(178 days)
Not Found
Not Found
No
The 510(k) summary describes a physical medical device (vaginal pessary) and contains no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is intended for support of prolapse, which is a therapeutic purpose.
No
Explanation: The Intended Use / Indications for Use section clearly states that the PelvX Ring Vaginal Pessary is "intended for support of 1st and 2nd degree prolapse," indicating a treatment or support function, not a diagnostic one. There is no mention of identifying, analyzing, or interpreting medical conditions.
No
The device is described as a "Vaginal Pessary," which is a physical medical device inserted into the vagina. The summary does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the physical support of vaginal prolapse. This is a mechanical function within the body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze samples (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
- Device Description (Not Found): While the description is missing, the intended use clearly points to a physical support device, not a diagnostic one.
- No Mention of IVD-related terms: There are no terms like "assay," "reagent," "sample analysis," or other terms typically associated with IVDs.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The PelvX Ring Vaginal Pessary does not fit this description.
N/A
Intended Use / Indications for Use
The PelvX Ring Vaginal Pessary is a vaginal pessary intended for support of 1st and 2nd degree prolapse.
The PelvX Ring with Support Vaginal Pessary is a vaginal pessary intended for support of 1st and 2nd degree prolapse combined with mild cystocele.
Product codes
85 HHW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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 & Human Services. The logo consists of two main elements: a circular text element and a symbolic design. The text element encircles the design and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbolic design features a stylized human figure in profile, with three wavy lines emanating from the head, representing growth and development.
. .
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 27 1998
Mr. Matthew Hoskins Vice President of Research and Development DesChutes Medical Products, Inc. 1011 SW Emkay Drive, #104 Bend, OR 97702
Re: K974115
PelvX Ring Vaginal Pessary and PelvX Ring with Support Vaginal Pessary Dated: January 29, 1998 Received: February 5, 1998 Regulatory Class: II 21 CFR 8884.3575/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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (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 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): KS 74115
Device name: PelvX Ring Vaginal Pessary and PelvX Ring with Support Vaginal Pessary
Indications for Use:
The PelvX Ring Vaginal Pessary is a vaginal pessary intended for support of 1st and 2nd degree prolapse.
The PelvX Ring with Support Vaginal Pessary is a vaginal pessary intended for support of 1st and 2nd degree prolapse combined with mild cystocele.
(Please do not write below this line) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Rathbun
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K974115
Prescription Use
OR
Over-The-Counter Use