(153 days)
The IB-Stim is a percutaneous electrical nerve field stimulator (PENFS) system intended to be used in patients 8-21 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-Stim is intended to be used for 120 hours per week, using 1 device per week for 4 consecutive weeks, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination, as an aid in the reduction of pain when combined with other therapies for IBS.
IB-Stim stimulator is a battery-operated micro-stimulation appliance weighing 5 grams designed as a disposable product for a single use. IB-Stim stimulator is placed behind the patient's ear and connected to stimulation needles on the auricle. IB-Stim stimulator offers regular therapy over several days. The appliance transmits low-frequency electric pulses.
IB-Stim is a device system that consists of a (1) percutaneous electrical nerve field stimulator (PENFS); (2) sterile multi-pin wire harness array; (3) round bandages to fasten the appliance leads, stimulator skin adhesive, alcohol swab, transparent dressing, biohazard bag, and Patient ID card; (4) tweezers; (5) surgical marker; and (6) transilluminator for use in transillumination technique that aids in needle implantation. The wire harness array consists of 4 leads. The 1-1-1-4 configuration consists of three single-needle leads, and one 4-needle array. The transilluminator emits a light for use in the trans-illumination technician in identifying the nerve bundles in the ear.
The provided FDA 510(k) document for the NeurAxis IB-Stim (01-1020) does not contain detailed information regarding acceptance criteria or a specific study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (NeurAxis, Inc. IB-Stim – DEN180057) to justify its market clearance.
The document explicitly states: "There are no changes to the device design. Therefore, previously conducted testing in DEN180057 remains applicable and no additional performance testing is required." This indicates that the 510(k) relies on the performance data and acceptance criteria established for the predicate device.
However, the document does mention updates to the "intended treatment population" and "treatment duration" with clinical literature supporting these changes. This implies that while no new performance testing was required for the device itself, the justification for these expanded indications likely involved a review of existing clinical evidence.
Given the information provided, it's not possible to populate all the requested sections. Here's what can be inferred or stated as not provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document for the current submission K241533. The submission relies on the predicate device's established performance. | Not explicitly stated in the document for the current submission K241533. The submission relies on the predicate device's established performance for the device design. For the expanded indications (age range, treatment duration), clinical literature provided support rather than new device performance metrics. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document for K241533 does not describe a new test set or its provenance for device performance. It refers to "clinical literature" for supporting expanded indications. This literature would represent a collection of studies, each with its own sample size and provenance, but these details are not aggregated or provided here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no new test set is described for K241533. For the predicate device, or within the supporting clinical literature, this information would have been specific to each study, but it is not provided in this 510(k) summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no new test set is described for K241533.
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
Not applicable. The NeurAxis IB-Stim is a nerve stimulator, not an AI-assisted diagnostic device. Therefore, MRMC studies related to human reader improvement with AI are not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The NeurAxis IB-Stim is a medical device, not a standalone software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the expanded indications (age range, treatment duration), the document states that "Real world evidence including clinical literature support these changes" and "Recommendation from the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) based on clinical literature and current practice of medicine support the 4-week treatment. In addition, clinical literature supports safe and effective use of the IB-Stim device in children as young as 8 years old." This implies that the 'ground truth' for validating the expanded indications relies on clinical outcomes data and expert consensus/recommendations derived from existing clinical literature.
8. The sample size for the training set
Not applicable, as this device is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this device is not an AI/machine learning device that requires a training set.
§ 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.