MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP

{0}------------------------------------------------ \$\qquad^{-2}\$ K980946 # Section 11 510(k) Summary of Safety and Effectiveness Date prepared: 02 February 1998 Submitter: Dentsleeve Pty Ltd 56a/b Crn St Annes Place & Glen Osmond Road Parkside SA 5063, Australia Telephone: +61-8-8271 0744 +61-8-8271 0084 Facsimile: Marcus Tippett, Technical Consultant | Trade Name: | Mark II Manometric Perfusion Pump<br>Mark II CO2 Flush Manometric Perfusion Pump | |----------------------|----------------------------------------------------------------------------------| | Common Name: | Manometric perfusion pump | | Classification Name: | Monitor, esophageal motility and tube | Substantial equivalence is claimed to the following devices: The Pneumo-Hydraulic Capillary Infusion System Arndorfer Medical Specialties. 5656 Grove Terrace Greendale WI 53129 U.S.A. #### Description The Mark II Manometric Perfusion Pump and the Mark II CO2 Flush Manometric Perfusion Pump are gas powered perfusion pumps designed to facilitate the monitoring and analysis of intragastrointestinal pressures. The Mark II Manometric Perfusion Pump and the Mark II CO2 Flush Manometric Perfusion Pump are comprised of a constant gas pressure delivery system and a constant flow constant pressure, multi-channel, perfusate system with the capacity to connect pressure transducers for monitoring intragastrointestinal pressures. The Mark II CO2 Flush Manometric Perfusion Pump has an addition CO2 gas circuit for facilitating the removal of air bubbles from the perfusate circuit prior to it clinical use. Both Manometric Perfusion Pump have been designed to be compatible with gastrointestinal motility catheters. #### Indications The Mark II Manometric Perfusion Pump is used to provide a low compliant fluid pathway to enable high fidelity dynamic intragastroesophageal pressured and analyzed in both pediatric and adult populations when used with a gastrointestinal motility catheter. The product is to be used on patients in the hospital environment under supervision of a trained physician. #### Technological Characteristics The Mark II Manometric Perfusion Pump is a medical gas cylinder powered perfusion pump. It has 6 to 24 perfusate channels with attachment squares to connect pressure transducers to each channel. The Mark II CO2 Flush Manometric Perfusion Pump is a medical gas cylinder powered perfusion pump. It has 6 to 24 perfusate channels with attachment squares to connect pressure transducers to It also has a CO2 flush circuit to assist the removal of air from the perfusate circuit. each channel. #### Testing The Mark II Manometric Perfusion Pump has been tested and shown to enable accurate intergastrointestinal pressure measurements. ## Other reports (scientific papers, validation of manometric equipment) - 1. Ronald C Arndorfer, et al. Improved infusion system for intraluminal esophageal manometry. Gastroenterology 73:23-27, 1977 Depts. of Radiology and Medical College of Wisconsin and dept. of Engineering, Marquette University, Milwaukee, Wisconsin Abstract Image /page/0/Picture/22 description: The image contains a solid black circle against a white background. The circle is centered vertically but slightly off-center horizontally, positioned towards the left side of the frame. The circle appears to be uniformly filled with black, creating a stark contrast with the surrounding white space. There are no other discernible elements or details within the image. {1}------------------------------------------------ An improved catheter infusion system is needed for esophageal intraluminal manometry. Using conventional syringe pump infusion systems undesirably rapid infusion rates of 6ml/min or more are often needed to achieve accurate recording of esophageal peristaltic pressure. These rapid baseline infusion rates are necessitated by the high compliance of syringe pump systems which causes substantial reduction in the infusion rate during dynamic pressure transients. In this study we tested a hydraulic capillary infusion system designed to have low compliance. This minimally compliant system yields accurate recording of esophageal peristaltic pressure at infusion rates of 0.6 ml/min or less. We believe that the hydraulic capillary infusion system is a useful tool for performing both clinical and investigative studies of esophageal motor function. - 2. JJ Dent et al. A pneumatically driven pump for constant perfusion manometry. The Australian Journal of Experimental Biology and Medical Science, 55:293-298, 1977 Monash University Dept. of Medicine and dept. of Medical Physics, Austin Hospital Victoria Australia. #### Abstract Syringe pumps are almost universally used for constant perfusion oesophageal manometry, despite important technical limitations. A pneumatically driven perfusion pump has been designed specifically for oesophageal manometry. This pump requires less than one third the flow setting of a syringe pump to achieve a given rate of pressure rise. It is simple to operate and needs infrequent refilling. Nearly two years' practical experience with this pump has confirmed its superiority over the syringe pump for constant perfusion manometry. - 3. Geoffrey S Hebbard et al. Assessment of gastrointestinal pressure gradients using high resolution perfusion manometry. Abstract, Digestive Diseases Week, Washington US, May 1997 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head in profile, with three lines representing the feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the left side of the eagle. The letters "USA" are located on the right side of the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Public Health Service JUN - 8 1998 Mr. Marcus Tippett Dentsleeve Pty, Ltd 56 A/B Glen Osmond RD. Parkside, South Australia Australia, 5063 Re: K980946 Mark II and Mark II CO2 Flush Manometric Perfusion Pump Dated: February 28, 1998 Received: March 13, 1998 Regulatory Class: II 21 CFR \$876.1725/Product code: 78 FFX Dear Mr. Tippett: 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 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. 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 regulation 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/odrh/dsmaldsmam.html". Sincerely yours Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal. Ear. Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(k) number (if known): K980946 Device Name: Mark II CO2 Manometric Perfosion Pump & Mark II Manometric Perfusion Pump Product code: 78KLA # Indications For Use: When used in conjunction with a gastrointestinal manometric assembly (catheter), the Mark II CO2 Manometric Perfusion Pump & Mark II Manometric Perfusion Fump, can be used where gastrointestinal manometry is indicated when the following conditions are satisfied; 1) When information about patterns of gastrointestinal pressures is judged to be of importance for either determining appropriate patient management or for research studies into gastro-intestinal motility. 2) Contra-indications are considered, and the risk-bencht analysis is judged to favour performance of the manometric study, after measures have been taken to minimise all possible risks. ### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------------------|----------------------------------| | <i>Carly Y Newland</i> for <i>R. Gatling</i> | | | (Division Sign-Off) | | | Division of Reproductive, Abdominal, ENT, and Radiological Devices | | | 510(k) Number | K980946 | | Prescription Use | OR Over-The-Counter Use ________ | | (Per 21 CFR 801.109) | (Optional Format 1-2-96) |