(105 days)
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No
The summary describes a standard implantable vascular access port kit with mechanical components and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device facilitates the administration of therapies (fluids, medications, etc.) but is not, in itself, a therapeutic agent or device that treats a condition. It is a delivery system.
No
The device described is an implantable port and catheter system used for fluid infusion, medication delivery, and blood withdrawal. It is a therapeutic device for patient access, not for diagnosing conditions.
No
The device description explicitly lists multiple hardware components (implantable port and catheter, introducer sheath/dilator, needles, guidewires) and does not mention any software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as an implantable vascular access system for administering fluids, medications, and withdrawing blood from the patient's body. This is a therapeutic and diagnostic procedure performed in vivo (within the living organism).
- Device Description: The components listed (port, catheter, needles, guidewires) are all instruments used for accessing the vascular system in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the body to aid in diagnosis, monitoring, or screening. This device's purpose is to facilitate access to the vascular system for treatment and sample collection, not to perform the diagnostic test itself.
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. The port kit, which is the subject of this premarket notification, provides procedural components necessary for percutaneous insertion of the implantable vascular access system.
Product codes
80 LJT
Device Description
The port kit provides an implantable port and catheter, an introducer sheath/dilator with a hemostasis valve, a 22 Ga. non-coring needle, a 21 Ga. entry needle, a 20 Ga. blunt needle, and 0.018" and 0.035" guidewires. All of these components have been found substantially equivalent through the premarket notification process for the use(s) for which the port vascular assess kit is intended.
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
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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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SUMMARY OF SAFETY AND EFFECTIVENESS
Pursuant to §513(i)(3)(A) of the Food, Drug, and cosmetic Act, Boston Scientlific Corporation submits this summary of safety and effectiveness.
A. GENERAL INFORMATION
Owner Operator Submitting Boston Scientific Corporation ramarkat Notification: 480 Pleasant Street
| | 450 Pleasant Street
Watertown, MA 02172 |
|------------------------|--------------------------------------------------|
| | (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. The port kit, which is the subject of this premarket notification, provides procedural components necessary for percutaneous insertion of the implantable vascular access system.
C. DESCRIPTIVE CHARACTERISTICS
The port kit provides an implantable port and catheter, an introducer sheath/dilator with a hemostasis valve, a 22 Ga. non-coring needle, a 21 Ga. entry needle, a 20 Ga. blunt needle, and 0.018" and 0.035" guidewires. All of these components have been found substantially equivalent through the premarket notification process for the use(s) for which the port vascular assess kit is intended.
D. SUBSTANTIAL EQUIVALENCE
The proposed venous access port kit has been shown to be substantially equivalent to the individual devices sold individually and to other predicate vascular access port kits, such as Cook's VITAL-PORT MINI Vascular Access Port with Detached Catheter and Pharmacia Deltec's PORT-A-CATH Implantable Access System.
E. PACKAGING, STERILIZATION, AND PYROGENICITY
Components comprising the kit are assembled in a PETG blister trav with a snap-fit lid. The tray is placed in a Tyvek/mylar pouch, which is then heat sealed. The kit is sterilized using ethylene oxide gas. Bacterial endotoxin levels are monitored for sterlify release purposes.
F. CONCLUSION
Based on the information presented. Boston Scientific Corporation believes that the proposed venous access port kit meets the minimum requirements that are considered acceptable for its intended use.