(178 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is a simple vaginal pessary, which is a mechanical device.
Yes
The device is intended for the treatment of urinary incontinence, which is a medical condition. Therefore, it serves a therapeutic purpose.
No.
The intended use states it is for "treatment of urinary incontinence," not for diagnosis.
No
The device description explicitly states "Vaginal Pessary," which is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information describes a "Vaginal Pessary" intended for the "treatment of urinary incontinence." This is a physical device inserted into the body for a therapeutic purpose (treating a condition).
- Lack of IVD Characteristics: The description does not mention any testing of samples, analysis of biological markers, or diagnostic information derived from the device's use.
Therefore, based on the provided information, the PelvX Incontinence Ring Vaginal Pessary is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PelvX Incontinence Ring Vaginal Pessary is a vaginal pessary intended for treatment of of a sourinary incontinence.
Product codes
85 HHW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vaginal
Indicated Patient Age Range
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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 shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming a stylized bird-like shape. The text "DEPARTMENT OF HEALTH" is arranged vertically along the left side of the logo.
DEPAR MEN.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 1998
Mr. Matthew Hoskins Vice President of Research and Development DesChutes Medical Products, Inc. 1011 SW Emkay Drive, #104 Bend, OR 97702
Re: K974116
PelvX Incontinence Ring Vaginal Pessary Dated: January 29, 1998 Received: February 5, 1998 Regulatory Class: II 21 CFR $884.3575/Procode: 85 HHW
Dear Mr. Hoskins:
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 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 (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 equivalient determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) 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 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/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Indications for Use Statement
510(k) Number (if known): _
Device name: PelvX Incontinence Ring Vaginal Pessary
Indications for Use:
The PelvX Incontinence Ring Vaginal Pessary is a vaginal pessary intended for treatment of of a sourinary incontinence.
(Please do not write below this line)
Concurrence of CDRH, Office of Device Evaluation (ODE)
============================================================================================================================================================================
Robert-D. Silling/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K974116
Prescription Use ✓
OR
Over-The-Counter Use