PERFUSOR COMPACT

{0}------------------------------------------------ 510(k) Notification June 30, 1998 #### ATTACHMENT 9 FEB 510(k) Summary K983005 {1}------------------------------------------------ # 510(k) SUMMARY "This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR \$807.92." > ני "The assigned 510(k) number is: ## 1. Submitter Information: June 30, 1998 B. Braun Medical Inc. 1601 Wallace Drive Ste. 150 Carrollton, TX. 75006 (972) 245-2243 ext. 206 - Contact Person: Mr. Gary A. Gulyas Quality Manager Phone: 972.245.2243 ext. 206 FAX: 972.245.1612 | 2: Name of Device: | Infusion Pump | |----------------------|------------------------------------| | Trade Name: | Perfusor® compact | | Classification Name: | Class II, 80FRN<br>21 CFR 880.5725 | Additionally, since the subject infusion pump is labeled and intended for use for enteral infusion, the product code, 80 LZH for Enteral Infusion Pumps also applies. #### 3: Predicate Device: The predicate device that B. Braun Medical Inc. is claiming substantial equivalence to is the BD 360 Infuser, (now marketed as 360infuser by B. Braun Medical Inc.) under cleared 510(k)s K844719 and K902409. The 360infuser is an external syringe infusion pump. There are no new issues of safety or effectiveness raised by the Perfusor® compact. {2}------------------------------------------------ 1 The term "substantially equivalent" as used herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product. # 4: Description of the Subject Device: In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun McGaw, Inc. intends to introduce into interstate commerce the Perfusor® compact. The Perfusor® compact is a transportable syringe pump that is suitable for dispensing liquids in nutritional and infusion therapy. The infusion pump contains the following hardware assemblies: swivel-drive pumping mechanism assembly, power supply assembly, pole clamp assembly, display assembly, and electronics assembly. The power supply cord is able to be mounted and removed from a receptacle in the rear of the pump. The battery power supply consists of four AA alkaline batteries. The display subassembly contains an LCD display and a keypad used to input data into the pump as well as to present pump status and information to the user. The electronics subassembly contains all of the electronics in the pump, including the microprocessors that run the software. The electronics subassembly also contains communications electronics that will allow the pump to transmit and receive messages to and from external devices, including personal computers and hospital monitoring systems. The software provides communication capabilities from the pump to external communication devices. This includes transmission of the following information: Operation / Alarm Log, pump status and pump configuration / calibration data. The software also provides communication abilities from external devices to the pump. This feature is only accessible by a trained Biomedical Technician. Programming of the pump is only performed by trained biomedical professionals. The pump's software does not allow for the capability to control rate, volume or therapy information from external devices. {3}------------------------------------------------ # 5: Intended Use of the Subject Device: The system created by using the Perfusor® compact with approved syringes is intended to provide accurate and continuous flow of parenteral and enteral fluids to the patient. The syringe interacts with the pump so that the size of the syringe is detected. The pump is software controlled and operates using a swivel-drive mechanism. The Perfusor® compact syringe pump is intended for but not limited to use in the hospital, home care and/or nursing home (extended care) settings. The Operation Manual is intended to reinforce the teaching given to the user by a trained healthcare professional or an authorized B. Braun Medical Inc. representative. A trained Biomedical Technician must perform a full set-up of the pump before use in a clinical setting. # 6: Technological Characteristics of the Subject Device The subject device, Perfusor® compact is substantially equivalent to the predicate device, the 360infuser. The subject and predicate devices are similar in design, material composition, components, manufacturing process, intended use and labeling. There are technological differences between the subject and predicate device, however, these differences do not raise new issues of safety and effectiveness. The substantial equivalence claim between the subject and predicate device is supported by the information and data provided in this 510(k) submission. This includes the following information: - Description of the subject and predicate devices. . - Intended use of the subject and predicate devices. . - Material composition of the subject and predicate devices. . - Labels and labeling for the subject and predicate devices. . - Comparison tables of attributes and specifications of the subject and predicate . devices. - Subject device customer functional specification. ● - Subject device system and software hazard analysis. ● - . Subject device system and software requirements. - . Subject device system and software test plans. - Subject device system and software test protocols. . - Subject device system and software test matrix. . {4}------------------------------------------------ 510(k) Notification June 30, 1998 # 7: Signature of Applicant B. Braun Medical Inc. Gary A. Gulyas Quality Manager Signature August 27, 1998 Date {5}------------------------------------------------ Image /page/5/Picture/1 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 of three human profiles facing right, with three curved lines above them, resembling a stylized bird or wing. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 4 :333 F = 3 Mr. Gary A. Gulyas Quality Manager B. Braun Medical, Incorporated 1601 Wallace Drive Suite 150 Carrollton, Texas 75006 K983005 Re: Perfusor Compact Trade Name: Requlatory Class: II Product Code: FRN December 3, 1998 Dated: Received: December 4, 1998 Dear Mr. Gulyas: 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 {6}------------------------------------------------ Page 2 - Mr. Gulyas the Act for devices under the Electronic Product Radiation the Act for devices ander one ederal laws or regulations. This letter will allow you to begin marketing your device as This lecter will arrow your on the motification. The FDA described in your 510(x) prematice noorsion device to a legally marketed predicate device results in a classification for your marketed predicate device rebares in a spoceed to the market. If you desire specific advice for your device on our labeling II you desire specific additionally 809.10 for in regulacion (21 crk Faros), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compilance at (301) 554 1032 of your device, please contact the promotion and advercibing of Jour 4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation entification" (21 CFR 807.97) . Other general information on your responsibilities under the Act may be Information on your respon of Small Manufacturers Assistance obtained from the bivibion of 638-2041 or (301) 443-6597 or at at its coll-free number (000)- 050 fda.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Timo hy A Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ 510(k) Notification September 1, 1998 #### Indications For Use Statement 510(k) Number (if known) Device Name: Perfusor® compact Indications For Use: The Perfusor® compact is a transportable syringe infusion pump that provides infusions of parenteral and enteral fluids. The system created by using syringes validated for use with the Perfusor® compact is intended to provide accurate and continuous flow of parenteral and enteral fluids to the patient. The syringe interacts with the pump so that the size of the syringe is detected. The pump is software controlled and operates using a drive mechanism. The Perfusor® compact is intended for but not limited to use in the hospital, home care and/or nursing home (extended care) settings. The Perfusor® compact is intended for use by trained healthcare providers in accordance with the instructions provided in the Operation Manual. All data entry and validation of the Perfusor® compact is performed by the trained healthcare provider per a physician's order. (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 Patricio Cuesate (Division Sign-Off) ivision of Dental, Infection Control. and General Hospital Device 510(k) Number K983005