(354 days)
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No
The device description and performance studies focus on mechanical and magnetic actuation for urine drainage, with no mention of AI or ML algorithms for control, analysis, or prediction.
Yes
The device is intended for use in female patients with incomplete bladder emptying due to impaired detrusor contractility of neurologic origin, which is a medical condition. The device directly addresses this condition by providing a mechanism to transfer urine out of the bladder, and clinical studies evaluate its effectiveness in resolving this issue and improving related quality of life, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This device is a therapeutic device designed for managing incomplete bladder emptying by assisting the transfer of urine out of the bladder. It does not diagnose any condition.
No
The device description clearly outlines three physical components: the inFlow device (a urethral insert), the Activator (a battery-powered handheld remote control), and the Sizing Device (a single-use urethral insert). These are all hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The inFlow Intraurethral Valve-Pump and Activator is a physical device inserted into the urethra to facilitate bladder emptying. It directly interacts with the patient's anatomy and manages urine flow. It does not analyze biological specimens in vitro.
- Intended Use: The intended use is to manage incomplete bladder emptying due to impaired detrusor contractility, which is a functional issue, not a diagnostic one based on specimen analysis.
Therefore, the inFlow system is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The inFlow Intraurethral Valve-Pump and Activator is a replaceable urinary prosthesis that is intended for use in female patients 18 years of age or older who have incomplete bladder emptying due to impaired detrusor contractility of neurologic origin, and who are capable of operating it in accordance with instructions or who have trained caregivers. The device must be replaced every 29 days (or less).
Product codes (comma separated list FDA assigned to the subject device)
PIH
Device Description
The inFlow Intraurethral Valve-Pump and Activator is a system that is designed for the management of impaired detrusor contractility in adult females, and consists of the following three components:
- inFlow device: This is the primary component of the system. The inFlow device is a temporary (≤ 29 days) urethral insert, consisting of a silicone (b)(4) TS/CCI which (b)(4) TS/CCl and an internal valve and pump mechanism. This insert is available in multiple shaft lengths selected based on the length of the female urethra. The distal end of the device has six flexible fins to retain the tip of the device at the bladder neck and minimize expulsion. The proximal end of the device has a flange that rests against the urethral meatus to prevent migration into the bladder. The inFlow device is labeled to be replaced every 29 days (or less). It is mounted on and inserted with the aid of a disposable "Introducer" , and is removed by manually pulling the proximal flange.
- Activator: The Activator is a battery-powered (b)(4) TS/CCI handheld remote control, which, when held close to the patient's pubic region and turned ON, magnetically actuates (rotates) the internal inFlow pump mechanism to transfer urine out of the bladder. After voiding, the Activator closes an internal magnetic valve to block urine flow. When not in use, a protective shield covers the Activator's magnet to minimize interference. This component only contacts the patient's hand.
- Sizing Device: To determine the proper inFlow device size to use in a given patient, the physician uses a separately-packaged Sizing Device. The Sizing Device is a single-use device that is inserted into the urethra to measure the distance between the bladder neck and urethral meatus. This component is constructed from a (b)(4) TS/CCl This component contacts the patient's intact urethra mucosa for a maximum of several minutes.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Urethra, bladder
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Patients or trained caregivers operate the Activator. The initial device insertion is performed by a physician. Device removal/reinsertion can be performed by the patient, healthcare provider, or caregiver.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pivotal Clinical Study:
- Study Type: A prospective, single-arm, cross-over study comparing the safety, effectiveness, and patient satisfaction of the inFlow device to clean intermittent catheterization (CIC).
- Sample Size: Enrolled a total of 273 patients at 18 sites (15 U.S., 2 Canada & 1 Israel). 88 subjects were enrolled under the original protocol, and 185 subjects under the amended protocol.
- Key Results - Safety:
- 85% of subjects experienced at least one adverse event while using the inFlow device.
- Most common device-related adverse events: Urinary incontinence/leakage (53%), genitourinary pain (31%), asymptomatic bacteriuria (30%), UTI (28%), frequency/urgency/bladder spasms (20%), insert expulsion (18%), vulvovaginal/periurethral disorders (15%), hematuria (11%), insert malfunction (10%), insert problems (7%), dysuria (7%), and bladder inflammation (6%).
- Bladder inflammation, genitourinary pain, hematuria, and urinary incontinence/leakage were higher for the inFlow device, but were mild to moderate in severity and none posed any lasting safety risk.
- UTI appears lower with the inFlow device compared to CIC for study completers.
