(86 days)
No
The description focuses on the physical components and intended use of an implantable port system, with no mention of AI or ML capabilities.
Yes
The device is described as being indicated for patient therapies requiring repeated access to the vascular system, including infusion of medications (such as anti-cancer medicines) and parenteral nutrition solutions, which are all forms of therapeutic intervention.
No
This device is an implantable port used for administering medications and fluids, and for withdrawing blood samples. It provides access to the vascular system rather than diagnosing a condition.
No
The device description clearly states it is an "implantable access device" consisting of physical components like an "injection port with a self-sealing silicone septum and a radiopaque catheter." This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for accessing the vascular system for infusion of substances and withdrawal of blood samples from a patient. This is an in-vivo application, meaning it interacts directly with the living body.
- Device Description: The description details an implantable device designed to be placed within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside of the body to provide information about a physiological state, health, or disease. IVDs typically involve tests performed on samples like blood, urine, or tissue in a laboratory setting.
The device is an implantable medical device used for direct patient care and treatment, not for diagnostic testing of samples in vitro.
N/A
Intended Use / Indications for Use
The PowerPort™ Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medicines (chemotherapy), I. V. Iluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
When used with the PowerLoc™ Safety Infusion Set, the PowerPort™ Implantable Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.
Product codes (comma separated list FDA assigned to the subject device)
LJT
Device Description
The PowerPort™ Implantable Port is an implantable access device designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a PowerLoc™ Safety Infusion Set only. The PowerPort™ Implantable Port consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Single lumen PowerPort™ Implantable Ports can be identified subcutaneously by feeling the top of the septum, which may include three palpation bumps arranged in a triangle, and by palpating the sides of the port, which is also triangular. Dual lumen PowerPort™ Implantable Ports can be identified subcutaneously by feeling the top of each septum; each septum may feature three palpation bumps arranged in a triangle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Most commonly on upper chest (for insertion site), Central venous system - lower 1/3 of superior vena cava preferred (for catheter tip termination)
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)
Design verification testing was conducted to evaluate device performance over the proposed 2year shelf life of the to-be-marketed configurations for all models of the subject device. Chemical conditioning was performed prior to testing to simulate the worst-case solutions used with ports and their components. Historical testing has been conducted and consisted of simulants used to account for the FDA approved oncology drugs, total parenteral nutrition (TPN) and vesicants used in intravascular access devices approved up to 2019. The testing evaluated the effects of the chemical simulants on silicone catheters as well as polyurethane catheters. It captures both medicines administrated, flushing solutions, and locking solutions. Material experts at BAS have confirmed the proposed locking solutions will not impact BAS catheters. The proposed locking solutions are within the pH range that will not impact the catheter materials. The functional testing with chemical conditioning demonstrates acceptable function of port devices.
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.
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 31, 2024
Bard Access Systems, Inc. Roessler Aaron Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116
Re: K242328
Trade/Device Name: PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port And Catheter Regulatory Class: Class II Product Code: LJT Dated: October 1, 2024 Received: October 1, 2024
Dear Roessler Aaron:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Porsche Bennett
Porsche Bennett, For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242328
Device Name
PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports
Indications for Use (Describe)
The PowerPort™ Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medicines (chemotherapy), I. V. Iluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
When used with the PowerLoc™ Safety Infusion Set, the PowerPort™ Implantable Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
K242328.510(K)SUMMARY
Submitter Information:
| Applicant: | Bard Access Systems, Inc
605 North 5600 West
Salt Lake City, UT 84116 |
|------------|-----------------------------------------------------------------------------|
| Phone: | 602-830-5612 |
| Contact: | Aaron Roessler, Regulatory Affairs Specialist |
| Date: | October 31, 2024 |
Subject Device Name:
| Device Trade Name: | PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports |
|---|---|
| Classification: | Class II |
| Regulation: | 21 CFR 880.5965, Subcutaneous, implanted, intravascular infusion port and catheter |
| Review Panel: | General Hospital |
| Product Code: | LJT |
Predicate Devices:
PowerPort™ Implanted Polymeric Port (K063377, cleared 1/25/2007)
PowerPort™ ClearVUE™ Slim Implantable (K122899, cleared 11/15/2012)
Device Description:
The PowerPort™ Implantable Port is an implantable access device designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a PowerLoc™ Safety Infusion Set only. The PowerPort™ Implantable Port consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Single lumen PowerPort™ Implantable Ports can be identified subcutaneously by feeling the top of the septum, which may include three palpation bumps arranged in a triangle, and by palpating the sides of the port, which is also triangular. Dual lumen PowerPort™ Implantable Ports can be identified subcutaneously by feeling the top of each septum; each septum may feature three palpation bumps arranged in a triangle.
