MARK II/MARK III MANOMETRIC PERFUSION PUMP

{0}------------------------------------------------ OCT 1 9 2001 PAGE 1 OF 2 K013154 # 510(k) Summarv ## Introduction This 510(k) Summary document is intended to comply with the 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) Submitted by Dentsleeve Pty Ltd 41 Goodwood Road Wayville, South Australia Australia 5034 #### USA Submission Correspondent Robert N. Clark Medical Device Regulatory Advisors Tel: 303-234-9412 / Fax: 303-234-9413 ## Date Prepared September 19, 2001 #### Trade Name of Device Mark II / Mark III Manometric Perfusion Pump #### Common Name of Device Manometric Perfusion Pump #### Classification Name System, Gastrointestinal Motility (Electrical) ## 510(k) Classification 21CFR§876.1725 Class II ## Device Description and Intended Use When used in conjunction with a gastrointestinal manometric assembly (catheter), the Manometric Perfusion Pump 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 gastrointestinal motility. 2) Contraindications are considered, and the risk-benefit analysis is judged to favor performance of the manometric study, after measures have been taken to minimize all possible risks. {1}------------------------------------------------ # Comparison to Predicate Devices The device is equivalent in safety and performance to prior legally marketed devices. In particular it is equivalent to: PAGE 2 OF 2 K013154 K980946 - Mark II / Mark II CO2 Flush Manometric Perfusion Pump, manufactured by Dentsleeve Pty Ltd. ### Recognized Standards The requirements of the following standards have been used in part to establish substantial equivalence: IEC 601-1 (1988) Medical Electrical Equipment - Part 1: General Requirements for Safety; including Amendment 1 (1991) & Amendment 2 (1995). IEC 601-1-2 (1993) Medical Electrical Equipment - Part 1: General Requirements for Safety; Electromagnetic Compatibility - Requirements and Tests ## Clinical 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 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: - Design modifications. 1. - Detection of hazard conditions and alerting of the user. 2. - 3. Identification of any potentially undetectable health hazard conditions in the instructions for use or other device labeling. The user must be qualified in gastrointestinal diagnostic procedures, trained in the use of manometric perfusion pumps and recording equipment; trained in the insertion and use of gastrointestinal manometry catheters; and must be familiar with all labeling and instructions for use associated with the device. The company believes many device health hazards are due to user error and failure to follow instructions for use. Dentsleeve Pty Ltd believes that the Mark II / Mark III Manometric Perfusion Pump products are safe and effective when used as instructed by knowledgeable and trained personnel, and perform as well as or better than the legally marketed predicate devices. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine and healthcare. The symbol features a staff with two snakes entwined around it, and a pair of wings at the top. OCT 1 9 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Dentsleeve Pty. Ltd. c/o Mr. Robert N. Clark Medical Device Regulatory Advisors 13605 West 7th Avenue GOLDEN CO 80401-4604 Re: K013154 Trade/Device Name: Mark II / Mark III Manometric Perfusion Pump Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: 78 FFX Dated: September 17, 2001 Received: September 20, 2001 Dear Mr. Clark: De have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) to regally the enactment date of the Medical Device Amendments, or to conninered price to May 20, 1978, ins easonance with the provisions of the Federal Food, Drug, devices that have ocon require approval of a premarket approval application (PMA). and Cosmetic Act (710t) that to not requent of the general controls provisions of the Act. The I ou may, dicierore, market and act include requirements for annual registration, listing of general controls profises in a prohibitions against misbranding against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is classified (800 a00 v) ... 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 I that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a sold regulations administered by other Federal agencies. You must or any I oderal surates and registments, including, but not limited to: registration and listing Compry with and rice broquientends, as 801); good manufacturing practice requirements as set (21 CFR Part 807), adoming (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html. Sincerely yours, Nancy Cbrogdon 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: _______________________________________________________________________________________________________________________________________________________________ K013154 Device Name: Mark II / Mark III Manometric Perfusion Pump Indications for Use: When used in conjunction with a gastrointestinal manometric assembly (catheter), the Manometric Perfusion Pump 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 gastrointestinal motility. 2) Contraindications are considered, and the risk-benefit analysis is judged to favor performance of the manometric study, after measures have been taken to minimize all possible risks. (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) OR Over-The-Counter Use | Nancy C Bragdon | | |---------------------------------------------------|---------| | (Division Sign-Off) | | | Division of Reproduction and Radiological Devices | | | 510(k) Number | K013154 |