The Anal Stimulation/EMG Probe - w/Stop, 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 Description

Hollister Incorporated through it's InCare Division currently markets an Anal 2-electrode Stimulation/EMG Probe (K891773 and K930530) as an accessories to it's Pelvic Floor Therapy System product line. The proposed probe uses the same identical raw material components and manufacturing process as the currently marketed predicate devices.

AI/ML Overview

The acceptance criteria and study proving device performance are not explicitly detailed in the provided documents. The documents are a 510(k) summary for a medical device (Anal Stimulation/EMG Probe - w/Stop) seeking substantial equivalence to a predicate device, rather than a clinical trial report or a performance validation study against specific acceptance criteria.

However, based on the information provided, we can infer the intent of the submission is to demonstrate that the new device is as safe and effective as the predicate device. The "study" in this context is the comparison of the technological characteristics and biological safety.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

1. A table of acceptance criteria and the reported device performance

Since specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are not provided for the new device, the "acceptance criteria" for a 510(k) submission seeking substantial equivalence are generally implied to be that the new device performs at least as well as or is functionally equivalent to the predicate device in terms of safety and effectiveness.

Acceptance Criteria (Implied for 510(k) Substantial Equivalence)	Reported Device Performance (Hollister Anal Stimulation/EMG Probe - w/Stop)
Safety: Biocompatibility with human tissue.	Meets: Biocompatibility assessed based on ISO 10993, FDA G95-1, USP guidelines. Materials deemed safe and effective.
Effectiveness: Achieve intended use (electromyographic feedback/electrical stimulation for pelvic musculature rehabilitation).	Meets: Identical intended use as predicate devices. Technological characteristics (e.g., number of electrodes, material, electrode placement, contact duration) are comparable or consistent with predicate.
Technological Characteristics: Similar materials, design principles, and functional capabilities to predicate devices.	Meets: Uses identical raw material components and manufacturing process as currently marketed predicate devices. Key technological characteristics are compared in a table and deemed substantially equivalent.
Performance: Maintain similar performance characteristics without raising new questions of safety or effectiveness.	Meets: No data on specific performance metrics (e.g., signal quality, stimulation efficacy) are provided, but the claim of substantial equivalence implies comparable performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable in the context of a clinical test set. The assessment is primarily based on a comparison of device characteristics and material biocompatibility. There is no mention of a "test set" of patients or data in the provided document for evaluating performance.
Data Provenance: The biocompatibility assessment relies on established international and national standards (ISO, FDA, USP) and laboratory evaluations. The information does not specify the country of origin for these laboratory evaluations, nor whether they were retrospective or prospective studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no "ground truth" derived from expert consensus on a test set mentioned in this 510(k) summary. The ground truth for biocompatibility would be the results of the laboratory tests against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no test set or adjudication method described.

5. 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

Not applicable. This device is not an AI-powered diagnostic tool, and no MRMC study or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical electromedical probe, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For biocompatibility, the "ground truth" would be the scientific data and established toxicological profiles of the materials, evaluated against international standards (ISO 10993) and regulatory guidelines (FDA, USP). For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable.

Summary

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3/25/99

riomster Incorporated 2000 Hollister Drive Libertyville, illinois 60048-3781 Telephone, 847,680,1000 Facsmile: 347.918 3860

Hollister Incorporated Anal Stimulation/EMG Probe - w/Stop

K990456

PG. 1 OF 3

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510(k) Summary

1. Submitter's Name, Address and Contact Person

Submitter Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 Contact Person Joseph S. Tokarz Manager, Regulatory Affairs (847)680-2849 Ph (847)918-3860 Fax

Date Summary Prepared - February 9, 1999

2. Name of Device:

Anal Stimulation/EMG Probe - w/Stop

3. Name of Predicate Device(s)

Anal Stimulation/EMG Probe, K891773 and K930530

4. Description of Device

5. Statement of Intended Use

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Hollister Incorporated Anal Stimulation/EMG Probe - w/Stop

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6. Statement of Technological Characteristics of the Device

The proposed device is substantially equivalent to the predicate devices. The following is a chart comparing the devices.

Electrode Characteristics	Anal Stimulation/EMGProbe - w/Stop	Anal Stimulation/EMGProbe - 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	2.349 inches nominal	3.45 inches nominal
Probe Diameter (betweenelectrode)	0.453 inch nominal	0.394 inch nominal
Electrode Material	Stainless Steel	Stainless Steel
Electrode Placement	Anal	Anal
Device Connector	Attached cord with 3.5 mmstereo phono plug	Attached cord with 3.5 mmstereo phono plug
Contact Duration	Intermittent mucosal contact<30 min/session - Stim<1 hour/session - EMGnot exceeding 1 hr combinedStim/EMG	Intermittent mucosal contact<30 min/session - Stim<1 hour/session - EMGnot exceeding 1 hr combinedStim/EMG
Indications for Use	Electrical stimulation of thepelvic floor muscles for theteatment of urinaryincontinence. EMG sensingof the pelvic floor muscles	Electrical stimulation of thepelvic floor muscles for thetreatment of urinaryincontinence. EMG sensingof the pelvic floor muscles

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Hollister Incorporated Anal Stimulation/EMG Probe - w/Stop

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7. Biocompatibility

The biocompatibility of the Anal Stimulation/EMG Probe - w/Stop, 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 States 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 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 evlautions have been contracted either by Hollister or the suppliers of the materials.

Based upon the results of this assessment, the materials used to fabricate Anal Stimulation/EMG Probe - w/Stop, is safe and effective for its intended use and is substantially equivalent to the predicate device.

8. Conclusion

Based upon the information presented above it is concluded that the proposed Anal Stimulation/EMG Probe - w/Stop, is safe and effective for its intended use and is substantially equivalent to the predicate device.

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Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

MAR 2 5 1999

Mr. Joseph S. Tokarz Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048-3781 Re: K990456

Anal Stimulation/EMG Probe with Stop Dated: February 9, 1999 Received: February 12, 1999 Regulatory Class: II 21 CFR 876.5320/Procode: 78 KPI 21 CFR 884.1425/Procode: 85 HIR

Dear Mr. Tokarz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act, You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Dan Setiz

APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Hollister Incorporated Anal Stimulation/EMG Probe - w/Stop

Statement of Intended Use

510(k) Number (if known):

1990456

Device Name:

Anal Stimulation/EMG Probe - w/Stop

Intended Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-the-Counter-Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Vinich Vr. Algnam

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number.

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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).