Indications for Use of Device:
The PowerPort™ Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti
5
cancer medicines (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
When used with the PowerLoc Safety Infusion Set, the PowerPort Implantable Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.
6
Page 3 of 16
Comparison to Predicate Device:
Table 1. Subject and Predicate Device Comparison – PowerPort™ ClearVUE™ Slim Implantable Port
| Attribute | Predicate Device
PowerPort™ ClearVUE™ Slim
Implantable (K122899) | Subject Device
PowerPort™ ClearVUE™ Slim
Implantable Port | Discussion | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note | 1. Bold Font indicates a difference between the subject device and predicate devices
2. Plain Type indicates that the attribute of the subject device is the same as that of the predicate device(s). | | | |
| Device Identification | | | | |
| Manufacturer | Bard Access Systems, Inc. | Bard Access Systems, Inc. | Same as Predicate | |
| Device
Classification
Name | Port & Catheter, Implanted,
Subcutaneous, Intravascular | Port & Catheter, Implanted,
Subcutaneous, Intravascular | Same as Predicate | |
| Regulation
Number | 21 CFR §880.5965 | 21 CFR §880.5965 | Same as Predicate | |
| FDA Product
Code | LJT | LJT | Same as Predicate | |
| Device Use | | | | |
| Intended Use | The PowerPort™ Implanted Port is a
totally implantable vascular access
device designed to provide long-term,
repeated access to the vascular system. | The PowerPort™ Implanted Port is a
totally implantable vascular access
device designed to provide long-term,
repeated access to the vascular system. | Same as Predicate | |
| Indications for
Use | The PowerPort® ClearVUE® Slim
Implantable Port with 8F Polyurethane
Catheter is 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.
When used with a Powerloc® Safety
Infusion Set (SIS), the PowerPort®
device is indicated for power injection
of contrast media. For power injection
of contrast media, the maximum
recommended infusion rate is 5 ml /s | The PowerPort™ Implanted Port is
indicated for patient therapies requiring
repeated access to the vascular system.
The port system can be used for infusion
of medications including anti-cancer
medicines (chemotherapy)1, I.V. fluids,
parenteral nutrition solutions, blood
products, and for the withdrawal of blood
samples.
When used with the PowerLoc™ Safety
Infusion Set, the PowerPort™
Implantable Port is indicated for power
injection of contrast media. For power
injection of contrast | Different than Predicate. The italicized
clarifying statement was cleared for all
PowerPorts™ in K181446, clearance
date 07/08/2019. | |
| Attribute | Predicate Device
PowerPort™ ClearVUE™ Slim
Implantable (K122899) | Subject Device
PowerPort™ ClearVUE™ Slim
Implantable Port | Discussion | |
| | | media, the maximum recommended
infusion rate is 5 ml/s. | | |
| | | 1The italicized clarifying statement was
cleared for all PowerPorts™ in K181446,
clearance date 07/08/2019. | | |
| Patient
Population | Patients requiring repeated access to the
vascular system | Patients requiring repeated access to the
vascular system | Same as Predicate | |
| Duration of Use | Long term (>30 days) | Long term (>30 days) | Same as Predicate | |
| Insertion Site | Most commonly on upper chest | Most commonly on upper chest | Same as Predicate | |
| Visualization
Techniques | Fluoroscopy | Fluoroscopy | Same as Predicate | |
| Principle of
Operation | The device's primary components consist
of a triangular injection port with self-
sealing silicone septum and a radiopaque
catheter. A simple sliding lock collar
secures the catheter to the port's stem.
