ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX

{0}------------------------------------------------ K011601 Image /page/0/Picture/1 description: The image shows the logo for ARDO. The logo consists of the word "ARDO" in a simple, sans-serif font, with the letters evenly spaced. Above the word "ARDO" is a stylized graphic that resembles a leaf or a pair of wings. The graphic is shaded with a stippled effect, giving it a textured appearance. JUN - 8 2001 Ardo Suction Pumps master, senator #### 510 (k) Summary ### 1. Submitted by: Ardo medical AG Gewerbestrasse 19 6314 Unterägeri Switzerland Tel. +41-(0)41 754 70 70 Tel. +41-(0)41 754 70 71 ardo@info.ch - www.ardo.ch #### 2. Contact Person: Eva Krähenbühl, Marketing Manager - 3. Date Prepared: 18 April 2001 ### 4. Product Classification: - Device Name: Ardo Suction Pumps master, senator ● - Common Name: Suction Pump - Classification Name: Powered Suction Pump (per 21 CFR 878.4780) . #### 5. Predicate Devices: - egnell compact suction pump by Ameda AG, K853917, November 25, 1985 . - Dominant suction pump by Medela AG, K983552, January 7, 1999 . #### 6. Device Description: The Ardo Suction Pumps master and senator are high performance suction pumps with maintenance-free glass piston/cylinder technology and a modern, functional design. They are the successor models of the egnell compact suction pump operating on the same basic principles. The mechanical over-flow safety device in the lid jar and the bacterial filter protect the pump against contamination. The suction pump is connected to the collection jars by means of collapse-resistant suction tubing. A longer piece of patient tubing is also connected to the jar. The latter transports the fluids from the patient to the jar. However, the tubing does not contact the patients directly. When the suction pump is switched to the ON position, the circuits direct electrical current from the external AC power supply to the pump/motor assembly. The pump operates to evacuate air from the collection jar. The resulting subatmospheric condition causes air to flow upward from the patient suction tubing and into the jars. Vacuum can be set by turning the adjustment knob. The difference between the master and senator is the suction capacity (master: 45 liter/minute, senator: 30 liter/minute). All other features are substantially equivalent. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for ARDO. The logo consists of a stylized image of a plant or leaf above the word "ARDO" in a simple, sans-serif font. The plant image is composed of three sections, with the top section being the largest and the bottom two sections being smaller and more rounded. # Ardo Suction Pumps master, senator ## 7. Indications for Use: The Ardo Suction Pumps master and senator are indicated for vacuum The Ardo Ouction Framoval of surgical fluids, tissue (including bone), extraction, aspliation and remover or strom wounds or from a patient's airway or respiratory support system, either during surgery or at the patient's bedside. The indications for use for Ardo Suction Pumps master and senator are identical to the predicate device, Dominant, K983552. #### 8. Test: The following standards were used in testing the suction pumps: - ISO 10079-1: Medical Suction Equipment Part 1: Electrically powered suction ● equipment - ISO 10079-3: Medical Suction Equipment -- Part 1: Suction equipment . powered from a vacuum or pressure source - IEC 601-1: Medical Electrical Equipment -- Part 1: General requirements for safety . #### 9. Conclusion: It is concluded that the proposed Ardo Suction Pumps master and senator are safe and effective for their intended use and are substantially equivalent to the predicate devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. Public Health Service JUN - 8 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ardo Medical Ag c/o Mr. Mark Job TÜV Product Service, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55112 Re: K011601 Trade/Device Name: Ardo Suction Pumps Master, Senator Regulation Number: 878.4780 Regulatory Class: II Product Code: BTA Dated: May 15, 2001 Received: May 24, 2001 Dear Mr. Job: 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 (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 (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 regulations. {3}------------------------------------------------ Page 2 - Mr. Mark Job 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) 594-4659. 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" (21CFR 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, O. Mark N. Milburn Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 1 of 1 510(k) Number (if known):_KO \ \ \ \ \ \ Device Name: Ardo Suction Pumps master, senator Indications For Use: The Ardo Suction Pumps master and senator are indicated for vacuum extraction, aspiration I he Ardo Daction Pumps nids, tissue (including bone), gases, bodily fluids or infectious and I cargical of bargion or from a patient's airway or respiratory support system, either during surgery or at the patient's bedside. (Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Lion Mach n Melkus (Division Sign-Off) (Division Sign of General, Restorative Divisiourological Devices (Optional Format 3-10-98) 510(k) Number - Prescription Use (Per 2) CFR & 801.109)