PANPAC DISPOSABLE VACUUM CURETTES

K161106 · Panpac Medical Corporation · HGH · Jan 13, 2017 · Obstetrics/Gynecology

Device Facts

• Record ID: K161106
• Device Name: PANPAC DISPOSABLE VACUUM CURETTES
• Applicant: Panpac Medical Corporation
• Product Code: HGH · Obstetrics/Gynecology
• Decision Date: Jan 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For transcervical aspiration of the uterine cavity.

Device Story

Panpac Disposable Vacuum Curettes are single-use medical instruments designed for transcervical aspiration of the uterine cavity. The device functions as a suction tool used during gynecological procedures. It is intended for use by healthcare professionals in clinical settings. The curette facilitates the removal of uterine contents through vacuum aspiration. Being disposable, it eliminates the need for reprocessing and reduces the risk of cross-contamination between patients.

Clinical Evidence

Bench testing only.

Technological Characteristics

Disposable vacuum curette; single-use; manual or vacuum-assisted aspiration interface; non-powered mechanical instrument.

Indications for Use

Indicated for transcervical aspiration of the uterine cavity in patients requiring such procedures.

Regulatory Classification

Identification

A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.

Submission Summary (Full Text)

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

January 13, 2017

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: K161106

Trade/Device Name: Panpac Disposable Vacuum Curettes Regulation Number: 21 CFR 884.5070 Regulation Name: Vacuum Abortion System Regulatory Class: Class II Product Code: HGH Dated: December 13, 2016 Received: December 14, 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. 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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K161106

Device Name

Panpac Disposable Vacuum Curettes

Indications for Use (Describe)

For transcervical aspiration of the uterine cavity.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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