The port can be identified through the
patient skin via the three palpation bumps
arranged in a triangle on the septum.
Port access is performed by
percutaneous needle insertion using a
non-coring needle. | The device's primary components consist
of a triangular injection port with self-
sealing silicone septum and a radiopaque
catheter. A simple sliding lock collar
secures the catheter to the port's stem.
The port can be identified through the
patient skin via the three palpation bumps
arranged in a triangle on the septum.
Port access is performed by
percutaneous needle insertion using a
non-coring needle. | Same as Predicate | |
| Catheter Tip
Termination
Location | Central venous system - lower 1/3 of
superior vena cava preferred | Central venous system - lower 1/3 of
superior vena cava preferred | Same as Predicate | |
| Design Characteristics | | | | |
| Device
Measurements | 8 F
Port Body:
Height: 10.6 mm
Width: 21.6 mm x 25.5 mm
Reservoir Volume: 0.4 mL | 8 F
Port Body:
Height: 10.4 mm
Width: 21.6 mm x 25.5 mm
Reservoir Volume: 0.4 mL
6 F
Port Body:
Height: 10.4 mm
Width: 21.6 mm x 25.5 mm
Reservoir Volume: 0.4 mL | Different than Predicate
The change in product dimensions did
not change product performance.
Labeling was updated for clarity only to
ensure safer or more effective use.
There were no changes to the
indications for use, warnings,
precautions or contraindications for the | |
| Attribute | Predicate Device
PowerPort™ ClearVUE™ Slim
Implantable (K122899) | Subject Device
PowerPort™ ClearVUE™ Slim
Implantable Port | Discussion | |
| | Catheter:
8 Fr x 46.4 cm
ChronoFlex, 1.6 mm ID | Catheter:
8 Fr x 46.4 cm
ChronoFlex, 1.6 mm ID | Catheter:
6 Fr x 46.4 cm
ChronoFlex, 1.3
mm ID | PowerPort™ ClearVUE™ Slim
Implantable Port. There was no
change in material composition,
sterilization, or biocompatibility, so
there was no change in safety or
efficacy of the device. Performance
testing was conducted on the to-be-
marketed version of the subject device
over the proposed shelf life to
demonstrate the difference does not
raise new questions of safety and
effectiveness.
Different than Predicate
The change in product dimensions did
not change product performance.
There were no changes to the
indications for use, warnings,
precautions or contraindications for the
PowerPort™ ClearVUE™ Slim
Implantable Port. There was no
change in material composition,
sterilization, or biocompatibility, so
there was no change in safety or
efficacy of the device. Performance
testing was conducted on the to-be-
marketed version of the subject device
over the proposed shelf life to
demonstrate the difference does not
raise new questions of safety and
effectiveness. |
| Device
Description and
Materials | Port Body:
- Triangular hard plastic PEEK
(polyetheretherketone) port cap and
base, including stem - One-piece silicone septum with 3 raised
palpation bumps - 3 suture holes with or without silicone
suture plugs - Radiopaque bismuth trioxide
(Bi2O3)/Delrin CT symbol captured
between the cap and base assembly | Port Body: - Triangular hard plastic PEEK
(polyetheretherketone) port cap and
base, including stem - One-piece silicone septum with 3 raised
palpation bumps - 3 suture holes with or without silicone
suture plugs - Radiopaque bismuth trioxide
(Bi2O3)/Delrin CT symbol captured
between the cap and base assembly | Same as Predicate | |
| | Catheter: - ChronoFlex
- depth markings | Catheter:
- ChronoFlex
- depth markings | Same as Predicate | |
| | Cathlock: - Polycarbonate | Cathlock:
- Polycarbonate | Same as Predicate | |
| Attribute | Predicate Device
PowerPort™ ClearVUE™ Slim
Implantable (K122899) | Subject Device
PowerPort™ ClearVUE™ Slim
Implantable Port | Discussion | |
| Locking
Solution | To help prevent clot formation and
catheter blockage, each lumen of the
implanted ports with open-ended
catheters should be filled with sterile
heparinized saline after each use. If the
port remains unused for long periods of
time, the heparin lock should be changed
at least once every four weeks. | To help prevent clot formation and
catheter blockage, each lumen of the
implanted ports with open-ended
catheters should be flushed with sterile
normal saline then filled with sterile
heparinized saline, sterile normal
saline, or other approved locking
solution per institutional protocol after
each use. If the port remains unused for
long periods of time, the lock should be
changed at least
once every 28 days.
