PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports

K242328 · Bard Access Systems, Inc. · LJT · Oct 31, 2024 · General Hospital

Device Facts

• Record ID: K242328
• Device Name: PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports
• Applicant: Bard Access Systems, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Oct 31, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PowerPort™ Implanted Port is a totally implantable vascular access device designed to provide long-term, repeated access to the vascular system.

Device Story

The PowerPort™ is an implantable vascular access device consisting of a triangular injection port with a self-sealing silicone septum and a radiopaque catheter. It is used for long-term, repeated vascular access in clinical settings. The port is identified subcutaneously via palpation bumps on the septum. Access is achieved via percutaneous needle insertion using a non-coring needle. When used with a PowerLoc™ Safety Infusion Set, the device supports power injection of contrast media. The device facilitates medication delivery, fluid administration, and blood sampling, benefiting patients requiring chronic therapy. Healthcare providers access the port percutaneously to deliver treatments or withdraw samples, streamlining clinical workflows for patients with long-term therapy needs.

Clinical Evidence

Bench testing only. No clinical data presented. Verification testing included port assembly leak, tensile, burst, lateral stem tensile, septum coring, multiple power injections, and catheter flow rate testing, demonstrating performance over a 2-year shelf life.

Technological Characteristics

Materials: PEEK (port body), silicone (septum), ChronoFlex polyurethane (catheter), polycarbonate (cathlock). Features: Triangular port, self-sealing septum, radiopaque catheter. Standards: NF S 94-370, ISO 10555-3, ISO 10555-1, ASTM D412. Sterilization: Ethylene Oxide. Connectivity: None (mechanical device).

Indications for Use

Indicated for patient therapies requiring repeated access to the vascular system, including infusion of medications (e.g., chemotherapy), I.V. fluids, parenteral nutrition, blood products, and blood withdrawal. When used with PowerLoc™ Safety Infusion Set, indicated for power injection of contrast media at a maximum rate of 5 ml/s.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.

Predicate Devices

• PowerPort™ Implanted Polymeric Port (K063377)
• PowerPort™ ClearVUE™ Slim Implantable (K122899)

Submission Summary (Full Text)

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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.

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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

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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# 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) |

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### K242328.510(K)SUMMARY

#### Submitter Information:

| Applicant: | Bard Access Systems, Inc<br>605 North 5600 West<br>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

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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.

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# Comparison to Predicate Device:

# Table 1. Subject and Predicate Device Comparison – PowerPort™ ClearVUE™ Slim Implantable Port

| Attribute | Predicate Device<br>PowerPort™ ClearVUE™ Slim<br>Implantable (K122899) | Subject Device<br>PowerPort™ ClearVUE™ Slim<br>Implantable Port | Discussion | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note | 1. <b>Bold Font</b> indicates a difference between the subject device and predicate devices<br>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<br>Classification<br>Name | Port & Catheter, Implanted,<br>Subcutaneous, Intravascular | Port & Catheter, Implanted,<br>Subcutaneous, Intravascular | Same as Predicate | |
| Regulation<br>Number | 21 CFR §880.5965 | 21 CFR §880.5965 | Same as Predicate | |
| FDA Product<br>Code | LJT | LJT | Same as Predicate | |
| Device Use | | | | |
| Intended Use | The PowerPort™ Implanted Port is a<br>totally implantable vascular access<br>device designed to provide long-term,<br>repeated access to the vascular system. | The PowerPort™ Implanted Port is a<br>totally implantable vascular access<br>device designed to provide long-term,<br>repeated access to the vascular system. | Same as Predicate | |
| Indications for<br>Use | The PowerPort® ClearVUE® Slim<br>Implantable Port with 8F Polyurethane<br>Catheter is indicated for patient<br>therapies requiring repeated access to<br>the vascular system. The port system<br>can be used for infusion of<br>medications, I.V. fluids, parenteral<br>nutrition solutions, blood products, and<br>for the withdrawal of blood samples.<br>When used with a Powerloc® Safety<br>Infusion Set (SIS), the PowerPort®<br>device is indicated for power injection<br>of contrast media. For power injection<br>of contrast media, the maximum<br>recommended infusion rate is 5 ml /s | The PowerPort™ Implanted Port is<br>indicated for patient therapies requiring<br>repeated access to the vascular system.<br>The port system can be used for infusion<br>of medications including anti-cancer<br>medicines (chemotherapy)1, I.V. fluids,<br>parenteral nutrition solutions, blood<br>products, and for the withdrawal of blood<br>samples.<br>When used with the PowerLoc™ Safety<br>Infusion Set, the PowerPort™<br>Implantable Port is indicated for power<br>injection of contrast media. For power<br>injection of contrast | Different than Predicate. The italicized<br>clarifying statement was cleared for all<br>PowerPorts™ in K181446, clearance<br>date 07/08/2019. | |
| Attribute | Predicate Device<br>PowerPort™ ClearVUE™ Slim<br>Implantable (K122899) | Subject Device<br>PowerPort™ ClearVUE™ Slim<br>Implantable Port | Discussion | |
| | | media, the maximum recommended<br>infusion rate is 5 ml/s. | | |
| | | 1The italicized clarifying statement was<br>cleared for all PowerPorts™ in K181446,<br>clearance date 07/08/2019. | | |
| Patient<br>Population | Patients requiring repeated access to the<br>vascular system | Patients requiring repeated access to the<br>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<br>Techniques | Fluoroscopy | Fluoroscopy | Same as Predicate | |
| Principle of<br>Operation | The device's primary components consist<br>of a triangular injection port with self-<br>sealing silicone septum and a radiopaque<br>catheter. A simple sliding lock collar<br>secures the catheter to the port's stem.<br>The port can be identified through the<br>patient skin via the three palpation bumps<br>arranged in a triangle on the septum.<br><br>Port access is performed by<br>percutaneous needle insertion using a<br>non-coring needle. | The device's primary components consist<br>of a triangular injection port with self-<br>sealing silicone septum and a radiopaque<br>catheter. A simple sliding lock collar<br>secures the catheter to the port's stem.<br>The port can be identified through the<br>patient skin via the three palpation bumps<br>arranged in a triangle on the septum.<br><br>Port access is performed by<br>percutaneous needle insertion using a<br>non-coring needle. | Same as Predicate | |
| Catheter Tip<br>Termination<br>Location | Central venous system - lower 1/3 of<br>superior vena cava preferred | Central venous system - lower 1/3 of<br>superior vena cava preferred | Same as Predicate | |
| Design Characteristics | | | |…