(233 days)
The Eclipse System is indicated for the treatment of fecal incontinence in adult women. It is intended for prescription use.
The Eclipse System is a device intended to treat women with fecal incontinence (FI), also referred to as "accidental bowel leakage", or "bowel control disorder". The Eclipse System contains the Eclipse Insert and the Pump, including Regulator. The Eclipse Insert is used intra-vaginally, is insertable/removable by the patient, and includes a balloon that when inflated, exerts a force posteriorly (trans-vaginally) against the wall in the rectum resulting in a decrease in the lumen of the rectum (Figure 1). The compression of the rectal space results in decreased frequency of fecal incontinence events. The Eclipse Insert consists primarily of a silicone and stainless steel base with an inflatable silicone balloon. The pump is used by the patient for inflating and deflating the balloon with a goal of improving control over bowel movements.
"The Eclipse System is designed to treat fecal incontinence in adult women. The acceptance criteria and the study proving the device meets these criteria are detailed below:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Eclipse System were primarily focused on its effectiveness in reducing fecal incontinence (FI) episodes, safety, and specific bench testing parameters.
| Attribute(s) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Effectiveness | Primary Endpoint: ≥40% of subjects reporting ≥50% reduction in FI episodes during the on-device period compared to baseline. | Primary Endpoint: 79% of subjects (ITT Cohort, n=61) reported ≥50% reduction in FI episodes (95% CI 66-88%, p |
§ 876.5930 Rectal control system.
(a)
Identification. A rectal control system is a prescription device intended to treat fecal incontinence by controlling the size of the rectal lumen. The device is inserted in the vagina and includes a portion that expands to reduce the rectal lumen to prevent stool leakage and retracts to allow normal passage of stool. The device includes an external regulator to control the state of expansion.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical testing must document the device acceptance data and the adverse event profile associated with clinical use, and demonstrate that the device performs as intended under anticipated conditions of use.
(2) The elements of the device that contact vaginal tissue must be demonstrated to be biocompatible.
(3) The cleaning and disinfection instructions for the device must be validated.
(4) Non-clinical (bench) testing must demonstrate that the device performs as intended under anticipated conditions of use.
(5) Non-clinical (bench) testing must demonstrate that the device does not:
(i) Enhance the growth of
Staphylococcus aureus. (ii) Increase production of Toxic Shock Syndrome Toxin-1 by
S. aureus. (iii) Alter the growth of normal vaginal flora.
(6) Labeling must include:
(i) Specific instructions, contraindications, warnings, cautions, limitations, and the clinical training needed for the safe use of the device.
(ii) The intended patient population and the intended use environment.
(iii) Information on how the device is to be fitted, how the device operates, and recommendations on device maintenance.
(iv) A detailed summary of the clinical testing pertinent to the use of the device, including a summary of the device- and procedure-related complications or adverse events related to use of the device, as well as relevant safety and performance information.
(7) Patient labeling must be provided and must include:
(i) Relevant contraindications, warnings, precautions, and adverse events/complications.
(ii) Information on how the device operates and the recommended device maintenance (
i.e. , care instructions), including cleaning and disinfection.(iii) Information on the patient population for which there was a favorable benefit/risk assessment.
(iv) The potential risks and benefits associated with the use of the device.