(260 days)
Not Found
No
The device description and performance studies focus on the mechanical and biocompatibility properties of a physical, non-electronic device. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for the treatment of pelvic organ prolapse and to relieve symptoms of pelvic relaxation and urinary incontinence, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a "removable device 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" and functions as a "supportive structure." It is a treatment device, not one used for diagnosis.
No
The device description explicitly states that the devices are "removable devices placed in the vaginal cavity" and "made from silicone that are inserted into the vagina". This indicates a physical, hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the 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." This describes a device that is inserted into the body for a therapeutic or supportive purpose.
- Device Description: The description reinforces this by stating they are "inserted into the vagina to function as a supportive structure... to manage and treat the symptoms of pelvic floor dysfunction."
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze samples from the body, or provide information about a patient's health status through in vitro testing.
- Performance Studies: The performance studies focus on mechanical properties, biocompatibility, cleaning validation, and packaging validation – all typical for a physical medical device, not an IVD.
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 any such function.
N/A
Intended Use / Indications for Use
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.
Product codes
HHW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal cavity, vagina, uterus, bladder, rectum
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies
Mechanical testing was performed to confirm that the device meets key performance specifications related to the functionality and safety of the device. Testing included: folding, 3-point bend, cord detachment, end of life, squeeze, knob displacement.
Biocompatibility testing was conducted according to ISO 10993-1:2018 and applicable FDA guidance documents. Tests included: Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Implantation, and Pyrogenicity. Results: non-cytotoxic, non-sensitizer, non-irritant, no mortality or systemic toxicity, minimal or no reaction in implantation, and non-pyrogenic. Chemical characterization and materials and toxicological risk assessments showed acceptable risk.
TSST-1 Risk laboratory testing evaluated the impact of the device on Staphylococcus aureus growth and TSST-1 production, following FDA guidance for Menstrual Tampons and Pads: Information for Premarket Notification Submissions, which demonstrated a low risk profile for the device.
Cleaning validation conducted as per AAMI ST98:2022, AAMI TIR12 and FDA guidance on Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labelling, demonstrated that the cleaning removes soil and contamination effectively.
Packaging validation conducted as per ASTM D4169-22 confirmed that the packaging materials are capable of withstanding the distribution environment during the rigors of shipping and handling.
Key Metrics
Not Found
Predicate Device(s)
K013289, K092981, K173351, K974116
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.3575 Vaginal pessary.
(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).
0
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"
1
(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
2
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)
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.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
16.2.1. Submitter Information
| Company Name | Cosm Medical Corp. |
|---|---|
| Company Address | 101 College Street, Toronto, ON M5G 1L7 |
| Company Phone | 1-888-589-2676 |
| Contact Person | Linda Wu (Head of Clinical, Regulatory, Quality) |
| Date Prepared | March 5, 2024 |
16.2.2. Device Information
| Device Trade Name | Gynethotics™ Pessary |
|---|---|
| Device Common Name | Vaginal Pessary |
| Product Code Name | Pessary, Vaginal |
| Product Code | HHW |
| Classification Panel | Obstetrical/Gynecological |
| Regulatory Class | 2 |
| Classification Number | 21 CFR 884.3575 |
| Classification Name | Vaginal pessary |
16.2.3. Predicate Devices
| Name | Manufacturer | 510(k) |
|---|---|---|
| Bioteque Vaginal Pessary | ||
| (primary) | Bioteque America, Inc. | K013289 |
| Panpac vaginal pessary | Panpac Medical Corporation | K092981 |
| Flexi-Shelf | Panpac Medical Corporation | K173351 |
| PelvX Incontinence Ring | DesChutes Medical Products | K974116 |
The predicate devices have not been subject to a design-related recall.
16.2.4. Intended Use
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.
16.2.5. Indications for use
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.
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K231786 Page 2 of 4
Gvnethotics 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 orqan 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.
16.2.6. 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.
16.2.7. Comparison to Predicate Devices
Gynethotics pessaries are vaqinal pessaries used to provide support to prolapse organs and treat symptoms of pelvic floor dysfunction. Similar to predicates. Gynethotics pessaries are available in multiple shapes and sizes. The kev difference between the subject and predicate devices is that Gynethotics pessaries allow for personalized configurations of certain shape features, as determined by the clinician. The differences do not raise different questions of safety or effectiveness, and can be evaluated through performance testing.
