Number (if known) :
Model No.: FD2070 Device Name: Mini TENS
FD TENS 2070
Indications For Use:
FD2070 is used for the symptomatic relief and management of chronic intractable
pain and/or as an adjunctive treatment in the pain and/or as an adjunctive treatment in the management of chronic intractable
post-traumatic acute pain. post-traumatic acute pain.
Prescription Use X
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) PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daryl L. Kaufman M.A.
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K111654
D-1/1
§ 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).