(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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2016
Panpac Medical Corporation Yen-Ming Pan President 6F-1, 2, No. 202, Sec. 3 Ta-Tong Road Shi-Chih District, New Taipei City 22103 Taiwan
Re: K153422 Trade/Device Name: Panpac Disposable Pessary Fitting Set Regulation Number: 21 CFR§ 884.3575 Regulation Name: Vaginal pessary Regulatory Class: II Product Code: HHW Dated: June 16, 2016 Received: June 17, 2016
Dear Yen-Ming Pan:
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 (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. 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.
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.
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153422
Device Name Panpac Disposable Pessary Fitting Set
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Research and/or Identification of CBD-Related Compounds
Other: This use requires a Material Transfer Agreement
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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).