(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<0.0001), significantly exceeding the 40% threshold. 86% of subjects (PP Cohort, n=56) reported ≥50% reduction (95% CI 74-94%, p<0.0001). 41% of the PP Cohort reported complete elimination of FI episodes. 70% reported ≥75% reduction. |
| Reduction in Incontinent Days | Not explicitly stated as an acceptance criterion, but a secondary endpoint. | Patients experienced a reduction from incontinence on 49% of days to 11% of days (average 6.9 incontinent days at baseline vs. 1.6 during treatment). |
| Reduction in Mean FI Episodes | Not explicitly stated as an acceptance criterion, but a secondary endpoint. | Mean FI Episodes per 2-week period reduced from 11.6±9.5 at baseline to 2.1±2.9 during the Treatment Period. |
| Quality of Life (QoL) Improvement | Not explicitly stated as an acceptance criterion, but evaluated. | All subscales of the Fecal Incontinence Quality of Life (FIQOL) and Modified Manchester Health Questionnaire (MMHQ) showed significant improvements. 86% of patients reported "very much better" or "much better" on PGI-I. 89% reported their most bothersome restriction was "completely addressed" or "helped a lot". 98% would recommend the system. |
| Safety - Serious Device-Related Adverse Events | No serious device-related adverse events. | No serious device-related adverse events reported in feasibility or pivotal studies. All 93 AEs (in 61 subjects) reported as device-related/possibly device-related were rated as mild (78%) or moderate (22%). |
| Safety - Comfort during use | Not explicitly stated as an acceptance criterion, but evaluated. | 96% of subjects (54/56 PP Cohort) found the Insert comfortable or could not feel it. One reported slightly uncomfortable but tolerable; one reported uncomfortable; zero reported painful. |
| Balloon Dimensions | Balloon dimensions must be ±3mm from nominal when insert is pressurized to 150mmHg. Must also meet width and height limits. | Performed successfully to characterize the safety and performance of the Eclipse System. (Specific values not provided in the summary, but stated as successful.) |
| Balloon Fatigue | No loss of integrity or function during worst case life cycling. After cycling, balloon dimensions and leak resistance must continue to pass. | Performed successfully. |
| Folding Fatigue | No loss of integrity or function during worst case life cycling. After cycling, base dimensions must continue to pass. | Performed successfully. |
| Leak Resistance | Balloon must maintain fluid volume between inflations. Insert inflated to maximum clinical amount, and with a 400g applied external load must lose <0.3mL of volume per hour during a test 4-36 hours. | Performed successfully. |
| Inflation Tool (Pump) use | Tool must inflate Insert to its Regulating Valve's pressure minimum and deflate. | Performed successfully. |
| Inflation Tool (Pump) & Relief Valve (Regulator) Fatigue | No loss of integrity or function during worst case life cycling. After cycling, Pump and Regulating Valve Function must continue to Pass. | Performed successfully. |
| Base Ring Deflection | No loss of integrity or function. Base dimensions must remain within tolerances and ≤ 3mm out of plane. | Performed successfully. |
| Accelerated Device Aging | Aged materials must pass all subsequent cycling tests and functional verifications. | Performed successfully. |
| Simulated Cleaning and Disinfection Cycling | No loss of integrity or function during worst case life cleaning and disinfection cycling. | Performed successfully. |
| Packaging and Effect of Distribution Stresses | Following testing, no loss of packaging or device integrity or function. | Performed successfully. |
| Biocompatibility | The elements of the device that contact vaginal tissue must be demonstrated to be biocompatible (Special Control 2). | Biocompatibility testing (Cytotoxicity, Sensitization, Vaginal Irritation, Muscle Implantation) was completed and supported by a Toxicological Risk Assessment. The materials were deemed biocompatible based on these tests. |
| Microbiological Testing | The device must not enhance the growth of Staphylococcus aureus, increase production of TSST-1 by S. aureus, or alter the growth of normal vaginal flora (Special Control 5). | Microbiological testing showed the use of the Eclipse System did not enhance S. aureus growth, increase TSST-1 production, or alter normal vaginal microflora. |
| Cleaning and Disinfection Validation | The cleaning and disinfection instructions for the device must be validated (Special Control 3). | The Eclipse System is provided non-sterile with cleaning instructions and low-level disinfection instructions. (Validation details not provided in the summary, but implied by special control satisfaction). |
2. Sample Size Used for the Test Set and Data Provenance
- Pivotal Study Sample Size (Test Set):
- Consented: 200 subjects.
