(232 days)
Panpac Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele, rectocele as well as stress urinary incontinence in women.
Not Found
This document is an FDA 510(k) clearance letter for the "Panpac Disposable Pessary Fitting Set." It primarily confirms substantial equivalence to a predicate device and outlines regulatory responsibilities, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.
The core of the request asks for specific details about acceptance criteria and a study. Since this type of information is generally found in the 510(k) submission itself (which includes detailed test reports and performance data), and not in the clearance letter, I cannot fulfill the request directly from the provided text.
The closest relevant information from the document is the "Indications for Use" statement, which describes the intended medical application of the device:
- Device Name: Panpac Disposable Pessary Fitting Set
- Indications for Use: Panpac Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele, rectocele as well as stress urinary incontinence in women.
To answer your specific questions, I would need access to the actual 510(k) summary or the full submission documentation.
§ 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).