(263 days)
ConTIPI ProVate Vaginal Support (K190277)
No
The device description and performance studies focus on the mechanical design and clinical effectiveness of a physical pessary, with no mention of AI or ML components.
Yes
The device is indicated for the "non-surgical management of Pelvic Organ Prolapse," which is a therapeutic purpose.
No
The device description indicates that the Reia pessary is used for "non-surgical management of Pelvic Organ Prolapse" by "supporting the vaginal wall" and "preventing the descending organs from dropping into the vaginal canal." This describes a treatment or management function, not a diagnostic one.
No
The device description clearly states that the Reia pessary is a physical, collapsible vaginal pessary made entirely of medical-grade silicone. It is a tangible hardware device used for the non-surgical management of Pelvic Organ Prolapse.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Reia Pessary Function: The Reia pessary is a physical device inserted into the vagina to provide structural support for pelvic organ prolapse. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states "temporary, non-surgical management of Pelvic Organ Prolapse," which is a mechanical function, not a diagnostic one.
- Device Description: The description details the physical characteristics, material, and mechanism of action of the pessary, all of which relate to its supportive function within the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on biological tests.
Therefore, the Reia pessary is a medical device, but it falls under a different classification than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Reia pessary is indicated for the temporary, non-surgical management of Pelvic Organ Prolapse.
Product codes
HHW
Device Description
The Reia pessary is a collapsible vaginal pessary for non-surgical treatment of pelvic organ prolapse. The Reia pessary is reusable by a single user and is intended for prescription home use following an in-office size fitting process performed by a healthcare professional using fitting pessaries.
The Reia pessary is placed in the vagina, similar to a tampon or diaphragm, and by supporting the vaginal wall, the pessary prevents the descending organs from dropping into the vaginal canal. Similar to currently available pessaries, the Reia pessary has been evaluated for continuous use; however, its collapsible design enables simpler insertion and removal.
The Reia pessary is made entirely of medical-grade silicone and is a single part. The geometry of the pessary and the flexible nature of the silicone allows the Reia pessary to collapse to facilitate easy, comfortable insertion and removal. In its supportive state, the Reia pessary is domed at the top with a stem at the bottom. The end of the stem has a large loop that allows the user to easily locate, grasp, and pull the pessary out for removal. The expandable and collapsible technology fits the user's anatomy during insertion, use, and removal.
The Reia pessary is designed for self-management and to be easily collapsed for insertion and removal by any user. To insert the pessary, a user (e.g., patient or practitioner) pinches the outside of the pessary to elongate it into a narrower shape, allowing for easier, more comfortable insertion. Once it is released in the vagina, the pessary naturally expands to return to its supportive state. To remove the user pulls on the loop to re-elongate the pessary allowing for easier, more comfortable removal.
The Reia pessary is manually cleaned with soap and water by the user in the home environment or a healthcare facility between periods of use. The Reia fitting pessaries are manually cleaned and sterilized at a healthcare facility between uses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use with an initial in-office size fitting performed by a healthcare professional. Self-management by user or healthcare practitioner.
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
Study Type: Prospective open label single-arm study with patients serving as their own control.
Sample Size: 78 subjects initially enrolled, 62 subjects (50 ring users and 12 Gellhorn users) were treated with the Reia pessary. All treated subjects included in effectiveness primary endpoint analyses.
Key Results:
Safety: The primary safety endpoint was the absence of serious and related adverse events (AEs) that could put the general population at risk. All related AEs were mild or moderate. There were 135 AEs that were new and/or worsening with the Reia pessary, 70 AEs that were persisting and unchanged across use of the current and Reia pessary, and 81 AEs existing with the subjects' current (ring or Gellhorn) pessary and improving with the Reia pessary. No serious and related adverse events, all related events associated with typical pessary use.
Effectiveness: The primary effectiveness endpoint was difference in Pelvic Floor Distress Inventory - 20 (PFDI-20) scores between current (ring or Gellhorn) and Reia pessaries. The study demonstrated that the Reia pessary is equivalent to current (ring or Gellhorn) pessaries in terms of treatment of the presence and bother of pelvic floor symptoms as evaluated by the PFDI-20 (p
§ 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).
