(233 days)
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Not Found
No
The device description and performance studies focus on a mechanical device (inflatable balloon) and its clinical effectiveness, with no mention of AI, ML, image processing, or data training/testing sets.
Yes
The device is indicated for the "treatment of fecal incontinence" and its description explains how it reduces "FI episodes" by mechanically compressing the rectum, which are direct therapeutic actions.
No
Explanation: The device description states that the Eclipse System is "intended to treat women with fecal incontinence (FI)". Its function is to inflate a balloon to compress the rectal space, which "results in decreased frequency of fecal incontinence events." This is a therapeutic function, not a diagnostic one.
No
The device description clearly states the system contains physical components: the Eclipse Insert (silicone and stainless steel base with an inflatable silicone balloon) and the Pump (including Regulator). These are hardware components, not software.
Based on the provided information, the Eclipse System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the treatment of fecal incontinence in adult women. IVDs are used for the diagnosis or monitoring of diseases or conditions.
- Device Description: The device description clearly outlines a physical device (insert and pump) that is used intra-vaginally to exert pressure and physically reduce the lumen of the rectum. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Mechanism of Action: The device works by physically compressing the rectum to prevent leakage, not by analyzing biological samples to detect or measure substances.
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample collection, or any other typical components or processes associated with IVD devices.
In summary, the Eclipse System is a therapeutic device designed to physically treat a condition, not a diagnostic device used to analyze samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Eclipse System is indicated for the treatment of fecal incontinence in adult women. It is intended for prescription use.
Product codes
PJH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Rectal lumen, Vagina
Indicated Patient Age Range
Adult women
Intended User / Care Setting
Physicians with expertise in the evaluation of pelvic floor anatomy for the initial fitting and placement. The device is intended for prescription use and to be used by the patient at home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The Eclipse System has been the subject of three clinical studies: two feasibility studies and a pivotal study. Across all studies, 219 subjects have worn the device.
Feasibility Studies:
Goal: Evaluate proof of concept regarding device stability, positioning, rectal occlusion, patient comfort, fitting process, and usability feedback.
Sample Size: 102 subjects exposed to the device.
Results: No serious device-related adverse events. 9 non-serious, device-related adverse events (mild, e.g., minor bleeding/superficial cuts from insertion/removal, minor ecchymosis), which resolved quickly.
Pivotal Study:
Study Design: Multi-center, prospective, open-label, safety and effectiveness study in women with fecal incontinence.
Eligibility: 6-month history of FI, ≥ 4 FI episodes during 2-week baseline, successful fitting of the Insert.
Primary Endpoint: Reduction of FI episodes after 1 month of treatment compared to baseline without the device.
Success Criterion: ≥40% of subjects reporting ≥50% reduction in FI episodes during the on-device period as compared to the baseline period.
Sample Size: 200 subjects consented, 61 subjects (31%) entered the Treatment Period.
Safety Results: 93 AEs in 61 subjects reported as device-related/possibly device-related. No serious device-related adverse events. All device-related AEs were rated as mild (78%) or moderate (22%) and none required medical intervention beyond topical creams. Most common AE was pelvic cramping or discomfort.
Effectiveness Results (ITT Cohort, N=61): 79% of subjects reported at least a 50% reduction in FI episodes (95% CI 66-88%), statistically exceeding the 40% threshold (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.
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DE NOVO CLASSIFICATION REQUEST FOR ECLIPSE SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Rectal Control System: 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.
NEW REGULATION NUMBER: 876.5930
CLASSIFICATION: II
PRODUCT CODE: PJH
BACKGROUND
DEVICE NAME: Eclipse System
SUBMISSION NUMBER: DEN140020
DATE OF DE NOVO: June 25, 2014
REQUESTOR CONTACT: Pelvalon, Inc. 923 Thompson Pl. Sunnyvale, CA 94085
REQUESTER'S RECOMMENDED CLASSIFICATION: II
INDICATIONS FOR USE
The Eclipse System is indicated for the treatment of fecal incontinence in adult women. It is intended for prescription use.
LIMITATIONS
The sale, distribution, and use of the Eclipse System are limited to prescription use only.
