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510(k) Data Aggregation
(199 days)
The Transcutaneous Electrical Applicator (TEA) is a transcutaneous electrical nerve field stimulator system intended to be used in adult patients with functional abdominal pain associated with irritable bowel syndrome (IBS) through application to Cranial Nerves V, VI, IX and X, and the occipital nerves, as an aid in the reduction of pain when combined with other therapies for IBS. TEA device is intended to be used for 7-120 hours per week up to 3 consecutive weeks.
The TEA Device is a non-invasive, battery-operated, prescription-based transcutaneous electrical nerve field stimulator indicated for use in adult patients with functional abdominal pain associated with the irritable bowel syndrome (IBS). The system includes the following components: TEA Device, lead cable, USB charging cable, USB power adapter, electrode pads, holding clip, and TEA IBS app. The device can be used in clinical environments (i.e., outpatient clinics and hospitals) and/or at home. The TEA Device is powered by an internal rechargeable lithium polymer battery and uses a microprocessor to control the working modes, the waveform and strength of the output pulse. The electric pulse generator is based on a current source circuit. The power management module contains a DC-DC boost conversion circuit that provides the required voltage for the electric pulse generator. The TEA Device is able to connect with the TEA IBS app, which is located on a smartphone. The user interface is available on both the TEA Device and TEA IBS app. The user can power on/off the device, adjust treatment time and treatment intensity. Treatment time is adjustable within the of range 5~240 minutes per treatment session with a maximal operating time of 8.6 hours per day. In addition, there is over-load, over-current and no-load protection as well as an automatic shut-off function. The Bluetooth transceiver module is responsible for communication between the TEA Device and TEA IBS app located on a smartphone.
The provided document describes the Transtimulation Research Inc.'s Transcutaneous Electrical Applicator (TEA) Device (Model: SNM-FDC01) and its substantial equivalence to a predicate device, the IB-Stim.
The acceptance criteria are derived from the special controls for devices under 21 CFR 876.5340, as well as general performance requirements for medical devices. The study provided focuses on the clinical effectiveness of the device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Patient-contacting components must be demonstrated to be biocompatible (ISO 10993-1, G95-1). | Biocompatibility evaluation conducted (Cytotoxicity, Irritation tests). The TEA pads and Device were evaluated for skin contact for prolonged use (>24 hours to 30 days). Outcome: Testing demonstrated compliance. |
| Electrical Safety & EMC | Electromagnetic compatibility, electrical, mechanical, and thermal safety testing must be performed (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, IEC 60601-1-2). | Electrical safety and EMC testing conducted. Outcome: The system complies with IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10 for safety and IEC 60601-1-2 for EMC. |
| Battery Safety | Battery evaluation must be performed (IEC 62133-2). | Battery evaluation conducted. Outcome: Compliance demonstrated to IEC 62133-2. |
| Wireless/Radio Testing | Radio and wireless testing (FCC 47 CFR Part 15 Subpart C, ANSI IEEE C63.27). | Compliance demonstrated to FCC 47 CFR Part 15 Subpart C, ANSI IEEE C63.27 for radio and wireless testing. Outcome: Compliance demonstrated. |
| Electrical Performance | Electrical performance testing of the device and electrodes must be conducted to validate specified electrical output and duration of stimulation. | "The TEA Device and its components were tested to validate the safety and effectiveness of the device. The TEA Device has equivalent performance specifications when compared to the predicate device." "The Model SNM-FDC01 has been previously cleared under K212377 with the identical design and performance specification." Outcome: Implicitly satisfied through testing and previous clearance of a device with identical design/performance. |
| Software Verification & Validation | Software verification, validation, and hazard analysis must be performed (FDA Guidance for Industry and FDA Staff). | Software verification and validation testing conducted, documentation provided. Outcome: Software considered "moderate" level of concern and testing performed as per guidance satisfied requirements. |
| Shelf Life | Shelf-life testing of the electrode pad must be performed to demonstrate continued package integrity and device functionality over labeled shelf life. | Shelf life of the TEA electrode pad demonstrated to be 2 years. Outcome: Satisfied. |
| Clinical Efficacy (for Indication of Use) | Reduction of functional abdominal pain and constipation associated with IBS. | Complete Spontaneous Bowel Movements (CSBMs) per week: TEA group tripled (2.8 ± 2.2) vs. sham (0.9 ± 0.9), P < 0.01. Bristol Stool Form Scale (BSFS) score: TEA group doubled (3.7 ± 1.3) vs. sham (1.8 ± 1.1), P < 0.001. Visual Analog Scale (VAS) for abdominal pain: TEA group was about one third (1.1 ± 1.1) vs. sham (3.1 ± 2.2), P < 0.01. Safety: No adverse effects observed in the TEA group. Outcome: Demonstrated significant benefits in relieving constipation and abdominal pain. |
| Clinical Safety (for Indication of Use) | Device is safe for its intended use. | No adverse effects observed in the TEA group during the 4-week clinical study. Outcome: Device shown to be safe. |
| Labeling | Must include: (i) detailed summary of technical parameters; (ii) warning for clean, intact skin; (iii) instructions for use including electrode placement; (iv) shelf life. | Required labeling components are listed as a special control. The document implies compliance will be met by including these in the final labeling. Outcome: A condition for acceptance, not explicitly tested in this summary. |
2. Sample size used for the test set and the data provenance
- Sample Size for Clinical Study (Test Set): A total of 42 patients (32 female and 10 male) with IBS-C were recruited.
- TEA therapy group: 21 patients
- Sham-TEA therapy group: 21 patients (2 dropped out, so 19 completed the study in this group).
- Data Provenance: The document does not specify the country of origin of the data. It was a prospective, randomized sham-controlled clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document does not detail the use of experts to establish a "ground truth" per se for the clinical study. The efficacy outcomes (CSBMs, BSFS, VAS scores) are patient-reported or clinically measured endpoints, rather than requiring expert adjudication of images or diagnoses. No information is provided about the qualifications of the clinicians or researchers who conducted the study or assessed these endpoints.
4. Adjudication method for the test set
- "Adjudication method" typically applies to expert review of diagnostic tasks (e.g., in radiology studies). This clinical study used direct patient outcomes and measurements (CSBMs, BSFS, VAS scores) as endpoints. Therefore, a formal expert adjudication method like 2+1 or 3+1 is not applicable and not mentioned. The study was randomized and sham-controlled to mitigate bias.
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
- No, an MRMC comparative effectiveness study was not done. This device is a direct treatment device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, the clinical study essentially demonstrates the standalone performance of the TEA device as a treatment. Healthcare professionals apply the device and instruct patients on its use, but the device itself delivers the therapy. The study compares the device's therapeutic effect (TEA group) against a sham control, not against human performance.
7. The type of ground truth used
- For the clinical study, the "ground truth" or primary endpoints were:
- Patient-reported outcomes: Complete Spontaneous Bowel Movements (CSBMs) per week, Bristol Stool Form Scale (BSFS), and Visual Analog Scale (VAS) for abdominal pain. These are direct measures of the patient's condition and response to treatment.
8. The sample size for the training set
- The document describes a clinical study to support the safety and efficacy of the device. This is a testing or validation study, not a training set for an AI/machine learning model. Therefore, no "training set" sample size is applicable or provided in this context.
9. How the ground truth for the training set was established
- As this is not an AI/ML development study, there is no "training set" or corresponding ground truth establishment process to describe. The clinical study was designed to validate the device's performance in a controlled environment.
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