- Entered Treatment Period (Intent-to-Treat - ITT Cohort): 61 subjects.
- Per Protocol (PP) Cohort: 56 patients (those with fully analyzable diary data).
- Data Provenance: The study was a multi-center, prospective, open-label study. While specific country of origin is not stated, "multi-center" implies data collection from several clinical sites. The "prospective" nature means data was collected specifically for the study as events occurred.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The ground truth for the effectiveness of the Eclipse System was established based on patient-reported outcomes, primarily through patient diaries tracking fecal incontinence episodes. There is no mention of external experts (e.g., clinicians, radiologists) establishing a separate "ground truth" for each patient's FI status or reduction. The primary endpoint definition relies on self-reported data from the subjects themselves.
4. Adjudication Method for the Test Set
Since the ground truth for effectiveness was based on patient-reported diaries, there was no explicit adjudication method by independent experts mentioned for the clinical endpoints. The study design likely included mechanisms for data integrity and completeness for the diaries, but not an external adjudication of the FI episodes themselves.
For safety events, adverse events were reported by investigators and classified as "device-related/possibly device-related," likely by the study investigators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, there is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study is typically performed for diagnostic imaging devices where different readers interpret the same cases. The Eclipse System is a therapeutic device for fecal incontinence, and its effectiveness was measured by changes in patient symptoms and quality of life, not by interpretive accuracy. Therefore, an MRMC study is not applicable here.
6. If a Standalone Study (Algorithm only without human-in-the-loop performance) was done
Yes, "standalone" performance in this context would refer to the device's efficacy when used as intended by the patient, without continuous human (clinician) intervention beyond fitting and instruction. The pivotal study assesses the "algorithm only" in the sense that it evaluates the device's performance as a therapeutic tool used by patients at home. The study directly measures how well the device, when used by the patient, reduces FI episodes and improves quality of life.
7. The Type of Ground Truth Used for the Test Set
The primary ground truth used for effectiveness was patient-reported outcomes via subject diaries.
- FI Episodes: Patients recorded the number of major or minor soiling episodes during baseline and treatment periods.
- Safety: Adverse events were reported by subjects and/or investigators.
- Quality of Life: Measured using validated questionnaires (FIQOL, MMHQ, PGI-I) and patient self-assessment of lifestyle restrictions.
8. The Sample Size for the Training Set
The document does not explicitly describe a separate "training set" in the context of an AI/algorithm where ground truth is independently established to train a model. This device is a physical medical device, not an AI or diagnostic algorithm that learns from data in that manner. The "training" for this device would refer to its development and iterative testing.
However, if "training set" is considered in the broader sense of initial clinical data used to refine the device or inform the pivotal study, then the two feasibility studies involved 102 subjects. This early data informed the pivotal study design and understanding of device performance and safety.
9. How the Ground Truth for the Training Set was Established
Given that this is a physical medical device and not an AI/ML algorithm requiring a distinct "training set" with established ground truth in the AI sense:
- For the feasibility studies (analogous to early development/training data), the goal was to "evaluate the proof of the Eclipse System by evaluating the device's stability and positioning, rectal occlusion, and patient comfort. The fitting process, comfort, and safety were evaluated, as well as usability feedback from those subjects suffering from FI."
