← Product Code [LJT](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT) · K962751 # IDEAS' DUAL PORT (K962751) _Ideas For Medicine, Inc. · LJT · Sep 30, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT/K962751 ## Device Facts - **Applicant:** Ideas For Medicine, Inc. - **Product Code:** [LJT](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT.md) - **Decision Date:** Sep 30, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5965 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The Ideas' Dual Port is a totally implantable system designed to provide repeated access to the vascular system. The Ideas' Port allows for the infusion of medications, total parenteral nutrition, blood products, imaging solution, as well as, venous blood sampling. Port access is performed by percutaneous needle insertion using a "Huber type" non-coring needle. The system includes an injection portal with self sealing septum, compression lock and Tecoflex® catheter. ## Device Story Totally implantable venous access port; provides repeated vascular access for infusion therapy and blood sampling. System components: injection portal with self-sealing septum, compression lock, and Tecoflex® catheter. Operated by clinicians via percutaneous insertion of Huber-type non-coring needle. Enables chronic venous access for medications, nutrition, and blood products. Benefits: facilitates repeated access while minimizing trauma; superior tensile strength at catheter-port junction compared to predicates. ## Clinical Evidence Bench testing only; no clinical data provided. Device meets or surpasses performance specifications for competitive ports. ## Technological Characteristics Totally implantable venous access system. Materials: Tecoflex® catheter, titanium portal outlet. Features self-sealing septum and compression lock. Mechanical device; no energy source or software. ## 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 - Life Port - Vital Port ## 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} Ideas for Medicine, Inc. Ideas Dual Port 510(k) Notification X962751 # SAFETY and EFFECTIVENESS SUMMARY ## PROPRIETARY NAME Ideas Dual Port ## COMMON/USUAL NAME Venous Access Port ## CLASSIFICATION Class II ## CLASSIFICATION NUMBER 80 LJT ## DEVICE DESCRIPTION The Ideas' Dual Port is a totally implantable system designed to provide repeated access to the vascular system. The Ideas' Port allows for the infusion of medications, total parenteral nutrition, blood products, imaging solution, as well as, venous blood sampling. Port access is performed by percutaneous needle insertion using a "Huber type" non-coring needle. The system includes an injection portal with self sealing septum, compression lock and Tecoflex® catheter. ## SUBSTANTIAL EQUIVALENCE The Ideas Dual Port is substantially equivalent in its intended use to other (Life Port and Vital Port) marketed dual ports: - to provide chronic venous access. The separate chamber allows for intermittent infusion therapy and/or blood sampling. Its' size, dimensions and geometry are comparable to other ports. Materials are identical to other Ideas Ports except the portal outlet, which is a different grade titanium from the one used in other Ideas Ports. The material, however, is fully biocompatibility. It meets or surpasses the performance specifications in the guidelines on competitive ports and has superior tensile strength at the junction of the catheter and port. Page 5 of 41 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT/K962751](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/LJT/K962751) **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