(77 days)
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No
The summary describes a physical implantable port for vascular access and does not mention any software, algorithms, or AI/ML capabilities.
No
A therapeutic device is one that treats a disease or condition. This device is used to provide access for infusions and blood sampling, which are diagnostic or supportive functions rather than direct treatment.
No
The device is described as providing access to the vascular system for infusion of substances and blood sampling, not for diagnosing conditions.
No
The device description clearly states it is a "totally implantable system" including physical components like an "injection portal with self sealing septum, compression lock and Tecoflex® catheter," indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide repeated access to the vascular system for infusion and blood sampling. This is a direct interaction with the patient's body for therapeutic and diagnostic purposes in vivo.
- Device Description: The description details an implantable system for accessing the vascular system. This is a medical device used in vivo.
- Lack of IVD Characteristics: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any analysis or testing of specimens in vitro.
The device described is a vascular access port, which is a type of medical device used for direct patient care in vivo.
N/A
Intended Use / 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.
Product codes
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
vascular system
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
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.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
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ldeas for Medicine, Inc. Ideas Dual Port 510(k) Notification
SAFETY and EFFECTIVENESS SUMMARY
PROPRIETARY NAME
Ideas Dual Port
30 996
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 internittent 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.