BT-CATH

{0}------------------------------------------------ K101535... Page 1/2 Image /page/0/Picture/1 description: The image shows the logo for Utah Medical Products Inc. The logo consists of the text "UTAH MEDICAL PRODUCTS INC." in a sans-serif font, with a line underneath the text. Below the text is a stylized symbol that resembles the letter "U" or a horseshoe shape, with a vertical line extending upwards from the center of the "U" shape. JAN 1 1 2011 ## SECTION 9: 510(k) SUMMARY and the state of the states and | 510(k) Owner:<br>Address: | Utah Medical Products, Inc.<br>7043 South 300 West<br>Midvale, UT 84047 USA | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Telephone No .:<br>Fax No .: | (801) 566-1200<br>(801) 566-2062 | | Contact: | Kevin L. Cornwell, CEO | | Date: | 3 January 2011 | | Trade Name: | BT-Cath | | Common Name: | Intrauterine Balloon Tamponade Catheter | | Classification: | Obstetric-gynecologic specialized manual instrument,<br>21 CFR 884.4530; Product Code OQY | | Predicate Devices: | Bakri Uterine Balloon Tamponade, (K013597, K062438)<br>Cook Ob/Gyn | | Indications for Use: | BT-Cath is intended to provide temporary control or reduction of<br>uterine bleeding during postpartum hemorrhage that is unresponsive<br>to standard conservative therapy including uterine massage and<br>oxytocin administration. | {1}------------------------------------------------ # 7080 2 #### Device Description: Comparison to predicate devices: Performance Data: The BT-Cath consists of an extruded silicone dual lumen catheter with an inflatable molded silicone tamponade balloon attached on the distal end. One lumen of the catheter serves as the conduit through which saline is infused into the balloon after insertion into the bleeding uterus. When inflated properly to press against the uterine wall, the balloon provides compression against multiple sites of torn arteries, ruptured sinuses, lacerations and other tissue evoking hemorrhage. The second lumen, which is open at the distal end of the catheter, provides a drainage port for blood and other bodily fluids. At the proximal end of the catheter, a stopcock retains the saline in the balloon until a clinician gradually drains it allowing the uterus to contract. For ease of filling the balloon with multiple syringes, a check valve is also provided at the proximal end. The device is latex-free and provided sterile. There are insignificant differences in the physical dimensions and physical configuration of the balloon tamponade catheters. The technological characteristics, methods of use, materials, intended use, indications for use and contraindications are the same as the predicate devices. Biocompatibility and shelf-life testing were also assessed to demonstrate substantial equivalence. Substantial equivalence is also based on an assessment of mechanical tests where the structural integrity of the balloon, including the relationship of volume of saline infused into the balloon and resulting balloon diameter, the burst volume of the balloon, and the ability of the balloon to hold its shape and not leak during repeated and prolonged inflations; the structural integrity of the catheter using leak tests; and the tensile strength in each joint in the devices were evaluated. Both the BT-Cath and the Bakri device were tested and found to achieve structural integrity with a reasonable safety factor. Clinical feedback was obtained after about 840 uses of BT-Cath by U.S. clinicians that indicates the device consistently achieved its intended purpose without any reported likelihood of patient injury. K. Howell Kevin L. Cornwell Kevin L. Cornwell Chairman & CEO Utah Medical Products, Inc. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN USA" around the edge. Inside the circle is a stylized eagle symbol. The eagle is depicted with three thick, curved lines representing its body and wings. The image is in black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 Mr. Kevin L. Cornwell Chairman & CEO Utah Medical Products, Inc. 7043 South 300 West MIDVALE UT 84047 JAN 1 1 201 Re: K101535 Trade Name: BT-Cath® Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: OQY Dated: January 3, 2011 Received: January 3, 2011 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. 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 {3}------------------------------------------------ Page 2 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/CDRH0ffices/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Herbert Semler MD Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### SECTION 3: INTENDED USE / INDICATIONS for USE | 510(k) Number: | K101535 | JAN 1 1 2011 | |----------------|---------|--------------| |----------------|---------|--------------| Device Name: UTMD BT-Cath - Balloon Tamponade Catheter for Postpartum Uterine Hemorrhage (BTC-100) #### Indications for Use: BT-Cath (BTC-100) is intended to provide temporary control or reduction of uterine bleeding during postpartum hemorrhage that is unresponsive to standard therapy including massage and oxytocin administration. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _ X (Per 21 CFR 801.109) OR Lori K. Wertz Visible Sign Off 10 Over-the-Counter Use