Warning: Alcohol should not be used to
soak or declot polyurethane catheters
because alcohol is known to degrade
polyurethane catheters over time with
repeated or prolonged exposure. | Different from Predicate
Additional locking solutions to align
with Infusion Therapy Standards of
Practice, 9th Edition (2024). The device
has the same intended use and this
change does not raise questions of
safety and effectiveness, so it is
deemed that there is no impact to
substantial equivalence due to this
change. | |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Same as Predicate | |
| Shelf Life | 1.5 years | 2 years | Different from Predicate
Verification testing demonstrated that
the device performed as intended by
meeting product performance
specifications and controlling risks to
an acceptable level following aging
and exposure to ethylene oxide
sterilization and simulated shipping.
Testing activities that were performed
for the original 510(k) submission were
conducted for the port configurations,
such as port assembly leak, port
assembly tensile, port assembly burst,
lateral stem tensile, septum coring
(needle obturation), port-catheter
system multiple power injection, and | |
| Attribute | Predicate Device
PowerPort™ ClearVUE™ Slim
Implantable (K122899) | Subject Device
PowerPort™ ClearVUE™ Slim
Implantable Port | Discussion | |
| | | | port system burst (power injection).
There was no change to indications for
use, warnings, precautions,
contraindications, sterilization, or
biocompatibility. As such, there was no
changes to device safety or
effectiveness. | |
| Packaging
Configuration | Triple tray packaging; two sterile barriers
in the form of nested, sealed trays | Triple tray packaging; two sterile barriers
in the form of nested, sealed trays | Same as Predicate | |
| | Predicate Device | Subject Device | Discussion | |
| Attribute | PowerPort™ Implanted
Polymeric Port (K063377) | PowerPort™ ClearVUE™ isp
Implantable Port | | |
| Note | 1. Bold Font indicates a difference between the subject device and predicate devices
- Plain Type indicates that the attribute of the subject device is the same as that of the predicate device(s). | | | |
| Device Identification | | | | |
| Manufacturer | Bard Access Systems, Inc. | Bard Access Systems, Inc. | Same as Predicate | |
| Device Classification
Name | Port & Catheter, Implanted,
Subcutaneous, Intravascular | Port & Catheter, Implanted,
Subcutaneous, Intravascular | Same as Predicate | |
| Regulation Number | 21 CFR §880.5965 | 21 CFR §880.5965 | Same as Predicate | |
| FDA Product Code | LJT | LJT | Same as Predicate | |
| Device Use | | | | |
| Intended Use | The PowerPort™ Implanted Port
is a totally implantable vascular
access device designed to
provide long-term, repeated
access to the vascular system. | The PowerPort™ Implanted Port is
a totally implantable vascular
access device designed to provide
long-term, repeated access to the
vascular system. | Same as Predicate | |
| Indications for Use | The PowerPort™ Implanted Port
is 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.
When used with the PowerLoc™
Safety Infusion Set, the
PowerPort™ device is indicated
for power injection of contrast
media. For power injection of
contrast media, the maximum | The PowerPort™ Implanted Port is
is indicated for patient therapies
requiring repeated access to the
vascular system. The port system
can be used for infusion of
medications including anti-cancer
medicines (chemotherapy)1, I.V.
fluids, parenteral nutrition solutions,
blood products, and for the
withdrawal of blood samples.
