(149 days)
PORT-A-CATH® P.A.S. PORT® Implantable Venous Access Systems, PeriPort™ Peripheral Access System
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No
The summary describes a physical medical device (an implantable venous access system) and its components, with no mention of software, algorithms, or any terms related to AI or ML.
No.
The devicefacilitates repeated venous access for injection or infusion therapy and/or venous blood sampling, but it does not directly treat or cure a medical condition itself.
No
The device is described as an implanted venous access system for repeated venous access for injection, infusion therapy, and/or venous blood sampling. Its function is to provide access for treatment and sampling, not to diagnose a condition.
No
The device description clearly outlines physical components like a portal shape, septum, housing material, and a vein pick, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for repeated venous access for injection or infusion therapy and/or venous blood sampling in a patient. This is a direct interaction with the patient's circulatory system for therapeutic or diagnostic sample collection purposes, not for testing samples outside the body.
- Device Description: The device is an implantable port system designed to be placed in the arm. This is a medical device for use in vivo (within a living organism).
- Lack of IVD Characteristics: There is no mention of the device being used to test samples of human origin in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are typically used to analyze samples like blood, urine, or tissue in a laboratory setting to diagnose or monitor conditions. This device is a tool for accessing the venous system, which can be used to obtain samples for IVD testing, but the device itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
Because of its low profile, the P.A.S. PORT II system is intended for peripheral placement in the arm. The portal can be implanted in the upper arm above the antecubital space below the axilla, or below the antecubital space in the upper part of the forearm. A system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
Product codes
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Device Description
The P.A.S. PORT® II System is similar to the current commercially available P.A.S. PORT® System. The systems have the identical outlet tube, catheter connector and catheter. The systems are also identical in that the P.A.S. PORT® II System will be made available with a sensor assembly and/or introducer set.
The P.A.S. PORT® II System will be modified to include a new portal shape, an increased septum diameter, an increased septum puncture life, a change in portal housing material (i.e. polysulfone/titanium), the rear suture hole will be filled with silicone, and a vein pick and a winged infusion set will be included with the systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
peripheral placement in the arm. The portal can be implanted in the upper arm above the antecubital space below the axilla, or below the antecubital space in the upper part of the forearm.
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
Functional Testing: In-vitro testing was conducted in accordance with the FDA "Guidance on 510(k) Submissions for Implanted Infusion Ports," dated October 1990. The testing included septum puncture, system leakage and clearance testing. Biocompatibility testing was conducted on all system components.
Clinical Studies: Clinical studies were not deemed necessary regarding the PORT-A-CATH® P.A.S. PORT® II Implantable Venous Access System due to its similarity in materials, design and function to current SIMS Deltec systems and other commercially available systems.
Conclusion: The results of the testing indicated that the PORT-A-CATH® P.A.S. PORT® II Implantable Venous Access System functions according to specification and the materials used in the system are biocompatible. Therefore, the system is considered acceptable for human use.
Key Metrics
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Predicate Device(s)
PORT-A-CATH® P.A.S. PORT® Implantable Venous Access Systems, PeriPort™ Peripheral Access System
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
SEP 2 0 1996
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS K 96/58
PORT-A-CATH® P.A.S. PORT® II Implantable Venous Access Systems
April 23, 1996
L GENERAL INFORMATION
| Applicant's Name and Address: | SIMS Deltec, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 |
|--------------------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Lisa Stone
Manager, Regulatory Affairs
Tel. (612) 628-7224 |
| Common/Usual Name: | Subcutaneously Implanted Intravascular Infusion
Port and Catheter |
| Proprietary Name: | PORT-A-CATH® P.A.S. PORT® II Implantable
Venous Access Systems |
| | PORT-A-CATH® P.A.S. PORT® II Fluoro-
Free™ Implantable Venous Access Systems |
| Equivalence Device Comparison: | PORT-A-CATH® P.A.S. PORT® Implantable
Venous Access Systems
(manufactured by SIMS Deltec, Inc.) |
| | PeriPort™ Peripheral Access System
(manufactured by Strato Medical Corp.) |
II. DEVICE DESCRIPTION
The P.A.S. PORT® II System is similar to the current commercially available P.A.S. PORT® System. The systems have the identical outlet tube, catheter connector and catheter. The systems are also identical in that the P.A.S. PORT® II System will be made available with a sensor assembly and/or introducer set.
