(414 days)
Not Found (De Novo Classification Request)
No
The device description and performance studies focus on electrical stimulation patterns and clinical outcomes, with no mention of AI/ML algorithms or data processing for decision-making or pattern recognition.
Yes
The device is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence, which is a medical condition.
No
The device is described as a transcutaneous electrical stimulator intended for the "treatment of stress urinary incontinence," not for diagnosis.
No
The device description explicitly lists multiple hardware components including a controller, body garments with electrodes, gel pads, battery charger, lead wire, and neck strap. It is a transcutaneous electrical stimulator, which is a hardware-based device.
Based on the provided information, the Innovo device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females." This describes a therapeutic device that directly interacts with the patient's body to treat a condition.
- Device Description: The description details how the device delivers electrical stimulation to the pelvic floor muscles via external electrodes and garments. This is a physical intervention, not a test performed on a sample taken from the body.
- IVD Definition: In Vitro Diagnostics are defined as medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Innovo does not perform any such examination of specimens.
The Innovo is a therapeutic medical device used for treatment, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The Innovo is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females.
The Innovo is indicated for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
QAJ
Device Description
The Innovo is a single channel, rechargeable, non-implanted electrical stimulator that is intended for the treatment of stress urinary incontinence.
The Innovo is comprised of the following main components, along with accessories:
- Controller ●
- Body Garments (right and left) ●
- Gel Pads (8 surface electrodes) ●
- . Battery Charger
- Lead Wire ●
- . Neck Strap
The Controller generates the electrical stimulation patterns for coupling the stimulation signals to the body when sued with the Gel Pad electrodes and lead wire. The Body Garments, equipped with 8 surface electrodes, are worn by the patient and cover the buttocks, lateral pelvis, and upper thighs. The electrodes have a skin conductive adhesive hydrogel laver, a current dispersing layer, and a garment conductive adhesive hydrogel layer.
The four electrodes on the right side are combined into a single equivalent electrode (and similarly as are the electrodes on the left side). The electrical stimulation current is passed across the pelvic area (from the right side to the left site), thereby stimulating the pelvic floor muscles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic area (pelvic floor muscles)
Indicated Patient Age Range
adult females
Intended User / Care Setting
Prescription use only. Not explicitly stated regarding user/setting, but the device is intended for use by patients at home for a 30-minute treatment session.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Study 1 - Sham Controlled Trial Germany:
Study Design: Randomized (1:1), double-blinded, sham-controlled study to evaluate the safety and performance of the Innovo device ("high dose") compared to a modified version ("low dose") of the device to be representative of sham treatment.
Patient Population: 50 women clinically diagnosed with stress urinary incontinence (SUI). (Treatment arm N=24, control (sham) arm N=26 completed 12 weeks of treatment due to premature stopping of the study).
Co-Primary Endpoints: Reduction from baseline to 12 weeks in the 1-hour Pad Weight Test and improvement in Incontinence Quality of Life Questionnaire (iQoL).
Secondary Endpoints: Proportion of subjects with greater than 50% reduction in 24-hour Pad Weight Test.
Key Results:
- Both active and sham groups had improved iQOL scores versus baseline after 12 weeks.
- The 1-hour pad weight test scores also showed improvement in both groups after 12 weeks compared to baseline.
- The one-hour pad weight test showed improvement in the percentage of subjects who experienced greater than 50% reduction in pad weight for the treatment over sham at 12 weeks (75% treatment versus 47% control).
- The 24-hour pad weight measures for treatment and control at 12 weeks showed little difference for the same outcome measure (44% treatment versus 41% control).
- Provided some evidence that there is an effect of the device over the sham in the one-hour pad weight test.
Study 2 - Randomized Non-Inferiority Study USA:
Study Design: Multicenter, randomized (1:1), non-inferiority clinical study involving 180 subjects at 12 US sites to assess the safety and performance of the Neurotech Vital Compact Device (Innovo device) compared to the iTouch Sure Pelvic Floor Exerciser (comparator device) for the treatment of stress urinary incontinence in females.
Patient Population: Women clinically diagnosed with stress urinary incontinence. (Innovo N=89, iTouch Sure N=91)
Primary Endpoint: Proportion of subjects with significant improvement (defined as at least 50% reduction) in the Provocative Pad Weight Test at 12 weeks.
Key Results:
- For the primary effectiveness endpoint (proportion of patients that had significant (at least 50%) improvement in the provocative pad weight test), the Innovo treatment arm failed to demonstrate non-inferiority against the active comparator (iTouch Sure).
- Innovo: ITT Population/Multiple Imputation 56.3% (45.4%, 66.8%)
- iTouch Sure: ITT Population/Multiple Imputation 63.0% (52.2%, 72.9%)
- The Innovo performed better than the active comparator for two of the secondary endpoints, the Global Impression of Improvement and the 24-hour pad weight test.
