← Product Code [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA) · K970076 # NIPRO DISPOSABLE SOLUTION INFUSION SET (K970076) _Nipro Medical Corp. · FPA · Mar 27, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K970076 ## Device Facts - **Applicant:** Nipro Medical Corp. - **Product Code:** [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA.md) - **Decision Date:** Mar 27, 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 Solution Infusion Sets are intended to be used for the administration of intravenous fluid solution into the body. ## Device Story Disposable solution infusion set; facilitates delivery of IV fluids to patient. Components: PVC tubing, roller clamp, male luer lock or cone luer slip connector, optional Y-connector with injection site. Used in clinical settings by healthcare professionals. Device connects fluid source to patient vascular access; flow regulated via roller clamp. Benefits: provides reliable, sterile fluid delivery path. ## Clinical Evidence No clinical data; safety and effectiveness established through historical clinical use and identical design to legally marketed predicate. ## Technological Characteristics Materials: Polyethylene (PE), polyvinylchloride (PVC) with DEHP, polypropylene (PP), acrylonitrile butadiene styrene (ABS). Components: Tubing, roller clamp, luer connectors, Y-connector. Non-vented, non-filtered. Sterilization method not specified. ## 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 - I.V. Administration Set, Gainor Medical U.S.A., Inc. ([K926448](/device/K926448.md)) ## 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} K970076 MAR 27 1997 NIPRO NIPRO MEDICAL CORPORATION 10877 N.W. 33rd Street Miami, Florida 33172 Tel.: (305) 599-7174 Fax: (305) 599-8454 SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO® DISPOSABLE SOLUTION INFUSION SET §807.92 (a)(1) Contact Person: Luis Candelario General Manager Address: Nipro Medical Corporation 10877 NW 33rd Street Miami, Florida 33172 (305) 599-7174 (telephone) (305) 599-8454 (fax) Date of Summary Preparation: March 19, 1997 §807.92 (a)(2) Trade Name: Nipro® Disposable Solution Infusion Set Common Name: Disposable Solution Infusion Set or I.V. Administration Set Classification Name: Intravascular administration set (21 CFR §880.5440) §807.92 (a)(3) Legally Marketed Substantially Equivalent Device: I.V. Administration Set, Gainor Medical U.S.A., Inc. (K926448) §807.92 (a)(4) Description of Device: Intravascular administration sets are described in 21 CFR §880.5440. The Disposable Solution Infusion Sets that we intend to market include 4 types of designs. The sets consist of a length of polyvinylchloride tubing with a clamp roller along it and a male luer lock at one end and a non-vented infusion subassembly without filter at the other end. Model number NNC-3L has a male luer-lock conector (without injection site) and NNC-3CL has the male luer- {1} lock connector and Y-connector with injection site. Model NNC-3CS has the cone luer slip and Y-connector with injection site and NNC-3C has the cone slip connector (without injection site). The materials used for the components include polyethylene (PE), polyvinylchloride (PVC) (contains DEHP), polypropylene (PP) and acrylonitrile butadiene styrene (ABS). Cyclohexanone and adhesive bond are used and are present in trace amounts. §807.92 (a)(5) Intended Use: The Solution Infusion Sets are intended to be used for the administration of intravenous fluid solution into the body. §807.92 (a)(6) Comparison of Technical Characteristics: The Nissho and Gainor Medical devices are exactly the same devices, therefore, all technical characteristics are identical. As these sets have been marketed for several years, safety and effectiveness has been established through years of clinical use. There have not been problems reported during use of the sets. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K970076](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K970076) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com