(132 days)
Not Found
No
The device description focuses on the physical components and materials of an implantable venous access system, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device facilitates therapeutic interventions by providing access for infusions and sampling, but it is not itself a therapeutic device that treats a condition.
No
The device is an implantable access system for repeated vascular access for injection/infusion therapy and venous blood sampling, not for diagnosing conditions.
No
The device description clearly outlines physical components such as portals, catheters, and connectors, indicating it is a hardware-based medical device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the systems are for "repeated vascular 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 access system" consisting of a portal, catheter, and connector, designed to be placed in the chest or arm. This further confirms its in vivo nature.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) outside the body to provide information about a person's health. The provided information does not mention any testing or analysis of samples performed by the device itself. While it facilitates blood sampling, the device's function is the access point, not the diagnostic test on the sample.
Therefore, the PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Systems with Dual Layer Catheter are not IVDs. They are implantable medical devices used for vascular access.
N/A
Intended Use / Indications for Use
PORT-A-CATH® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.
PORT-A-CATH® II Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.
ProPort® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
P.A.S. PORT® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
Product codes
LJT
Device Description
The PORT-A-CATH® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems and are designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids nutritional solutions and for the sampling of venous blood. The PORT-A-CATH® venous systems can be placed in the chest.
The PORT-A-CATH® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems consisting of the following components; a portal. catheter and connector. The components are assembled during implantation. The portals are available in titanium standard or Low Profile", and the ULTRA-LOCK® catheter connector is utilized in the PORT-A-CATH® systems. The catheter is a Polyether block amide outer lining and an aliphatic polyurethane inner lining. This catheter will replace the current single layer polyurethane catheters on the equivalent Smiths Medical MD, Inc. PORT-A-CATH® Implantable Venous Access Systems, The systems are offered in either a kit or a tray configuration.
The PORT-A-CATH® II Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems and are designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids nutritional solutions and for the sampling of venous blood. The PORT-A-CATH® II venous systems can be placed in the chest.
The PORT-A-CATH® II Implantable Venous Access Systems with Dual Laver Catheter are totally implantable access systems consisting of the following components: a portal, catheter and connector. The components are assembled during implantation. The portals are available in polysulfone/titanium standard or Low Profile", and the ULTRA-LOCK® catheter connector is utilized in the PORT-A-CATH® II systems. The catheter is a Polyether block amide outer lining and an aliphatic polyurethane inner lining. This catheter will replace the current single layer polyurethane catheters on the equivalent Smiths Medical MD, Inc. PORT-A-CATH® II Implantable Venous Access Systems. The systems are offered in either a kit or a tray configuration.
The ProPort® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems and are designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids nutritional solutions and for the sampling of venous blood. The ProPort venous systems can be placed in the chest.
The ProPort® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems consisting of the following components: a portal, catheter and connector. The components are during implantation. The portals are available in plastic standard or Low Profile", and the SlideLock connector is utilized in the ProPort® systems. The catheter is a Polyether block amide outer lining and an aliphatic polyurethane inner lining. This catheter will replace the current single layer polyurethane catheters on the equivalent Smiths Medical MD, Inc. ProPort® Implantable Venous Access Systems. The systems are offered in either a kit or a tray configuration.
The P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems and are designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids nutritional solutions and for the sampling of venous blood. The P.A.S. PORT® venous systems can be placed in the arm or chest.
The P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems consisting of the following components: a portal, catheter and connector. The components are assembled during implantation. The portals are available in titanium or plastic/titanium standard or Low Profile™, and the ULTRA-LOCK® catheter connector is utilized in the P.A.S. PORT® systems. The catheter is a Polyether block amide outer lining and an aliphatic polyurethane inner lining. This catheter will replace the current single layer polyurethane catheters on the equivalent Smiths Medical MD, Inc. P.A.S. PORT® Implantable Venous Access Systems. The systems are offered in either a kit or a tray configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous system, chest, arm
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)
A. Functional Testing
In-vitro testing was conducted in accordance with the FDA guidance, "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters," dated March 16, 1995. All testing met product specification.
In-vivo testing of the new catheter material of the PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter was conducted to evaluate product performance. All testing met product specification.
Biocompatibility testing was conducted on system components. All testing passed.
Packaging and Sterilization systems are unchanged from predicate devices.
