INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300

{0}------------------------------------------------ MAY 1 2 1999 # Summary of Safety and Effectiveness ## Introduction The Safe Medical Device Act (SMDA) of 1990 requires that in addition to other information submitted in a 510(k), medical device manufacturers submit a summary of information regarding safety and effectiveness for the device subject to the 510(k). The summary is to include detailed information regarding adverse health effects of the device. This Summary of Safety and Effectiveness document is intended to comply with the SMDA requirement. FDA will make this summary available to the public within 30 days following a finding of substantial equivalence. ### 510(k) Submitted by Sandhill Scientific, Inc. 8955 S. Ridgeline Blvd., #500 Highlands Ranch, CO 80126 ### USA Contact Person Linda L. Diederich, MT-ASCP VP of Marketing & Customer Relations Tel: 303-470-7020 / Fax: 303-470-2975 ### Date Prepared January 22, 1999 #### Trade Name of Device InSIGHT Sphincter of Oddi Manometry Module #### Common Name of Device Sphincter of Oddi Manometry #### Classification Name System, Gastrointestinal Motility (Electrical) #### 510(k) Classification Class II {1}------------------------------------------------ K990441 PAGE 2 OF 3 # Comparison to Predicate Devices The InSIGHT Sphincter of Oddi Manometry (SOM) Module is a manometry recording device with features equivalent in safety and performance to those included on prior legally marketed devices. The InSIGHT SOM Module is Substantially Equivalent to: K932306 Microinfuser, Manufactured by Sandhill Scientific, Inc. K900058, Wilson-Cook Biliary Motility Catheter, Manufactured by Wilson-Cook Medical. Inc. Pre-Amendment, Hewlett-Packard Model 7788-A. Manufactured by Hewlett-Packard Corporation. ## Device Description and Intended Use The Sphincter of Oddi Manometry Module is intended for use by Gastroenterologists or Surgeons to determine intraluminal pressures within the pancreaticobiliary ductal system and motor activity within the sphincter of Oddi zone. The InSIGHT Sphincter of Oddi Manometry Module includes analysis software, but requires skilled interpretation by a physician to make a diagnosis. # Technological Characteristics The SOM Module is intended for use only with the InSIGHT Model S980000 Gastrointestinal Motility system (K984444). The InSIGHT system consists of three basic subsystems. These are: #### Signal conditioning and recording hardware This subsystem includes the hardware that amplifies the transduced signals for recording. provides electrical isolation for safety, and processes the signals for subsequent analysis. #### Analysis software The software displays the waveforms, shows the analyzed results and incorporates these results into reports. #### Probes and transducers These are used to generate the signal that is recorded. Sandhill does not manufacture the transducers and probes that are intended for use with the system, but these carry the manufacturers' approval to market and meet the manufacturers' safety requirements for their use. The technological characteristics of the InSIGHT SOM Module are the same as, or perform equivalently to, the predicate devices. # Applicable Standards and Non-Clinical Testing In compliance with the company's Design Controls procedures, the InSIGHT Model S980000 system has been designed to meet the requirements of the following standard: {2}------------------------------------------------ Medical Electrical Equipment. Part 1: General Requirements 990441 PAGE 3 OF 3 UL 2601-1: Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety Certification of the design to the above standards and the device design specifications is through a planned combination of internal design testing to written protocols and outside laboratories. No formal clinical testing has been performed, nor is any believed to be necessary. # Potential Adverse Health Effects The InSIGHT SOM Module has been designed to either completely eliminate or mitigate all 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. One or more of the following means (in order of preference) was used to implement mitigation of health hazards identified by the risk management program: - 1. Design modifications. - 2. Detection of hazard conditions and alerting of the user through alarms and visual indications. - 3. Identification of any potentially undetectable health hazard conditions in the instruction manual and other device labeling. The user must be qualified in biliary diagnostic procedures, trained in the use of the system, and must be familiar with all labeling and instructions for use associated with the equipment. Many device injuries are due to user error and failure to follow the instructions for use. The user of the device is advised to thoroughly understand the use of the equipment, and familiarize themselves with the location and function of all controls and alarms prior to using the equipment. Sandhill Scientific believes that the InSIGHT SOM Module is safe and effective when used as instructed by knowledgeable and trained personnel, and performs as well as or better than the legally marketed predicate devices. {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. MAY 1 2 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Linda L. Diederich, MT-ASCP Vice-President of Marketing & Customer Relations Sandhill Scientific, Inc. 8955 South Ridgeline Boulevard Unit #500 Highlands Ranch, Colorado 80126 Re: K990441 InSIGHT Sphincter of Oddi Manometry Module, Model S981300 Dated: February 9, 1999 Received: February 11, 1999 Requiatory Class: II 21 CFR 876.1725/Procode: 78 FFX Dear Ms. Diederich: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 vour device is classified (see above) into either 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### Indications for Use 510(k) Number: InSIGHT Sphincter of Oddi Manometry Module Device Name: Indications for Use: The Sphincter of Oddi Manometry Module is intended for use by Gastroenterologists or Surgeons to determine intraluminal pressures within the pancreaticobiliary ductal system and motor activity within the sphincter of Oddi zone. The InSIGHT Sphincter of Oddi Manometry Module includes analysis software, but requires skilled interpretation by a physician to make a diagnosis. #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use : (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number. OR