Gynethotics pessaries are removable devices placed in the vaginal cavity to provide a nonsurgical alternative for the treatment of pelvic organ prolapse and to relieve the symptoms of pelvic relaxation with or without urinary incontinence in adults.

Gynethotics Ring Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse.

Gynethotics Ring with Support Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse.

Gynethotics Ring with Knob Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse, and stress urinary incontinence.

Gynethotics Ring with Support and Knob is indicated for use in cases of mild (Stage I) pelvic organ prolapse, and stress urinary incontinence.

Gynethotics Incontinence Ring Pessary is indicated for use in cases of stress urinary incontinence.

Gynethotics Marland Pessary is indicated for use in cases of mild (Stage I) and moderate (Stage II) pelvic organ prolapse, and stress urinary incontinence.

Gynethotics Marland with Support Pessary is indicated for use in cases of mild (Stage I) and moderate (Stage II) pelvic organ prolapse, and stress urinary incontinence.

Gynethotics Gellhorn Pessary is indicated for use in cases of mild (Stage I) to severe (Stage III or procidentia) pelvic organ prolapse.

Gynethotics Cube Pessary is indicated for use in cases of moderate (Stage II) to severe (Stage III or procidentia) pelvic organ prolapse.

Device Description

Gynethotics pessaries are vaginal pessaries made from silicone that are inserted into the vagina to function as a supportive structure of the vagina, uterus, bladder and/or rectum to manage and treat the symptoms of pelvic floor dysfunction, such as pelvic organ prolapse and incontinence. Gynethotics pessaries come in four general shapes, including: Ring, Gellhorn, Marland, and Cube. Each shape comes in a range of configurable features and dimensions.

AI/ML Overview

The provided text is a 510(k) Summary for the Gynethotics™ Pessary, a medical device. It does not describe a study involving an AI or software device that classifies, diagnoses, or assists human readers with medical images or data. Therefore, I cannot extract the information required to populate the fields related to acceptance criteria and study designs typically associated with such devices (e.g., sample size for test set, number of experts, MRMC studies, ground truth establishment, etc.).

The document focuses on demonstrating substantial equivalence of the Gynethotics™ Pessary, a physical vaginal pessary, to predicate devices through:

Indications for Use Comparison: Showing similar intended medical applications (pelvic organ prolapse, stress urinary incontinence).
Technological Characteristics Comparison: Highlighting that the device is made of similar materials (silicone) and has comparable dimensions to predicates, with differences not raising new safety/effectiveness questions.
Performance Data (Bench/Lab Testing): Including mechanical testing (folding, bend, cord detachment, etc.) and biocompatibility testing (cytotoxicity, sensitization, irritation, etc.), TSST-1 risk assessment, cleaning validation, and packaging validation.

Therefore, it is impossible to provide the requested information based on the provided text. The information pertains to the regulatory submission for a physical medical device, not a diagnostic AI/software tool.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

March 6, 2024

Cosm Medical Linda Wu Head of Clinical, Regulatory and Quality 101 College Street Toronto, ON M5G1L7 CANADA

Re: K231786 Trade/Device Name: Gynethotics™ Pessary Regulation Number: 21 CFR 884.3575 Regulation Name: Vaginal Pessary Regulatory Class: II Product Code: HHW Dated: February 3, 2024 Received: February 5, 2024

Dear Linda Wu:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and 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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jason Roberts -S

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231786

Device Name Gynethotics™ Pessary

Indications for Use (Describe)