AUTOMED 3000 INFUSION PUMP

{0}------------------------------------------------ K023863 # SUMMARY OF SAFETY AND EFFECTIVENESS September 20, 2002 FEB 0 7 2003 Trade Name: AutoMed 3000 infusion pump Common Name: Infusion Pump Classification Name: Pump, Infusion, Classification Panel: General Hospital and Personal Use Device All questions and/or comments concerning this document should be made to: Robert J. Bard, Esq. Managing Director HELP Technologies 24312 Armada Dr. Dana Point, CA 92629 Telephone: 949.235.0545 Fax: 949.240.3460 #### 1.0 DEVICE DESCRIPTIONS The AutoMed 3000 infusion pump with integrated administration set and drug reservoir is a rotary peristaltic pump. Associated dedicated administration set AM 330 and accessories are part of the overall system. The system is suitable for use as ambulatory devices and is intended for use in the hospital, home environment or alternative care sites. ### INTENDED USE 2.0 For general infusion use. Routes of infusion include intravenous. percutaneous, subcutaneous, inter-arterial and epidural and into the intraoperative (soft tissue / body cavity) site. General infusion use includes continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for preoperative, perioperative and postoperative surgery. ### PREDICATE PRODUCTS 3.0 The AutoMed 3000 infusion pump is substantially similar to the following devices: McKinley WalkMed® 300, 350, PCA and IC; Sorenson Medical, Inc, MicroJect® Model 30 pump, Model 200 Pump, Model PCA Pump, Model PCEA Pump: Stryker Instruments Pain Pump II; and the I-Flow PainBuster Infusion Kit. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design of the eagle's body. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 0 7 2003 Mr. Robert J. Bard, Esq. Managing Director HELP Technologies 24312 Armada Drive Dana Point, California 92629 Re: K023863 Trade/Device Name: AutoMed 3000 Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: September 20, 2002 Received: November 20, 2002 Dear Mr. Bard: 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 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) 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 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 (PMA), 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 898, In addition, FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ Page 2 - Mr. Bard 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 (OS) 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 (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 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/dsma/dsmamain.html Sincerely yours. Susan Runner Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(k) Number (if known): 1 023863 Device Name: AutoMed 3000 infusion pump ## Indications for Use: The AutoMed 3000 ambulatory infusion pump with integrated administration set/drug reservoir is intended for general infusion use. Routes of infusion include intravenous. percutaneous, subcutaneous, inter-arterial and epidural, and into intra-operative (soft tissue / body cavity) sites. General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUED ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use √ OR Over-The-Counter Use __ (Per 21 CFR 801.109) *talucia cente* Division Sian-Off) ion of Anesthesiology, General Hospital. (Optional Format 1-2-96) 510(k) Number K023863