CORE RESISTANT HUBER INFUSION SETS

{0}------------------------------------------------ ICU Medical Inc. Core Resistant Huber Infusion Sets 510(k) Notification Page 20 of 24 OCT - 1 1997 #### Appendix F. 510(k) Summary of Safety and Effectiveness 15. The following section is included as required by the Safe Medical Device Act (SMDA) of 1990. Name: Arlene Dutchik Address: 951 Calle Amanecer San Clemente, CA 92673 | Contact Person: | Arlene Dutchik | |-----------------|----------------| | Phone Number: | (714)366-2183 | | Fax Number: | (714)366-8368 | # 510(k) Summary of Safety and Effectiveness 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. The assigned 510(k) number is: ### Applicant Information: | Date Prepared: | July 17, 1997 | |----------------|-----------------------------------------------| | Name: | ICU Medical, Inc. | | Address: | 951 Calle Amanecer.<br>San Clemente, Ca 92673 | Contact Person: Arlene Dutchik Phone Number: (714)366-2183 Fax Number: (714)366-8368 ### Device Information: Trade Name: Intravascular Administration Set Common Name: Core Resistant Huber Needle Sets Classification Name: Intravascular Administration Set #### Equivalent Device: Micro Med/Core-Resistant Huber Infusion Set with and without Y-Site {1}------------------------------------------------ # Device Description: The ICU Medical Core Resistant Huber Infusion Sets are single use, sterile and non pyrogenic devices intended for use as an accessory to deliver solutions and drugs into a patient's vascular implant port. Components used in the sets may be either manufactured by ICU Medical or purchased from approved contract manufacturers. Components will be assembled into standard configurations or configurations specified by the customer and packaged. ## Intended Use: The ICU Medical, Inc. Core Resistant Huber Needle Infusion Set, Core Resistant Huber Infusion Set with Y Site and Core Resistant Huber Infusion Set with Y Site and Clave are intended for use to deliver solutions and drugs through vascular implant ports. ## Comparison To Predicate Device: | CHARACTERISTIC<br>COMPARED | ICU MEDICAL CORE<br>RESISTANT HUBER<br>INFUSION SET | MICRO MED, CORE<br>RESISTANT HUBER<br>NEEDLE INFUSION SET<br>WITH OR WITHOUT Y SITE | |--------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | Product Labeling | Sterile Use, Non Pyrogenic in<br>unopened, undamaged, package.<br>Directions for Use on label. | Sterile Use, Non Pyrogenic in<br>unopened, undamaged,<br>package. | | Intended Use | Deliver solutions and drugs<br>through vascular implant ports. | Deliver solutions and drugs<br>through vascular implant ports. | | Needle Gauges | 19, 20, 22 gauge | 19, 20, 22 gauge | | Needle Lengths | 1/2", 3/4", 1", 11/2" | 1/2", 3/4", 1", 11/2" | | Tubing Size | Macrobore and Minibore | Macrobore and Minibore | | Color Coded Wings | Yes | Yes | | Wing Assembly | Fixed | Fixed | | CLAVE® Needleless<br>Connector | Yes | No | | Luer Lock | Yes | Yes | ## 15.1. Comparative Information {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of a human figure with three wavy lines emanating from it. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT - 1 1997 Ms. Arlene Dutchik Requlatory Affairs Specialist ICU Medical, Incorporated 951 Calle Amanecer San Clemente, California 92673 Re: K972712 Core resistant Huber Infusion Sets Trade Name: Requlatory Class: II Product Code: FPA Dated: July 17, 1997 Received: July 21, 1997 Dear Ms. Dutchik: 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 requlations 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 current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. 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 {3}------------------------------------------------ Page 2 - Ms. Dutchik through 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) 594-4618. 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/cdrh/dsmamain.html". Sincerely yours, K. Autrust Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ : : #### 12. Appendix C. Indications for Use The ICU Medical, Inc. Core Resistant Huber Infusion Set, Core Resistant Huber Infusion Set with Y Site and Core Resistant Huber Infusion Set with Y Site and CLAVE® are used to deliver solutions and drugs into vascular implant ports. Patrici Crescenti (Division Slets (11) (Division Status (1) Division of Desta), infection of Democracy Division of General Finspilal Devices 1972212 510(k) Number Prescription Use (Per 21 CFR 801.109)