When used with the PowerLoc™
Safety Infusion Set, the PowerPort™
Implantable Port is indicated for
power injection of contrast media.
For power injection of contrast
media, the maximum recommended
infusion rate is 5 ml/s. | Different than Predicate. The italicized
clarifying statement was
cleared for all PowerPorts™ in K181446,
clearance date 07/08/2019. | |
| Attribute | Predicate Device
PowerPort™ Implanted
Polymeric Port (K063377) | Subject Device
PowerPort™ ClearVUE™ isp
Implantable Port | Discussion | |
| | recommended infusion rate is 5 ml/s. | ¹The italicized clarifying statement
was cleared for all PowerPorts™ in
K181446, clearance date 07/08/2019. | | |
| Patient Population | Patients requiring repeated access to the vascular system | Patients requiring repeated access to the vascular system | Same as Predicate | |
| Duration of Use | Long term (>30 days) | Long term (>30 days) | Same as Predicate | |
| Insertion Site | Most commonly on upper chest | Most commonly on upper chest | Same as Predicate | |
| Visualization
Techniques | Fluoroscopy | Fluoroscopy | Same as Predicate | |
| Principle of Operation | The device's primary components consist of a
triangular injection port with self-sealing silicone septum and a
radiopaque catheter. A simple sliding lock collar secures the
catheter to the port's stem. The port can be identified through the
patient skin via the three palpation bumps arranged in a
triangle on the septum.
Port access is performed by
percutaneous needle insertion using a non-coring needle. | The device's primary components
consist of a triangular injection port
with self-sealing silicone septum
and a radiopaque catheter. A simple
sliding lock collar secures the
catheter to the port's stem. The port
can be identified through the patient
skin via the three palpation bumps
arranged in a triangle on the
septum.
Port access is performed by
percutaneous needle insertion
using a non-coring needle. | Same as Predicate | |
| Catheter Tip
Termination Location | Central venous system - lower
1/3 of superior vena cava preferred | Central venous system - lower 1/3
of superior vena cava preferred | Same as Predicate | |
| Design Characteristics | | | | |
| Device Measurements | PowerPort M.R.I 8 F | ClearVUE™ isp 8 F
Port Body: | Different than Predicate
The change in product dimensions did not
change product performance. Labeling | |
| | | ClearVUE™ isp 6 F
Port Body: | | |
| Attribute | Predicate Device
PowerPort™ Implanted
Polymeric Port (K063377) | Subject Device
PowerPort™ ClearVUE™ isp
Implantable Port | | Discussion |
| Height: 13.7mm
Width: 30.0mm x Length:
28.8mm
Reservoir Volume: 0.6mL | Height: 11.9
mm
Width: 24.4 mm
25.9 mm
Reservoir
Volume: 0.6 mL | Height: 11.9
mm
Width: 24.4mm
x 25.9 mm
Reservoir
Volume: 0.6 mL | was updated for clarity only to insure safer
or more effective use. There were no
changes to the indications for use,
warnings, precautions or contraindications
for the PowerPort™ ClearVUE™ isp
Implantable Port. There was no change in
material composition, sterilization, or
biocompatibility, so there was no change in
safety or efficacy of the device.
Performance testing was conducted on the
to-be-marketed version of the subject
device over the proposed shelf life to
demonstrate the difference does not raise
new questions of safety and effectiveness. | |
| Catheter:
8Fr x 45cm ChronoFlex | Catheter:
8 Fr x 46.4 cm
ChronoFlex,
1.6 mm ID | Catheter:
6 Fr x 46.4 cm
ChronoFlex,
1.3 mm ID | Different than Predicate
The change in product dimensions did not
change product performance. Labeling
was updated for clarity only to insure safer
or more effective use. There were no
changes to the indications for use,
warnings, precautions or contraindications
for the PowerPort™ ClearVUE™ isp
Implantable Port. There was no change in
material composition, sterilization, or
biocompatibility, so there was no change in
safety or efficacy of the device.