B. Clinical Studies
Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter.
C. Conclusions Drawn from the Studies
Based upon the information provided, the PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter is safe, effective and performs to established specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter Summary of Safety and Effectiveness
MAY 17 2006
GENERAL INFORMATION
| Applicant's Name and Address: | Smiths Medical MD, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Melanie Hess RN, BSN
Regulatory and Clinical Affairs Associate |
| Common/Usual Name: | Implantable Access System |
| Proprietary Name: | PORT-A-CATH®, PORT-A-CATH® II,
ProPort®, and P.A.S. PORT® Implantable
Venous Access Systems with Dual Layer
Catheter |
| Equivalence Device Comparison: | PORT-A-CATH®, PORT-A-CATH® II,
ProPort®, and P.A.S. PORT® Implantable
Venous Access Systems |
II. DEVICE DESCRIPTION
PORT-A-CATH® Implantable Venous Access Systems with Dual Layer Catheter
The PORT-A-CATH® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems and are designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids nutritional solutions and for the sampling of venous blood. The PORT-A-CATH® venous systems can be placed in the chest.
The PORT-A-CATH® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems consisting of the following components; a portal. catheter and connector. The components are assembled during implantation. The portals are available in titanium standard or Low Profile", and the ULTRA-LOCK® catheter connector is utilized in the PORT-A-CATH® systems. The catheter is a Polyether block amide outer lining and an aliphatic polyurethane inner lining. This catheter will replace the current single layer polyurethane catheters on the equivalent Smiths Medical MD, Inc. PORT-A-CATH® Implantable Venous Access Systems, The systems are offered in either a kit or a tray configuration.
Confidential
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January 03, 2006
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PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter Summary of Safety and Effectiveness
PORT-A-CATH® II Implantable Venous Access Systems with Dual Layer Catheter
The PORT-A-CATH® II Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems and are designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids nutritional solutions and for the sampling of venous blood. The PORT-A-CATH® II venous systems can be placed in the chest.
The PORT-A-CATH® II Implantable Venous Access Systems with Dual Laver Catheter are totally implantable access systems consisting of the following components: a portal, catheter and connector. The components are assembled during implantation. The portals are available in polysulfone/titanium standard or Low Profile", and the ULTRA-LOCK® catheter connector is utilized in the PORT-A-CATH® II systems. The catheter is a Polyether block amide outer lining and an aliphatic polyurethane inner lining. This catheter will replace the current single layer polyurethane catheters on the equivalent Smiths Medical MD, Inc. PORT-A-CATH® II Implantable Venous Access Systems. The systems are offered in either a kit or a tray configuration.
ProPort® Implantable Venous Access Systems with Dual Layer Catheter
The ProPort® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems and are designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids nutritional solutions and for the sampling of venous blood. The ProPort venous systems can be placed in the chest.
The ProPort® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems consisting of the following components: a portal, catheter and connector. The components are during implantation. The portals are available in plastic standard or Low Profile", and the SlideLock connector is utilized in the ProPort® systems. The catheter is a Polyether block amide outer lining and an aliphatic polyurethane inner lining. This catheter will replace the current single layer polyurethane catheters on the equivalent Smiths Medical MD, Inc. ProPort® Implantable Venous Access Systems. The systems are offered in either a kit or a tray configuration.
P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter
The P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems and are designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids nutritional solutions and for the sampling of venous blood. The P.A.S. PORT® venous systems can be placed in the arm or chest.
The P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems consisting of the following components: a portal, catheter and connector. The components are assembled during implantation. The portals
Confidential
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January 03, 2006
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PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter Summary of Safety and Effectiveness
are available in titanium or plastic/titanium standard or Low Profile™, and the ULTRA-LOCK® catheter connector is utilized in the P.A.S. PORT® systems. The catheter is a Polyether block amide outer lining and an aliphatic polyurethane inner lining. This catheter will replace the current single layer polyurethane catheters on the equivalent Smiths Medical MD, Inc. P.A.S. PORT® Implantable Venous Access Systems. The systems are offered in either a kit or a tray configuration.
III. INTENDED USE OF THE DEVICE
PORT-A-CATH® Implantable Venous Access Systems with Dual Layer Catheter
PORT-A-CATH® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.
PORT-A-CATH® II Implantable Venous Access Systems with Dual Layer Catheter
PORT-A-CATH® II Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.
