(118 days)
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None
No
The summary describes a standard vascular access port and catheter system with no mention of AI or ML features.
No
The device is a vascular access system used for administering fluids or drawing blood, which supports therapy but is not therapeutic in itself.
No
The device description indicates it is a vascular access system used for administering fluids and withdrawing blood samples for therapy, not for diagnosing medical conditions.
No
The device description clearly states it is a vascular access system consisting of a port, catheter, and needle, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Description: The description clearly states that this is a vascular access system consisting of a port and catheter for implantation within the body. It is used for direct access to the bloodstream for infusion and withdrawal of blood from the body.
- Intended Use: The intended use describes the delivery of substances into the body and the withdrawal of blood samples, not the analysis of those samples.
Therefore, this device is an implantable medical device used for vascular access, not an in vitro diagnostic.
N/A
Intended Use / 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, nutitionals and the withdrawal of venous blood samples.
Product codes
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Device Description
The device is a vascular access system consisting of an low profile port with an injectable septurn 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.
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
arm, chest wall
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
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Key Metrics
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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
Not Found
§ 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.
0
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, nutitionals 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 septurn 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.