(92 days)
No
The device description focuses on the physical components of the implantable port and the use of ECG technology for tip positioning, which is a signal processing technique, not AI/ML. There is no mention of AI, ML, or related concepts in the document.
No.
The device facilitates the delivery of therapies and withdrawal of blood, but it does not directly perform the therapy itself.
No.
The PowerPort™ Implantable Port is designed for delivering substances (medications, fluids, nutrition) into the vascular system and withdrawing blood samples. While the ECG Enabled Implantable Ports can aid in catheter tip location during implantation using ECG, the primary function of the port itself is not to diagnose a medical condition in the patient. The ECG function is for placement assistance, not patient diagnosis.
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." While it utilizes software (the BD Sherlock 3CG+™ TCS) for tip confirmation, the core device itself is hardware.
Based on the provided information, the PowerPort™ Implantable Port is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for repeated access to the vascular system for infusion of various substances and withdrawal of blood samples. This is a direct interaction with the patient's circulatory system, not the examination of samples outside the body.
- Device Description: The device is an implantable access device designed to be placed within the body.
- Function: Its primary function is to provide a point of access for administering or withdrawing substances from the vascular system. While it can be used for withdrawing blood samples, the device itself is not performing a diagnostic test on those samples. The diagnostic testing would occur separately in a laboratory setting.
- No mention of in vitro testing: The description focuses on the physical characteristics of the port and its use in accessing the vascular system. There is no mention of analyzing samples or performing tests on them outside the body.
In Vitro Diagnostic devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. The PowerPort™ facilitates the collection of such specimens, but it does not perform the diagnostic analysis itself.
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. 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 recommended infusion rate is 5 mL/s.
Product codes (comma separated list FDA assigned to the subject device)
LJT
Device Description
The PowerPort™ implantable ports, including ECG Enabled Implantable Ports, are implantable access devices 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 includes three palpation bumps arranged in a triangle and by palpating the sides of the port, which is also triangular. Radiopaque identifiers for the PowerPort™ devices aid in identification as a BD power injectable port.
The ECG Enabled Implantable Ports function identically to other PowerPort™ power-injectable ports with the option to use ECG instead of fluoroscopy during the implantation procedure for catheter advancement and tip location confirmation using the BD Sherlock 3CG™ Tip Positioning System (TPS) stylet and BD Sherlock 3CG+™ Tip Confirmation System (TCS). ECG technology provides real-time catheter tip location information and is indicated for use as an alternative method to chest X-ray and fluoroscopy for central venous access device (CVAD) tip placement confirmation. When used with the BD Sherlock 3CG+™ TCS, the Sherlock 3CG™ TPS stylet also provides the placer real-time feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection. The Sherlock 3CG™ Tip Confirmation System (TCS) product and accessories are sold separately (refer to K180560, cleared 6/18/2018, for information on Sherlock 3CG+™ product and accessories).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system, Central venous system - lower 1/3 of superior vena cava preferred (catheter tip termination location), Most commonly on upper chest (insertion site)
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)
To demonstrate substantial equivalence, both technical characteristics and performance criteria were evaluated. Testing for the following characteristics and performance criteria were evaluated for the subject device: Catheter Air Leak, Packaging Validation, Usability, ECG Accuracy Verification, Catheter Air Burst, Catheter Flow Rate, Catheter Tensile Strength, Flow Rate/Multiple Power Injection, Lateral Stem Tensile Strength, Magnetic Resonance Imaging Compatibility, Multiple Power Injections, Needle Retention Tensile Strength, Port Bottom Thickness, Port Reservoir Height, Port Subassembly Air Burst, Port Subassembly Air Leak, Port Subassembly Tensile Strength, Port System Burst, Power Injection, Port System Flow Rate, Port System Injection Rate, Septum Obturation, Stem Catheter Burst, Stem Catheter Leak, Stem Connection Tensile, Port Identification.
The tests were performed in accordance with FDA Guidance and standards including ASTM D4332, ASTM D4169, ISO 11607-1, FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices, February 2016", Guidance on 510(k) Submissions for Implanted Infusion Ports, ASTM D 412 Rev 06a, ISO 10555-1, ISO 10555-3, and NF S 94-370.
The results from these tests demonstrate that the technical characteristics and performance criteria of the ECG Enabled Implantable Ports are substantially equivalent to the predicate devices and can perform in a manner equivalent to devices currently on the market for the same intended use. All testing passed the predetermined acceptance criteria.