| Shape Description | Indications for Use
(subject device) | Indications for Use
(predicate devices) |
|-------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Ring | Indicated for use in cases of mild
(Stage I) pelvic organ prolapse. | K013289: Indicated for use
in cases of first or mild
second-degree prolapse. |
| Ring with Support | Indicated for use in cases of mild
(Stage I) pelvic organ prolapse. | K013289: Indicated for use
in cases of first or mild
second-degree prolapse. |
| Ring with Knob | Indicated for use in cases of mild
(Stage I) pelvic organ prolapse, and
stress urinary incontinence. | K092981: Indicated for first
or second-degree prolapse
and stress urinary
incontinence. |
6
| Page 3 of 4 | ||
|---|---|---|
| Shape Description | Indications for Use | |
| (subject device) | Indications for Use | |
| (predicate devices) | ||
| Ring with Support | ||
| and Knob | Indicated for use in cases of mild | |
| (Stage I) pelvic organ prolapse, and | ||
| stress urinary incontinence. | K092981: Indicated for first | |
| or second-degree prolapse | ||
| and stress urinary | ||
| incontinence. | ||
| Incontinence Ring | Indicated for use in cases of stress | |
| urinary incontinence. | K974116: for treatment of | |
| urinary incontinence. | ||
| Marland | Indicated for use in cases of mild | |
| (Stage I) and moderate (Stage II) | ||
| pelvic organ prolapse, and stress | ||
| urinary incontinence. | K013289: Indicated for use | |
| for the control of stress | ||
| urinary incontinence and first | ||
| or mild second-degree | ||
| prolapse. | ||
| Marland with | ||
| Support | Indicated for use in cases of mild | |
| (Stage I) and moderate (Stage II) | ||
| pelvic organ prolapse, and stress | ||
| urinary incontinence. | K013289: Indicated for use | |
| for the control of stress | ||
| urinary incontinence and first | ||
| or mild second-degree | ||
| prolapse. | ||
| Gellhorn | Indicated for use in cases of mild | |
| (Stage I) to severe (Stage III or | ||
| procidentia) pelvic organ prolapse. | K173351: Indicated for the | |
| support of a second to third | ||
| degree prolapse or | ||
| procidentia. | ||
| Cube | Indicated for use in cases of | |
| moderate (Stage II) to severe | ||
| (Stage III or procidentia) pelvic | ||
| organ prolapse. | K013289: Indicated for use | |
| in the support of a third | ||
| degree prolapse, including | ||
| procidentia, as well as | ||
| cystocele and rectocele. |
Any differences in wording of the Indications for use statements between subject and predicate devices, do not impact the intended use of the device. Indications for use language of the subject device is reflective of currently recognized medical terminology and reflects the same understanding of Indications for use in predicate devices.
| Technological characteristic | Differences |
|---|---|
| Dimensions and sizing increments | The min and max feature sizes are within range of predicate pessaries. Subject device sizes increment with greater degrees of freedom within the cleared ranges, thereby offering greater sizing options. |
| Materials | Subject device is made of silicone and colorant. Predicate devices are also made of silicone and colorant, but formulation differs. |
16.2.8. Performance Data
The following testing was conducted to evaluate that the device meets its specifications:
- Mechanical testing was performed to confirm that the device meets key performance ● specifications related to the functionality and safety of the device. Testing included: folding, 3-point bend, cord detachment, end of life, squeeze, knob displacement.
7
- Biocompatibility according to ISO 10993-1:2018 and applicable FDA quidance ● documents. Testing included:
| Test name | Results | Standards |
|---|---|---|
| Cytotoxicity | Non-cytotoxic | ISO 10993-5:2009 |
| Sensitization | Non-sensitizer | ISO 10993-10:2021 |
| Irritation | Non-irritant | ISO 10993-23:2021 |
| Acute systemic toxicity | No mortality or evidence of systemic toxicity | ISO 10993-11:2017 |
| Implantation | Compared to negative control: | |
| Macroscopic - difference not significant; Microscopic – minimal or no reaction | ISO 10993-6:2016 | |
| Pyrogenicity | Non-pyrogenic | ISO 10993-11:2017 |
| Chemical characterization and | ||
| Materials and | ||
| Toxicological Risk assessments | Acceptable risk of daily dose-exposure to compounds from device use | ISO 10993-17:2002 |
| ISO 10993-17:2023 | ||
| ISO 10993-18:2020 |
- TSST-1 Risk laboratory testing to evaluate the impact of the device on Staphylococcus ● aureus growth and TSST-1 production, following FDA guidance for Menstrual Tampons and Pads: Information for Premarket Notification Submissions, which demonstrated a low risk profile for the device.
- Cleaning validation conducted as per AAMI ST98:2022, AAMI TIR12 and FDA guidance on Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labelling, demonstrated that the cleaning removes soil and contamination effectively.
- Packaging validation conducted as per ASTM D4169-22 confirmed that the packaging ● materials are capable of withstanding the distribution environment during the rigors of shipping and handling.
16.2.9. Conclusions
Subject and predicate devices share the same intended use and fundamental scientific technology, including principles of operation and mechanism of action. Differences in design and technological characteristics between the subject and predicate devices do not raise any new types of questions of safety and effectiveness. The results of performance testing demonstrate that the subject device is as safe and effective as the predicate devices to support a substantial equivalence determination.