(43 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of an implantable venous access system, with no mention of AI or ML.
No
The device facilitates the delivery of therapy (injections, infusions) and blood sampling, but it is not itself a therapeutic agent or treatment.
No
The device description and intended use indicate it is an implantable venous access system for repeated venous access for injection, infusion therapy, and/or venous blood sampling. These functions are therapeutic and for administration, not for diagnosing a medical condition.
No
The device description explicitly lists physical components such as a plastic portal, silicone or polyurethane catheter connector, access needle, blunt needle, and vein pick, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states that this device is an "Implantable Venous Access System." Its purpose is to provide repeated venous access for injection or infusion therapy and/or venous blood sampling. This is a device used in vivo (within the living body) for delivering substances or collecting samples, not for analyzing samples in vitro (outside the living body).
- Lack of Diagnostic Testing: The description focuses on the physical components and function of the implantable port and catheter system. There is no mention of any diagnostic testing being performed by the device itself. The blood sampling is for subsequent analysis, which would be done using separate IVD devices or laboratory procedures.
Therefore, based on the provided information, this device is a medical device used for patient therapy and sample collection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
Product codes
LJT
Device Description
Plastic Port Implantable Venous Access Systems consist of a plastic portal (standard or Low Profile™ size), silicone or polyurethane catheter connector, PORT-A-CATH® access needle, blunt needle, and vein pick. The systems will be made available with and without introducer sets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous
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 510(k) Submissions for Implanted Infusion Ports," dated October 1990. The testing included catheter to port connection, septum puncture, system leakage and clearance testing. Biocompatibility testing was conducted on system components. The results indicated that the Plastic Port Implantable Venous Access Systems function according to specifications and the materials used in the system are biocompatible.
Clinical Studies: Clinical studies were not deemed necessary.
Key Metrics
Not Found
Predicate Device(s)
K830730B, K875276, K932840, K942024
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 7 2000
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Plastic Port Implantable Venous Access Systems
December 14, 1999
I. 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 |
| Common/Usual Name: | Subcutaneously Implanted Intravascular Infusion
Port and Catheter |
| Proprietary Name: | Plastic Port Implantable Venous Access System |
| Equivalence Device Comparison: | PORT-A-CATH® Implantable Venous Access
Systems
(manufactured by SIMS Deltec, Inc.)
M.R.I.® Implanted Ports
(manufactured by Bard Access Systems) |
IL DEVICE DESCRIPTION
Plastic Port Implantable Venous Access Systems consist of a plastic portal (standard or Low Profile™ size), silicone or polyurethane catheter connector, PORT-A-CATH® access needle, blunt needle, and vein pick. The systems will be made available with and without introducer sets.
III. INTENDED USE OF DEVICE
A Plastic Port System is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
1
510(k) Summary of Safety and Effectiveness Page 2 of 4
| | Plastic Port Systems | PORT-A-CATH®
Systems | M.R.I.® Implanted
Port |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Bard Access System |
| 510(K) NUMBER | Subject Device | K830730B
K875276
K932840
K942024 | Unknown |
| INDICATION FOR USE | A system is indicated
when patient therapy
requires repeated venous
access for injection or
infusion therapy and/or
venous blood sampling. | A system is indicated
when patient therapy
requires repeated venous
access for injection or
infusion therapy and/or
venous blood sampling. | The BardPort Implanted
Ports are indicated for
patient therapies
requiring repeated access
to the vascular system.
The port system can be
used for infusion of
medications, I.V. fluids,
parenteral nutrition
solutions, blood products
and for the withdrawal of
blood samples. |
| PORTAL AND
CONNECTOR
MATERIALS | | | |
| Housing | Acetal | Polysulfone/Titanium or
Titanium | Acetal |
| Septum | Silicone | Silicone | Silicone |
| Connector | Polypropylene/Acetal or
Silicone | Polypropylene/Titanium
or Titanium | Unknown |
| PORTAL DIMENSIONS
- STANDARD SIZE
(Nominal) | | | |
| Height
Portal Base
Septum Diameter | 14.0 mm
30.5 mm
12.7 mm | 14.7 mm
30.5 mm
11.4 mm | 13.5 mm
32.0 mm
12.7 mm |
| PORTAL DIMENSIONS - LOW PROFILE SIZE
(Nominal) | | | |
| Height
Portal Base
Septum Diameter | 10.0 mm
25.0 mm
10.5 mm | 11.5 mm
25.0 mm
9.5 mm | 10.0 mm
24.8 mm
10.8 mm |
| | Plastic Port Systems | PORT-A-CATH®
Systems | M.R.I.® Implanted
Port |
| CATHETER
MATERIAL AND
DIMENSIONS
(Nominal) | | | |
| SILICONE
I.D.
O.D.
Length | 1.0 mm
2.8 mm
76 cm | 1.0 mm
2.8 mm
76 cm | 1.0 mm
Unknown
76 cm |
| POLYURETHANE
I.D.
O.D.
Length | 1.0 mm
1.9 mm
76 cm | 1.0 mm
1.9 mm
76 cm | n/a1
n/a
n/a |
| I.D.
O.D.
Length | 1.6 mm
2.6 mm
76 cm | 1.6 mm
2.6 mm
76 cm | n/a
n/a
n/a |
| CATHETER
CONNECTOR | SLIDE-LOCK® or
CATH-SHIELD®
Connector | CATH-SHIELD® or
ULTRA-LOCK®
Connector | Strain relief connection |
IV. DEVICE COMPARISON
2
510(k) Summary of Safety and Effectiveness Page 3 of 4
III. 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 catheter to port connection, septum puncture, system leakage and clearance testing.
Biocompatibility testing was conducted on system components.
Clinical Studies B.
Clinical studies were not deemed necessary regarding Plastic Port Implantable Venous Access Systems due to their similarity in materials, design and function to current SIMS Deltec systems and other commercially available systems.
3
C. Conclusions Drawn from the Studies
The results of the testing indicated that the Plastic Port Implantable Venous Access Systems function 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 stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 7 2000
Ms. Lisa J. Stone Manager, Regulatory Affairs Smiths Industries Medical Systems Deltec 1265 Grey Fox Road St. Paul, Minnesota 55112
Re : K994216 Deltec Plastic Port Implantable Venous Trade Name: Access System Requlatory Class: Unclassified Product Code: LJT December 14, 1999 Dated: Received: December 15, 1999
Dear Ms. Stone:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 either class II (Special Controls) or class III (Premarket Approval), 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 895. ਬ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
5
Page 2 - Ms. Stone
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known):
Device Name: Plastic Port Implantable Venous Access Systems
Indications for Use:
" A system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
Patricio Guereida
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 1: 0(k) Number_K 99 4-210