- The ground truth in these feasibility studies would have been established through direct observation, patient feedback, and reporting of adverse events during device use, similar to the pivotal study but on a smaller scale and likely with broader objectives for product refinement rather than formal hypothesis testing."
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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
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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.
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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 MeasurementLength x Width (mm) | Balloon MeasurementHeight 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 MeasurementLength x Width (mm) | Balloon MeasurementHeight 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:
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| Regulator # | Pressure at FullInflation (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 (< 24 hours) contact with intact skin.
| Part Description | Material |
|---|---|
| Parts listed below may contact vaginal mucosa: | |
| Base Tubing | b(4) |
| Adhesive | b(4) |
| Silicone tubing | b(4) |
| Straight connector | b(4) |
| Valve | b(4) |
| Parts listed below do not contact the patient: | |
| Spring | b(4) |
| Wire (for base) | b(4) |
| Bladder Material | b(4) |
Table 3. List of component materials used in the Eclipse Insert.
Table 4. List of component materials used in the Eclipse Pump
| Part Description | Material |
|---|---|
| Parts listed below may contact skin (hand): | |
| Hand Pump | b(4) |
| Elbow connector | |
| T-connector | |
| Primer |
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| Check Valve Adapter | b(4) |
|---|---|
| Check valve | b(4) |
| Check Valve Adapter, printed | |
| Relief valves (5 sizes) | |
| Parts listed below do not contact the patient: | |
| Check Valve Shim | b(4) |
| Filter Paper | b(4) |
| Polyurethane Foam |
Biocompatibility testing (Table 5) was completed based on the nature of patient contact on the test articles identified as Eclipse Insert and Eclipse Patient Pump.
Table 5. Tests Completed for the Eclipse System.
| Eclipse Insert | ||
|---|---|---|
| ISO Cytotoxicity – L929 MEM Elution Test | ||
| ISO Maximization Sensitization – Guinea Pig | ||
| ISO Vaginal Irritation and Histopathology | ||
| ISO Muscle Implantation 1 week Interval | ||
| ISO Muscle Implantation 4 week Interval | ||
| Eclipse Pump | ||
| ISO Cytotoxicity – L929 MEM Elution Test | ||
| ISO Maximization Sensitization – Guinea Pig | ||
| ISO Skin Irritation |
In lieu of additional recommended tests for devices of this nature of contact (Genotoxicity, Systemic Toxicity (acute), Sub Chronic Toxicity, and Chronic Toxicity), a Toxicological Risk Assessment was completed to further support the biocompatibility of the Eclipse System.
SHELF LIFE/STERILITY
The Eclipse System (Insert and Pump), is provided non-sterile with cleaning instructions and low level disinfection instructions if the device should become soiled.
The device has not been labeled with a shelf life or expiration date, although the user is instructed that the device should be replaced annually.
Please refer to the labeling for a complete list of patient cleaning and disinfecting instructions.
