← Product Code [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA) · K961225 # CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET (K961225) _Baxter Healthcare Corp · FPA · Jun 21, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K961225 ## Device Facts - **Applicant:** Baxter Healthcare Corp - **Product Code:** [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA.md) - **Decision Date:** Jun 21, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5440 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use Baxter Healthcare Corporation intends to manufacture and market solution administration sets with an alternate design of the spike and drip chamber components. ## Device Story Modified solution administration sets; alternate design of spike and drip chamber components. Device facilitates fluid delivery from solution containers to patients. Spike interfaces with containers; drip chamber regulates flow. Used in clinical settings by healthcare professionals. Design maintains compatibility with Baxter and competitive containers. Functional performance verified via air passage, air leakage, and tensile strength testing. ## Clinical Evidence Bench testing only. Functional performance data generated for spike and drip chamber assemblies, including air passage, air leakage, and tensile strength tests. Results indicate proposed components meet or exceed functional requirements. ## Technological Characteristics Solution administration set with modified spike and drip chamber. Materials identical to predicate. Mechanical interface for fluid administration. No electronic or software components. ## 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 - Current Baxter Solution Administration 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} K96/225 JUN 21 1996 510(k) Premarket Notification Modified Solution Administration Sets # 510(k) SUMMARY ## Submitted by: Mary Ellen Snyder Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073 ## Date Prepared: March 18, 1996 ## Proposed Device: Modified Baxter Solution Administration Sets ## Predicate Devices: Current Baxter Solution Administration Sets ## Proposed Device Description: Baxter Healthcare Corporation intends to manufacture and market solution administration sets with an alternate design of the spike and drip chamber components. ## Summary of Technological Characteristics of New Device to Predicate Devices The proposed Baxter sets are the same as existing Baxter sets except for the design change in the spike and drip chamber components. All other components of the solution administration sets remain unchanged. The proposed spike and drip chamber components are identical in material composition and function to existing components. The spike remains the same in all container interfacing dimensions. Thus the proposed sets will continue to be compatible with both Baxter and competitive solution containers as was established in K860272 for the current spike design. Also the geometry of the drop former and portion of the spike which engages the drip chamber is the same as the current design. ## Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests Data regarding the functional performance of the proposed spike and drip chamber assemblies have been generated including air passage, air leakage and tensile strength tests. Performance testing indicates that sets with the proposed components will meet or exceed all functional requirements. s:\510k\valuesum MAR 18 1996 49 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K961225](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K961225) **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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