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May 21, 2024
Reia, LLC Kaitlin Maier CEO 331 River Road Lyme, New Hampshire 03768
Re: K232677 Trade/Device Name: Reia pessary Regulation Number: 21 CFR 884.3575 Regulation Name: Vaginal Pessary Regulatory Class: II Product Code: HHW Dated: April 18, 2024 Received: April 19, 2024
Dear Kaitlin Maier:
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" (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).
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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 medical devices and radiation-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 Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
2
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) K232677
Device Name Reia pessary
Indications for Use (Describe)
The Reia pessary is indicated for the temporary, non-surgical management of Pelvic Organ Prolapse.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Submitter
Reia, LLC 331 River Road Lyme, NH 03768
Phone: (917) 719-0045 Contact person: Kaitlin Maier, CEO
Date Prepared: May 21, 2024
Name of Device Reia pessary
Common or Usual Name Vaginal pessary
Classification Name Vaginal pessary (21 CFR 884.3575)
Regulatory Class Class II
Product Code HHW (Pessary, vaginal)
Predicate Devices ConTIPI ProVate Vaginal Support (K190277)
The predicate device has not been subject to a design-related recall.
Device Description
The Reia pessary is a collapsible vaginal pessary for non-surgical treatment of pelvic organ prolapse. The Reia pessary is reusable by a single user and is intended for prescription home use following an in-office size fitting process performed by a healthcare professional using fitting pessaries.
The Reia pessary is placed in the vagina, similar to a tampon or diaphragm, and by supporting the vaginal wall, the pessary prevents the descending organs from dropping into the vaginal canal. Similar to currently available pessaries, the Reia pessary has been evaluated for continuous use; however, its collapsible design enables simpler insertion and removal.
The Reia pessary is made entirely of medical-grade silicone and is a single part. The geometry of the pessary and the flexible nature of the silicone allows the Reia pessary to collapse to facilitate easy, comfortable insertion and removal. In its supportive state, the Reia pessary is domed at the top with a stem at the bottom. The end of the stem has a large loop that allows the user to easily locate, grasp, and pull the pessary out for removal. The expandable and collapsible technology fits the user's anatomy during insertion, use, and removal.
The Reia pessary is designed for self-management and to be easily collapsed for insertion and removal by any user. To insert the pessary, a user (e.g., patient or practitioner) pinches the outside of the pessary to
510(k) Summary
Traditional 510(k): Reia pessary
5
elongate it into a narrower shape, allowing for easier, more comfortable insertion. Once it is released in the vagina, the pessary naturally expands to return to its supportive state. To remove the user pulls on the loop to re-elongate the pessary allowing for easier, more comfortable removal.
The Reia pessary is manually cleaned with soap and water by the user in the home environment or a healthcare facility between periods of use. The Reia fitting pessaries are manually cleaned and sterilized at a healthcare facility between uses.
Intended Use / Indications for Use
The Reia pessary is indicated for the temporary, non-surgical management of Pelvic Organ Prolapse.
Comparison of Technological Characteristics with the Predicate Device
The Reia pessary is a vaginal pessary that is used to provide support to prolapsed organs, in a manner similar to the predicate, ProVate Vaginal Support (K190277). The devices have the same intended use and similar principles of operation and technological characteristics. Bench tests have been conducted and demonstrated the biocompatibility and performance properties of both devices. Both the Reia pessary and the predicate pessary support the vaginal wall, collapse in shape for insertion and removal, are fit by practitioners, can be inserted and removed by the user, and come in multiple sizes.
The differences between the subject and predicate devices are:
- . The subject device is a single piece construction and made of 100% medical grade silicone while the predicate device has multiple parts and is made of multiple materials. However, the construction of the subject device is similar to other commonly marketed pessaries that are also a single piece and 100% silicone.
- The subject device is reusable with cleaning instructions while the predicate device is single use for . up to 7 days. However, the subject device reprocessing is the same as other currently marketed pessaries. To support reuse, the subject device has been tested for and will be indicated for 1 year of repeated use by a single user.