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PERFORMANCE TESTING - BENCH
Microbiological testing on vaginal microflora and Toxic Shock Syndrome Toxin-1 (TSST-1) was performed to show that the use of the Eclipse System did not:
- Enhance the growth of Staphylococcus aureus
- Increase the production of TSST-1 by S. aureus
- Alter the growth of the normal vaginal microflora
The following bench tests were performed successfully to characterize the safety and performance of the Eclipse System:
| Attribute(s) | Test Description | Acceptance Criteria |
|---|---|---|
| Balloon Dimensions | Measure balloonwidth and height at150mmHg (MaxRegulating valvepressure + 21mmHgbuffer) | Balloon dimensionsmust be ±3mm fromnominal when insertis pressurized to150mmHg. Must alsomeet width and heightlimits. |
| Balloon Fatigue | Inflate balloon to150mmHg, then cycledeflation andinflation. Repeatdimensional and leakresistance testing. | No loss of integrity orfunction during worstcase life cycling.After cycling, balloondimensions and leakresistance mustcontinue to pass. |
| Folding Fatigue | Cycle device basebetween fully foldedand flatconfigurations. | No loss of integrity orfunction during worstcase life cycling.After cycling, basedimensions mustcontinue to pass. |
| Leak Resistance | Inflate balloon to 134mmHg under $\ge$ 400gload, then measure airloss over time. | Balloon mustmaintain fluid volumebetween inflations.Insert inflated tomaximum clinicalamount, and with a400g applied externalload must lose<0.3mL of volume perhour during a test 4-36 hours. |
| Inflation Tool (Pump) use | Use the Pump toinflate and deflate the | Tool must inflateInsert to its |
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| Attribute(s) | Test Description | Acceptance Criteria |
|---|---|---|
| Insert. | Regulating Valve'spressure minimumand deflate. | |
| Inflation Tool (Pump)& Relief Valve(Regulator) Fatigue | Pump with regulatingvalve into devicerepeatedly. RepeatPump and RegulatingValve use testing. | No loss of integrity orfunction during worstcase life cycling.After cycling, Pumpand Regulating ValveFunction mustcontinue to Pass. |
| Base Ring Deflection | Pull base ringmounted to a 35mmopening, with approx.5lbs force. | No loss of integrity orfunction. Basedimensions mustremain withintolerances and $\le$ 3mmout of plane. |
| Accelerated DeviceAging | Expose materials to 1year simulated agingat acceleratingtemperature. | Aged materials mustpass all subsequentcycling tests andfunctionalverifications. |
| Simulated Cleaningand DisinfectionCycling | Expose device tosimulated cycles ofcleaning anddisinfection. | No loss of integrity orfunction during worstcase life cleaning anddisinfection cycling. |
| Packaging and Effectof DistributionStresses | Expose packagedmaterials to climaticconditioning andpackage performancetesting. | Following testing, noloss of packaging ordevice integrity orfunction. |
SUMMARY OF CLINICAL INFORMATION
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
The goal of these studies was to evaluate the proof of the Eclipse System by evaluating the device's stability and positioning, rectal occlusion, and patient comfort. The fitting process, comfort, and safety were evaluated, as well as usability feedback from those subjects suffering from FI.
In the 102 subjects exposed to the device, there were no serious device-related adverse events and 9 non-serious, device-related adverse events. All 9 were mild [minor
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bleeding/superficial cuts due to tissue stretching upon insertion/removal (3) or minor ecchymosis (6)] and resolved quickly without medical intervention other than vaginal estrogen cream.
Pivotal Study
Study Design
The study design was a multi-center, prospective, open-label, safety and effectiveness study of the Eclipse System in women with fecal incontinence. To be eligible for treatment, patients must have met several screening criteria, including a 6-month history of FI, ≥ (greater than or equal to) 4 FI episodes (defined as major or minor soiling) during their 2-week baseline diary, and successful fitting of the Insert. The primary endpoint was reduction of FI episodes (as recorded in a patient diary) after 1 month of treatment with the Eclipse System (Treatment Period) compared to baseline without the device. A study success criterion was ≥40% of subjects reporting ≥50% reduction in FI episodes during the on-device period as compared to the baseline period. Subjects were invited to enter an Optional Treatment Period for an additional two months, for a total of 3 months of treatment.
Study Results
Two hundred (200) subjects were consented with 61 subjects (31%) entering the Treatment Period. The most common reason for screening exclusions prior to fitting was insufficient frequency of FI episodes during the baseline period (<4 FI episodes in two weeks), which accounted for 49% of exclusions prior to fitting. Of the 110 patients who continued to the fitting assessment, 49 (45%) did not achieve a successful fit or successfully complete the fitting assessment.