ProPort® Implantable Venous Access Systems with Dual Layer Catheter
ProPort® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter
P.A.S. PORT® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
IV. DEVICE COMPARISON
PORT-A-CATH® Implantable Venous Access Systems with Dual Layer Catheter
The PORT-A-CATH® Implantable Venous Access Systems with Dual Layer Catheter was compared to and found to be substantially equivalent to the following commercially available predicate systems with respect to indications for use and performance features PORT-A-CATH® Implantable Venous Access Systems.
Confidential
Page 3 of 5
January 03, 2006
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page 4 of 5
K060036
PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter Summary of Safety and Effectiveness
PORT-A-CATH® II Implantable Venous Access Systems with Dual Layer Catheter
The PORT-A-CATH® II Implantable Venous Access Systems with Dual Layer Catheter was compared to and found to be substantially equivalent to the following commercially available predicate systems with respect to indications for use and performance features: PORT-A-CATH® II Implantable Venous Access Systems.
ProPort® Implantable Venous Access Systems with Dual Layer Catheter
The ProPort® Implantable Venous Access Systems with Dual Layer Catheter was compared to and found to be substantially equivalent to the following commercially available predicate systems with respect to indications for use and performance features: ProPort® Implantable Venous Access Systems.
P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter
The P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter was compared to and found to be substantially equivalent to the following commercially available predicate systems with respect to indications for use and performance features: P.A.S. PORT® Implantable Venous Access Systems.
SUMMARY OF STUDIES V.
A. Functional Testing
In-vitro testing was conducted in accordance with the FDA guidance, "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters," dated March 16, 1995. All testing met product specification.
In-vivo testing of the new catheter material of the PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter was conducted to evaluate product performance. All testing met product specification.
Biocompatibility testing was conducted on system components. All testing passed.
Packaging and Sterilization systems are unchanged from predicate devices.
B. Clinical Studies
Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter.
Confidential
Page 4 of 5
・・・
4
SMITHS MEDICAL MD, INC.
510(k) Premarket Notification
PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter Summary of Safety and Effectiveness
C. Conclusions Drawn from the Studies
Based upon the information provided, the PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter is safe, effective and performs to established specifications.
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Confidential
January 03, 2006
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized graphic of three abstract human figures connected by flowing lines, arranged in a triangular shape. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the graphic.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 17 2006
Ms. Melanie Hess Regulatory and Clinical Affairs Associate Smiths Medical MD, Incorporated 1265 Grey Fox Road St. Paul. Minnesota 55112
Re: K060036
Trade/Device Name: PORT-A-CATH® Systems with Dual Layer Catheter, PORT-A-CATH® II Systems with Dual Layer Catheter, ProPort ® Systems with Dual Layer Catheter, P.A.S. Port® Systems with Dual Layer Catheter Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: January 3, 2006 Received: January 5, 2006
Dear Ms. Hess:
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 either 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.
6
Page 2 - Ms. Hess
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 (QS) 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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours.
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
7
PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter Indications for Use
510(k) Number (if known): TBD
Device Name: PORT-A-CATH® Systems with Dual Layer Catheter
Indications for Use:
"PORT-A-CATH® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling."
Prescription Use X 21 CFR 801.109)
OR
Over-The Counter Use Per
Device Name: PORT-A-CATH® II Systems with Dual Layer Catheter
Indications for Use:
"PORT-A-CATH" II Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling."
Prescription Use X 21 CFR 801.109)
OR
Over-The Counter Use Per
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anthony D. Vincent
an Sign-City) of sion of Anesthesiology, General Hospital,
action Control, Dental Devices
: * * (x) Number: _ Kybopp 36
8
PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter Indications for Use
510(k) Number (if known): TBD
Device Name: ProPort® Systems with Dual Layer Catheter
Indications for Use:
"ProPort® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling."
Prescription Use X 21 CFR 801.109)
OR
Over-The Counter Use Per
Device Name: P.A.S. Port® Systems with Dual Layer Catheter
Indications for Use:
"P. A.S. PORT Systems with Dual Layer Catheter are indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling."
Prescription Use X 21 CFR 801.109)
OR
Over-The Counter Use Per
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clutos Vime
on of Anesthesiology, General Hospital, Control, Dental Devices
Number: K 469936