Performance testing was conducted on the
to-be-marketed version of the subject
device over the proposed shelf life to
demonstrate the difference does not raise
new questions of safety and effectiveness. | |
| Device Description and
Materials | PowerPort M.R.I. | ClearVUE™ isp
8 | ClearVUE™ isp
6 | Different than Predicate
The "C T" symbol changed from titanium to |
| Port Body:
- Purple Triangular Delrin plastic
port - radiopaque identifying feature
displaying power injection
symbol and the letters "C T" - one piece silicone septum
- septum with 3 raised palpation
bumps | Port Body: - Triangular
Delrin plastic
port (with no
colorant) - radiopaque
non-metallic
identifying
feature
displaying
power injection
symbol and the
letters "C T" | Port Body: - Triangular
Delrin plastic
port (with no
colorant) - radiopaque
identifying
feature
displaying
power injection
symbol and the
letters "C T" | Delrin 500 NC-010 with 25% Bismuth
Trioxide (Bi2O3); however, the new
material is encapsulated and does not
contact tissue or fluid. Encapsulation is
achieved by dipping the CT symbol in a
mixture of silicone thinned with hexane to
create a thin skim-coat. The symbol is then
assembled onto the port reservoir and the
entire subassembly is over-molded in
silicone. There was no change in
sterilization and biocompatibility, and as
such, there were no introduction or | |
| Attribute | Predicate Device | Subject Device | Discussion | |
| | PowerPort™ Implanted
Polymeric Port (K063377) | PowerPort™ ClearVUE™ isp
Implantable Port | | |
| | | - Integral
molded Delrin
stem with two
distal barbs - one piece
silicone septum - septum with 3
raised palpation
bumps - base is
encapsulated | - one piece
silicone septum - septum with 3
raised palpation
bumps | modification of risks associated with the
final product. |
| | Catheter: - ChronoFlex polyurethane (with
no colorant) - open-ended
- single lumen
- attachable | Catheter:
- ChronoFlex
polyurethane
(with no
colorant) - open-ended
- single lumen
- attachable | Catheter:
- ChronoFlex
polyurethane
(with no
colorant) - open-ended
- single lumen
- attachable | Same as Predicate |
| | Cathlock: - Polycarbonate | Cathlock:
- Polycarbonate | | Same as Predicate |
| Locking Solution | To help prevent clot formation
and catheter blockage, each
lumen of the implanted ports with
open-ended catheters should be
filled with sterile heparinized
saline after each use. If the port
remains unused for long periods
of time, the heparin lock should
be changed at least once every
four weeks. | To help prevent clot formation and
catheter blockage, each lumen of
the implanted ports with open-
ended catheters should be flushed
with sterile normal saline then
filled with sterile heparinized
saline, sterile normal saline, or
other approved locking solution
per institutional protocol after
each use. If the port remains
unused for long periods of time, the
lock should be changed at least
once every 28 days. | | Different from Predicate
Additional locking solutions to align with
Infusion Therapy Standards of Practice, 9th
Edition (2024). The device has the same
intended use and this change does not
raise questions of safety and effectiveness,
so it is deemed that there is no impact to
substantial equivalence due to this change. |
| Attribute | Predicate Device
PowerPort™ Implanted
Polymeric Port (K063377) | Subject Device
PowerPort™ ClearVUE™ isp
Implantable Port | Discussion | |
| | | Warning: Alcohol should not be
used to soak or declot polyurethane
catheters because alcohol is known
to degrade polyurethane catheters
over time with repeated or
prolonged exposure. | | |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same as Predicate | |
| Shelf Life | 1 year | 2 years | Different than Predicate
Verification testing demonstrated that the
device performed as intended by meeting
product performance specifications and
controlling risks to an acceptable level
following aging and exposure to ethylene
oxide sterilization and simulated shipping.