Safetv
There were 93 AEs in 61 subjects reported as device-related/possibly device-related. There were no serious device-related adverse events reported. All device-related adverse events were rated as mild (78%) or moderate (22%) and none required medical intervention beyond a topical vaginal steroid cream for vaginal erythema and an antifungal cream/suppository for yeast infection. The most common AE was pelvic cramping or discomfort which occurred in 15% of subjects during the fitting period. 11% of subjects during the treatment period and 8% of subjects who elected to continue use during the optional treatment period. There were substantially fewer occurrences in the Treatment Period and Optional Treatment Period once subjects were successfully fit with the device and entered treatment.
Effectiveness
The primary endpoint of the pivotal study was the reduction in the number of FI episodes/2 weeks during the 3rd and 4th week of study participation compared to the baseline 2 week assessment period. The study success criteria was that > 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<0.0001). Five (5) patients included in the ITT analysis were counted as treatment failures due to: unanalyzable diary data (2), exited due to unrelated health issues (2), and withdrew consent (1). In the Per Protocol (PP) Cohort, which included the 56 patients with fully analyzable diary data. 86% of subjects reported at least a 50% reduction in FI (95% CI 74-94%), also statistically exceeding the study's predetermined 40% threshold for success (p<0.0001). Twenty-three (23) subjects (41% of the PP Cohort) reported a complete elimination of FI episodes during the Treatment Period. Seventy percent (70%) of subjects reported 75% or greater reduction in FI episodes.
A secondary FI endpoint was the reduction in number of incontinent days while wearing the device during the 2 week assessment period as compared to the baseline 2 week assessment period. Patients experienced a reduction from incontinence on 49% of days to 11% of days (an average of 6.9 incontinent days in a 2-week period at baseline versus 1.6 incontinent days during the 2-week treatment diary). Additionally, patients experienced a reduction in the mean number of FI Episodes per 2-week period from 11.6±9.5 at baseline to 2.1±2.9 during the Treatment Period.
The sub-population evaluated were subjects with total hysterectomies. Of the 63 subjects with total hysterectomies in the Safety Cohort, 14 subjects reported devicerelated/possibly device-related adverse events (22%), which is less than the observed percentage of device-related/possibly device-related adverse events in the entire Safety Cohort (52%; 61/117). Additionally. 7/63 (11%) subjects in the Safety Cohort with total hysterectomies reported adverse events related to possible vaginal irritation or tissue damage, compared to 25/117 (21%) in the entire Safety Cohort. For the purpose of this analysis, adverse events in this category included the following: vaginal abrasion, vaginal irritation, vaginal ecchymosis or bruising, vaginal erythema/petechiae, vaginal bleeding, or vaginal spotting.
Due to the observed lower rates of device-related/possibly device-related adverse events and adverse events related to possible vaginal irrigation or tissue damage in women with a total hysterectomy, there is no increased risk of irritation, abrasion, or ulceration at the location of the vaginal cuff repair.
Quality of Life - All subscales of the Fecal Incontinence Quality of Life (FIQOL) and the Modified Manchester Health Questionnaire (MMHQ) showed significant improvements. In response to a Patient Global Impression of Improvement (PGI-I) question that asked patients to "check the item that best describes how [their] control of bowel leakage is now, compared with how it was without the [insert]". 86% of patients selected "very much better" or "much better". Patients were also asked to list their most bothersome lifestyle restriction, and rank the impact that use of the Eclipse had on it. Of the 53
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respondents to this question, 89% indicated that their most bothersome restriction was "completely addressed", or had been "helped a lot" (47% and 42%, respectively). Additionally, 98% (54/55) of patients responded that they would recommend the Eclipse System to a friend with FI. Finally, after completing the Treatment Period, 54/56 subjects (96%, PP Cohort) said the Insert was comfortable or they could not feel it (48% and 48% respectively); one subject reported the Insert was slightly uncomfortable, but tolerable; one reported the Insert was uncomfortable; and 0 patients reported the Insert was painful.
