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

K232737 · Bard Peripheral Vascular, Inc. · LJT · Dec 8, 2023 · General Hospital

Device Facts

• Record ID: K232737
• 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
• Applicant: Bard Peripheral Vascular, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Dec 8, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5965
• Device Class: Class 2

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.

Device Story

Implantable vascular access port consisting of injection port with self-sealing silicone septum and radiopaque catheter. Used for repeated vascular access (chemotherapy, fluids, blood products, sampling). Power injection requires PowerLoc Safety Infusion Set. ECG-enabled versions allow catheter tip location confirmation using BD Sherlock 3CG Tip Positioning System (TPS) stylet and BD Sherlock 3CG+ Tip Confirmation System (TCS) as alternative to fluoroscopy/X-ray. Stylet uses passive magnets and cardiac electrical signal detection for real-time tip location feedback. Used in clinical settings by healthcare providers. Output is real-time catheter tip location data, aiding in accurate placement and reducing need for radiation-based imaging.

Clinical Evidence

Bench testing only. No clinical data. Performance evaluated via non-clinical verification and validation, including catheter air leak/burst, tensile strength, flow rates, multiple power injections, septum obturation, packaging validation, and ECG accuracy verification. All tests met predetermined acceptance criteria.

Technological Characteristics

Materials: PEEK, silicone, Bi2O3/acetyl polymer, Delrin, titanium, Chronoflex (catheter), polycarbonate (Cathlock). Sensing: Passive magnets and cardiac electrical signal detection (via stylet). Energy: Passive (ECG signal). Dimensions: Various (height 9.8-11.9mm). Connectivity: Compatible with BD Sherlock 3CG+ TCS. Sterilization: Ethylene Oxide (10^-6 SAL).

Indications for Use

Indicated for patients requiring repeated vascular access for infusion of medications (including chemotherapy), IV fluids, parenteral nutrition, blood products, and blood sampling. When used with PowerLoc Safety Infusion Set, indicated for power injection of contrast media at max 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™ ClearVUE™ Slim Implantable Port (K122899)
• PowerPort™ Implanted Polymeric Port (K063377)
• Titanium PowerPort™ isp Implanted Port (K072549)

Reference Devices

• BD Sherlock 3CG+™ Tip Confirmation System (K180560)

Submission Summary (Full Text)

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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"

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(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 [phone] 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

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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

Submission Number (if known)

K232737

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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### 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<br>1625 West 3rd Street<br>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<br>Implantable Port;<br>PowerPort™ ClearVUE™ isp ECG Enabled<br>Implantable Port;<br>PowerPort™ isp M.R.I.™ ECG Enabled<br>Implantable Port;<br>PowerPort™ Slim ECG Enabled Implantable Port |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification: | Class II |
| Regulation: | 21 CFR 880.5965, Subcutaneous, implanted,<br>intravascular infusion port and catheter |
| Review Panel: | General Hospital |
| Product Code: | LJT |

#### Predicate Devices:

| Predicate Device | Subject Device |
|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| PowerPort™ ClearVUE™ Slim Implantable<br>Port (K122899, cleared 11/15/2012) | PowerPort™ ClearVUE™ Slim ECG Enabled<br>Implantable Port |
| PowerPort™ Implanted Polymeric Port<br>(K063377, cleared 1/25/2007) | PowerPort™ ClearVUE™ isp ECG Enabled<br>Implantable Port;<br>PowerPort™ isp M.R.I.™ ECG Enabled<br>Implantable Port |
| Titanium PowerPort™ isp Implanted Port<br>(K072549, cleared 11/14/2007) | PowerPort™ Slim ECG Enabled Implantable<br>Port |

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### 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.

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# Comparison to Predicate Device:

| | Predicate Device | Subject Device | |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristic | PowerPort™ ClearVUE™<br>Slim Implantable Port<br>(K122899) | PowerPort™ ClearVUE™<br>Slim ECG Enabled<br>Implantable Port | Discussion |
| | PowerPort™ Implanted<br>Polymeric Port (K063377) | PowerPort™<br>ClearVUE™ isp ECG<br>Enabled Implantable<br>Port; | |
| | | PowerPort™ isp M.R.I.™<br>ECG Enabled<br>Implantable Port | |
| | Titanium PowerPort™ isp<br>Implanted Port (K072549) | PowerPort™ Slim ECG<br>Enabled Implantable Port | |
| Intended use | The PowerPort™<br>Implanted Port is a totally<br>implantable vascular<br>access device designed<br>to provide long-term,<br>repeated access to the<br>vascular system. | Same | Same as Predicate |
| Indications for<br>use | The PowerPort™ Implanted<br>Port is indicated for patient<br>therapies requiring<br>repeated access to the<br>vascular system. The port<br>system can be used for<br>infusion of medications, I.V<br>fluids, parenteral nutrition<br>solutions, blood products,<br>and for the withdrawal of<br>blood samples. | The PowerPort™<br>Implanted Port is<br>indicated for patient<br>therapies requiring<br>repeated access to the<br>vascular system. The port<br>system can be used for<br>infusion of medications<br><b>including anti-cancer<br/>medicines<br/>(chemotherapy)</b> , I.V.<br>fluids, parenteral nutrition<br>solutions, blood products,<br>and for the withdrawal of<br>blood samples. | The addition of "anti-<br>cancer medicines<br>(chemotherapy)," was<br>cleared under K181446. |
| | When used with the<br>PowerLoc™ Safety<br>Infusion Set, the<br>PowerPort™ device is<br>indicated for power<br>injection of contrast<br>media. For power<br>injection of contrast<br>media, the maximum<br>recommended infusion<br>rate is 5 ml/s. | When used with the<br>PowerLoc™ Safety<br>Infusion Set, the<br>PowerPort™ device is<br>indicated for power<br>injection of contrast<br>media. For power<br>injection of contrast<br>media, the maximum<br>recommended infusion<br>rate is 5 ml/s. | |
| Patient<br>population | Patients requiring<br>repeated access to the<br>vascular system | Same | Same as Predicate |
| | Predicate Device | Subject Device | |
| Technological<br>Characteristic | PowerPort™ ClearVUE™<br>Slim Implantable Port<br>(K122899)<br>PowerPort™ Implanted<br>Polymeric Port (K063377)<br>Titanium PowerPort™ isp<br>Implanted Port (K072549) | PowerPort™ ClearVUE™<br>Slim ECG Enabled<br>Implantable Port<br>PowerPort™<br>ClearVUE™ isp ECG<br>Enabled Implantable<br>Port;<br>PowerPort™ isp M.R.I.™<br>ECG Enabled<br>Implantable Port<br>PowerPort™ Slim ECG<br>Enabled Implantable Port | Discussion |
| Principle of<br>operation | The device's primary<br>components consist of a<br>triangular injection port<br>with self-sealing silicone<br>septum and a radiopaque<br>catheter. A simple sliding<br>lock collar secures the<br>catheter to the port's<br>stem. The port can be<br>identified through the<br>patient skin via the three<br>palpation bumps arranged<br>in a triangle on the<br>septum.<br><br>Port access is performed<br>by percutaneous needle<br>insertion using a non-<br>coring needle. | Same | Same as Predicate |
| Insertion site | Most commonly on upper<br>chest | Same | Same as Predicate |
| Catheter tip<br>termination<br>location | Central venous system -<br>lower 1/3 of superior vena<br>cava preferred | Same | Same as Predicate |
| Duration of use | Long term (>30 days) | Same | Same as Predicate |
| Method of<br>sterilization<br>and<br>sterility<br>assurance<br>level | Ethylene Oxide, 10-6 | Same | Same as Predicate |