- The primary outcome of 56.3 percent of the patients experiencing a clinically significant (at least 50% reduction in the provocative pad weight test) is clinically meaningful. All of the secondary outcomes showed evidence of clinical improvement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics presented are proportions/percentages of improvement in various incontinence measures and mean changes from baseline. Specific sensitivity, specificity, PPV, NPV values are not explicitly stated.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found (De Novo Classification Request)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K000947 (for Gel Pads biocompatibility evaluation)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5330 Transcutaneous electrical continence device.
(a)
Identification. A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must characterize the electrical stimulation, including the following: Waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.
(2) The patient-contacting materials must be demonstrated to be biocompatible.
(3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, thermal safety, and mechanical safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) Instructions for use, including specific instructions regarding the proper placement of electrodes;
(ii) A summary of electrical stimulation parameters; and
(iii) Cleaning instructions and reuse information.
0
DE NOVO CLASSIFICATION REQUEST FOR INNOVO
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Transcutaneous electrical continence device. A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.
NEW REGULATION NUMBER: 21 CFR 876.5330
CLASSIFICATION: Class II
PRODUCT CODE: QAJ
BACKGROUND
DEVICE NAME: Innovo
SUBMISSION NUMBER: DEN170049
DATE DE NOVO RECEIVED: September 18, 2017
Bio-Medical Research Ltd. CONTACT: Parkmore Business Park West Galway H91 NHT7 Ireland
INDICATIONS FOR USE
The Innovo is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females.
The Innovo is indicated for prescription use only.
LIMITATIONS
The sale, distribution, and use of the Innovo are restricted to prescription use in accordance with 21 CFR 801.109.
The device is not intended for uses other than that described in the labeling.
1
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The Innovo is a single channel, rechargeable, non-implanted electrical stimulator that is intended for the treatment of stress urinary incontinence.
The Innovo is comprised of the following main components, along with accessories:
- Controller ●
- Body Garments (right and left) ●
- Gel Pads (8 surface electrodes) ●
- . Battery Charger
- Lead Wire ●
- . Neck Strap
Image /page/1/Picture/10 description: The image shows a pair of Innovo pelvic floor muscle stimulators and a controller. The stimulators are black and have the Innovo logo on them. One stimulator has the letter "R" on it, and the other has the letter "L" on it. The controller is blue and has a screen and buttons.
Figure 1: Innovo Controller and Body Garments
The Controller generates the electrical stimulation patterns for coupling the stimulation signals to the body when sued with the Gel Pad electrodes and lead wire. The Body Garments, equipped with 8 surface electrodes, are worn by the patient and cover the buttocks, lateral pelvis, and upper thighs. The electrodes have a skin conductive adhesive hydrogel laver, a current dispersing layer, and a garment conductive adhesive hydrogel layer.
The four electrodes on the right side are combined into a single equivalent electrode (and similarly as are the electrodes on the left side). The electrical stimulation current is passed across the pelvic area (from the right side to the left site), thereby stimulating the pelvic floor muscles.
| No. of Output Modes | 1 |
|---|---|
| Number of Output Channels | 1 |
| Regulated Current or Regulated Voltage | Regulated Current |
| Software/Firmware/Microprocessor Control? | Yes |
| Table 1: General Features | |
|---|---|
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| Automatic Shut Off | Yes |
|---|---|
| Patient Override Control? | Yes (Pause Button) |
| Indicator Display - On/Off Status? | Yes |
| Indicator Display -Low Battery? | Yes |
| Indicator Display -Voltage/Current Level? | Yes |
| Timer range (minutes) | 30 minutes |
Table 2: Output Specifications
| Waveform | Pulsed, Symmetrical, Biphasic |
|---|---|
| Shape | Rectangular, with interphase interval |
| Pulse Width | 620 μS |
| Baseline to peak current @ 500 Ω | 120 mA |
| Peak Voltage | (b) (4) |
| Frequency | 50 Hz |
| Maximum Current Density | (b) (4) @ 500 Ω |
| Maximum Power Density | |
| (using smallest electrode conductive surface area) | (b) (4) @ 500 Ω |
| Maximum Phase Charge | (b) (4) |
| Net Charge | (b) (4)@ 500 Ω |
| Maximum Output Voltage (RMSV) (+/-10%) | (b) (4) |