- One device-related SAE was reported (device migration).
- Cystoscopy examinations found no evidence that the inFlow device alters the urethra or bladder mucosa.
- Approximately half of study subjects discontinued use within the first two weeks, primarily due to discomfort and urine leakage.
- Key Results - Effectiveness:
- Primary effectiveness: Comparison of post-void residual urine volume (PVR) during inFlow & CIC phases. Success defined as PVR
§ 876.5140 Urethral insert with pump for bladder drainage.
(a)
Identification. A urethral insert with pump for bladder drainage is a catheter-like device with internal pump mechanism that is placed in the urethra. Under patient control the internal pump draws urine out of the bladder when voiding is desired, and blocks urine flow when continence is desired. The device is intended for use by women who cannot empty their bladder due to impaired detrusor contractility.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The elements of the device that may contact the urinary tract must be demonstrated to be biocompatible.
(2) Performance data must demonstrate the sterility of the device components that contact the urinary tract.
(3) Performance data must support shelf life by demonstrating continued sterility of the device (or the sterile components), package integrity, and device functionality over the requested shelf life.
(4) Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Urine flow rate testing.
(ii) Valve integrity testing.
(iii) Bladder neck retention force testing.
(iv) Pump/valve endurance testing.
(v) Encrustation testing.
(vi) Remote control reliability, mechanical integrity, and battery life testing.
(5) Clinical testing must demonstrate safe and effective use, document the device acceptance rate and the adverse event profile associated with clinical use, and demonstrate that the device performs as intended under anticipated conditions of use.
(6) Labeling must include:
(i) Specific instructions, contraindications, warnings, cautions, limitations, and the clinical training needed for the safe use of the device.
(ii) Statement of the maximum insert indwelling period.
(iii) Information on the patient education and support program prior to and during initial device use.
(iv) Information on the patient population for which the device has been demonstrated to be safe and effective.
(v) Information on how the device operates and the recommended treatment regimen.
(vi) A detailed summary of the device- and procedure-related complications or adverse events pertinent to use of the device.
(vii) An expiration date/shelf life.
(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 treatment regimen.
(iii) Information on the patient education and support program prior to and during initial device use.
(iv) Information on the patient population for which there is clinical evidence of safety and effectiveness.
(v) The potential risks and benefits associated with the use of the device.
(vi) Post-insertion care instructions.
(vii) Alternative treatments.
0
DE NOVO CLASSIFICATION REQUEST FOR INFLOW INTRAURETHRAL VALVE-PUMP AND ACTIVATOR
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Urethral insert with pump for bladder drainage. A urethral insert with pump for bladder drainage is a catheter-like device with internal pump mechanism that is placed in the urethra. Under patient control the internal pump draws urine out of the bladder when voiding is desired, and blocks urine flow when continence is desired. The device is intended for use by women who cannot empty their bladder due to impaired detrusor contractility.
NEW REGULATION NUMBER: 21 CFR 876.5140
CLASSIFICATION: II
PRODUCT CODE: PIH
BACKGROUND
DEVICE NAME: INFLOW INTRAURETHRAL VALVE-PUMP AND ACTIVATOR
SUBMISSION NUMBER: DEN130044
DATE OF DE NOVO: OCTOBER 25, 2013
- CONTACT: VESIFLO, INC. KEVIN M. CONNOLLY, CEO 8672 154TH Avenue NE REDMOND, WA 98052
REQUESTER'S RECOMMENDED CLASSIFICATION: II
INDICATIONS FOR USE
The inFlow Intraurethral Valve-Pump and Activator is a replaceable urinary prosthesis that is intended for use in female patients 18 years of age or older who have incomplete bladder emptying due to impaired detrusor contractility of neurologic origin, and who are capable of operating it in accordance with instructions or who have trained caregivers. The device must be replaced every 29 days (or less).
1
LIMITATIONS
The sale, distribution, and use of the inFlow Intraurethral Valve-Pump and Activator is limited to prescription use only.
Limitations on device use are also achieved through the following statements included in the Instructions for Use: Contraindications:
Active urinary tract infection. The inFlow device can be used once the infection has been treated.
Patients who are allergic to or otherwise cannot take oral antibiotics.
Warnings:
The inFlow device is intended for a maximum indwelling time of 29 days. Failure to replace the device at this frequency can increase the risks of infection and device malfunction.
