(90 days)
The First Relief v1 is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The First Relief v1 is intended to be used for 120 hours per week up to 3 consecutive weeks, through application to Cranial Nerves V, VII, IX and X, and the occipital nerves identified by trans-illumination, as an aid in the reduction of pain when with other therapies for IBS.
The First Relief v1 is designed to aid in the reduction of pain when combined with other therapies of IBS in patients 11 - 18 years of age with Functional Pain associated with the Irritable bowel syndrome (IBS) by the method of Cranial electrical stimulation at the auricular stimulation points. The First 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 (V, VII, IX and X) on the ear through a set of wire assembly and Stimulation needles. Three zinc air batteries with 1.4 V each provides the required stimulation energy for a maximum of 120 hours. There are three Stimulation electrodes 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.
This FDA 510(k) summary for the "First Relief v1" device does not contain a study that establishes acceptance criteria and then proves the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device ("IB-Stim", DEN180057) through non-clinical testing and comparison of technical characteristics.
Here's a breakdown of the information that is and is not available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a formal table of acceptance criteria derived from a clinical trial or performance study, nor does it report specific device performance metrics against such criteria. The comparison table provided (pages 4-5) details the technical characteristics of the applicant's device (First Relief v1), their own previous device (Drug Relief), and the predicate device (IB-Stim). It highlights similarities and minor differences in design and specifications, not performance outcomes against predefined acceptance criteria.
2. Sample size used for the test set and data provenance:
- Sample size: Not applicable, as no clinical test set for performance against acceptance criteria is described. The document mentions "non-clinical testing" and "bench tests" but does not specify sample sizes for these.
- Data provenance: Not applicable for a clinical test set. The data presented are technical specifications and test results from non-clinical (bench) testing.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
Not applicable, as no clinical test set with human-established ground truth is described.
4. Adjudication method for the test set:
Not applicable, as no clinical test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating physical and technical equivalence to a predicate device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The "First Relief v1" is a physical medical device (percutaneous electrical nerve field stimulator), not an algorithm or software requiring standalone performance evaluation in the context of AI.
7. The type of ground truth used:
Not applicable, as there is no clinical study that would require a ground truth determination for diagnostic or treatment outcomes. The "ground truth" in this context refers to engineering specifications and performance benchmarks established during non-clinical testing (e.g., electrical output measurements).
8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is presented in the document instead:
The document demonstrates substantial equivalence to the predicate device (IB-Stim) based on:
- Intended Use: Nearly identical.
- Technological Characteristics: Very similar, with minor differences outlined in the table (e.g., product dimensions, weight, battery type/capacity, wire assembly type, sterilization method, shelf life).
- Non-Clinical Performance Testing: "The First Relief v1 has equivalent Performance specifications when compared to the predicate device." This includes functional testing for 120 hours to monitor continuous performance, capturing pulse width, pulse duration, amplitude, and current values.
- Compliance with Standards: The device complies with a list of IEC and ISO standards related to electrical safety, EMC, biocompatibility, and sterilization.
- Sterilization Testing: Detailed information on EtO sterilization validation for the needle package.
- Biocompatibility Testing: Performed per ISO 10993.
The key statement regarding performance is: "The First Relief v1 has equivalent Performance specifications when compared to the predicate device." This is a qualitative statement based on non-clinical (bench) testing, rather than a quantitative comparison against specific acceptance criteria from a clinical study. The FDA's clearance is based on the argument that these similarities and non-clinical test results demonstrate that the new device is as safe and effective as the predicate.
§ 876.5340 Nonimplanted nerve stimulator for functional abdominal pain relief.
(a)
Identification. A nonimplanted nerve stimulator for functional abdominal pain relief is a device that stimulates nerves remotely from the source of pain with the intent to relieve functional abdominal pain. This generic type of device does not include devices designed to relieve pelvic pain.(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 labeled 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.