| Maximum Output Current (RMSA) (+/-10%) | (b) (4) |
| Contraction Time | 5 seconds |
| Relaxation Time | (b) (4) econds |
| Treatment Session | 30 minutes, fixed |
| Maximum Charge Current | (b) (4) |
| Power Source | Battery Pack (7.2 V) |
The Innovo delivers a symmetric biphasic, current controlled waveform. The amplitude is modulated for the contraction cycle for the pelvic floor muscles. The clinician guides the user to set the stimulation intensity. A treatment session is fixed and lasts for 30 minutes. The Controller is powered by a pre-installed rechargeable battery pack. It has a mechanical interlock to prevent connections to a charger or USB cable during treatment. The Innovo is recommended for use for one treatment session per day for a minimum 12-week treatment plan.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The Innovo has components that have direct or indirect patient contact. The Gel Pads (external hydrogel electrodes), were previously evaluated for biocompatibility and
3
cleared under K000947. Biological safety report was provided for fabrics and ink used in the Body Garments. Other patient-contacting components of the device were evaluated for biocompatibility per ISO 10993-1 and tested as a surface device with limited (1 Subject per Treatment Group
7
| | Vital Compact
(N=89) | | itouch sure
(N=91) | |
|------------------------------------------------------|-------------------------|-------------|-----------------------|-------------|
| System Organ Class
Preferred Term | Subjectsa
n (%) | #
Events | Subjectsa
n (%) | #
Events |
| Any Adverse Event | | | | |
| Overall | 17 (19.1%) | 24 | 11 (12.1%) | 13 |
| Gastrointestinal disorders | | | | |
| Overall | 0 | 0 | 1 (1.1%) | 1 |
| Abdominal pain | 0 | 0 | 1 (1.1%) | 1 |
| General disorders and administration site conditions | | | | |
| Overall | 12 (13.5%) | 15 | 2 (2.2%) | 2 |
| Medical device discomfort | 8 (9.0%) | 10 | 1 (1.1%) | 1 |
| Medical device pain | 4 (4.5%) | 4 | 1 (1.1%) | 1 |
| Pain | 1 (1.1%) | 1 | 0 | 0 |
| Infections and infestations | | | | |
| Overall | 0 | 0 | 7 (7.7%) | 7 |
| Urinary tract infection | 0 | 0 | 3 (3.3%) | 3 |
| Vaginal infection | 0 | 0 | 2 (2.2%) | 2 |
| Vulvovaginal mycotic infection | 0 | 0 | 2 (2.2%) | 2 |
| Musculoskeletal and connective tissue disorders | | | | |
| Overall | 2 (2.2%) | 2 | 0 | 0 |
| Arthralgia | 1 (1.1%) | 1 | 0 | 0 |
| Myalgia | 1 (1.1%) | 1 | 0 | 0 |
| Renal and urinary disorders | | | | |
| Overall | 2 (2.2%) | 2 | 0 | 0 |
| Dysuria | 1 (1.1%) | 1 | 0 | 0 |
| Micturition urgency | 1 (1.1%) | 1 | 0 | 0 |
| Reproductive system and breast disorders | | | | |
| Overall | 0 | 0 | 1 (1.1%) | 1 |
| Vaginal discharge | 0 | 0 | 1 (1.1%) | 1 |
| Skin and subcutaneous tissue disorders | | | | |
| Overall | 5 (5.6%) | 5 | 2 (2.2%) | 2 |
| Erythema | 1 (1.1%) | 1 | 0 | 0 |
| Pruritus | 0 | 0 | 1 (1.1%) | 1 |
| Rash | 1 (1.1%) | 1 | 0 | 0 |
| Skin irritation | 3 (3.4%) | 3 | 1 (1.1%) | 1 |
Table 5: Summary of Device Related Adverse Events by Treatment >1 Subject by Treatment Group
The most common adverse events observed were pain, medical device discomfort, skin irritation, and urinary tract and vaginal infections. There were 24 adverse events in 17 subjects (19.1%) for the Innovo group and 13 events in 11 subjects (12.1%) for itouch sure group that were considered to be related to the device. Most of the adverse events were considered to be mild or moderate in both groups and were resolved by stopping the treatment and/or reducing the stimulation intensity of the device. Overall, the Innovo (identified as Vital Compact in the above table) had a low adverse event profile.
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| Outcome Measure | Treatment Device | Control Device |
|---|---|---|
| Primary Endpoint: Proportion of Patients who attained significant improvement (50% reduction) in Provocative Pad Test | ||
| (95% CI) at Week 12 | ||
| ITT Population/Multiple Imputation | N=89 | |
| 56.3% (45.4%, 66.8%) | N=91 | |
| 63.0% (52.2%, 72.9%) | ||
| ITT Population/LOCF | N=89 | |
| 58.4% (47.5%, 68.8%) | N=91 | |
| 61.5% (50.8%, 71.6%) | ||
| Per Protocol Population/Observed Case | N=72 | |
| 59.7% (47.5%, 71.1%) | N=70 | |
| 70% (57.9%, 80.4%) | ||
| Key Secondary Endpoints: Change from Baseline at Week 12 (LOCF) | ||
| Provocative pad weight test (Mean $\pm$ SD) | -8.48 $\pm$ 25.053 | -9.66 $\pm$ 22.876 |
| 24-hour pad weight test (Mean $\pm$ SD) | -13.07 $\pm$ 21.531 | -9.89 $\pm$ 19.989 |
| Number of incontinence episodes/day (Mean $\pm$ SD) | -1.24 $\pm$ 1.564 | -1.43 $\pm$ 4.120 |
| Incontinence Quality of Life Questionnaire (I-QOL) | 13.41 $\pm$ 16.463 | 15.42 $\pm$ 18.376 |
| Number of pads used/day | -0.30 $\pm$ 0.998 | -0.44 $\pm$ 0.984 |
| Other Secondary Endpoints: Change from Baseline at Week 12 (Observed Case) | ||
| Dryness ( |