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TENS applications:

• Symptomatic relief and management of chronic, intractable pain .
• Adjunctive treatment for post-surgical and post-trauma acute pain .

The Fenzian Treatment System is an electrical device designed for use as a Transcutaneous Electrical Nerve Stimulator (TENS) which operates by delivering an electrical current through the skin to the cutaneous (surface) and afferent (deep) nerves to control pain. The complete system is comprised of the stimulator and battery.

Here's a breakdown of the acceptance criteria and study information for the Fenzian Treatment System based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

For medical devices seeking 510(k) clearance, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. This often involves showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

In this case, the Fenzian Treatment System claims substantial equivalence to the EMPI - Focus 795 (K951951). The evaluation focuses on comparing key technical specifications and indications for use.

• Adjunctive treatment for post-surgical and post-trauma acute pain | - Symptomatic relief and management of chronic, intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain |
  | Device Classification | Transcutaneous Nerve Stimulator (TENS) 882.5890 | Transcutaneous Nerve Stimulator (TENS) 882.5890 |
  | Product Code | 84 GZJ TENS | 84 GZJ TENS |
  | Regulated Voltage | Yes | Yes |
  | Indicator Display - On/Off | Yes | Yes |
  | Indicator Display - Low Battery | Yes | Yes |
  | Waveform | Symmetrical biphasic (predicate) | Biphasic |
  | Maximum Output Voltages | ± 100V @ 1 k ohm | 88 V @ 500 ohms; 306 V @ 2 k ohms; 650 V @ 10 k ohms |
  | Maximum Output Current | 0-60 mA (normal), 0-100 mA (high) | 46 milliamps @ 500 ohms, 16.8 milliamps @ 2 k ohms, 8.0 milliamps @ 10 k ohms |
  | Pulse Width | 300 $\mu$ S of peak amplitude | 498 $\mu$ S |
  | Frequency | 25, 30, 35, 45, 50, 80 pps | 15-350 Hz |
  | Maximum Patient Leakage Current | Pulses per burst: 1-8Bursts per second: 15-2800Burst duration: 1-5 seconds |
  | Time On | 2.5 – 50 seconds | 1-5 seconds |
  | Off Time | 0-50 seconds | 1 second |
  | Maximum Charge per Pulse | Unknown (predicate) | 37.5 µC @ 500 ohms |
  | Maximum Average Current | Unknown (predicate) | 2.19 mA |

Points specific to the study and acceptance:

1. Sample size for the test set and data provenance:

   • The document primarily presents a comparison of technical specifications between the new device and the predicate device, rather than a clinical study with a "test set" of patients.
   • Therefore, there's no explicit sample size mentioned for a test set in the traditional sense of a clinical trial for device efficacy.
   • The data provenance for the comparison features is from the manufacturer's reported specifications for both the Fenzian Treatment System (new device) and the EMPI - Focus 795 (predicate), which is a retrospective comparison based on published specifications for the predicate. Given "Eumedic Limited" is a UK company, and the predicate is from a US company, the data may originate from different countries in terms of where the devices were developed and tested, but the comparison itself is against documented specs.

2. Number of experts used to establish the ground truth for the test set and their qualifications:

   • Not applicable. This 510(k) summary does not describe a study involving expert assessment of a "test set" of patient data or outcomes. The "ground truth" for the comparison is the documented specifications of the predicate device.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable, as there is no clinical test set requiring adjudication in this summary.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is not an AI-assisted diagnostic device, nor does the submission describe an MRMC study.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable. This is a TENS device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the substantial equivalence claim is the technical specifications and cleared indications for use of the legally marketed predicate device (EMPI - Focus 795). The submission argues that the Fenzian device's specifications and intended uses are either identical or equivalent to the predicate.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device.

8. How the ground truth for the training set was established:

   • Not applicable.

Overall Study Information / Conclusion:

The "study" demonstrating the device meets acceptance criteria in this 510(k) is a non-clinical comparative analysis against a predicate device.

• Rationale for Substantial Equivalence: The manufacturer asserts substantial equivalence based on:

  1. Same Indications for Use and equivalent output.
  2. Equivalent technological characteristics.
  3. Comparative information (presented in the table above) demonstrating this equivalence.

• Non-Clinical Data: This submission relies on non-clinical data to support safety and performance, which include:

  • Risk Analysis: Demonstrated acceptable and mitigated potential hazards.
  • Standards Compliance: The device meets requirements for EN 60601-1-2 EMC (Electromagnetic Compatibility, covering radiated emissions, electrostatic discharge, radiated immunity) and general device safety.
  • CE Mark: Meets European requirements for the CE Mark, indicating compliance with relevant EU directives for health, safety, and environmental protection.

• Conclusion: The manufacturer concludes that the device is designed, labeled, and verified for performance and safety, and its performance is equivalent to a legally marketed predicate device, with no unmitigated design or performance potential hazards. The FDA's letter (K041575) confirms substantial equivalence based on the provided information.

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