(81 days)
Not Found
No
The device description explicitly states that no changes were made to the product and it is the same in design and function as currently available systems. There is no mention of AI, ML, or image processing, and the performance studies section indicates no functional testing was needed due to the lack of changes.
Yes
Explanation: The device is indicated for repeated vascular access for injection or infusion therapy and/or venous blood sampling, which are therapeutic interventions.
No
The device is described as an access system for repeated vascular access for injection, infusion, and blood sampling, which are therapeutic and monitoring functions, not diagnostic.
No
The device description explicitly states "The modified PORT-A-CATH® Low-Profile™ Systems are exactly the same in design and function as the current commercially available systems. No change to the product has been made." This indicates a physical implantable access system, not a software-only device.
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 repeated vascular access for injection, infusion therapy, and blood sampling. This is a procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is described as an implantable access system (PORT-A-CATH®). These are physical devices implanted in the body to facilitate access to the vascular system.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information. IVDs typically involve reagents, analyzers, or other tools for testing samples.
Therefore, the device described is a medical device for vascular access, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"A system is indicated when a patient requires repeated vascular access for injection (bolus) or infusion therapy and/or venous blood sampling."
Product codes
LTS
Device Description
The modified PORT-A-CATH® Low-Profile™ Systems are exactly the same in design and function as the current commercially available systems. No change to the product has been made.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
- Chest placement
- Arm placement
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 was not deemed necessary, since no changes were made to the product.
Clinical studies were not deemed necessary regarding the PORT-A-CATH® Low-Profile™ Implantable Access Systems due to their similarity in materials, design and function to current commercially available product (i.e. PORT-A-CATH® P.A.S. PORT® II Implantable Access System and BardPort™ SlimPort™ Low Profile Port).
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
19973862
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
DEC 2 9 1997
PORT-A-CATH® Low-Profile™ Implantable Access Systems
October 6, 1997
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
Tel. (612) 628-7224 |
| Common/Usual Name: | Subcutaneously Implanted Intravascular
Infusion Port and Catheter |
| Proprietary Name: | PORT-A-CATH® Low-Profile™
Implantable Access Systems |
| Equivalence Device Comparison: | PORT-A-CATH® P.A.S. PORT® II
Implantable Access System
(manufactured by SIMS Deltec, Inc.)
BardPort™ SlimPort™ Low Profile Port
(manufactured by Bard Access Systems) |
II. DEVICE DESCRIPTION
The modified PORT-A-CATH® Low-Profile™ Systems are exactly the same in design and function as the current commercially available systems. No change to the product has been made.
INTENDED USE OF DEVICE III.
The indications for this device will not change [i.e. A system is indicated when a patient requires repeated vascular access for injection (bolus) or infusion therapy and/or venous blood sampling]. However, the intended use of the device will be modified to include peripheral placement of the device in large or obese patients.
1
IV. DEVICE COMPARISON
| | PORT-A-CATH®
Low-Profile™
Systems | PORT-A-CATH®
P.A.S. PORT® II
Systems | BardPort™
SlimPort™ Low
Profile Port |
|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Bard Access Systems |
| INDICATIONS FOR USE | A system is indicated when a
patient requires repeated
vascular access for injection
(bolus) or infusion therapy
and/or venous blood
sampling. | Because of its low profile,
the P.A.S. PORT system is
intended for peripheral
placement in the arm. The
portal can be implanted in
the upper arm above the
antecubital space below the
axilla, or below the ante-
cubital space in the upper
part of the forearm. 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. |
| INTENDED USE | - Chest placement
- Arm placement | - Arm placement | - Chest placement
- Arm placement |
| PORTAL DIMENSIONS
(Nominal)
Height
Length
Width
Septum Diameter | 11.5 mm
25.0 mm
25.0 mm
9.5 mm | 8.9 mm
23.9 mm
16.5 mm
9.7 mm | 9.8 mm
24.7 mm
19.0 mm
9.0 mm |
SUMMARY OF STUDIES V.
Functional Testing A.
Functional testing was not deemed necessary, since no changes were made to the product.
Clinical Studies B.
Clinical studies were not deemed necessary regarding the PORT-A-CATH® Low-Profile™ Implantable Access Systems due to their similarity in materials, design and function to current commercially available product (i.e. PORT-A-CATH® P.A.S. PORT® II Implantable Access System and BardPort™ SlimPort™ Low Profile Port).
2
Conclusion Drawn from the Studies C.
As noted above, no functional testing or clinical studies were deemed necessary regarding the PORT-A-CATH® Low-Profile™ Implantable Access Systems.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three human profiles incorporated into its design. The eagle and profiles are enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 29 1997
Ms. Lisa Stone Manager Requlatory Affairs Sims Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112
K973862 Re : Port-A-Cath Low Profile Implantable Access Trade Name: Systems Requlatory Class: Unclassified Product Code: LTS October 6, 1997 Dated: Received: October 9, 1997
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 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obliqation you might have under sections 531
4
Page 2 - Ms. Stone
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketinq your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 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 Other qeneral 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Us. Childrust
Timothy A. Ulatowski Directbr 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® Low-Profile™ Implantable Access Systems
Indications for Use:
"A system is indicated when a patient requires repeated vascular 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)
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K973862 |
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use _