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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 8, 2023
Bard Peripheral Vascular, Inc. Kristen Ortiz Regulatory Affairs Manager 1625 W 3rd St Tempe, Arizona 85281
Re: K232737
Trade/Device Name: PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous. Implanted. Intravascular Infusion Port And Catheter Regulatory Class: Class II Product Code: LJT Dated: November 8, 2023 Received: November 8, 2023
Dear Kristen Ortiz:
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 (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/cdrb/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.
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"
1
(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 OS regulation requires device manufacturers to review and approve changes to device design and production (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.
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-regulatoryassistance/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,
David Walloschek
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors
2
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
Submission Number (if known)
Device Name
PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port;
PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port;
PowerPort™ isp M.R.I. ™ ECG Enabled Implantable Port;
PowerPort™ Slim ECG Enabled Implantable Port
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. 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 recommended infusion rate is 5 mL/s.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
)ver-The-Counter Use (21 CFR 801 Subpart C)
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4
K232737 - ECG Enabled Implantable Ports Special 510(k) Summary 21 CFR 807.92
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:
Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc
1625 West 3rd Street
Tempe, Arizona 85281 |
|------------|-------------------------------------------------------------------------------|
| Phone: | 602-830-5652 |
| Fax: | 312-949-0436 |
| Contact: | Kristen Ortiz, Regulatory Affairs Manager |
| Date: | December 8, 2023 |
Subject Device Name:
| Device Trade Name: | PowerPort™ ClearVUE™ Slim ECG Enabled
Implantable Port;
PowerPort™ ClearVUE™ isp ECG Enabled
Implantable Port;
PowerPort™ isp M.R.I.™ ECG Enabled
Implantable Port;
PowerPort™ Slim ECG Enabled Implantable Port |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification: | Class II |
| Regulation: | 21 CFR 880.5965, Subcutaneous, implanted,
intravascular infusion port and catheter |
| Review Panel: | General Hospital |
| Product Code: | LJT |
Predicate Devices:
| Predicate Device | Subject Device |
|---|---|
| PowerPort™ ClearVUE™ Slim Implantable | |
| Port (K122899, cleared 11/15/2012) | PowerPort™ ClearVUE™ Slim ECG Enabled |
| Implantable Port | |
| PowerPort™ Implanted Polymeric Port | |
| (K063377, cleared 1/25/2007) | PowerPort™ ClearVUE™ isp ECG Enabled |
| Implantable Port; | |
| PowerPort™ isp M.R.I.™ ECG Enabled | |
| Implantable Port | |
| Titanium PowerPort™ isp Implanted Port | |
| (K072549, cleared 11/14/2007) | PowerPort™ Slim ECG Enabled Implantable |
| Port |
5
Device Description:
The PowerPort™ implantable ports, including ECG Enabled Implantable Ports, are implantable access devices 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 includes three palpation bumps arranged in a triangle and by palpating the sides of the port, which is also triangular. Radiopaque identifiers for the PowerPort™ devices aid in identification as a BD power injectable port.
The ECG Enabled Implantable Ports function identically to other PowerPort™ power-injectable ports with the option to use ECG instead of fluoroscopy during the implantation procedure for catheter advancement and tip location confirmation using the BD Sherlock 3CG™ Tip Positioning System (TPS) stylet and BD Sherlock 3CG+™ Tip Confirmation System (TCS). ECG technology provides real-time catheter tip location information and is indicated for use as an alternative method to chest X-ray and fluoroscopy for central venous access device (CVAD) tip placement confirmation. When used with the BD Sherlock 3CG+™ TCS, the Sherlock 3CG™ TPS stylet also provides the placer real-time feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection. The Sherlock 3CG™ Tip Confirmation System (TCS) product and accessories are sold separately (refer to K180560, cleared 6/18/2018, for information on Sherlock 3CG+™ product and accessories).
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 anticancer 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 device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.
