← Product Code [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA) · K964812 # NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET (K964812) _Critical Device Corp. · FPA · Feb 10, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K964812 ## Device Facts - **Applicant:** Critical Device Corp. - **Product Code:** [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA.md) - **Decision Date:** Feb 10, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5440 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for Use a. For use as a needleless alternative to IV set injection ports. The NIMA™ adapter will replace the conventional Y-site on a primary IV line as a continuous or intermittent connection. b. For use as part of a program to reduce needle stick injuries and the associated transmission of blood borne pathogens such as HIV and HBV. c. For use as a replacement to the injection cap (heparin cap) on an I. V. catheter for intermittent injections. d. For use for injection, as a gravity flow connector, and as an access port for withdrawal of fluids. e. For use with standard luer taper connections. f. For single patient use. ## Device Story NIMA™ adapter; two-way valve; enables needleless intermittent/continuous IV access; connects to peripheral/central venous catheters or Y-sites; activated by standard male luer taper insertion; prevents needle stick injuries; reduces blood-borne pathogen transmission risk (HIV/HBV); used in clinical settings; operated by healthcare providers; replaces conventional injection ports/heparin caps; supports gravity flow and fluid withdrawal. ## Clinical Evidence Bench testing only. Tripartite biocompatibility testing performed on new materials; performance specifications verified against original device requirements. ## Technological Characteristics Two-way valve mechanism; standard luer taper interface; single patient use; materials meet performance specifications; biocompatibility verified per tripartite standards. ## 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 - NIMA™ Needleless Injectionsite Master Adapter and IV Sets ([K964812](/device/K964812.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} Critical Device Corporation 499 Nibus Street • Brea • CA • 92821 FEB 10 1997 K964812 # 510(k) Summary 1. Submitter: Critical Device Corporation 499 Nibus Street Brea, CA 92821 Tel: 714-257-2197 or 800-321-6462 Fax: 800-299-4849 2. Contact: Dan Hyun, President Critical Device Corporation 3. Date prepared: November 22, 1996 4. Device trade name: NIMA™ Needleless Injectionsite Master Adapter and IV Sets Common name: Intravenous (IV) Medication Connector and IV Sets 5. Predicate device: NIMA™ Needleless Injectionsite Master Adapter and IV Sets 6. Description: The NIMA™ adapter is a two-way valve that permits easy needleless intermittent and continuous access in IV therapy. It can be connected to peripheral or central venous catheters or Y-sites. The normally closed NIMA™ adapter valve is opened by inserting a standard male luer taper, such as on an extension set, IV tubing or syringe to the female end of the NIMA™ adapter. This device does not require the use of hypodermic needles for the infusion of IV solutions. Thus preventing needle stick injuries. The NIMA™ adapter is packaged individually and as attached as part of extension sets 7. Intended Use: a. For use as a needleless alternative to IV set injection ports. The NIMA™ adapter will replace the conventional Y-site on a primary IV line as a continuous or intermittent connection. b. For use as part of a program to reduce needle stick injuries and the associated transmission of blood borne pathogens such as HIV and HBV. c. For use as a replacement to the injection cap (heparin cap) on an I. V. catheter for intermittent injections. Toll Free (800) 321-NIMA • Phone (714) 257-2197 • Fax (800) 299-4849 {1} page 2 of 2 # Critical Device Corporation ## 510(k) Summary d. For use for injection, as a gravity flow connector, and as an access port for withdrawal of fluids. e. For use with standard luer taper connections. f. For single patient use. 8. Technological comparison to predicate device: The technological characteristics are equivalent to the currently approved NIMA™ Needleless Injectionsite Master Adapter and IV Sets. Alternate materials and use duration extended from 24 to 96 hours are approved in this application. 9. Nonclinical test summary: New materials meet all performance specifications established for the originally approved device. Tripartite biocompatibility testing indicates that the new materials are safe and biocompatible. 10. Conclusion: The NIMA™ modification(s) have demonstrated safety and effectiveness, and is substantially equivalent to the legally marketed predicate device. 2 - 4 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K964812](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K964812) **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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