Limitations on device use are also achieved through the following statements included in the Physician Instructions:
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Contraindications
- . Presence of vaginal infection
- . Presence of open vaginal wound
Warnings
- This product contains metal and so must be removed before undergoing an MRI, in . order to prevent any potential adverse events that may occur due to heating or movement of the Insert during the MRI.
- . Before obtaining a pelvic X-ray, patients should consult their physician about whether or not to remove the Eclipse Insert as the Insert may obscure images.
- . The Eclipse Insert and the Pump are for single-patient use only.
Precautions
- This device should only be prescribed by physicians with expertise in the evaluation of pelvic floor anatomy.
- . Prior to each use, inspect the Eclipse Insert and Pump for possible damage. If damaged, do not use.
- . Patients should continue the use of any treatment they are using for vaginal atrophy (e.g., topical estrogen cream).
- . Care should be taken to avoid use in patients with severe vaginal atrophy that would prevent safe, effective, or comfortable use of the Insert.
- The safety and effectiveness of the Eclipse System have not been evaluated in patients with pelvic organ prolapse beyond the plane of the hymen or who are pregnant.
- The safety and effectiveness of the Eclipse System have not been evaluated in women ● who use an IUD.
- Use of the Eclipse System after a recent hysterectomy may compromise the integrity ● of the vaginal cuff repair.
- . The safety and effectiveness of the Eclipse System for use in women with less than 4 episodes of fecal incontinence over a 2-week period have not been demonstrated.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
Device Description
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
2
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.
Image /page/2/Picture/1 description: The image shows two diagrams of the female reproductive system. The diagrams show the uterus, bladder, and vagina. The diagram on the left shows a normal bladder, while the diagram on the right shows a bladder prolapse. In the bladder prolapse diagram, the bladder has dropped down into the vagina.
Figure 1. Eclipse Insert; balloon deflated (left) and inflated (right)
The Eclipse System is composed of: The Eclipse Insert and a Patient Pump (or simply called "the pump").
Eclipse Insert (Figure 2): The insert is composed of a base portion, an inflatable balloon portion, and inflation tube (also called a tube), and a valve (also referred to as inflation valve or self-closing Luer valve). The base portion positions the balloon and helps maintain the placement of the Insert in the vagina; its exterior (patient contact) is silicone with internal stainless steel and silicone components. The base is flexible to allow for ease of insertion and removal. The balloon is made of thin walled silicone, with an enclosed, non-body contacting polyurethane liner to enhance its impermeability to air, minimizing air loss. The silicone inflation tube connects the balloon on one end, and on the other end, terminates in a self-closing Luer valve. A silicone cap is included to keep contaminate out of the valve. An optional extension tube is also provided that can be added to the existing tube to increase its length.
Image /page/2/Picture/5 description: The image shows a medical device with several labeled components. The device includes an inflatable balloon connected to an inflation tube. There is also a base and a self-closing luer valve with a cap, which are all part of the device's structure.
3
Figure 2. Eclipse Insert (inflated)
The following is recommended regarding the Insert:
- . The initial fitting and placement of the Eclipse should be done by a physician, to estimate the size of the vagina, and to match the appropriate Eclipse size with the patient's anatomy
- It can remain in the vagina continuously up to a week, but can be removed by the ● patient at any time
- It should be removed during sexual intercourse ●
- . Air should be added to the balloon at least three times daily (minimally including morning, night and after bowel movements), as some air will leak out over time
- It should be removed and cleaned on a weekly basis ●
- . It should be removed and cleaned daily during menstruation
- It should be disinfected if it becomes soiled
- . For bowel movements, air is removed from the balloon and then when the patient has defecated, the device is re-inflated
- The device should be replaced yearly
- . Special instructions are provided for women with a prior hysterectomy
Table 1 shows the different sizes that are available to clinicians for ensuring the best fit for the patients.