6
Comparison to Predicate Device:
| Predicate Device | Subject Device | ||
|---|---|---|---|
| Technological | |||
| Characteristic | PowerPort™ ClearVUE™ | ||
| Slim Implantable Port | |||
| (K122899) | PowerPort™ ClearVUE™ | ||
| Slim ECG Enabled | |||
| Implantable Port | Discussion | ||
| PowerPort™ Implanted | |||
| Polymeric Port (K063377) | PowerPort™ | ||
| ClearVUE™ isp ECG | |||
| Enabled Implantable | |||
| Port; | |||
| PowerPort™ isp M.R.I.™ | |||
| ECG Enabled | |||
| Implantable Port | |||
| Titanium PowerPort™ isp | |||
| Implanted Port (K072549) | PowerPort™ Slim ECG | ||
| Enabled Implantable Port | |||
| Intended use | The PowerPort™ | ||
| Implanted Port is a totally | |||
| implantable vascular | |||
| access device designed | |||
| to provide long-term, | |||
| repeated access to the | |||
| vascular system. | Same | 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. | 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) , I.V. | |||
| fluids, parenteral nutrition | |||
| solutions, blood products, | |||
| and for the withdrawal of | |||
| blood samples. | The addition of "anti- | ||
| cancer medicines | |||
| (chemotherapy)," was | |||
| cleared under K181446. | |||
| 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 | |||
| recommended infusion | |||
| rate is 5 ml/s. | 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 | |||
| recommended infusion | |||
| rate is 5 ml/s. | |||
| Patient | |||
| population | Patients requiring | ||
| repeated access to the | |||
| vascular system | Same | Same as Predicate | |
| Predicate Device | Subject Device | ||
| Technological | |||
| Characteristic | PowerPort™ ClearVUE™ | ||
| Slim Implantable Port | |||
| (K122899) | |||
| PowerPort™ Implanted | |||
| Polymeric Port (K063377) | |||
| Titanium PowerPort™ isp | |||
| Implanted Port (K072549) | PowerPort™ ClearVUE™ | ||
| Slim ECG Enabled | |||
| Implantable Port | |||
| PowerPort™ | |||
| ClearVUE™ isp ECG | |||
| Enabled Implantable | |||
| Port; | |||
| PowerPort™ isp M.R.I.™ | |||
| ECG Enabled | |||
| Implantable Port | |||
| PowerPort™ Slim ECG | |||
| Enabled Implantable Port | Discussion | ||
| 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. | Same | Same as Predicate |
| Insertion site | Most commonly on upper
chest | Same | Same as Predicate |
| Catheter tip
termination
location | Central venous system -
lower 1/3 of superior vena
cava preferred | Same | Same as Predicate |
| Duration of use | Long term (>30 days) | Same | Same as Predicate |
| Method of
sterilization
and
sterility
assurance
level | Ethylene Oxide, 10-6 | Same | Same as Predicate |
| Visualization
technique | Fluoroscopy | Fluoroscopy or ECG | The subject devices
facilitate accurate
reproduction of source
ECG signals as shown by
ECG Accuracy Verification
Testing. Therefore, when
used with the BD Sherlock
3CG+™ TCS, the subject
devices can be used to |
| | Predicate Device | Subject Device | |
| Technological
Characteristic | PowerPort™ ClearVUE™
Slim Implantable Port
(K122899)
PowerPort™ Implanted
Polymeric Port (K063377)
Titanium PowerPort™ isp
Implanted Port (K072549) | PowerPort™ ClearVUE™
Slim ECG Enabled
Implantable Port
PowerPort™
ClearVUE™ isp ECG
Enabled Implantable
Port;
PowerPort™ isp M.R.I.™
ECG Enabled
Implantable Port
PowerPort™ Slim ECG
Enabled Implantable Port | Discussion |
| | | | facilitate catheter
advancement and tip
location confirmation using
patient ECG. No new or
different questions of safety
and effectiveness areraised because the device
can be accurately
visualized using
fluoroscopy or ECG. |
| ECG-
compatible
components | None | Included, such as stylet
that is used during
catheter placement | In addition to ECG
Accuracy Verification
testing, Catheter Air Leak
and Usability testing were
