← Product Code [KPI](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPI) · K970602 # VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL (K970602) _Hollister, Inc. · KPI · Apr 15, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPI/K970602 ## Device Facts - **Applicant:** Hollister, Inc. - **Product Code:** [KPI](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPI.md) - **Decision Date:** Apr 15, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5320 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use The Vaginal Stimulation/EMG Probe - Small is intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence. ## Device Story Vaginal 2-electrode probe designed for pelvic floor therapy; provides electromyographic (EMG) feedback or electrical stimulation to pelvic musculature. Used as an accessory to Pelvic Floor Therapy Systems. Input: pelvic muscle electrical activity (EMG) or electrical stimulation signals. Output: EMG signals for biofeedback or stimulation for muscle rehabilitation. Used in clinical or home settings under physician/caregiver guidance. Smaller diameter (0.750 inch) compared to standard probe to accommodate patients with smaller vaginal anatomy. Connects via 3.5 mm stereo phono plug. Benefits patients by enabling therapy for those unable to use standard-sized probes. ## Clinical Evidence No clinical data. Biocompatibility assessed via in vitro/in vivo laboratory evaluations based on ISO 10993, FDA G95-1, and USP guidelines. ## Technological Characteristics 2-electrode vaginal probe; body material: Acrylonitrile-Butadiene-Styrene (ABS); electrode material: stainless steel; diameter: 0.750 inch; length: 4.8 inches; connectivity: 3.5 mm stereo phono plug; usage: reusable, single-patient; contact duration: <1 hour/session. ## Regulatory 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). ## Predicate Devices - Vaginal Stimulation/EMG Probe ([K891773](/device/K891773.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Hollister APR 15 1997 Hollister Incorporated 2000 Hollister Drive Libertyville, Illinois 60048-3781 K970602 P193 # Hollister Incorporated ## Vaginal Stimulation/EMG Probe - Small ### 510(k) Summary 1. Submitter's name, Address and Contact Person | Submitter | Contact Person | | --- | --- | | Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 | Joseph S. Tokarz Manager, Regulatory Affairs Ph (847)680-2849 Fax (847)918-3860 | Date Summary Prepared - February 13, 1997 2. Name of Device: Vaginal Stimulation/EMG Probe - Small 3. Name of Predicate Device(s) Vaginal Stimulation/EMG Probe, K891773 4. Description of Device Hollister Incorporated through it’s InCare Division currently markets a vaginal 2-electrode stimulation/EMG probe (K891773) as an accessory to it’s Pelvic Floor Therapy System product line. Requests and comments from physicians and caregivers has indicated the need for a smaller diameter vaginal probe that would be used by patients that have a smaller vaginal anatomy and who cannot use the currently marketed vaginal probe. In response to these comments, Hollister has developed the vaginal 2-electrode stimulation/EMG probe - small. This probe uses the same identical raw material components and manufacturing process as the currently marketed device. The only difference is that the proposed probe has a smaller diameter to accommodate smaller vaginal anatomies. 5. Statement of Intended Use The Vaginal Stimulation/EMG Probe - Small is intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence. 6. Statement of Technological Characteristics of the Device The proposed device is substantially equivalent to the predicate device. The following is a chart comparing the two devices. Page 24 TEL 847.680.1000 FAX 847.918.3860 {1} K970602 p2073 # Hollister ## Hollister Incorporated ### Vaginal Stimulation/EMG Probe - Small Comparison of the Vaginal Stimulation/EMG Probe-Small and Predicate device | Electrode Characteristics | Vaginal Stimulation/EMG Probe-Small | Vaginal Stimulation/EMG Probe - Standard | | --- | --- | --- | | Number of Electrode | 2-Stimulation/EMG | 2-Stimulation/EMG | | Usage Conditions | Reusable - single patient use | Reusable - single patient use | | Electrode Orientation | Circular | Circular | | Body Material | Acrylonitrile-Butadiene-Styrene copolymer (ABS) | Acrylonitrile-Butadiene-Styrene copolymer (ABS) | | Probe Length | 4.8 inches nominal | 4.8 inches nominal | | Probe Diameter | 0.750 inch nominal | 1.0 inch nominal | | Electrode Material | Stainless steel | Stainless steel | | Electrode Placement | Vaginal | Vaginal | | Device Connector | Attached cord with 3.5 mm stereo phono plug | Attached cord with 3.5 mm stereo phono plug | | Contact Duration | Intermittent mucosal contact <30 min/session - stimulation <1 hour/session - biofeedback not exceeding 1 hr combined stimulation/biofeedback | Intermittent mucosal contact <30 min/session - stimulation <1 hour/session - biofeedback not exceeding 1 hr combined stimulation/biofeedback | | Indications for Use | Electrical stimulation of the pelvic floor muscles for the treatment of urinary incontinence. EMG sensing of the pelvic floor muscles | Electrical stimulation of the pelvic floor muscles for the treatment of urinary incontinence. EMG sensing of the pelvic floor muscles | ## 7. Biocompatibility The biocompatibility of the Vaginal Stimulation Probe, in nonsterilized configurations was assessed based on principles and guidelines established by various governmental and standard setting organizations, such as: - ISO 10993, International Standards Organization (ISO) Standard - General Program Memorandum #G95-1, United States FDA Office of Device Evaluation - United Stated Pharmacopeia (USP) Material biocompatibility issues have been addressed based upon biomaterial history or in separate *in vitro* or *in vivo* laboratory evaluations using licensed commercial reference Page 25 {2} K970602 P393 # Hollister ## Hollister Incorporated ### Vaginal Stimulation/EMG Probe - Small laboratories. Specific test methodology has been chosen, where appropriate, from test protocols established or recommended by the aforementioned agencies or organizations. Product use conditions have been mimicked in testing procedures where possible. These evaluations have been contracted either by Hollister or the suppliers of the materials. Based upon the results of this assessment, the materials used to fabricate Vaginal Stimulation Probe - Small are considered biocompatible and appropriate for their intended use. ## 8. Conclusion Based upon the information presented above it is concluded that the proposed Vaginal Stimulation/EMG Probe - Small is safe and effective for its intended use and is substantially equivalent to the predicate device. Page 26 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPI/K970602](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPI/K970602) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com