| Product Code | Base Measurement
Length x Width (mm) | Balloon Measurement
Height x Width (mm) |
|--------------|-----------------------------------------|--------------------------------------------|
| 48ES | 48x48 | 37x36 |
| 48EL | 48x48 | 47x42 |
| 51US | 51x48 | 37x36 |
| 51UL | 51x48 | 47x42 |
| 51ES | 51x51 | 37x36 |
| 51EL | 51x51 | 47x42 |
| 54ES | 54x54 | 37x36 |
| 54EL | 54x54 | 47x42 |
| 55US | 55.5x51 | 37x36 |
| 55UL | 55.5x51 | 47x42 |
| 57US | 57x54 | 37x36 |
| 57UL | 57x54 | 47x42 |
| 57ES | 57x57 | 37x36 |
| 57EL | 57x57 | 47x42 |
| 62US | 62x57 | 37x36 |
Table 1. Balloon Measurements
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| Product Code | Base Measurement
Length x Width (mm) | Balloon Measurement
Height x Width (mm) |
|--------------|-----------------------------------------|--------------------------------------------|
| 62UL | 62x57 | 47x42 |
| 64ES | 64x64 | 37x36 |
| 64EL | 64x64 | 47x42 |
| 70US | 70x64 | 37x36 |
| 70UL | 70x64 | 47x42 |
| 70ES | 70x70 | 37x36 |
| 70EL | 70x70 | 47x42 |
| 76US | 76x70 | 37x36 |
| 76UL | 76x70 | 47x42 |
| 76ES | 76x76 | 37x36 |
| 76UL | 76x76 | 47x42 |
| 83US | 83x76 | 37x36 |
| 83UL | 83x76 | 47x42 |
Table 1. Balloon Measurements, continued
Patient Pump (Figure 3): As shown in Figure 3a, the patient pump (external to the patient) has two ends that connect to the valve: one end for adding air, and the other end for removing air (labeled with a "+" and "-", respectively). The patient pump interfaces with the Eclipse insert via the self- closing Luer valve (Figure 3b). The pump is fitted with a regulating valve (also called a Regulator), also external to the patient, which regulates the amount of air introduced to the inflatable balloon portion of the Eclipse insert. Air is moved through the pump by squeezing the pump body. During inflation, the Pump is squeezed seven to ten times. Typically, fewer than seven pumping motions are necessary to adequately fill the balloon and any excess air is vented out by the regulator. Regulators are removable so that different balloon pressures can be achieved. Regulators are provided as single -patient use only. The patient pump is:
- Supplied non-sterile .
- . For single-patient use
Image /page/4/Picture/5 description: The image shows a medical inflation device against a blue background. The device has a black, bulbous pump body with a white regulating valve attached to one side. An inflation port is located on the same side as the regulating valve, while a deflation port is on the opposite side of the pump body. The device appears to be designed for inflating medical devices or components.
Image /page/4/Picture/6 description: The image shows a medical device with several components. There is a clear, circular device connected to a thin, transparent tube. The tube leads to a pump with a self-closing luer valve, which is connected to a black, oval-shaped bulb pump. The device appears to be designed for inflating or deflating the circular component using the bulb pump.
Figure 3a. Patient Pump.
Figure 3b. Eclipse insert connected to patient pump.
There are five regulators that come with the device, and they are listed in Table 2:
5
| Regulator # | Pressure at Full
Inflation (mmHg) |
|-------------|--------------------------------------|
| 1 | 45-57 |
| 2 | 58-69 |
| 3 | 70-92 |
| 4 | 93-113 |
| 5 | 114-129 |
Table 2. Regulator Pressures.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The Eclipse System is comprised of an Insert and a Pump. The Insert part of the Eclipse System, when used as intended, is considered as a surface device with long term (> 30 days) contact with intact mucosal membrane. As discussed in Tables 3 and 4 below, the body-contacting materials on the portion of the Insert that typically reside inside the vagina are the base, balloon, and tube. The Pump part of the Eclipse System, when used as intended, is considered as a surface device with limited ( 40% of the subjects would have a ≥ 50% reduction in FI episodes. FI episodes were categorized as major soiling (a large accident that required an immediate change of undergarment, pad. or clothing) or minor soiling (stool leakage that is more than just staining, but did not
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require an immediate change of undergarment, pad, or clothing). Episodes of staining were not considered as FI episodes.
The primary effectiveness analysis performed on the intent to treat (ITT) Cohort demonstrated that 79% of the 61 subjects reported at least a 50% reduction in FI episodes (95% CI 66-88%), which statistically exceeded the study's predetermined 40% threshold for success (p