| Visualization<br>technique | Fluoroscopy | Fluoroscopy or ECG | The subject devices<br>facilitate accurate<br>reproduction of source<br>ECG signals as shown by<br>ECG Accuracy Verification<br>Testing. Therefore, when<br>used with the BD Sherlock<br>3CG+™ TCS, the subject<br>devices can be used to |
| | Predicate Device | Subject Device | |
| Technological<br>Characteristic | PowerPort™ ClearVUE™<br>Slim Implantable Port<br>(K122899)<br>PowerPort™ Implanted<br>Polymeric Port (K063377)<br>Titanium PowerPort™ isp<br>Implanted Port (K072549) | PowerPort™ ClearVUE™<br>Slim ECG Enabled<br>Implantable Port<br>PowerPort™<br>ClearVUE™ isp ECG<br>Enabled Implantable<br>Port;<br>PowerPort™ isp M.R.I.™<br>ECG Enabled<br>Implantable Port<br>PowerPort™ Slim ECG<br>Enabled Implantable Port | Discussion |
| | | | facilitate catheter<br>advancement and tip<br>location confirmation using<br>patient ECG. No new or<br>different questions of safety<br>and effectiveness areraised because the device<br>can be accurately<br>visualized using<br>fluoroscopy or ECG. |
| ECG-<br>compatible<br>components | None | Included, such as stylet<br>that is used during<br>catheter placement | In addition to ECG<br>Accuracy Verification<br>testing, Catheter Air Leak<br>and Usability testing were<br>conducted to evaluate the<br>functionality and<br>acceptability of stylet use<br>with the port catheter. All<br>testing passed the<br>predetermined acceptance<br>criteria. No new or different<br>questions of safety and<br>effectiveness are raised<br>because the device can be<br>accurately placed using the<br>stylet. |
| Packaging<br>configuration | Triple tray packaging; two<br>sterile<br>barriers in the form of<br>nested, sealed trays | Organizational tray and<br>retainer lid sealed inside<br>a header bag | Packaging validation<br>testing evaluated the<br>functionality and<br>acceptability of the final<br>product. All testing passed<br>the predetermined<br>acceptance criteria. |
| Device<br>Dimensions | | | Changes to dimensions<br>were qualified through the<br>following performance<br>tests. All testing passed the<br>predetermined acceptance<br>criteria. No new or different<br>questions of safety and<br>effectiveness are raised |
| | Predicate Device | Subject Device | |
| Technological<br>Characteristic | PowerPort™ ClearVUE™<br>Slim Implantable Port<br>(K122899)<br>PowerPort™ Implanted<br>Polymeric Port (K063377)<br>Titanium PowerPort™ isp | PowerPort™ ClearVUE™<br>Slim ECG Enabled<br>Implantable Port<br>PowerPort™<br>ClearVUE™ isp ECG<br>Enabled Implantable<br>Port;<br>PowerPort™ isp M.R.I. ™<br>ECG Enabled<br>Implantable Port<br>PowerPort™ Slim ECG | Discussion |
| | Implanted Port (K072549) | Enabled Implantable Port | |
| | | | because the dimensional<br>changes do not affect the<br>device performance. |
| | PowerPort™ ClearVUE™<br>Slim:<br>Height: 10.6 mm<br>Width: 21.6 mm x 25.5 mm<br>Reservoir Volume: 0.4 mL<br>Catheter:<br>8 Fr x 46.4 cm, 1.6 mm ID | PowerPort™ ClearVUE™<br>Slim:<br>Height: 10.4 mm<br>Width: 21.6 mm x 25.5<br>mm<br>Reservoir Volume: 0.4 mL<br>Catheter:<br>8 Fr x 46.4 cm, 1.6 mm ID<br>6 Fr x 46.4 cm, 1.3 mm<br>ID | PowerPort™ ClearVUE™<br>Slim:<br>● Stem Catheter Leak<br>● Stem Connection<br>● Tensile<br>● Stem Catheter Burst<br>● Port Subassembly Air<br>● Leak<br>● Lateral Stem Tensile<br>Strength<br>● Port Subassembly<br>Tensile Strength<br>● Multiple Power<br>Injections<br>● Port System Burst,<br>Power Injection<br>● Port Subassembly Air<br>Burst<br>● Catheter Flow Rate |
