SALINE/ CONTRAST MEDIA INFUSION CATHETER

{0}------------------------------------------------ K063611 Image /page/0/Picture/1 description: The image shows the logo for Utah Medical Products Inc. The logo features the company name in bold, uppercase letters above a large, stylized symbol. The symbol resembles a combination of the letters 'U' and 'M', forming a circular shape with a gap in the middle. MAY 2 3 2007 . # SECTION 9: 510(k) SUMMARY 新疆 | 510(k) Owner: | Utah Medical Products, Inc. | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | 7043 South 300 West<br>Midvale, UT 84047 USA | | Telephone No.: | (801) 566-1200 | | Fax No.: | (801) 566-2062 | | Contact: | Kevin L. Cornwell, CEO | | Date: | 9 April 2007 | | Trade Name: | TVUS/HSG-Cath™ Saline/ Contrast Media Infusion Catheter | | Common Name: | Hysterosonography or Hysterosalpingography Catheter | | Classification: | Obstetric-gynecologic specialized manual instrument,<br>21 CFR 884.1700 (a)(4) | | Predicate Device: | H/S Elliptosphere Catheter, (K013972)<br>ACKRAD Laboratories, Inc., a CooperSurgical company. | | Intended Use: | TVUS/HSG-Cath™ is intended for intracervical injection of saline<br>into the uterus for enhanced transvaginal ultrasonography (TVUS)<br>also known as saline infusion sonography (SIS). TVUS/HSG-Cath<br>may also be used for the delivery of contrast media into the female<br>reproductive tract for diagnostic examination of the uterus and<br>fallopian tubes. | | Indications for Use: | TVUS (SIS) with saline infusion:<br>persistent abnormal or dysfunctional uterine bleeding suspected myometrial or intraluminal abnormalities (e.g., fibroids or polyps) thickened or irregular endometrium recurrent pregnancy loss pre- and post-operative assessment of uterine pathology HSG with contrast media: unexplained infertility recurrent pregnancy loss | {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 Mr. Kevin Cornwell Chairman & CEO Utah Medical Products, Inc. (UTMD) 7043 South 300 West MIDVALE UT 84047 MAY 2 3 2007 Re: K063611 Trade/Device Name: TVUS/HSG-Cath"; Saline/Contrast Media Infusion Catheter Regulation Number: None Regulation Name: Unclassified Regulatory Class: II Product Code: 85 LKF Dated: April 13, 2007 Received: April 16, 2007 Dear Mr. Cornwell: 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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. Image /page/1/Picture/10 description: The image is a circular logo for the FDA Centennial, celebrating 1906-2006. The letters "FDA" are prominently displayed in the center of the circle. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". Protecting and Promoting Public Health {2}------------------------------------------------ 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html Sincerely vours, Nancy C. Brogdon Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # SECTION 3: INTENDED USE / INDICATIONS for USE ## 510(k) Number: K063611 Device Name: TVUS/HSG-Cath™; Saline/ Contrast Media Infusion Catheter Intended Use: TVUS/HSG-Cath™ is intended for intracervical injection of saline into the uterus for enhanced transvaginal ultrasonography (TVUS), also known as saline infusion sonography (SIS). TVUS/HSG-Cath may also be used for the delivery of contrast media into the female reproductive tract for diagnostic examination of the uterus and fallopian tubes. (The intended use is the same as the intended use of the predicate devices listed in Section 8, Substantial Equivalence.) ### Indications for Use: TVUS (SIS) with saline infusion: - persistent abnormal or dysfunctional uterine bleeding . - suspected myometrial or intraluminal abnormalities (e.g., . fibroids or polyps) - . thickened or irregular endometrium - recurrent pregnancy loss t - pre- and post-operative assessment of uterine pathology . HSG with contrast media: - unexplained infertility . - recurrent pregnancy loss ## Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Nancy Brogdon Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number 10