(134 days)
The Drug Relief v1 is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of cranial nerves V, VII, IX and X, and the occipital nerves identified by transillumination.
The Drug Relief v1 is designed to be used as an aid to reduce opioid withdrawal symptoms by the method of cranial electrical stimulation at the auricular stimulation points. The Drug Relief v1 is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over five days / 120 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the branches of cranial Nerves on the ear through a set of wire assembly and stimulation needles. Three zinc air batteries with 1.4 V each provide the required stimulation energy for 120 hours. There atimulation electrode and one ground electrode which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The stimulation pattern consists of rectangular pulses with differing inter-pulse intervals and a duty cycle of 2 hours ON/1 minute OFF. A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.
The provided text describes the Drug Relief v1 device and its substantial equivalence to a predicate device, Drug Relief (K173861). The document primarily focuses on demonstrating that the new device has similar performance specifications and safety characteristics to the previously cleared predicate.
Here's an analysis of the provided information concerning acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of predetermined acceptance criteria with corresponding performance results. Instead, it relies on demonstrating that the "Drug Relief v1 has equivalent performance specifications when compared to the predicate device." This is a common approach for 510(k) submissions, where the new device's performance is compared to a legally marketed predicate rather than against absolute, pre-defined acceptance metrics for efficacy in a clinical setting.
However, the core of the performance evaluation for this type of device, as indicated, revolves around:
- Electrical Safety Parameters: Max Charge Density (µC/cm²) and Max Average Power Density (W/cm²).
- Functional Performance: Pulse width, duty cycle, amplitude, and current values over the intended operating time (120 hours).
- Biocompatibility: Ensuring materials are safe for patient contact.
- Software Verification and Validation: Confirming the software functions as intended.
- Sterilization: Achieving a defined sterility assurance level (SAL).
The document states that the reported device performance for the Drug Relief v1 shows these characteristics are "identical or near identical" to the predicate device. Specifically, the electrical output parameters are presented in "Table 13.3.2 Comparison of Technical System Characteristics" (pages 6-7).
| System Characteristic / Parameter | Predicate Device (Drug Relief K173861) Performance | Subject Device (Drug Relief v1) Performance | Justification / Outcome |
|---|---|---|---|
| Max Charge Density (µC / cm²) per needle | 65.67 @ 1 kΩ; 7.96 @ 10 kΩ | 67.16 @ 1 kΩ; 8.01 @ 10 kΩ | Near identical; minor technological differences do not impact safety/effectiveness. |
| Max Average Power Density (W / cm²) | 0.346 @ 1 kΩ; 0.0509 @ 10 kΩ | 0.363 @ 1 kΩ; 0.0516 @ 10 kΩ | Near identical; minor technological differences do not impact safety/effectiveness. |
| Pulse Shape | Rectangle | Rectangle | Identical |
| Frequency (HZ) | 1 - 10 (Pulse with modulating frequency) | 1 - 10 (Pulse with modulating frequency) | Identical |
| Waveform | Rectangular Pulse | Rectangle pulse | Identical |
| Pulse Width (ms) | 0.980 | 0.980 | Identical |
| Duty Cycle | 2 hours ON / 1 min OFF | 2 hours ON / 1 min OFF | Identical |
| Battery Operating Time (hours) | 120 | 120 | Identical |
| Biocompatibility | Passed (Implied, as K211971 passed) | Passed | Demonstrated via nonclinical testing. |
| Electrical Safety (EMC and Safety) | Passed (Implied, as K211971 passed) | Passed | Demonstrated via nonclinical testing, shown as "near identical" to predicate. |
| Software Verification and Validation | Performed | Performed | Demonstrated via nonclinical testing. |
| Sterility Assurance Level (SAL) | Achieved (Implied, as K211971 passed) | Achieved | Evidenced by bio-burden, EtO sterilization, and sterility tests per ISO standards. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes nonclinical testing, including "performance bench testing" and "electrical safety (electromagnetic compatibility and safety)" for the Drug Relief v1 device (page 7). It also mentions "software verification and validation" and "biocompatibility testing."
- Sample Size: The specific sample sizes for these tests (e.g., how many devices were tested for electrical safety or how many batches for sterilization) are not explicitly stated in the provided text.
- Data Provenance: The studies are described as nonclinical (bench testing) and likely conducted by the manufacturer (DyAnsys, Inc.). There is no mention of clinical data, human subjects, country of origin related to human data, or retrospective/prospective study design, as this submission is based on demonstrating substantial equivalence through technical and performance comparisons to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided because the evaluation presented is based on nonclinical testing (bench tests, electrical safety, etc.) and direct comparison to a predicate device's technical specifications. There is no "ground truth" derived from expert interpretation of clinical data in this document.
4. Adjudication Method for the Test Set
This is not applicable and not provided as the submission does not involve clinical studies with human readers or diagnostic interpretations requiring adjudication.
5. 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
This is not applicable and not provided. The Drug Relief v1 is a percutaneous nerve stimulator, not an AI-based diagnostic imaging or analysis device. There is no mention of human readers, AI assistance, or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable and not provided. The device is a nerve stimulator, not an algorithm, and the submission does not refer to AI or algorithmic performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As this is a nonclinical performance and electrical safety submission, the "ground truth" refers to established engineering standards, electrical measurement protocols, and material science specifications. For example:
- Electrical Safety: Standards like those for current leakage, output parameters, and EMC.
- Biocompatibility: ISO standards for biological evaluation of medical devices.
- Sterilization: ISO standards for sterilization processes and sterility assurance.
- Functional Performance: The established specifications of the predicate device (Drug Relief K173861) serve as the benchmark for "equivalent performance."
8. The Sample Size for the Training Set
This is not applicable and not provided, as there is no mention of an algorithm or AI model requiring a training set in this submission.
9. How the Ground Truth for the Training Set was Established
This is not applicable and not provided, for the same reason as point 8.
§ 882.5896 Percutaneous nerve stimulator for substance use disorders.
(a)
Identification. A percutaneous nerve stimulator for substance use disorders is a device that stimulates nerves percutaneously to aid in the reduction of withdrawal symptoms associated with substance use disorders.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed.
(3) Electrical performance testing of the device and electrodes must be conducted to validate the specified electrical output and duration of stimulation of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Sterility testing of the percutaneous components of the device must be performed.
(6) Shelf life testing must be performed to demonstrate continued sterility, package integrity, and device functionality over the specified shelf life.
(7) Labeling must include the following:
(i) A detailed summary of the device technical parameters;
(ii) A warning stating that the device is only for use on clean, intact skin;
(iii) Instructions for use, including placement of the device on the patient; and
(iv) A shelf life.