Patients (and caregivers, where appropriate) must receive proper education and instruction in the insertion, removal, and use of the device. Specifically, emphasis must be placed on their responsibility to:
- Keep the Activator available for use at all times;
- Keep both an extra inFlow device and an alternate means of bladder drainage ● on hand at all times, to use in the event that the current inFlow device is expelled, removed, or is not working properly;
- Urinate every three to four hours during waking hours, even if they do not have ● bladder sensations;
- Contact their physician if they see blood in their urine, sense irritation or ● burning when urinating, suspect that the device is not functioning properly, or require MRI or radiation procedures (the device must be removed).
The safety and effectiveness of the inFlow Device have not been evaluated and are unknown in patients with the following conditions:
- Contracted, low-volume bladder (bladder capacity Screening phase (1 week CIC use + 1 week inFlow use)
- Baseline phase (8 weeks CIC use) o
- Treatment phase (16 weeks inFlow use) → primary effectiveness assessment O at Week 8
- o Follow-up phase (4 weeks CIC use)
- o Post-treatment phase (ongoing inFlow use)
The amended protocol specified the enrollment of 274 subjects. This increased enrollment limit allowed for (1) 50% drop out during the 1-week screening phases (e.g., tolerability problems), followed by (2) a 10% rate of loss to follow-up through the 8-week CIC baseline phase and the first 8 weeks of the inFlow device treatment phase. Based on these assumptions, it was anticipated that 137/274 subjects would complete the screening phase and start the main study, and 123/137 subjects would complete 8 weeks of the treatment phase.
Demographics:
- . Age: Mean = 51 yrs (range: 17-83 yrs)
- Race: 92% Caucasian, 5% Black, 3% Hispanic ●
Patient accountability and device tolerance:
A total of 273 female subjects were enrolled at 18 sites (15 U.S., 2 Canada & 1 Israel). Eightyeight (88) of the 273 subjects were enrolled under the original protocol (without a screening phase), and the remaining 185 subjects were enrolled under the amended protocol. Table 5 below summarizes the numbers of subjects completing the various study phases:
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Original protocol (n=88 enrolled) | Amended protocol (n=185 enrolled) |
---|---|
--Screening phase-- | --Screening phase-- |
N/A | 185 entered 1-week CIC screening phase |
N/A | 173 entered 1-week inFlow screening phase |
--Enrollment/Start of study-- | --Start of study-- |
88 entered baseline phase | 102 entered baseline phase |
71 entered treatment phase | 86 entered treatment phase |
→45 "evaluable" | →70 "evaluable" |
28 completed treatment phase | 49 completed treatment phase |
(28/71=39% treatment phase completion) | (49/86=57% treatment phase completion) |
Table 5: Patient accountability in the original and amended protocols | ||
---|---|---|
As anticipated, the 1-week inFlow device screening period was successful in identifying a large percentage of subjects (71/173=41%) who are not suited for device use. However, significant patient drop-out was observed during the 16 week inFlow device treatment phase in both the original and amended protocol populations: 61% in the original protocol, which improved to 43% in the amended protocol (after adding the 1-week tolerability screening phase). Therefore, while the patient drop-out rate experienced during the inFlow device treatment phase was significantly reduced with the addition of the 1-week tolerability screening phase (i.e., 61% to 43%), it remains non-negligible and prevents a meaningful intention-to-treat analysis. Despite this finding, it is noteworthy that nearly all subjects who completed the treatment phase (i.e., 75/77) went on to continue to use the inFlow device, indicating that a subset of subjects become accustomed to its long-term use.
Reasons for subject withdrawal were mostly device-related. Of these, the predominant reasons for drop-out were discomfort and urine leakage around the device (termed "incontinence"). The reports of discomfort were typically an unnatural feeling of the presence of the device (likened to the adjustment period to contact lenses), and not major pain.
The following patient characteristics were found to be predictive of inFlow device tolerance:
- Successful completion of a 1-week device trial period.
- Low quality of life using CIC for bladder drainage. ●
- Absence of hypersensitivity of the urethra or bladder neck.
In addition to these predictive characteristics. Australian researchers found that instituting patient education and support programs was effective in maintaining patient motivation during the device acclimation period (discussed further, below).
Safety:
The safety of the inFlow device was assessed by analyzing the adverse event profile across the entire study population, and comparing these events to those experienced by the same subjects at baseline and during CIC. Analysis was performed both on all available subjects entering inFlow device treatment phase (n=157) and on "completers" (n=77).
