PANPAC VAGINAL DILATORS

K130273 · Panpac Medical Corporation · HDX · Aug 8, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K130273
• Device Name: PANPAC VAGINAL DILATORS
• Applicant: Panpac Medical Corporation
• Product Code: HDX · Obstetrics/Gynecology
• Decision Date: Aug 8, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.3900
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Panpac Vaginal Dilators are indicated for women who need vaginal dilation for an examination, a surgical procedure, or for the relief of vaginismus.

Device Story

Panpac Vaginal Dilators are medical devices designed to assist in vaginal dilation. They are used for clinical examinations, surgical procedures, or the management of vaginismus. The device consists of a set of dilators available in four sizes (small, medium, large, extra large) and three distinct family types (A, B, and C). The dilators are intended for prescription use by healthcare professionals or patients under clinical guidance to facilitate physical access or therapeutic stretching of the vaginal canal.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Vaginal stent device; available in four sizes and three family configurations. Class II device (21 CFR 884.3900).

Indications for Use

Indicated for women requiring vaginal dilation for medical examinations, surgical procedures, or treatment of vaginismus. Available in four sizes (small, medium, large, extra large) across three family types (A, B, C).

Regulatory Classification

Identification

A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.

Submission Summary (Full Text)

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Public Health Service

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

August 8, 2013

Panpac Medical Corporation % Yen-Ming Pan President 6F-2, No. 202, Sec. 3. Ta-Tong Road Shi-Chih District, New Taipei City China (Taiwan) 22103

Re: K130273

Trade/Device Name: Panpac Vaginal Dilators Regulation Number: 21 CFR§ 884.3900 Regulation Name: Vaginal stent Regulatory Class: II Product Code: HDX Dated: July 3, 2013 Received: July 8, 2013

Dear Yon-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 cither 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 1 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/ReportalProblem/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,

## Herbert P. Lerner -S

for 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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Panpac Vaginal Dilators

PANPAC MEDICAL CORPORATION 510(k): Notification

510(k) Number (if known):

## Device Name: Panpac Vaginal Dilators

Panpac Vaginal Dilators are indicated for women who Indications for Use: need vaginal dilation for an examination, a surgical procedure, or for the relief of vaginismus. Panpac Vaginal Dilators has four different size (small, medium, large and extra large) in three family types; Family A, Family B and Family C with variant sizes.

Prescription Use_ × (Per 21 CFR 801. 109) OR

Over-The-Counter Use_

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

## Herbert P. Lerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130273 510(k) Number