(178 days)
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Not Found
No
The summary describes a physical medical device (vaginal pessary) and does not mention any software, algorithms, or AI/ML capabilities.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is intended for support of prolapse, which implies a supportive rather than a therapeutic function.
No
Explanation: The device is described as a vaginal pessary intended for support of prolapse, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "Vaginal Pessary," which is a physical medical device inserted into the vagina. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the PelvX Donut and Cube Vaginal Pessaries is for the physical support of vaginal prolapse, rectocele, and/or cystocele. This is a mechanical function within the body, not an examination of a biological sample.
- The description focuses on physical support. The intended use clearly states "support of... prolapse" and "support of... prolapse combined with rectocele and/or cystocele." This describes a physical intervention, not a diagnostic test.
- There is no mention of analyzing biological samples. The provided text does not mention any analysis of blood, urine, tissue, or any other biological specimen.
Therefore, the PelvX Donut and Cube Vaginal Pessaries are medical devices, but they are not IVDs.
N/A
Intended Use / Indications for Use
The PelvX Donut Vaginal Pessary is a vaginal pessary intended for support of 310 degree prolapse.
The PelvX Cube Vaginal Pessary is a vaginal pessary intended for support of 314 degree prolapse combined with rectocele and/or 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
vagina
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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 a black and white logo. The logo is a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The logo is oriented vertically and appears to be part of a larger document or image, as indicated by the partial text on the left side.
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: K974117
PelyX Donut and PelvX Cube Vaginal Pessaries 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 (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 (QS) 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 531 through 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 vito 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): K97417
Device name: PelvX Donut Vaginal Pessary and PelvX Cube Vaginal Pessary
Indications for Use:
The PelvX Donut Vaginal Pessary is a vaginal pessary intended for support of 310 degree prolapse.
The PelvX Cube Vaginal Pessary is a vaginal pessary intended for support of 314 degree prolapse combined with rectocele and/or cystocele.
(Please do not write below this line) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Satlung/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K974112
Prescription Use ✓
OR
Over-The-Counter Use