← Product Code [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA) · K960391 # STRATO/INFUSAID PERIPORT INFUSION SET 41770,41771 (K960391) _Strato/Infusaid, Inc. · FPA · Jul 3, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K960391 ## Device Facts - **Applicant:** Strato/Infusaid, Inc. - **Product Code:** [FPA](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA.md) - **Decision Date:** Jul 3, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5440 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The Strato/Infusaid PeriPort Infusion Set is indicated for the infusion of drugs and fluids into the Strato/Infusaid PeriPort Peripheral Access Device. ## Device Story Device provides straight needle access to Strato/Infusaid PeriPort System for infusion of drugs/fluids into vascular access system. Used in clinical settings by healthcare professionals. Device facilitates delivery of therapeutic agents to patient via implanted peripheral access port. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Infusion set for vascular access; features straight needle and specific wing design. Mechanical device; no energy source or software. ## 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 - Strato/Infusaid LifePort Infusion Set (Model No. LPS 3004, LPS 3005, LPS 3006, LPS 3007, LPS 3008, LPS 3009, LPS 3017, LPS 3023, LPS 3025) - Strato/Infusaid Infuse-a-Port Winged Infusion Set (Model Nos. 41129-1, 41129-2, 41129-3, 41129-4, 41129-5) ## 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} PREMARKET NOTIFICATION # VII. 510(k) Summary of Safety and Effectiveness K960391 ## General Information Manufacturer: Strato/Infusaid Inc. 1400 Providence Highway Norwood, MA 02167 JUL - 3 1996 Contact Person: Craig M. Audet Director, Worldwide Regulatory Affairs Telephone #(617) 255-6765 Date Prepared: January 25, 1996 ## Device Name Proprietary Name: Strato/Infusaid PeriPort Infusion Set Model Nos. 41770, 41771 Classification Name: Infusion Set, Administration, Intravascular ## Predicate Devices Strato/Infusaid LifePort Infusion Set Model No. LPS 3004, LPS 3005, LPS 3006, LPS 3007, LPS 3008, LPS 3009, LPS 3017, LPS 3023, LPS 3025 Strato/Infusaid Infuse-a-Port Winged Infusion Set Model Nos. 41129-1, 41129-2, 41129-3, 41129-4, 41129-5 ## Product Description The Strato/Infusaid PeriPort Infusion Set is a device designed to provide straight needle access to the Strato/Infusaid PeriPort System for the infusion of drugs and fluids into the vascular access system. ## Indications for Use The Strato/Infusaid PeriPort Infusion Set is indicated for the infusion of drugs and fluids into the Strato/Infusaid PeriPort Peripheral Access Device. PeriPort Infusion Set STRATO/INFUSAID RA001 Page 45 {1} PREMARKET NOTIFICATION ## Substantial Equivalence The subject Strato/Infusaid PeriPort Infusion Set is substantially equivalent to the commercially available Strato/Infusaid LifePort Infusion Set and the Strato/Infusaid Infuse-a-Port Winged Infusion Set. The Strato/Infusaid PeriPort Infusion Set has the same indications, contraindications and design principles as the commercially available (substantially equivalent device), the Strato/Infusaid LifePort Infusion Set. The difference between the infusion sets is the wing design and straight vs. 90° needle. The Strato/Infusaid PeriPort Infusion Set has the same indications, contraindications and design principles as the commercially available (substantially equivalent device), the Strato/Infusaid Infuse-a-Port Winged Infusion Set. The difference between the infusion sets is the straight vs. 90° needle PeriPort Infusion Set STRATO/INFUSAID RA001 Page 46 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K960391](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPA/K960391) **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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