(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.
§ 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).