The Innova Rectal Stimulation Electrode is designed for use with the Innova PFS System which has market clearance for the treatment of unnary incominence.

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.

AI/ML Overview

The provided text describes the "Innova Rectal Stimulation Electrode" and its performance in comparison to a predicate device, the "InCare Rectal Electrode."

Here's an analysis of the acceptance criteria and study data based on the provided input:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Aspect	Innova Rectal Electrode's Performance
I. Product Verification and Validation:
Leadwire placement and integrity	"The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met)
Impedance	"The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met)
Tensile strength	"The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met)
Connection strength	"The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met)
Flexion	"The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met)
Label durability	"The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met)
Surface integrity	"The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met)
Material integrity (mechanical stability)	"The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met)
Dimensions	"The results of the functional testing were analyzed against product specifications and demonstrate that the product meets requirements and is acceptable for its intended use." (Implied met)
Material biocompatibility	"Meets ISO 10993 and USP class VI"
II. Clinical Performance (vs. InCare Rectal Electrode):
Produce pelvic floor contraction equal to or greater than InCare Rectal Electrode	All subjects had pelvic muscle contractions using both electrodes that were of sufficient amplitude to produce an observable and measurable response at maximum comfortable intensity.
Maximum comfortable current intensity	Innova rectal electrode achieved significantly higher maximum comfortable current intensity (p < 0.05).
Contraction induced pressures	Innova rectal electrode achieved significantly higher contraction induced pressures (p < 0.01).
Maximum current density	Innova rectal electrode attained significantly lower maximum current density than InCare rectal electrode (p < 0.01).
Adverse effects	No adverse effects were noted by the investigator in any of the subjects tested.
III. Comparison of Product Specifications:
Reusable single patient use	Matches InCare Rectal Electrode.
Circular electrode orientation	Matches InCare Rectal Electrode.
Rectal Placement	Matches InCare Rectal Electrode.
Indications for Use (Electrical stimulation of pelvic floor muscles for incontinence treatment)	Matches InCare Rectal Electrode.
Max. Power Density	51 mW/cm² (Lower than InCare's 81 mW/cm²)
Max. Current Density	3.0 mA/cm² (Lower than InCare's 6.5 mA/cm²)

Study Details

This submission focuses on establishing substantial equivalence to the predicate device, the Innova Vaginal Stimulation Electrode and the InCare Rectal Electrode.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document states "All subjects had pelvic muscle contractions using both electrodes," but does not explicitly state the number of subjects in the clinical test.
- The study is described as an "acute clinical test," suggesting a prospective design.
- Data provenance (country of origin) is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Ground truth for the clinical test was based on "observable and measurable response" of pelvic muscle contractions. It was assessed by an "investigator." The number and qualifications of this investigator(s) are not specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document implies a single "investigator" observing and measuring responses. No adjudication method is mentioned, suggesting "none" explicitly.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This is a medical device, not an AI or imaging diagnostic tool. The comparison is between two physical electrodes.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable as this is a physical medical device (electrode), not an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical testing, the ground truth was based on physiological measurements and observations of "pelvic muscle contractions" and "contraction induced pressures." This is a form of physiological measurement/observable response.
The sample size for the training set:
- Not applicable. This is a medical device, not an algorithm requiring a training set. The "product verification and validation" (functional testing) refers to engineering tests against specifications, not a machine learning training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an algorithm. The "product specifications" served as the benchmark for the functional tests.

Summary

{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

K954272

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:

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 < 0.05).
నా The contraction induced pressures achieved with the Innova rectal electrode were significantly higher than the pressures achieved with the InCare rectal electrode (p < 0.01).
The maximum current density attained with the Innova rectal electrode was significantly lower than with the র্ব -InCare rectal electrode (p < 0.01).

No adverse effects were noted by the investigator in any of the subjects tested.

{1}------------------------------------------------

Conclusion from Non-Clinical and Clinical Testing

The data obtained from the non-clinical and clinical tests demonstrate that this electrode is as safe, as effective and performs as well or better than the InCare Rectal Electrode.

Comparison of Product Specifications

See the following chart for details on the similarities and differences of the predicate devices and the Innova Rectal Stimulation Electrode.

COMPARISON OF INNOVA RECTAL ELECTRODE SPECIFICATIONS TO PREDICATE DEVICES

ElectrodeCharacteristics	InCare RectalElectrode	Innova RectalElectrode	Innova VaginalElectrode
PremarketNotification	Stimulation - K891773EMG Sensing - K891774	Current Submission	Stimulation - K910081EMG Sensing - K940091
Number OfElectrodes	2 - Stimulation	2 - Stimulation	3 - Sensing4 - Stimulation
Biocompatibility	Unknown	Meets ISO 10993 and USPclass VI	Meets the TripartiteGuidance and USP class VI
Usage Conditions	Reusable single patient use	Reusable single patient use	Reusable single patient use
Electrode Orientation	Circular	Circular	Circular
Body Material	plastic	Medical-Grade Santoprene	Medical-Grade silicone rubber
Insertable Length	2.3 in. nominal	2.4 in. nominal	3 in. nominal
Diameter (Max.)	0.6 in. nominal	0.8 in. nominal	1 in. nominal
Electrode Material	Metal	Carbon loaded Santoprene	Carbon loaded silicone rubber
Electrode Spacing	0.32 in. nominal	0.43 in. nominal	1.7 in. nominal
Active Surface Arca(nominal)	0.3 in²/band	0.9 in²/band	1.9 in.²/band
Electrode Placement	Rectum	Rectum	Vagina
Device Connection	Attached cord with 3.5mmphone plug.	Attached cord with custom2.5mm 2 pin plug*	Attached cord with custom2.5mm 2 pin plug*
Max. Power Density	81 mW/cm²	51 mW/cm²	24.45 mW/cm²
Max. Current Density	6.5 mA/cm²	3.0 mA/cm²	1.41 mA/cm²
ContactDuration	Unknown	Intermittent mucosal contact< 30 days but > 24 hours	Intermittent mucosal contact< 30 days but > 24 hours
IndicationsFor Use	Electrical stimulation of thepelvic floor muscles for thetreatment of incontinence;EMG sensing of the pelvicfloor muscles.	Electrical stimulation of thepelvic floor muscles for thetreatment of incontinence	Electrical stimulation of thepelvic floor muscles for thetreatment of incontinence; EMGsensing of the pelvic floormuscles.

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.

4757212

Regulation Number and Section

§ 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).