conducted to evaluate the
functionality and
acceptability of stylet use
with the port catheter. All
testing passed the
predetermined acceptance
criteria. No new or different
questions of safety and
effectiveness are raised
because the device can be
accurately placed using the
stylet. |
| Packaging
configuration | Triple tray packaging; two
sterile
barriers in the form of
nested, sealed trays | Organizational tray and
retainer lid sealed inside
a header bag | Packaging validation
testing evaluated the
functionality and
acceptability of the final
product. All testing passed
the predetermined
acceptance criteria. |
| Device
Dimensions | | | Changes to dimensions
were qualified through the
following performance
tests. All testing passed the
predetermined acceptance
criteria. No new or different
questions of safety and
effectiveness are raised |
| | Predicate Device | Subject Device | |
| Technological
Characteristic | PowerPort™ ClearVUE™
Slim Implantable Port
(K122899)
PowerPort™ Implanted
Polymeric Port (K063377)
Titanium PowerPort™ isp | PowerPort™ ClearVUE™
Slim ECG Enabled
Implantable Port
PowerPort™
ClearVUE™ isp ECG
Enabled Implantable
Port;
PowerPort™ isp M.R.I. ™
ECG Enabled
Implantable Port
PowerPort™ Slim ECG | Discussion |
| | Implanted Port (K072549) | Enabled Implantable Port | |
| | | | because the dimensional
changes do not affect the
device performance. |
| | PowerPort™ ClearVUE™
Slim:
Height: 10.6 mm
Width: 21.6 mm x 25.5 mm
Reservoir Volume: 0.4 mL
Catheter:
8 Fr x 46.4 cm, 1.6 mm ID | PowerPort™ ClearVUE™
Slim:
Height: 10.4 mm
Width: 21.6 mm x 25.5
mm
Reservoir Volume: 0.4 mL
Catheter:
8 Fr x 46.4 cm, 1.6 mm ID
6 Fr x 46.4 cm, 1.3 mm
ID | PowerPort™ ClearVUE™
Slim:
● Stem Catheter Leak
● Stem Connection
● Tensile
● Stem Catheter Burst
● Port Subassembly Air
● Leak
● Lateral Stem Tensile
Strength
● Port Subassembly
Tensile Strength
● Multiple Power
Injections
● Port System Burst,
Power Injection
● Port Subassembly Air
Burst
● Catheter Flow Rate |
| | PowerPort™ Implanted
Polymeric Port:
Height: 13.7 mm
Width: 30.0 mm x 28.8 mm
Reservoir Volume: 0.6 mL
Catheter:
8 Fr x 46.4 cm, 1.6 mm ID | PowerPort™ ClearVUE™
isp:
Height: 11.9 mm
Width: 24.4 mm x 25.9
mm
Reservoir Volume: 0.6 mL
Catheter:
8 Fr x 46.4 cm, 1.6 mm ID
6 Fr x 46.4 cm, 1.3 mm
ID | PowerPort™ ClearVUE™
isp:
● Stem Catheter Leak
● Stem Connection
● Tensile
● Stem Catheter Burst
● Port Subassembly Air
● Leak
● Port System Burst,
Power Injection
● Port Subassembly
Tensile Strength
● Multiple Power
Injections
● Port Subassembly Air |
| | Predicate Device | Subject Device | |
| Technological
Characteristic | PowerPort™ ClearVUE™
Slim Implantable Port
(K122899)
PowerPort™ Implanted
Polymeric Port (K063377)
Titanium PowerPort™ isp
Implanted Port (K072549) | PowerPort™ ClearVUE™
Slim ECG Enabled
Implantable Port
PowerPort™ ClearVUE™ isp ECG
Enabled Implantable
Port;
PowerPort™ isp M.R.I.™
ECG Enabled
Implantable Port
PowerPort™ Slim ECG
Enabled Implantable Port | Discussion |
| | | | Burst Catheter Flow Rate Magnetic Resonance Imaging Compatibility |
| | | PowerPort™ isp M.R.I.™:
Height: 11.7 mm
Width: 23.7 mm x 26.6
mm
Reservoir Volume: 0.6 mL
Catheter:
8 Fr x 46.4 cm, 1.6 mm ID
6 Fr x 46.4 cm, 1.3 mm
ID | PowerPort™ isp M.R.I.™: Port Subassembly Tensile Strength Port Subassembly Air Leak Port Subassembly Air Burst Septum Obturation Multiple Power Injections Port System Burst, Power Injection Port System Injection Rate |
| | Titanium PowerPort™ isp
Implanted Port:
Height: 11.2 mm
Width: 24.1 mm x 27.3 mm
Reservoir Volume: 0.6 mL
Catheter:
6.0 Fr x 45 cm, 1.3 mm ID | PowerPort™ Slim:
Height: 9.8 mm
Base Width: 21.2 mm x
25.5 mm
Reservoir Volume: 0.5 mL
Catheter:
