(82 days)
Not Found
No
The summary describes a physical medical device (venous access system) and its manufacturing process. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML.
No.
The device is used for venous access and sampling, facilitating therapeutic interventions rather than being a therapeutic device itself.
No
The device is described as allowing "repeated venous access for injection or infusion therapy and/or venous blood sampling," which are therapeutic and sampling functions, not diagnostic ones. There is no mention of diagnostic capabilities, image processing, or AI/ML.
No
The device description clearly outlines physical components made of titanium, polysulfone, and polyurethane, 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, infusion therapy, and blood sampling in a patient. This is a direct interaction with the human body for therapeutic and diagnostic purposes, not for testing samples outside the body.
- Device Description: The device is an implanted system (portal and catheter) designed to be placed within the venous system of a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) in vitro to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests on samples taken from the body, while this device is used to access the body directly for treatment and sample collection.
N/A
Intended Use / Indications for Use
PORT-A-CATH® II Venous Systems Preconnected with Polyurethane Catheter are indicated when a patient requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
Product codes
Not Found
Device Description
These systems differ from current commercially available systems in that the portal/catheter connection is made during the manufacturing process, by placing a polyurethane strain relief over the catheter and outlet tubes of the portal.
These systems consist of a standard or low profile portal (titanium/polysulfone) preconnected to a radiopaque catheter (polyurethane) and an access needle. Two catheter options will be available: a 2.6 mm O.D. catheter and a 1.9 mm O.D. catheter. Additionally, systems will be made available with introducer sets.
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
A. Functional Testing
In-vitro mechanical testing was conducted according to the "Guidance on 510(k) Submissions for Implanted Infusion Ports," October 1990. Only catheter to portal connection testing was performed, since these preconnected systems are the same as current commercially available systems, except for the connection scheme.
Biocompatibility testing was conducted on all system components.
B. Clinical Studies
Clinical studies were not deemed necessary regarding PORT-A-CATH® II Venous Systems Preconnected with Polyurethane Catheter due to their similarity in materials, design and function to current SIMS Deltec commercially available systems.
C. Conclusions Drawn from the Studies
The results of the testing indicated that PORT-A-CATH II Venous Systems Preconnected with Polyurethane Catheter function according to specification and the materials used in the system are biocompatible. Therefore, these systems are considered acceptable for human use.
Key Metrics
Not Found
Predicate Device(s)
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
K9626695
OCT .. 1 1996
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
PORT-A-CATH® II Implantable Venous Access Systems Preconnected with Polyurethane Catheter
July 8, 1996
GENERAL INFORMATION I.
| 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® II Venous Implantable Access
Systems Preconnected with Polyurethane Catheter |
| Equivalence Device Comparison: | PORT-A-CATH® II Venous Implantable Access
Systems with Polyurethane Catheter
(manufactured by SIMS Deltec, Inc.)
PORT-A-CATH® II Dual Lumen Venous
Implantable Access Systems Preconnected with
Silicone Catheter
(manufactured by SIMS Deltec Inc) |
II. DEVICE DESCRIPTION
PORT-A-CATH® II Venous Systems Preconnected with Polyurethane Catheter are similar in design and function to the current commercially available PORT-A-CATH® II Venous Systems with Polyurethane Catheter.
These systems differ from current commercially available systems in that the portal/catheter connection is made during the manufacturing process, by placing a polyurethane strain relief over the catheter and outlet tubes of the portal.
These systems consist of a standard or low profile portal (titanium/polysulfone) preconnected to a radiopaque catheter (polyurethane) and an access needle. Two catheter options will be available: a 2.6 mm O.D. catheter and a 1.9 mm O.D. catheter. Additionally, systems will be made available with introducer sets.
1
ロ. INTENDED USE OF DEVICE
PORT-A-CATH® II Venous Systems Preconnected with Polyurethane Catheter are indicated when a patient requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
IV. DEVICE COMPARISON
| | PORT-A-CATH® II
Systems Preconnected
with Polyurethane
Catheter | PORT-A-CATH® II Dual
Lumen Systems
Preconnected with
Silicone Catheter
K955407 | PORT-A-CATH® II
Systems with
Polyurethane Catheter
K932840
K942024 | | | |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|---------------------------------------------|---------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | SIMS Deltec, Inc. | | | |
| INDICATIONS FOR USE | A system is indicated when a
patient requires repeated
venous access for injection
(bolus) or infusion therapy
and/or venous blood
sampling. | A system is indicated when a
patient requires repeated
venous access for injection
(bolus) or infusion therapy
and/or venous blood
sampling. | A system is indicated when a
patient requires repeated
venous access for injection
(bolus) or infusion therapy
and/or venous blood
sampling. | | | |
| PORTAL DIMENSIONS | | | | | | |
| | STANDARD
14.7 mm
30.5 mm
11.4 mm | LOW-PROFILE
11.5 mm
25.0 mm
9.5 mm | DUAL-LUMEN
16.0 mm
50.0 (L) mm x 30.0 (W) mm
11.4 mm | STANDARD
14.7 mm
30.5 mm
11.4 mm | LOW PROFILE
11.5 mm
25.0 mm
9.5 mm | |
| MATERIALS | | | | | | |
| | Portal Housing
Septum
Catheter | Titanium/Polysulfone
Silicone
Polyurethane | Titanium/Polysulfone
Silicone
Silicone | Titanium/Polysulfone
Silicone
Polyurethane | | |
| CATHETER
DIMENSIONS | | | | | | |
| | I.D.
O.D.
Length | 1.0 mm
1.9 mm
76 cm | 1.6 mm
2.6 mm
76 cm | 1.1 mm/1.1 mm
3.4 mm
76 cm | 1.0 mm
1.9 mm
76 cm | 1.6 mm
2.6 mm
76 cm |
| PORTAL/CATHETER
PRECONNECTED | | YES | | YES | NO | |
2
SUMMARY OF STUDIES V.
A. Functional Testing
In-vitro mechanical testing was conducted according to the "Guidance on 510(k) Submissions for Implanted Infusion Ports," October 1990. Only catheter to portal connection testing was performed, since these preconnected systems are the same as current commercially available systems, except for the connection scheme.
Biocompatibility testing was conducted on all system components.
B. Clinical Studies
Clinical studies were not deemed necessary regarding PORT-A-CATH® II Venous Systems Preconnected with Polyurethane Catheter due to their similarity in materials, design and function to current SIMS Deltec commercially available systems.
C. Conclusions Drawn from the Studies
The results of the testing indicated that PORT-A-CATH II Venous Systems Preconnected with Polyurethane Catheter function according to specification and the materials used in the system are biocompatible. Therefore, these systems are considered acceptable for human use.