(81 days)
K960350, K9ua550
Not Found
No
The summary describes a physical implantable device for venous access and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used for repeated venous access for injection or infusion therapy, which are therapeutic interventions.
No
The device description and intended use indicate it is an access system for venous therapy (injection, infusion, blood sampling), not for diagnosing medical conditions.
No
The device description explicitly states it is a "totally implantable venous access system consisting of a detached catheter and port," which are physical hardware components. The performance studies also focus on physical characteristics like connection strength, durability, and leakage.
Based on the provided information, the theraPORT® is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "repeated venous access for injection or infusion therapy and/or venous blood sampling." This describes a device used on a patient for direct medical intervention and sample collection, not for testing samples outside the body.
- Device Description: It's described as a "totally implantable venous access system consisting of a detached catheter and port." This is a physical device implanted in the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any process that would be performed in vitro (in glass, or outside the living organism).
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The theraPORT® facilitates the collection of such specimens and the delivery of substances, but it doesn't perform the diagnostic testing itself.
N/A
Intended Use / Indications for Use
The theraPORT® is intended for use with patients that require repeated venous access for injection or infusion therapy and/or venous blood sampling.
Product codes
Not Found
Device Description
The theraPORT® Vascular Access System is a totally implantable venous access system consisting of a detached catheter and port.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing of the theraPORT® Vascular Access System was conducted in accordance with the "Guidance on 510(k) Submissions for Implanted Infusion Ports," Center for Devices and Radiological Health, Office of Device Evaluation, Division of Gastroenterology/Urology and General Use Devices, Food and Drug Administration, October 1990. Catheter-to-port connection strength tests, septum puncture durability tests, port leakage integrity tests and port/catheter clearance tests were all performed.
Biocompatibility testing was not conducted since all materials, their processing, and their sterilization are identical to substantially equivalent devices.
Clinical studies were not conducted as they were determined to be not necessary due to the similarity in design, performance, materials, function and intended use of the theraPORT® Vascular Access System to other commercially available systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K960350, K9ua550
Reference Device(s)
Not Found
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
K9ua550
510(k) Summary for the theraPORT® Vascular Access System
APR 1 5 1996
GENERAL INFORMATION:
| Common/Usual Names: | Implanted Subcutaneous Intravascular Catheter;
Implantable Vascular Access System; Implanted
Infusion Port |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | theraPORT® Vascular Access System |
| Applicant: | Biocontrol Technology, Inc.
300 Indian Springs Road
Indiana, PA 15701
(412)349-1811 |
| Equivalence Device Comparison: | Cook Pacemaker Corporation, VITAL-PORT®
Vascular Access Port with Detached Catheter;
Pharmacia Deltec, Inc., PORT-A-CATH® Implant-
able Access System; and Therex, Inc., A-PORT®
Implantable Vascular Access System. |
DEVICE DESCRIPTION:
The theraPORT® Vascular Access System is a totally implantable venous access system consisting of a detached catheter and port.
INTENDED USE:
The theraPORT® is intended for use with patients that require repeated venous access for injection or infusion therapy and/or venous blood sampling.
ALTERNATIVE DEVICES:
Alternative devices to the theraPORT® Vascular Access System are other commercially available implantable vascular venous access systems such as the Cook Pacemaker Corporation, VITAL- PORT® Vascular Access Port with Detached Catheter, the Pharmacia Deltec, Inc. PORT-A-CATH® Implantable Access System, and the Therex Corporation, A-PORT® Implantable Vascular Access System.
1
POTENTIAL ADVERSE EFFECTS:
The following adverse effects, which are normally associated with the insertion or use of any implanted device or indwelling catheter, may occur when using the theraPORT® Vascular Access System: air embolism, bacteremia, catheter disconnection, catheter fragmentation, cardiac arthythmia, cardiac puncture, cardiac tamponade, catheter occlusion, catheter rupture, catheter shearing, catheter/port erosion through blood vessel/skin, catheter/port migration, drug extravasation, hematoma, hemothorax, implant rejection, laceration or puncture of vessels, pneumothorax, sepsis, thromboembolism, thrombophlebitis, thrombosis.
SUMMARY OF STUDIES:
Performance Testing:
Performance testing of the theraPORT® Vascular Access System was conducted in accordance with the "Guidance on 510(k) Submissions for Implanted Infusion Ports," Center for Devices and Radiological Health, Office of Device Evaluation, Division of Gastroenterology/Urology and General Use Devices, Food and Drug Administration, October 1990. Catheter-to-port connection strength tests, septum puncture durability tests, port leakage integrity tests and port/catheter clearance tests were all performed.
Biocompatibility testing was not conducted since all materials, their processing, and their sterilization are identical to substantially equivalent devices.
Clinical Studies:
Clinical studies were not conducted as they were determined to be not necessary due to the similarity in design, performance, materials, function and intended use of the theraPORT® Vascular Access System to other commercially available systems.
CONCLUSIONS DETERMINED FROM TESTS:
The above described studies demonstrate that the theraPORT® Vascular Access System functions properly and is substantially equivalent to the aforementioned commercially available predicate devices. Therefore, the theraPORT® Vascular Access System is determined to be safe and effective for its intended use.
theraPORT® is a registered trademark of Biocontrol Technology, Inc.
A-Port® is a registered trademark of Therex, Corp.
Port-A-Cath® is a registered trademark of Pharmacia-Deltec, Inc.
Vital-Port® is a registered trademark of Cook Pacemaker Corp.