The P.A.S. PORT® II System will be modified to include a new portal shape, an increased septum diameter, an increased septum puncture life, a change in portal housing material (i.e. polysulfone/titanium), the rear suture hole will be filled with silicone, and a vein pick and a winged infusion set will be included with the systems.
1
III. INTENDED USE OF DEVICE
Because of its low profile, the P.A.S. PORT II system is intended for peripheral placement in the arm. The portal can be implanted in the upper arm above the antecubital space below the axilla, or below the antecubital space in the upper part of the forearm. A system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
IV. DEVICE COMPARISON
| | PORT-A-CATH®
P.A.S. PORT® II
Systems | PORT-A-CATH®
P.A.S. PORT® Systems | PeriPort™ Peripheral
Access System |
|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Strato Medical Corp. |
| INDICATION FOR USE | Because of its low profile,
the P.A.S. PORT system is
intended for peripheral
placement in the arm. The
portal can be implanted in
the upper arm above the
antecubital space below the
axilla, or below the
antecubital space in the
upper part of the forearm.
A system is indicated when
patient therapy requires
repeated venous access for
injection or infusion therapy
and/or venous blood
sampling. | Because of its low profile.
the P.A.S. PORT system is
intended for peripheral
placement in the arm. A
system is indicated when
patient therapy requires
repeated venous access for
injection or infusion therapy
and/or venous blood
sampling. | The PeriPort System is
indicated for peripheral
placement in the midarm.
above the anticubital space
and well below the
subaxillary area, when
patient therapy requires
repeated venous access for
injection or infusion therapy
and/or venous blood
sampling. |
| PORTAL DIMENSIONS
(Nominal)
Height
Length
Width
Septum Diameter | 8.75 mm
29.5 mm
16.3 mm
9.5 mm | 10.0 mm
26.7 mm
16.5 mm
6.6 mm | 10.2 mm
19.5 mm
10.2 mm
5.7 mm |
| CATHETER DIMENSIONS
(Nominal)
I.D.
O.D.
Length | 1.0 mm
1.9 mm
76 cm | 1.0 mm
1.9 mm
76 cm | 1.0 mm
1.7 mm
76 cm |
2
| | PORT-A-CATH®
P.A.S. PORT® II
Systems | PORT-A-CATH®
P.A.S. PORT® Systems | PeriPort™ Peripheral
Access System |
|----------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------------------|
| MATERIALS
Portal Housing
Septum
Connector
Catheter | Polysulfone/Titanium
Silicone
Titanium
Polyurethane | Titanium
Silicone
Titanium
Polyurethane | Polysulfone/Titanium
Silicone
Titanium
Polyurethane |
| CATHETER CONNECTOR | ULTRA-LOCK® Connector | ULTRA-LOCK® Connector | Strain relief connection |
V. SUMMARY OF STUDIES
A. Functional Testing
In-vitro testing was conducted in accordance with the FDA "Guidance on 510(k) Submissions for Implanted Infusion Ports," dated October 1990. The testing included septum puncture, system leakage and clearance testing.
Biocompatibility testing was conducted on all system components.
B. Clinical Studies
Clinical studies were not deemed necessary regarding the PORT-A-CATH® P.A.S. PORT® II Implantable Venous Access System due to its similarity in materials, design and function to current SIMS Deltec systems and other commercially available systems.
C. Conclusion Drawn from the Studies
The results of the testing indicated that the PORT-A-CATH® P.A.S. PORT® II Implantable Venous Access System functions according to specification and the materials used in the system are biocompatible. Therefore, the system is considered acceptable for human use.