(216 days)
Not Found
No
The summary describes a simple stimulation electrode and does not mention any AI/ML components or capabilities.
Yes
The device is designed to treat urinary incontinence, which is a medical condition, making it a therapeutic device.
No
The document states the device is used for treatment of urinary incontinence and describes performance testing based on muscle contraction and pressure, not for diagnosing a condition.
No
The device description clearly describes a physical electrode assembly, which is a hardware component, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "treatment of urinary incontinence" through "rectal stimulation." This is a therapeutic application, not a diagnostic one.
- Device Description: The device is an electrode designed for electrical stimulation. This is consistent with a therapeutic device, not a device used to examine specimens from the human body.
- Performance Studies: The performance studies focus on the device's ability to produce pelvic floor contractions and the comfort/intensity of the stimulation, which are relevant to its therapeutic function. There are no studies related to analyzing biological samples or diagnosing a condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such functions.
N/A
Intended Use / Indications for Use
The Innova Rectal Stimulation Electrode is designed for use with the Innova PFS System which has market clearance for the treatment of unnary incominence.
Electrical stimulation of the pelvic floor muscles for the treatment of incontinence
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Innova Rectal Stimmlation Electrode assembly is a light-weight cylinder consisting of two conductive rings that are paired and isolated, physically. The cylinder is shaped with a waist and a handle for confort, positioning and ease in removing, It is watertight to allow for washing with socop and water between uses. The electrode is designed for repeated intermittent use in the home or clinic for up to one year by a single user. It does not require sterilization, but does require washing with soap and water and drying between uses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Rectum
pelvic floor muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home or clinic
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
An acute clinical test was performed to verify that the Innova Recral Stimulation Electrode could produce a pervic floor contraction equal to or greater than the InCare Rectal Electrode. The results showed that:
- All subjects had pelvic muscle contractions using both electrodes that were of sufficient amplitude to produce I. an observable and measurable response at maximum comfortable intensity.
- The maximum comfortable current intensity achieved with the Innova recral electrode was significantly 2. higher than with the InCare rectal electrode (p
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).
0
$\supset 1212$
SUMMARY OF 510(k) SAFETY AND EFFECTIVENESS INFORMATI()N
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K954272
Applicam name: Applicant address:
Contact person: Phone: FAX: Date Prepared: Identification:
Empi, Inc. 5255 East River Rd. Fridley, MN 55421 Stacy Mattson, Regulatory Affairs Manager 612-586-7354 612-586-7314 August 8, 1995
Nonimplanted Electrical Continence Device
Rectal Stimulation Electrode
APR | 5 1996
Equivalent Devices:
Classification Name: Common/Usual Name:
Innova Vaginal Stimulation Electrode (K910081,K940091) InCare Rectal Electrode (K891773)
Trade/Proprietary Name: Innova Rectal Stimulation Electrode
Product Description:
The Innova Rectal Stimmlation Electrode assembly is a light-weight cylinder consisting of two conductive rings that are paired and isolated, physically. The cylinder is shaped with a waist and a handle for confort, positioning and ease in removing, It is watertight to allow for washing with socop and water between uses. The electrode is designed for repeated intermittent use in the home or clinic for up to one year by a single user. It does not require sterilization, but does require washing with soap and water and drying between uses.
Intended Use:
The Innova Rectal Stimulation Electrode is designed for use with the Innova PFS System which has market clearance for the treatment of unnary incominence.
Product Verification and Validation:
The following parameers were tested: leadwire placement and integrity, impediance, tensile strength; connection strength; flexion; label durability; surface integrity; material integrity (mechanical shability; dimensions, and material biocompatibility. The results of the finctional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use.
Clinical Testing:
An acute clinical test was performed to verify that the Innova Recral Stimulation Electrode could produce a pervic floor contraction equal to or greater than the InCare Rectal Electrode. The results showed that:
- All subjects had pelvic muscle contractions using both electrodes that were of sufficient amplitude to produce I. an observable and measurable response at maximum comfortable intensity.
- The maximum comfortable current intensity achieved with the Innova recral electrode was significantly 2. higher than with the InCare rectal electrode (p 24 hours | Intermittent mucosal contact
24 hours |
| Indications
For Use | Electrical stimulation of the
pelvic floor muscles for the
treatment of incontinence;
EMG sensing of the pelvic
floor muscles. | Electrical stimulation of the
pelvic floor muscles for the
treatment of incontinence | Electrical stimulation of the
pelvic floor muscles for the
treatment of incontinence; EMG
sensing of the pelvic floor
muscles. |
Note: The italics indicate parameters which are the same or equivalent.
*Meets the proposed performance standard, described in FR Volume 60, No. 119, in that the pins are set too closely together to allow insertion into a wall socket or power cord such that conductive contact would occur without damaging the connector.
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