(57 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical and biocompatibility testing of an implantable port system, with no mention of AI or ML capabilities.
Yes
The device is described as an "implantable access system" used for "venous access for injection (bolus) or infusion therapy and/or venous blood sampling," which directly involves medical treatment and patient management.
No
The device is described as an implanted infusion port for venous access, used for injection, infusion therapy, and blood sampling. This function is therapeutic and interventional, not diagnostic.
No
The device description explicitly lists multiple hardware components including a portal, catheter, connector, needles, and vein pick.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system for providing venous access for injection, infusion, and blood sampling from a patient. This is a direct interaction with the human body for therapeutic and diagnostic purposes, not a test performed in vitro (outside the body) on biological samples.
- Device Description: The description details an implantable system consisting of a portal, catheter, and accessories for accessing the venous system. This is a medical device designed for use within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue) to provide diagnostic information about a patient's health status. The device facilitates the collection of blood, but it doesn't perform the diagnostic test itself.
In summary, the PORT-A-CATH® II Dual-Lumen Low Profile™ System is a medical device used for accessing the venous system in vivo, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LJT
Device Description
PORT-A-CATH® II Dual-Lumen Low Profile™ Systems are similar in design and function to the current commercially available PORT-A-CATH® II Dual-Lumen Systems.
These systems differ from current commercially available PORT-A-CATH® systems in that the portal is dimensionally smaller and a dual-lumen polyurethane catheter is being offered.
These systems consist of one low profile dual-lumen portal (titanium/polysulfone), one radiopaque catheter (polyurethane), one catheter connector, one access needle, one blunt needle and one vein pick. Introducer sets and a Fluoro-Free™ system will also be made available.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional Testing: In-vitro mechanical testing was conducted according to the "Guidance on 510(k) Submissions for Implanted Infusion Ports," October 1990.
Biocompatibility testing was conducted on all system components.
Clinical Studies: Clinical studies were not deemed necessary regarding PORT-A-CATH® II Dual-Lumen Low Profile™ Systems due to their similarity in materials, design and function to current SIMS Deltec commercially available systems.
Conclusions: The results of the testing indicated that PORT-A-CATH® II Dual-Lumen Low Profile™ Systems function according to specification and the materials used in the system are biocompatible. Therefore, these systems are considered acceptable for human use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
JAN 2 2 1998
PORT-A-CATH® II Dual-Lumen Low Profile™ Systems
November 25, 1997
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 Dual-Lumen Low Profile™
Implantable Access Systems |
| Equivalence Device Comparison: | PORT-A-CATH® II Dual-Lumen Implantable
Access Systems
(manufactured by SIMS Deltec, Inc.)
LifePort® Low Profile Dual Lumen System
(manufactured by Strato/Infusaid) |
DEVICE DESCRIPTION IL
PORT-A-CATH® II Dual-Lumen Low Profile™ Systems are similar in design and function to the current commercially available PORT-A-CATH® II Dual-Lumen Systems.
These systems differ from current commercially available PORT-A-CATH® systems in that the portal is dimensionally smaller and a dual-lumen polyurethane catheter is being offered.
These systems consist of one low profile dual-lumen portal (titanium/polysulfone), one radiopaque catheter (polyurethane), one catheter connector, one access needle, one blunt needle and one vein pick. Introducer sets and a Fluoro-Free™ system will also be made available.
1
INTENDED USE OF DEVICE III.
The PORT-A-CATH® II Dual-Lumen Low Profile™ Systems are indicated when a The I ORT 11 erreated venous access for injection (bolus) or infusion therapy and/or venous blood sampling.
DEVICE COMPARISON IV.
| | PORT-A-CATH® II
Dual-Lumen Low
Profile™ Systems | PORT-A-CATH® II
Dual-Lumen Systems | LifePort® Low Profile
Dual Lumen System |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Strato/Infusaid Inc. |
| INDICATION 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. | The LifePort system is
indicated for patient therapy
that requires repeated entry
to the vascular system for the
delivery of medications,
fluids, nutritional solutions
and blood products or the
withdrawal of venous blood
samples. |
| PORTAL DIMENSIONS
(Nominal) | | | |
| Height
Base
Septum Diameter | 11.0 mm
38.7 (L) mm x 23.5 (W) mm
9.5 mm | 16.0 mm
50.0 (L) mm x 30.0 (W) mm
11.4 mm | 10.8 mm
40.8 (L) mm x 26.5 (W) mm
10.2 mm |
| MATERIALS | | | |
| Portal Housing
Septum
Catheter | Titanium/Polysulfone
Silicone
Polyurethane | Titanium/Polysulfone
Silicone
Silicone | Acetal
Silicone
Polyurethane |
| CATHETER
DIMENSIONS
(Nominal) | | | |
| I.D. | 1.0 mm/1.0 mm or
1.4 mm/1.4 mm | 1.1 mm/1.1 mm | 1.0 mm/1.0mm |
| O.D.
Length | 2.2 mm or 3.2 mm
76 cm | 3.4 mm
76 cm | 2.2 mm
76 cm |
2
SUMMARY OF STUDIES V.
Functional Testing A.
In-vitro mechanical testing was conducted according to the "Guidance on 510(k) Submissions for Implanted Infusion Ports," October 1990.
Biocompatibility testing was conducted on all system components.
B. Clinical Studies
Clinical studies were not deemed necessary regarding PORT-A-CATH® II Dual-Lumen Low Profile™ Systems 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 Dual-Lumen Low Profile™ Systems function according to specification and the materials used in the system are biocompatible. Therefore, these systems are 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 eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 1998
Ms. Lisa Stone Manager, Regulatory Affairs SIMS Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112
K974471 Re : PORT-A-CATH® II Dual-Lumen Low Profile™ Trade Name: Implantable Access Systems Requlatory Class: Unclassified LJT Product Code: November 25, 1997 Dated: November 26, 1997 Received:
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 However, you are responsible to determine that of the Act. the medical devices you use as components in the PORT-A-CATH® II Dual-Lumen Low Profile™ Implantable Access Systems have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510 (k) before including these components in your " PORT-A-CATH® II Dual-Lumen Low Profile™ Implantable Access The general controls provisions of the Act include Systems. requirements for annual registration, listing of devices, good manufacturing practice, and 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
4
Page 2 - Ms. Stone
Federal Regulations, 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. may publish further announcements concerning your device in 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 "dsmo@fdagr.cdrh.fda.gov".
Sincerely yours
Timothy A. Ulatowski
Director 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): ____________________________________________________________________________________________________________________________________________________
Device Name: PORT-A-CATH® II Dual-Lumen Low Profile™ Implantable Access Systems
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."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patucia Crescenti
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________