← Product Code [FMG](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG) · K964435 # PRIMARY IV SET (K964435) _Icu Medical, Inc. · FMG · Apr 2, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K964435 ## Device Facts - **Applicant:** Icu Medical, Inc. - **Product Code:** [FMG](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG.md) - **Decision Date:** Apr 2, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5440 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein). ## Device Story Intravascular administration set; single-use, sterile, non-pyrogenic tubing assembly. Provides fluid path from container to patient vein via needle or catheter. Components include spike/drip chambers, clamps, injection sites, filters, backcheck valves, and male luer fitments. Used in clinical settings for fluid delivery. Healthcare providers configure sets based on specific patient/procedure needs. Benefits include reliable, sterile fluid access for therapy. ## Clinical Evidence Bench testing only. ## Technological Characteristics Tubing of various lengths/diameters; components include spike/drip chambers, clamps, injection sites, filters, backcheck valves, male luer fitments. Materials: medical grade. Packaging: fiber-free peelable paper lidding and pouching. Sterilization: sterile fluid pathway. ## Regulatory Identification An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container. ## Special Controls *Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9. ## Predicate Devices - Medical Product Specialists I.V./Secondary Sets - McGaw Intravenous Administration Sets - Churchill Medical Systems IV/Extension Sets ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} APR 01 '97 07:59 FR ICU MEDICAL 714 366 8368 TO 13014803002 P.05/06 K964435 ICU Medical Inc. Intravascular Administration Set APR -2 1997 510(k) Notification Page 17 of 50 ## 14. Appendix F. 510(k) Summary of Safety and Effectiveness The following section is included as required by the Safe Medical Device Act (SMDA) of 1990. ### 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: K964435 ### Applicant Information: Date Prepared: May 29, 1996 Name: ICU Medical Inc. Address: 951 Calle Amanecer San Clemente, CA 92673 Contact Person: Richard Waters Phone Number: (714) 366-4330 Fax Number: (714) 366-8368 ### Device Information: Trade Name: Intravascular Administration Set Common Name: IV Set Classification Name: Intravascular Administration Set ### Equivalent Devices: Medical Product Specialists I.V./Secondary Sets McGaw Intravenous Administration Sets Churchill Medical Systems IV/Extension Sets ### Device Description: The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein). Each set will be manufactured to unique specifications using dimensions, components and configurations specified by the customer. Standard sets will also be offered. Components used in the IV sets may be either manufactured by ICU Medical or purchased from other manufacturers. Components will be assembled into configurations specified by the customer and packaged. ### Intended Use: The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein). 510(k), Primary Sets {1} APR 01 '97 07:59 FR ICU MEDICAL 714 366 8368 TO 13014803002 P.06/06 ICU Medical Inc. Intravascular Administration Set 510(k) Notification Page 18 of 50 Comparison To Predicate Device: | Characteristic Compared | ICU MEDICAL INTRAVASCULAR ADMINISTRATION SET | PREDICATE INTRAVASCULAR ADMINISTRATION SET | | --- | --- | --- | | Product Labeling | Single Use, Non-pyrogenic, Sterile fluid pathway in un-opened, undamaged package. Directions for use on labeling | Single Use, Non-pyrogenic, Sterile fluid pathway in un-opened, undamaged package. Directions for use on labeling | | Intended Use | Single use, Sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein). | Single use, Sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein). | | Design | Tubing of various lengths and inside diameters are configured with some or all of the following: spike/drip chambers (as part of a set only), clamps, injection site(s), filters, backcheck valves and male luer fitments. Packaged in medical grade fiber-free peelable paper lidding and pouching material. | Tubing of various lengths and inside diameters are configured with some or all of the following: spike/drip chambers, clamps, injection site(s), filters, backcheck valves and male luer fitments, huber needle. Packaged in medical grade fiber-free peelable paper lidding and pouching material. | 510(k), Primary Sets **TOTAL PAGE.06** --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K964435](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMG/K964435) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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