6.0 Fr x 61 cm, 1.3 mm ID | PowerPort™ Slim: Port Reservoir Height Port Bottom Thickness Port Subassembly Tensile Strength Port Subassembly Air Leak Septum Obturation Multiple Power Injections Port System Burst, Power Injection Port System Injection Rate Port Identification |
| Device
Materials | PowerPort™ ClearVUE™
Slim:
PEEK, silicone,
Bi2O3/acetyl polymer | PowerPort™ ClearVUE™
Slim:
Same | Same as Predicate |
| | Predicate Device | Subject Device | |
| Technological
Characteristic | PowerPort™ ClearVUE™
Slim Implantable Port
(K122899)
PowerPort™ Implanted
Polymeric Port (K063377) | PowerPort™ ClearVUE™
Slim ECG Enabled
Implantable Port
PowerPort™
ClearVUE™ isp ECG
Enabled Implantable
Port;
PowerPort™ isp M.R.I.™
ECG Enabled
Implantable Port | Discussion |
| | Titanium PowerPort™ isp
Implanted Port (K072549) | PowerPort™ Slim ECG
Enabled Implantable Port | |
| | PowerPort™ Implanted
Polymeric Port:
Delrin, silicone, titanium | PowerPort™ ClearVUE™
isp:
Delrin, silicone,
Bi2O3/acetyl polymer | Changes to PowerPort™
ClearVUE™ isp materials
were qualified through the
following performance
tests. All testing passed the
predetermined acceptance
criteria. No new or different
questions of safety and
effectiveness are raised
because the material
changes do not affect the
device performance.
Stem Catheter Leak Stem Connection Tensile Stem Catheter Burst Port Subassembly Air Leak Port System Burst,
Power Injection Port Subassembly Tensile Strength Multiple Power Injections Port Subassembly Air Burst Catheter Flow Rate |
| | | PowerPort™ isp M.R.I.™:
Same | Same as Predicate |
| | Titanium PowerPort™ isp
Implanted Port:
Titanium, silicone | PowerPort™ Slim:
Same | Same as Predicate |
| | Catheter:
Chronoflex (purple) for
Titanium PowerPort™ isp;
Chronoflex (white) for all
other ports | Catheter (all ports):
Chronoflex (white) | The PowerPort™ Slim port
catheter change was
qualified through the
following performance
tests. All testing passed the |
| | Predicate Device | Subject Device | |
| Technological
Characteristic | PowerPort™ ClearVUE™
Slim Implantable Port
(K122899)
PowerPort™ Implanted
Polymeric Port (K063377)
Titanium PowerPort™ isp
Implanted Port (K072549) | PowerPort™ ClearVUE™
Slim ECG Enabled
Implantable Port
PowerPort™
ClearVUE™ isp ECG
Enabled Implantable
Port;
PowerPort™ isp M.R.I.™
ECG Enabled
Implantable Port
PowerPort™ Slim ECG
Enabled Implantable Port | Discussion |
| | Cathlock (all ports):
Polycarbonate | Cathlock (all ports):
Same | Same as Predicate |
| Shelf Life | PowerPort™ ClearVUE™
Slim:
1.5 years | PowerPort™ ClearVUE™
Slim:
2 years | Changes to shelf life were
qualified through the
following performance
tests. All testing passed the
predetermined acceptance
criteria. No new or different
questions of safety and
effectiveness are raised
because the device
performance met
requirements after shelf life
testing. |
| | | | PowerPort™ ClearVUE™
Slim:
• Port System Burst,
Power Injection
• Septum Obturation
• Needle Retention
• Tensile Strength
• Port Subassembly
Tensile Strength
• Port Subassembly Air |
| | Predicate Device | Subject Device | |
| Technological
Characteristic | PowerPort™ ClearVUE™
Slim Implantable Port
(K122899)
PowerPort™ Implanted
Polymeric Port (K063377)
Titanium PowerPort™ isp
Implanted Port (K072549) | PowerPort™ ClearVUE™
Slim ECG Enabled
Implantable Port
PowerPort™
ClearVUE™ isp ECG
Enabled Implantable
Port;
PowerPort™ isp M.R.I.™
ECG Enabled
Implantable Port
PowerPort™ Slim ECG
Enabled Implantable Port | Discussion |
| | | | Port Subassembly Air Burst Stem Catheter Leak Stem Catheter Burst Stem Connection Tensile Multiple Power Injections Catheter Flow Rate |
| | PowerPort™ Implanted
Polymeric Port:
1 year | PowerPort™ ClearVUE™
isp:
2 years
PowerPort™ isp M.R.I.™:
2 years | PowerPort™ ClearVUE™
isp/PowerPort™ isp
M.R.I.™:
