PANPAC VAGINAL PESSARY

K092981 · Panpac Medical Corporation · HHW · Jul 22, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K092981
• Device Name: PANPAC VAGINAL PESSARY
• Applicant: Panpac Medical Corporation
• Product Code: HHW · Obstetrics/Gynecology
• Decision Date: Jul 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.3575
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Panpac Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele as well as stress urinary incontinence in women.

Device Story

Panpac Vaginal Pessaries are removable medical devices designed for intravaginal placement. Used by clinicians to provide structural support to treat uterine prolapse, cystocele, and stress urinary incontinence. Device functions as a mechanical support structure to alleviate symptoms associated with pelvic organ prolapse. Intended for prescription use.

Clinical Evidence

bench testing only

Technological Characteristics

Vaginal pessary; removable structure; material composition not specified in provided text.

Indications for Use

Indicated for women requiring treatment for uterine prolapse, including cystocele, and stress urinary incontinence. Device is a removable structure placed in the vagina.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Yen-Ming Pan President Panpac Medical Corporation 6F-1,2, No. 202, Sec 3 Ta-tong Road Shi-Chih City, Taipei Hsien, 22103 TAIWAN

IJUL 2 2 2010

Re: K092981

Trade/Device Name: Panpac Vaginal Pessaries Regulation Number: 21 CFR §884.3575 Regulation Name: Vaginal Pessary Regulatory Class: II Product Code: HHW Dated: July 9, 2010 Received: July 12, 2010

Dear Mr. 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, Drig, 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. 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 of medical device-related

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### PANPAC MEDICAL CORPORATION 510(k) Notification

## PANPAC VAGINAL PESSARY

# 510(k) Number (if known):K092981

..

## Device Name: PANPAC VAGINAL PESSARY

#### Indications for Use:

Panpac Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele as well as stress urinary incontinence in women.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR .

Prescription Use (Per 21 CFR 801. 109)

Over-The-Counter Use

Per 21 CFR 801. 109)

Signature

(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

025