- The subject device is intended to be inserted and removed by either a healthcare practitioner or the . user in the home while the predicate device is only intended to be inserted by the user in the home. Due to the disposable nature and short use life of the predical for practical for practitioners to insert and remove the predicate device for each use. The subject device is reusable and can be managed by the user at home or by the healthcare practitioner. This dual management of insertion and removal is also similar to commonly marketed vaginal pessaries.
These identified differences were assessed through a combination of biocompatibility, benchtop performance, and clinical performance tests. The testing demonstrated that the identified differences did not impact the subject device performance, safety, or efficacy compared with the predicate device.
Performance Data
Testing was performed to evaluate the properties and performance of the device and to confirm the device meets its specifications and intended use requirements. Specifically, the following testing was conducted successfully:
Bench Testing
Bench testing was performed to confirm that the Reia pessary met key specifications related to insertion and removal force, use-life, and hinge strength. The pessary was also tested to ensure it did not affect vaginal microflora, enhance the growth of Staphylococcus aureus, nor increase the production of Toxic Shock Syndrome Toxin-1. Additional bench testing was performed to confirm the fitting pessary maintains performance properties following repeated sterilization. All tests passed.
510(k) Summary
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Biocompatibility Testing
Biocompatibility testing and chemical characterization of the device according to ISO 10993-1 and applicable FDA guidance documents were conducted on new devices to confirm the biocompatibility requirements. All tests passed. The testing included the following:
- ISO 10993-5 Cytotoxicity ●
- ISO 10993-10 Sensitization ●
- ISO 10993-23 Irritation ●
- ISO 10993-3 Genotoxicity ●
- ISO 10993-6 Implantation .
- ISO 10993-11 Systemic Toxicity
- ISO 10993-18 Extractable/Leachable Evaluation with ISO 10993-17 Risk Assessment ●
Additional biocompatibility testing was conducted on repeatedly sterilized devices, simulating typical fitting pessary usage, to confirm sterilization of Reia's fitting pessary does not affect biocompatibility properties. The testing included the following:
- ISO 10993-5 Cytotoxicity ●
- ISO 10993-10 Sensitization
- ISO 10993-10 Irritation ●
Reprocessing Testing
Reprocessing testing was conducted to confirm the fitting pessary could be adequately sterilized between uses with different patients. Reia's pessaries are not packaged or shipped sterile.
Clinical Testing
Study Overview
A prospective open label single-arm study with patients serving as their own control was conducted to evaluate safety and effectiveness of the Reia pessary for the non-surgical management of pelvic organ prolapse. The study was performed at seven sites in the United States. Following an approximately 1 month period using their own pessary (ring or Gellhorn), subjects were fit with a Reia pessary, which they used for approximately 3 months. The Reia pessary was used in the home environment and the protocol mirrored the routine clinical care for the management of pessaries. Surveys were initially conducted to assess baseline effectiveness with the current (ring or Gellhorn) pessary and again at the end of the study with the Reia pessary. Vaginal examinations were conducted during each visit to the study clinic.
78 subjects initially enrolled and 62 subjects (50 ring users and 12 Gellhorn users) were treated with the Reia pessary. All subjects who were treated were included in the effectiveness primary endpoint analyses. The study met both primary endpoints.
Safetv
The primary safety endpoint was the absence of serious and related adverse events (AEs) that could put the general population at risk. All related AEs were mild or moderate as defined by the Common Terminology Criteria for Adverse Events (Version 5.0). There were 135 AEs that were new and/or worsening with the Reia pessary, 70 AEs that were persisting and unchanged across use of the current and Reia pessary, and 81 AEs existing with the subjects' current (ring or Gellhorn) pessary and improving with the Reia pessary. The use of the Reia pessary did not result in any serious and related adverse events and all related events were associated with typical pessary use.
Effectiveness
The primary effectiveness endpoint was difference in Pelvic Floor Distress Inventory - 20 (PFDI-20) scores between current (ring or Gellhorn) and Reia pessaries. The PFDI-20 is a validated instrument to assess the presence and bother of symptoms that pelvic floor disorders have on health-related quality of life and widely
7
accepted as a standard subjective outcome for efficacy in urogynecology literature. The study demonstrated that the Reia pessary is equivalent to current (ring or Gellhorn) pessaries in terms of treatment of the presence and bother of pelvic floor symptoms as evaluated by the PFDI-20 (p