(60 days)
Not Found
No
The summary describes a physical medical device (a portal and catheter system) for vascular access. There is no mention of software, algorithms, image processing, or terms related to AI/ML. The performance studies focus on physical properties and in-vivo/in-vitro testing of the hardware.
No
This device is for access and infusion, not for directly treating a disease or condition.
No
The device is described as an access system for prolonged or repeated intra-arterial access for injection or infusion regimes, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly lists physical components (portal, septum, catheter, hemostasis assembly, micro-catheter assembly) and the performance studies describe in-vitro and in-vivo testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "prolonged or repeated intra-arterial access for injection or infusion regimes." This describes a device used within the body for delivering substances, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a system for accessing arteries, including a portal, catheter, and related components. This aligns with a device used for direct patient intervention, not for laboratory testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The focus is entirely on providing access to the arterial system for therapeutic purposes.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The PORT-A-CATH® II Regional Arterial Portal System is indicated when patient therapy requires prolonged or repeated intra-arterial access for injection or infusion regimes.
Product codes
LJT
Device Description
A system consists of a portal with a self-sealing silicone septum, accessible by percutaneous needle puncture, a single lumen silicone catheter, a hemostasis sy assembly, and a micro-catheter assembly
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-arterial, hepatic or other target arteries
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
- Functional Testing: In-vitro testing was conducted in accordance with the FDA "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters," dated March 16, 1995. The testing included tensile strength, flow-rate, catheter stiffness, catheter flexural fatigue, system leakage, and guidewire removal testing. In-vitro Simulated Life Testing documented performance under simulated, but accelerated, in-use conditions. In-vivo testing evaluated the feasibility of implantation and immediate post-implant performance of an arterial port-catheter system into the hepatic or other target arteries using minimally invasive, image-guided techniques.
- Biocompatibility Testing: Biocompatibility testing was conducted on system components.
- Clinical Studies: Clinical studies were not deemed necessary due to the similarity in materials, design and function to current Deltec systems.
- Key Results: The results of the testing indicated that the PORT-A-CATH® II Regional Arterial Portal System functions according to specifications 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
JAN 2 3 2004
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
PORT-A-CATH® II Regional Arterial System
November 21, 2003
I. GENERAL INFORMATION
| Applicant's Name and Address: | Deltec, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia LaForte
Regulatory Affairs Associate |
| Common/Usual Name: | Implantable Access System |
| Proprietary Name: | Regional Arterial Port/Catheter System for
Local/Regional Drug Delivery |
| Equivalence Device Comparison: | PORT-A-CATH® II Trans-Arterial Percutaneous
System
PORT-A-CATH® II Implantable Venous Access
System |
II. DEVICE DESCRIPTION
A system consists of a portal with a self-sealing silicone septum, accessible by percutaneous needle puncture, a single lumen silicone catheter, a hemostasis sy assembly, and a micro-catheter assembly
III. INTENDED USE OF DEVICE
The PORT-A-CATH® II Regional Arterial Portal System is indicated when patient therapy requires prolonged or repeated intra-arterial access for injection or infusion regimes.