Testing activities that were performed for
the original 510(k) submission were
conducted for the port configurations,
including port assembly leak, port
assembly tensile, port assembly burst,
lateral stem tensile, septum coring (needle
obturation), port-catheter system multiple
power injection, and port system burst
(power injection). As such, there was no
changes to device safety or effectiveness. | |
| Packaging
Configuration | Triple tray packaging; two sterile
barriers in the form of nested,
sealed trays | Triple tray packaging; two sterile
barriers in the form of nested,
sealed trays | Same as Predicate | |
7
Page 4 of 16
8
Page 5 of 16
9
Page 6 of 16
10
11
Page 8 of 16
12
Table 2. Subject and Predicate Device Comparison – PowerPort™ ClearVUE™ isp Implantable Port
13
Page 10 of 16
14
15
Page 12 of 16
16
17
18
Design Verification:
Design verification testing was conducted to evaluate device performance over the proposed 2year shelf life of the to-be-marketed configurations for all models of the subject device. Chemical conditioning was performed prior to testing to simulate the worst-case solutions used with ports and their components. Historical testing has been conducted and consisted of simulants used to account for the FDA approved oncology drugs, total parenteral nutrition (TPN) and vesicants used in intravascular access devices approved up to 2019. The testing evaluated the effects of the chemical simulants on silicone catheters as well as polyurethane catheters. It captures both medicines administrated, flushing solutions, and locking solutions. Material experts at BAS have confirmed the proposed locking solutions will not impact BAS catheters. The proposed locking solutions are within the pH range that will not impact the catheter materials. The functional testing with chemical conditioning demonstrates acceptable function of port devices. Studies evaluating these proposed solutions as well as guidelines of the use of these solutions in the field by health care providers are captured and summarized in the most recent Infusion Nurse Society guidelines, "Infusion Therapy Standards of Practice, revision 9".
For changes, a Risk Assessment and Design Failure Mode and Effects Analysis (DFMEA) was used in accordance with internal procedures based on ISO 14971:2007, "Medical Devices - Application of Risk Management to Medical Devices," to analyze the risks posed by the device changes and assure that risks posed by each device change were acceptable. No new risks were posed as a result of these changes.
Table 3: List of Verification/Validation Methods and Standards
| Verification/Validation Method(s) | Standard/Guidance |
|---|---|
| Stem-Catheter Connection Air Leak Test | NF S 94-370 (1999) |
| Stem-Catheter Connection Tensile | NF S 94-370 (1999) |
| Stem-Catheter Air Burst | BAS Internal Test-Method |
| Port Subassembly Air Leak | FDA Implanted Infusion Port Guidance |
| Lateral Stem Tensile Strength | NF S 94-370 (1999) |
| Lateral Stem Tensile Strength | BAS Internal Test-Method |
| Port Subassembly Tensile Strength | BAS Internal Test-Method |
| Multiple Power Injections | BAS Internal Test-Method |
| Port System Burst, Power Injection | BAS Internal Test-Method |
| Catheter Flow Rate | ISO 10555-3 (2002) |
| Septum Obturation | BAS Internal Test-Method |
| Septum Obturation | NF S 94-370 (1999) |
19
| Needle Retention Tensile Strength | NF S 94-370 (1999) |
|---|---|
| Stem Catheter Leak I | NF S 94-370 (1999) |
| Stem Catheter Leak II | NF S 94-370 (1999) |
| Stem Catheter Burst | BAS Internal Test-Method |
| Port Sub-assembly Air Burst | FDA Implanted Infusion Port Guidance |
| Catheter Air Burst | BAS Internal Test-Method |
| Catheter Tensile Strength | ISO 10555-1 (1995) |
| ASTM D412 | |
| Port System Flow Rate | BAS Internal Test-Method |
Conclusion:
The Bard Access Systems, Inc. concludes that the subject devices, the PowerPort™ ClearVUE™ Slim Slim Implantable Ports and PowerPort™ ClearVUE™ isp Implantable Ports, are substantially equivalent to the legally marketed predicate devices.