UNITIP HIGH RESOLUTION CATHETER

{0}------------------------------------------------ 510(k) Number: K0622222 Date: Page 1 of 2 # 510(k) Summary MAR 1 5 2007 #### Introduction This summary is intended to comply with requirements of the SMDA and 21CFR §807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence. #### 510(k) Applicant & Holder Unisensor AG Bahnstrasse 12a Attikon CH-8544 Switzerland ### 510(k) Correspondent Robert N. Clark, President and Senior Consultant Medical Device Regulatory Advisors 13605 West 7th Ave., Golden, CO USA Tel: 303-234-9412 / Fax: 303-234-9413 ### Date Prepared July 19, 2006 #### Proprietary Name of Device UniTip High Resolution GI Catheter #### Classification Name Gastrointestinal motility monitoring system #### 510(k) Classification Class II FFX #### Device Description and Intended Use The Unisensor UniTip Gastrointestinal Pressure Sensor Catheter product line consists of multiple ultra-miniature solid-state pressure sensors, located at the distal end of a gastrointestinal catheter. pH sensors, silicon rubber sleeves, lumen, and conductive impedance rings, may also be included. There are scanning electronics for multiplexing the sensor signals, and an electrical connection located at the proximal end to carry the sensor element signals to an external gastrointestinal motility recording equipment. The UniTip GI catheters are produced in various lengths and catheter sizes. This modification consists of increasing the maximum number of pressure sensor elements to 40. The closer proximity of the pressure sensor elements to each other allows for high-resolution {1}------------------------------------------------ 510(k) Number: K0622222 Date: Date: Date: Date: Page 2 of 2 mapping of pressures within the organs of the human gastrointestinal tract. This modification also increases the maximum number of pH sensors to 7, and the maximum number of impedence rings to 14. ### Predicate Devices Unisensor AG, UniTip Pressure Sensor Catheter K003580 Sierra Scientific Instruments, Inc., Motility Visualization System K031169 ### Biocompatibility The requirements of the following standards have been used in part to establish substantial equivalence: EN 30993-1/ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing" The company did not conduct, nor depend on, clinical studies in order to establish substantial equivalence. ### Risk Management This device has been designed to either completely eliminate or mitigate known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program. Unisensor AG believes that the UniTip High Resolution GI Catheter is safe and effective when used as instructed by knowledgeable and trained personnel, and is substantially equivalent to the legally marketed predicate devices. . {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 AR 1 5 2007 Unisensor AG c/o Mr. Robert N. Clark Medical Device Regulatory Advisors 13605 West 7" Avenue GOLDEN CO 80401 Re: K062222 Trade/Device Name: Unitip High Resolution Catheter Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: FFX Dated: February 22, 2007 Received: February 26, 2007 Dear Mr. Clark: 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 indivious 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 Coometic 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 greeral controls provisions of the Act include requirements for annual registration, listing of devines, good manufacturing practice, labeling, and prohibitions against misbranding and adulter of on. 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 899. In addition, FDA may publish further announcements concerning your device in the Federal Register. Image /page/2/Picture/10 description: The image is a circular logo or seal. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo, and the word "Centennial" is below the letters. The text around the edge of the circle is difficult to read. *Protecting and Promoting Public Health* {3}------------------------------------------------ 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 (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. 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 yours, 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 {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): _________________ Device Name: Indications for Use: The catheter probe is used to obtain a high resolution mapping of peristaltic activity or pressure within the organs of the gastrointestinal tract, and to allow storage of the corresponding data. The device is manufactured in the basic model variations listed below: - 1. High Resolution Gastrointestinal Catheter with up to 40 pressure sensors: This model variation is intended for simple direct esophageal pressure, either at, above, or below the specific site of interest. Pressure information is provided at multiple sensor sites. Pressures may be measured continuously, at rest, or dynamically. - 2. Gastrointestinal catheter, with pH sensors: This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except that this model variation includes up to 7 pH sensors. PH probes are added to allow measurements of pH in the stomach and/or esophagus. Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David h. Ingram Division of Reproductive, Abdominal 510k) Num l of 2 {5}------------------------------------------------ - 3. Gastrointestinal catheter, with sleeve: This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except one or more of the pressure sensor sites will include a sleeve. The sleeve is added to broaden the pressure sensitive one for the sensor site, and reduce positioning sensitivity. - 4. Gastrointestinal catheter, with impedance rings: This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except it includes up to 14 conductive rings for impedance studies. - 5. Gastrointestinal catheter, with lumen This model variation is the same as the High Resolution Gastrointestinal (GI) catheter described above, except it includes a lumen.