1
510(k) Summary of Safety and Effectiveness Page 2 of 4
IV. DEVICE COMPARISON
| | PORT-A-CATH® II
Regional Arterial
Drug Delivery System | PORT-A-CATH® II
Trans-Arterial
Percutaneous System | PORT-A-CATH® II
Implantable Venous
Access System |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | Deltec, Inc. | Deltec, Inc. | Deltec, Inc. |
| 510(K) NUMBER | Subject Device | K992697 | K932840 |
| INDICATION FOR USE | A system is indicated
when patient therapy
requires prolonged or
repeated intra-arterial
infusions. | A system is indicated
when patient therapy
requires prolonged or
repeated intra-arterial
infusions. | A system is indicated
when patient therapy
requires repeated access
to the venous system for
the parenteral delivery of
medications, fluids, and
nutritional solutions, and
for the sampling of
venous blood. |
| PORTAL AND
CONNECTOR
MATERIALS | | | |
| Housing | Polysulfone/Titanium | Polysulfone/Titanium | Polysulfone/Titanium |
| Septum | Silicone | Silicone | Silicone |
| Connector | Polypropylene/Titanium | Polypropylene/Titanium | Polypropylene/Titanium |
| PORTAL DIMENSIONS
(Nominal) | | | |
| Height
Portal Base
Septum Diameter | 15.2 mm
30.5 mm
11.4 mm | 11.5 mm
25.0 mm
9.5 mm | 15.2 mm
30.5 mm
11.4 mm |
| PORTAL
CONNECTING
CATHETER | | | |
| OD/ID | 2.8mm/1.0mm | 1.9mm/1.0mm | 2.8mm/1.0mm |
| | PORT-A-CATH® II
Regional Arterial
Drug Delivery System | PORT-A-CATH® II
Trans-Arterial
Percutaneous System | PORT-A-CATH® II
Implantable Venous
Access System |
| LENGTH
MATERIAL | 38cm
Silicone | 76cm
Polyurethane | 76cm
Silicone |
| PORTAL TUBE
CONNECTOR | CATH-SHIELD®
Connector | ULTRA-LOCK®
Connector | CATH-SHIELD®
Connector |
| INTRA-VASCULAR
CATHETER
OD/ID
Length
Material | 1.0mm/0.72mm
100cm
Pebax/PTFE/Stainless
Steel | All same as above
(same catheter connects
to portal and to vascular
system) | All same as above
(same catheter connects
to portal and to vascular
system) |
| CATHETER TO
CATHETER
CONNECTOR | Boot- Silicone
Clamp - Acetal
Sleeve - Tecoflex 93A
Bushing - Polyvinyl Chloride
(TOTM plasticized) | n/a1 | n/a |
| ACCESSORIES
Needles | 1 blunt / 1 huber | 1 blunt / 1 huber | 1 blunt / 1 huber |
| Sharps Safety | 1 Point Lok® | n/a | n/a |
| Portal Access | 1 GRIPPER PLUS® | n/a | n/a |
| Other | n/a | Guidewire, introducer
needle, introducer,
syringe | Vein Pick |
2
510(k) Summary of Safety and Effectiveness Page 3 of 4
DELTEC, INC.
Comparison Chart (Continued)
1 n/a = not applicable
3
III. SUMMARY OF STUDIES
A. Functional Testing
In-vitro testing was conducted in accordance with the FDA "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters," dated March 16, 1995. The testing included tensile strength, flow-rate, catheter stiffness, catheter flexural fatigue, system leakage, and guidewire removal testing.
In-vitro Simulated Life Testing to document performance of the PORT-A-CATH® II Regional Arterial System under simulated, but accelerated, in-use conditions was performed.
In-vivo testing of the PORT-A-CATH® II Regional Arterial System to evaluate the feasibility of the implantation and immediate post-implant performance of an arterial port-catheter system into the hepatic or other target arteries using minimally invasive, image-guided techniques was conducted.
Biocompatibility testing was conducted on system components.
B. Clinical Studies
Clinical studies were not deemed necessary regarding PORT-A-CATH® II Regional Arterial System due to their similarity in materials, design and function to current Deltec systems.
C. Conclusions Drawn from the Studies
The results of the testing indicated that the PORT-A-CATH® II Regional Arterial Portal System functions according to specifications and the materials used in the system are biocompatible. Therefore, these systems are considered acceptable for human use.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The overall design is simple and conveys a sense of government authority and public service.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2004
Ms. Patricia LaForte Regulatory Affairs Associate Smiths Medical MD, Incorporated 1265 Grey Fox Road Saint Paul, Minnesota 55112
Re: K033686
Trade/Device Name: PORT-A-CATH® II Regional Arterial Portal System Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Codc: LJT Dated: November 21, 2003 Received: November 24, 2003
Dear Ms. LaForte:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
5
Page 2 - Ms. LaForte
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Cls
SG. Liu, Ph.D.
Chiu Lin, Ph., D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): _____________________
Device Name: PORT-A-CATH® II Regional Arterial Portal System
Indications for Use:
"The PORT-A-CATH® II Regional Arterial Portal System will be indicated when patient therapy requires prolonged or repeated intra-arterial access for injection or infusion regimes."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Zork Dillard, Interim Branch Chief
(Division Sian-Off) Division of Anesthesiology, Ge Infection Control, Dental De
510(k) Number: K0331
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use