Optional Treatment Period - The treatment effect was maintained at the 3-month followup in the Optional Treatment Period for those that elected to continue use of the Eclipse System: 38 of 44 patients achieved treatment success (86.4%, 95% CI 73-95%). Significant improvements were also shown for clinical impact, comfort, and lifestyle, as measured by the FIQOL, MMHQ, and PGI-I scales, as well as subject satisfaction, comfort, and impact on lifestyle restrictions.
LABELING
Labeling for the Eclipse System includes Physician's Instructions for Use and a Patient Instructions for Use Manual, since the device is to be used at home. A package label is also included. The labeling is sufficient and satisfies the requirements of 21 CFR 801.109. The Instructions for Use and Patient Instructions for Use Manual provide all of the elements required as part of the Special Controls. Please refer to the Instructions for Use and Patient Instructions for Use Manual for device labeling.
RISKS TO HEALTH
Table 6 identifies the risks to health that may be associated with use of the Rectal Control System and the measures necessary to mitigate these risks.
| Identified Risk | Mitigation Method |
|---|---|
| Vaginal Wall Trauma | Clinical Testing Labeling |
| Adverse Tissue Reaction | Biocompatibility Testing |
| Infection | Non Clinical (bench) Testing Cleaning and Disinfection Validation Labeling |
| Device Malfunction | Non Clinical (bench) Testing Labeling |
| Urinary Urgency, Incontinence orVoiding Problems | Clinical Testing Labeling |
| Fecal Urgency, or Difficulty inEvacuation | Clinical Testing Labeling |
Table 6. Identified Risks to Health and Mitigation Measures
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| Identified Risk | Mitigation Method |
|---|---|
| Discomfort, Pain | Clinical Testing Labeling |
| Change in Amount, color, orconsistency of vaginal discharge | Labeling |
SPECIAL CONTROLS:
In combination with the general controls of the FD&C Act. the rectal control system is subject to the following special controls:
-
- 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.
-
- The elements of the device that contact vaginal tissue must be demonstrated to be biocompatible.
-
- The cleaning and disinfection instructions for the device must be validated.
-
- Non-clinical (bench) testing must demonstrate that the device performs as intended under anticipated conditions of use.
-
- Non-clinical (bench) testing must demonstrate that the device does not:
- a. Enhance the growth of Staphylococcus aureus
- b. Increase production of Toxic Shock Syndrome Toxin -1 by S. aureus
- c. Alter the growth of normal vaginal flora
-
- Labeling must include:
- a. Specific instructions, contraindications, warnings, cautions, limitations, and the clinical training needed for the safe use of the device.
- b. The intended patient population and the intended use environment.
- Information on how the device is to be fitted, how the device operates, and c. recommendations on device maintenance.
- d. 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.
-
- Patient labeling must be provided and must include:
- a. Relevant contraindications, warnings, precautions, and adverse events/complications.
- b. Information on how the device operates and the recommended device maintenance (i.e., care instructions) including cleaning and disinfection.
- Information on the patient population for which there was a favorable benefit/risk C. assessment.
- d. The potential risks and benefits associated with the use of the device.
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BENEFIT/RISK DETERMINATION
The data demonstrate a clinically meaningful improvement in terms of fecal incontinence episodes and fecal incontinent days along with an improvement in quality of life. This was achieved without any reported serious device-related adverse events.
The study design reflected the use of the device in clinical practice. The data demonstrated a high likelihood of success from the use of the device given the patient population as described in the indications for use, inclusion and exclusion criteria.
In conclusion, given the available information above, the data support the treatment of fecal incontinence in adult women, the probable benefits outweigh the probable risks for the Eclipse System. The device provides substantial benefits and the risks can be mitigated by the use of general and the identified special controls.
CONCLUSION
The de novo for the Eclipse System is granted and the device is classified under the following:
Product Code: PJH Device Type: Rectal Control System Class: II Regulation: 21 CFR 876.5930
§ 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.