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A total of 85% of subjects experience at least one adverse event while using the inFlow device. Those events likely related to the device that occurred with the most frequency are listed in Table 6:
| Adverse event type | inFlow device rate
(n=157 subjects) |
|-------------------------------------|----------------------------------------|
| Asymptomatic bacteriuria | 30% |
| Bladder inflammation | 6% |
| Dysuria | 7% |
| Frequency, urgency, bladder spasms | 20% |
| Genitourinary pain | 31% |
| Hematuria | 11% |
| Insert malfunction | 10% |
| Insert problems | 7% |
| Insert expulsion* | 18% |
| Urinary incontinence** (“leakage”) | 53% |
| UTI | 28% |
| Vulvovaginal/periurethral disorders | 15% |
Table 6: Adverse events - inFlow device
- "Insert expulsion" refers to expulsion of the valve-pump mechanism from the insert, not expulsion of the entire insert due to failure of the bladder neck retention mechanism. In 2000, the device was modified to correct this problem.
** "Urinary incontinence", when reported with use of the inFlow device, refers to intermittent urine leakage around the outside of the insert, and not true onset of incontinence.
Of note, no inFlow device failed due to encrustation.
Six subjects experienced a serious adverse event (SAE) while using the inFlow device: accidental injury, device migration, gastrointestinal disorder, neurological disorder, and nongenitourinary pain. The device migration was the only device-related SAE.
For comparison, 54% of subjects reported at least one pre-existing adverse event at study entry, and 74% of subjects reported at least one adverse event during the 8-week CIC baseline period. Table 7 compares the adverse event rates among the 77 subjects that completed both CIC and inFlow arms. These results are presented for equal 8-week periods, dividing the inFlow device treatment period into weeks 1-8 and weeks 9-16.
Adverse event type | CIC events (%) | inFlow device | inFlow device |
---|---|---|---|
events (%) | events (%) | ||
(weeks 1-8) | (weeks 9-16) | ||
(n=77 completers) | (n=77 completers) | (n=77 completers) | |
Asymptomatic bacteriuria | 31 (40%) | 18 (23%) | 24 (31%) |
Bladder inflammation | 0 | 0 | 8 (10%) |
Frequency, urgency, bladder | 10 (13%) | 13 (17%) | 7 (9%) |
spasms |
Table 7: Adverse events - Comparison CIC to inFlow (study completers only)
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Genitourinary pain | 10 (13%) | 15 (19%) | 16 (21%) |
---|---|---|---|
Hematuria | 1 (1%) | 3 (4%) | 4 (5%) |
Urinary incontinence/leakage | 14 (18%) | 40 (52%) | 37 (48%) |
UTI | 21 (27%) | 15 (19%) | 16 (21%) |
Vulvovaginal/periurethral disorders | 11 (14%) | 12 (16%) | 10 (13%) |
Of these events, only bladder inflammation, genitourinary pain, hematuria, and urinary incontinence/leakage were higher for the inFlow device, and none posed any lasting safety risk. Additionally:
- All 8 bladder inflammations were of mild severity.
- All genitourinary pain events were mild to moderate in severity.
- Hematuria events were of mild to moderate severity, and none required treatment or ● device removal.
- All incontinence (i.e., urine leakage) events were of mild to moderate severity. ●
It is noteworthy that the most potentially significant of these adverse events – UTI – appears lower with the inFlow device, was stable, and was easily managed with antibiotics.
With the exception of "genitourinary pain" and "urinary incontinence," comparisons of the adverse events reported by study completers and those who withdrew early do not show any significant differences. "Genitourinary pain" and "urinary incontinence" were higher among non-completers, which are expected given that "discomfort" and "urine leakage" were the two main reasons cited for discontinuing use of the inFlow device.
In addition to adverse event data, the protocol also collected safety information in the form of cystoscopy examinations performed (i) at baseline, (ii) after the 8-week CIC usage period, and (iii) after the 16 week inFlow device period. These exams found no evidence that the inFlow device alters the urethra or bladder mucosa.
Effectiveness:
The effectiveness data are presented for the "evaluable" subjects (n=115), which are those subjects who have any PVR data available for both the baseline and treatment periods. This number is higher than the number of completers (n=77), and is closer to the intent of the protocol (which was to analyze subjects who completed 8 weeks of inFlow device treatment). To support pooling PVR data from across all evaluable subjects, the submission shows that PVR measurements were independent of the duration of inFlow device use (i.e., similar values regardless of whether the measurement was taken early or late in the inFlow device treatment period).
For the primary effectiveness analysis, a patient was considered to be a "success" if her PVR was "comparable to CIC," defined as either:
(i)