← Product Code [LJT](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT) · K964538 # R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM (K964538) _Boston Scientific Corp · LJT · Mar 10, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT/K964538 ## Device Facts - **Applicant:** Boston Scientific Corp - **Product Code:** [LJT](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT.md) - **Decision Date:** Mar 10, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5965 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use Implantation of a port and catheter is indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples. ## Device Story Vascular access system; consists of low-profile subcutaneous port with injectable septum and detached catheter; includes non-coring stainless steel needle. Implanted in chest wall or arm by physician. Provides access for repeated intravascular injection, continuous infusion of fluids/medications/nutritionals, and blood withdrawal. Benefits patient by facilitating long-term venous access while minimizing repeated venipuncture. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Low-profile port with injectable septum; detached catheter; stainless steel non-coring needle. Sterilization: Ethylene oxide gas. Packaging: PETG blister tray with Tyvek lid. ## Regulatory Identification A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design. ## Special Controls *Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990. ## Predicate Devices - Therex low profile ports ## 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} MAR 10 1997 X964538 # SUMMARY OF SAFETY AND EFFECTIVENESS Pursuant to §513(i)(3)(A) of the Food, Drug, and cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness. ## A. GENERAL INFORMATION Owner Operator Submitting Boston Scientific Corporation this Premarket Notification: One Boston Scientific Place Natick, MA 01757 (508) 650.8174 Contact Person: Wanda M. Carpinella Regulatory Affairs Department Device Generic Name: Venous Access Port Kit Device Classification: 80 LJT, Implanted Subcutaneous Port and Catheter ## B. INDICATIONS FOR USE Implantation of a port and catheter is indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples. ## C. DESCRIPTIVE CHARACTERISTICS The device is a vascular access system consisting of an low profile port with an injectable septum and a detached catheter. The low profile port is suitable for arm placement or for implantation in the chest wall. A non-coring, stainless steel needle is supplied with each port. ## D. SUBSTANTIAL EQUIVALENCE The proposed port has been shown to be substantially equivalent to Therex's low profile ports. ## E. PACKAGING, STERILIZATION, AND PYROGENICITY The low profile port is packaged in a PETG blister tray covered with a heat-sealed Tyvek lid. The product is sterilized using ethylene oxide gas. Bacterial endotoxin levels are monitored for sterility release purposes. ## F. CONCLUSION Based on the information presented, Boston Scientific Corporation believes that the proposed low profile port meets the minimum requirements that are considered acceptable for its intended use and is substantially equivalent to other currently marketed vascular access port and catheter systems. 00010 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT/K964538](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT/K964538) **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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