(53 days)
No
The 510(k) summary describes a mechanical implantable venous access system with no mention of software, algorithms, or any technology related to AI or ML. The changes described are purely physical modifications to the device's structure and materials.
No
A therapeutic device actively treats or cures a condition. This device is a venous access system, acting as a portal for administering therapy, not the therapy itself.
No
The device is indicated for repeated venous access for injection or infusion therapy and/or venous blood sampling, which are therapeutic and collection functions, not diagnostic.
No
The device description clearly outlines physical components such as a portal shape, septum, portal housing material, suture hole, sensor assembly, and introducer set, 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." This describes a device used in vivo (within the body) for delivering substances or collecting samples directly from the bloodstream.
- Device Description: The description details an "Implantable Venous Access System" with components like a portal, septum, catheter, etc. These are all parts of a system designed to be surgically placed within the body.
- Lack of Diagnostic Purpose: The intended use does not mention any diagnostic purpose. It's about accessing the venous system for therapeutic or sampling purposes, not for analyzing samples in vitro to diagnose a condition.
- Performance Studies: The performance studies focus on functional testing (septum puncture, leakage, clearance) and biocompatibility, which are relevant for an implanted medical device, not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
"A P.A.S. PORT® 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
The P.A.S. PORT® Elite 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 P.A.S. PORT® Elite System differs from the current commercially available P.A.S. PORT System as follows: modified portal shape, increased septum diameter, new portal housing material, and a pierceable rear suture hole.
The P.A.S. PORT® Elite System will be made available with a sensor assembly and/or introducer set.
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 septum puncture, system leakage and clearance testing. Biocompatibility testing was conducted on system components.
Clinical Studies: Clinical studies were not deemed necessary regarding the P.A.S. PORT® Elite Implantable Venous Access System due to its similarity in materials, design and function to current SIMS Deltec systems and other commercially available systems.
Conclusions: The results of the testing indicated that the P.A.S. PORT® Elite 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
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
K99 2880
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
P.A.S. PORT® Elite Implantable Venous Access System
August 25, 1999
GENERAL INFORMATION 1.
| 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: | P.A.S. PORT® Elite Implantable Venous
Access System |
| Equivalence Device Comparison: | P.A.S. PORT® Implantable Venous Access System
(manufactured by SIMS Deltec, Inc.)
M.R.I.® Low Profile Implanted Port
(manufactured by Bard Access Systems) |
II. DEVICE DESCRIPTION
The P.A.S. PORT® Elite 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 P.A.S. PORT® Elite System differs from the current commercially available P.A.S. PORT System as follows: modified portal shape, increased septum diameter, new portal housing material, and a pierceable rear suture hole.
The P.A.S. PORT® Elite System will be made available with a sensor assembly and/or introducer set.
III. INTENDED USE OF DEVICE
A P.A.S. 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 3
IV. DEVICE COMPARISON
| | P.A.S. PORT® Elite
Systems | P.A.S. PORT®
Systems | M.R.L. Low Profile
Implanted Port |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Bard Access Systems |
| 510(K) NUMBER | Subject Device | K875276 | — |
| INDICATION FOR
USE | A P.A.S. PORT® 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 M.R.I. Low Profile
Implanted Port is indicated
for patient therapy requir-ing
repeated access to the
vascular system in pedia-tric
cases or where a small port
profile is desired or required.
The port system can be used
for infusion of medications,
parenteral nutrition solution,
blood products or imaging
solutions and for the
withdrawal of blood samples. |
| PORTAL
DIMENSIONS
(Nominal) | | | |
| Height
Length
Width
Septum Diameter | 9.5 mm
25 mm
17.2 mm
9.7 mm | 10.0 mm
26.7 mm
16.5 mm
6.6 mm | 10.0 mm
24.8 mm (diameter)
—
10.8 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
—
76 cm |
| MATERIALS | | | |
| Portal Housing
Septum
Connector
Catheter | Acetal and Titanium
Silicone
Titanium
Polyurethane | Titanium
Silicone
Titanium
Polyurethane | Acetal
Silicone
—
Silicone |
| CATHETER
CONNECTOR | ULTRA-LOCK®
Connector | ULTRA-LOCK®
Connector | Strain relief connection |
--- Information is unknown.
2
510(k) Summary of Safety and Effectiveness Page 3 of 3
SUMMARY OF STUDIES V.
Functional Testing A.
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 system components.
B. Clinical Studies
Clinical studies were not deemed necessary regarding the P.A.S. PORT® Elite Implantable Venous Access System due to its similarity in materials, design and function to current SIMS Deltec systems and other commercially available systems.
C. Conclusions Drawn from the Studies
The results of the testing indicated that the P.A.S. PORT® Elite 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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The caduceus is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 1999
Ms. Lisa J. Stone Manager, Regulatory Affairs Smiths Industries Medical Systems SIMS Deltec, Inc. 1265 Grey Fox Road St. Paul, MN 55112
Re : K992880
Trade Name: P.A.S.PORT® Elite Implantable Venous Access System Class: Unclassified Product Code: LJT August 25, 1999 Dated: Received: August 27, 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, Druq, 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbrandinq 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
4
Page 2 - Ms. Stone
the Federal Register. Please note: this response to your premarket notification submission does not affect any 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 diaqnostic 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,
Kollatrik
Timothy A. Ulatowski
hy A. Ulatowski Timot Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): _ K 992880
Device Name: P.A.S. PORT® Elite Implantable Venous Access System
Indications for Use:
"A P.A.S. PORT® 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_ OR (Per 21 CFR 801.109) (Division Sign-Off) Division of Dental, Infection C ntrol/
510(k) Number
and General Hospital Devices
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________