Catheter Air Burst Catheter Tensile Strength Flow Rate/Multiple Power Injection Port System Burst, Power Injection Septum Obturation Needle Retention Tensile Strength Port Subassembly Tensile Strength Port Subassembly Air Leak Port Subassembly Air Burst Stem Catheter Leak Stem Catheter Burst Stem Connection Tensile Port System Flow Rate |
| | Titanium PowerPort™ isp
Implanted Port:
1 year | PowerPort™ Slim:
2 years | PowerPort™ Slim:
Port System Injection Rate Multiple Power Injections |
| | Predicate Device | Subject Device | |
| Technological
Characteristic | PowerPort™ ClearVUE™
Slim Implantable Port
(K122899) | PowerPort™ ClearVUE™
Slim ECG Enabled
Implantable Port | Discussion |
| | PowerPort™ Implanted
Polymeric Port (K063377) | PowerPort™
ClearVUE™ isp ECG
Enabled Implantable
Port;
PowerPort™ isp M.R.I.™
ECG Enabled
Implantable Port | |
| | Titanium PowerPort™ isp
Implanted Port (K072549) | PowerPort™ Slim ECG
Enabled Implantable Port | |
| | | | • Port System Burst,
Power Injection |
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Performance Data:
To demonstrate substantial equivalence of the subject device to the predicate device, both technical characteristics and performance criteria were evaluated. Using FDA Guidance documents on non-clinical testing of medical devices and internal Risk Assessment procedures, tests for the following characteristics and performance criteria were evaluated for the subject device:
- Catheter Air Leak ●
- . Packaging Validation
- Usability ●
- ECG Accuracy Verification .
- Catheter Air Burst ●
- Catheter Flow Rate .
- Catheter Tensile Strength
- Flow Rate/Multiple Power Injection ●
- . Lateral Stem Tensile Strength
- Magnetic Resonance Imaging Compatibility .
- Multiple Power Injections
- Needle Retention Tensile Strength ●
- . Port Bottom Thickness
- Port Reservoir Height ●
- Port Subassembly Air Burst
- Port Subassembly Air Leak .
- Port Subassembly Tensile Strength
- Port System Burst, Power Injection ●
15
- Port System Flow Rate .
- . Port System Injection Rate
- . Septum Obturation
- Stem Catheter Burst
- Stem Catheter Leak
- . Stem Connection Tensile
- Port Identification .
These tests were performed in accordance with the following FDA Guidance and standards:
- ASTM D4332, 2022: Standard Practice for Conditioning Containers, Packaging . Components for Testing
- . ASTM D4169, 2022: Standard Practice for Performance Testing of Shipping Containers and Systems
- ISO 11607-1, 2019: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
- . FDA Guidance, Applying Human Factors and Usability Engineering to Medical Devices, February 2016
- . Guidance on 510(k) Submissions for Implanted Infusion Ports, dated October 1990
- . ASTM D 412 Rev 06a, Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension
- ISO 10555-1, 1995, Sterile, single-use intravascular catheters, Part 1. General requirements ●
- . ISO 10555-3, 2002. Sterile, single-use intravascular catheters, Part 3. Central venous catheters
- . NF S 94-370, French Standard, Surgical Implantable catheter chambers, intravenous, intraarterial, intraperitoneal, intrathecal and epidural use (April 1999)
The results from these tests demonstrate that the technical characteristics and performance criteria of the ECG Enabled Implantable Ports are substantially equivalent to the predicate devices and can perform in a manner equivalent to devices currently on the market for the same intended use.
Conclusion:
The subject device, the ECG Enabled Implantable Ports, met all predetermined acceptance criteria for design verification and validation activities as specified by applicable standards, quidance, test protocols and/or customer inputs.
Therefore, Bard Peripheral Vascular, Inc. concludes that the subject device, the ECG Enabled Implantable Port, is substantially equivalent to the legally marketed predicate devices.