| | PowerPort™ Implanted<br>Polymeric Port:<br>Height: 13.7 mm<br>Width: 30.0 mm x 28.8 mm<br>Reservoir Volume: 0.6 mL<br>Catheter:<br>8 Fr x 46.4 cm, 1.6 mm ID | PowerPort™ ClearVUE™<br>isp:<br>Height: 11.9 mm<br>Width: 24.4 mm x 25.9<br>mm<br>Reservoir Volume: 0.6 mL<br>Catheter:<br>8 Fr x 46.4 cm, 1.6 mm ID<br>6 Fr x 46.4 cm, 1.3 mm<br>ID | PowerPort™ ClearVUE™<br>isp:<br>● Stem Catheter Leak<br>● Stem Connection<br>● Tensile<br>● Stem Catheter Burst<br>● Port Subassembly Air<br>● Leak<br>● Port System Burst,<br>Power Injection<br>● Port Subassembly<br>Tensile Strength<br>● Multiple Power<br>Injections<br>● Port Subassembly Air |
| | Predicate Device | Subject Device | |
| Technological<br>Characteristic | PowerPort™ ClearVUE™<br>Slim Implantable Port<br>(K122899)<br>PowerPort™ Implanted<br>Polymeric Port (K063377)<br>Titanium PowerPort™ isp<br>Implanted Port (K072549) | PowerPort™ ClearVUE™<br>Slim ECG Enabled<br>Implantable Port<br>PowerPort™ ClearVUE™ isp ECG<br>Enabled Implantable<br>Port;<br>PowerPort™ isp M.R.I.™<br>ECG Enabled<br>Implantable Port<br>PowerPort™ Slim ECG<br>Enabled Implantable Port | Discussion |
| | | | Burst Catheter Flow Rate Magnetic Resonance Imaging Compatibility |
| | | PowerPort™ isp M.R.I.™:<br>Height: 11.7 mm<br>Width: 23.7 mm x 26.6<br>mm<br>Reservoir Volume: 0.6 mL<br>Catheter:<br>8 Fr x 46.4 cm, 1.6 mm ID<br>6 Fr x 46.4 cm, 1.3 mm<br>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<br>Implanted Port:<br>Height: 11.2 mm<br>Width: 24.1 mm x 27.3 mm<br>Reservoir Volume: 0.6 mL<br>Catheter:<br>6.0 Fr x 45 cm, 1.3 mm ID | PowerPort™ Slim:<br>Height: 9.8 mm<br>Base Width: 21.2 mm x<br>25.5 mm<br>Reservoir Volume: 0.5 mL<br>Catheter:<br>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<br>Materials | PowerPort™ ClearVUE™<br>Slim:<br>PEEK, silicone,<br>Bi2O3/acetyl polymer | PowerPort™ ClearVUE™<br>Slim:<br>Same | Same as Predicate |
| | Predicate Device | Subject Device | |
| Technological<br>Characteristic | PowerPort™ ClearVUE™<br>Slim Implantable Port<br>(K122899)<br>PowerPort™ Implanted<br>Polymeric Port (K063377) | PowerPort™ ClearVUE™<br>Slim ECG Enabled<br>Implantable Port<br>PowerPort™<br>ClearVUE™ isp ECG<br>Enabled Implantable<br>Port;<br>PowerPort™ isp M.R.I.™<br>ECG Enabled<br>Implantable Port | Discussion |
| | Titanium PowerPort™ isp<br>Implanted Port (K072549) | PowerPort™ Slim ECG<br>Enabled Implantable Port | |
| | PowerPort™ Implanted<br>Polymeric Port:<br>Delrin, silicone, titanium | PowerPort™ ClearVUE™<br>isp:<br>Delrin, silicone,<br>Bi2O3/acetyl polymer | Changes to PowerPort™<br>ClearVUE™ isp materials<br>were qualified through the<br>following performance<br>tests. All testing passed the<br>predetermined acceptance<br>criteria. No new or different<br>questions of safety and<br>effectiveness are raised<br>because the material<br>changes do not affect the<br>device performance.<br>Stem Catheter Leak Stem Connection Tensile Stem Catheter Burst Port Subassembly Air Leak Port System Burst,<br>Power Injection Port Subassembly Tensile Strength Multiple Power Injections Port Subassembly Air Burst Catheter Flow Rate |
| | | PowerPort™ isp M.R.I.™:<br>Same | Same as Predicate |
| | Titanium PowerPort™ isp<br>Implanted Port:<br>Titanium, silicone | PowerPort™ Slim:<br>Same | Same as Predicate |
| | Catheter:<br>Chronoflex (purple) for<br>Titanium PowerPort™ isp;<br>Chronoflex (white) for all<br>other ports | Catheter (all ports):<br>Chronoflex (white) | The PowerPort™ Slim port<br>catheter change was<br>qualified through the<br>following performance<br>tests. All testing passed the |
| | Predicate Device | Subject Device | |
| Technological<br>Characteristic | PowerPort™ ClearVUE™<br>Slim Implantable Port<br>(K122899)<br>PowerPort™ Implanted<br>Polymeric Port (K063377)<br>Titanium PowerPort™ isp<br>Implanted Port (K072549) | PowerPort™ ClearVUE™<br>Slim ECG Enabled…