RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)

K093508 · Womancare Global · HGH · Mar 4, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K093508
• Device Name: RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)
• Applicant: Womancare Global
• Product Code: HGH · Obstetrics/Gynecology
• Decision Date: Mar 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For uterine aspiration/uterine evacuation in obstetric and gynecologic patients. Indications for use are rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy.

Device Story

Rigid Uterine Cannulae are injection-molded styrenic copolymer devices, approximately 190mm in length, available in 6mm-12mm outer diameters in straight or curved configurations. Used in clinical settings by healthcare providers for uterine aspiration or evacuation. The device connects to an external vacuum source to perform suction. The scoop-end design facilitates the removal of uterine contents. By providing a standardized, rigid conduit for vacuum-assisted procedures, the device enables efficient first-trimester uterine evacuation, aiding in obstetric and gynecologic care.

Clinical Evidence

Bench testing only. Testing included physical strength evaluation (three-point bend and compression testing) and vacuum performance/integrity testing to demonstrate equivalence to predicate devices.

Technological Characteristics

Injection-molded styrenic copolymer; 190mm length; 6mm-12mm outer diameters; straight and curved configurations; single scoop-end design; connects to external vacuum source; non-powered; manual/mechanical operation.

Indications for Use

Indicated for rapid transcervical aspiration of the uterine cavity in obstetric and gynecologic patients during the first trimester of pregnancy.

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.

Predicate Devices

• Berkeley VC10-Vacuum Curettage System and Accessories (K030935)
• Synevac Vacuum Curettage System 10 (K813282)

Submission Summary (Full Text)

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KO93508

5. 510(k) Summary

Submitters Name: Address:

Doranne Frano WomanCare Global 300 Market Street Suite 134 Chapel Hill, NC 27516 919 442-2621 Susanne Parks November 6, 2009

Phone Number: Contact Person: Date Summary Prepared:

Device Name: Rigid Uterine Cannulae Common Name: Uterine Cannulae Classification Name: Vacuum Abortion System, Regulation Number (884.5070) Product Code: Cannulae Suction Uterine (HGH), Class II device

## Establishment Registration Number: 3008007615

Identification of Substantially Equivalent Device: Berkeley VC10-Vacuum Curettage System and Accessories (K030935) and Synevac Vacuum Curettage System 10 (K813282). These 510(k) applications include vacuum pumps as well as the uterine suction cannulae and accessories.

Description of Device: The Rigid Cannulae are injection molded plastic devices approximately 190mm in length, made from a styrenic copolymer manufactured in sizes 6mm. 7mm. 8mm. 9mm. 10mm, 11mm, and 12mm (outer diameter), straight and curved.

Intended Use: For uterine aspiration/uterine evacuation in obstetric and gynecologic patients. Indications for use are rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy.

Comparison to Predicate: The Rigid Cannulae and the predicate device are both plastic injection molded devices. They share the same design. They both have a single scoop end and similar dimensional features. The raw materials used to produce the parts are similar. Both are attached to a vacuum source to perform uterine aspiration procedures. Bench Testing was performed to compare the physical strength of the materials (three point bend and compression testing) as well as vacuum testing (integrity and performance).

## MAR - 4 2010

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

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

## MAR - 4 2010

:--.

Ms. Susanne Parks Director Regulatory and Logistics WomanCare Global 300 Market Street, Suite 134 CHAPEL HILL NC 27516

Re: K093508

Trade/Device Name: Rigid Uterine Cannulae, Curved and Straight Regulation Number: 21 CFR §884.5070 Regulation Name: Vacuum abortion system Regulatory Class: II Product Code: HGH Dated: February 1, 2010 Received: February 3, 2010

Dear Ms. Parks:

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 Devise-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 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/ucm115809.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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## 4. Indications for Use Statement

Device Name:

Rigid Uterine Cannulae

KO93508

Indications for Use: For rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy.

Prescription Use X ___________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)

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

(Please do not write below this line-continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation(ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K093508