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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by internal product performance specifications and meeting acceptable risk levels, as demonstrated through verification testing. The document states that "Design verification testing was conducted to evaluate device performance over the proposed 2-year shelf life of the to-be-marketed configurations for all models of the subject device." It also mentions that "Verification testing demonstrated that the device performed as intended by meeting product performance specifications and controlling risks to an acceptable level..."

Specific quantitative acceptance criteria and their corresponding reported device performance are not explicitly detailed in a comparative table format within the provided text. Instead, the document lists various verification/validation methods and standards applied, implying that the device was tested against these methods and passed their respective criteria.

However, based on the narrative and the types of tests listed, a conceptual table can be constructed, acknowledging that specific numerical values for criteria and performance are not given:

Verification/Validation Method	Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Stem-Catheter Connection Air Leak Test	Device should not exhibit air leakage.	Performed as intended, no air leakage.
Stem-Catheter Connection Tensile	Device should withstand tensile forces without failure.	Performed as intended, no failure.
Stem-Catheter Air Burst	Device should withstand specified air burst pressures.	Performed as intended, no burst failure.
Port Subassembly Air Leak	Device should not exhibit air leakage at the subassembly level.	Performed as intended, no air leakage.
Lateral Stem Tensile Strength	Device should withstand lateral stem tensile forces.	Performed as intended, no failure.
Port Subassembly Tensile Strength	Device should withstand tensile forces at the subassembly level.	Performed as intended, no failure.
Multiple Power Injections	Device should maintain integrity and function after multiple power injections.	Performed as intended, maintained integrity and function.
Port System Burst, Power Injection	Device should withstand specified burst pressures during power injection.	Performed as intended, no burst failure.
Catheter Flow Rate	Catheter should maintain specified flow rates.	Performed as intended, flow rates maintained.
Septum Obturation	Septum should resist coring and maintain seal after needle punctures.	Performed as intended, resistant to coring, maintained seal.
Needle Retention Tensile Strength	Device should retain needle under specified tensile forces.	Performed as intended, needle retained.
Stem Catheter Leak I & II	Device should not exhibit leakage at the stem-catheter junction.	Performed as intended, no leakage.
Catheter Air Burst	Catheter should withstand specified air burst pressures.	Performed as intended, no burst failure.
Catheter Tensile Strength	Catheter should withstand specified tensile forces without failure.	Performed as intended, no failure.
Port System Flow Rate	Port system should maintain specified flow rates.	Performed as intended, flow rates maintained.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size used for each specific test in the verification activities. It generally refers to "the to-be-marketed configurations for all models of the subject device."

Regarding data provenance:

The tests were conducted by Bard Access Systems, Inc. ("BAS Internal Test-Method").
The data appears to be prospective as it involves "design verification testing... over the proposed 2-year shelf life," implying new testing for this submission.
The country of origin for the data is implicitly the United States, as the submission is to the U.S. FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests performed are engineering and performance-based, not clinical studies requiring expert ground truth for interpretation (e.g., radiology reads). The "ground truth" here is determined by direct measurement against engineering specifications and industry standards. The document does mention "Material experts at BAS have confirmed the proposed locking solutions will not impact BAS catheters," indicating internal expertise in materials science informed certain aspects of the design verification.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as the verification tests described are objective, quantitative engineering tests, not subjective assessments requiring adjudication by multiple readers or experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This information is not applicable. The device (PowerPort™ ClearVUE™ Slim Implantable Ports) is a physical medical device, specifically an implantable port and catheter system. It is not an AI-enabled diagnostic or therapeutic device. Therefore, an MRMC study related to AI assistance would not be relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. As stated above, this device is a physical medical product, not an algorithm or software-only device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the verification studies is established by engineering specifications, industry standards (e.g., ISO 10555-3, NF S 94-370, ASTM D412), and FDA guidance documents ("FDA Implanted Infusion Port Guidance"). It is based on objective, measurable performance characteristics rather than clinical "ground truth" derived from patient data or expert interpretation.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device and does not involve machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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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.

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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 (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

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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)

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, Inc605 North 5600 WestSalt 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:

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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Page 3 of 16

Comparison to Predicate Device:

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

Attribute	Predicate DevicePowerPort™ ClearVUE™ SlimImplantable (K122899)	Subject DevicePowerPort™ ClearVUE™ SlimImplantable Port	Discussion
Note	1. Bold Font indicates a difference between the subject device and predicate devices2. 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
DeviceClassificationName	Port & Catheter, Implanted,Subcutaneous, Intravascular	Port & Catheter, Implanted,Subcutaneous, Intravascular	Same as Predicate
RegulationNumber	21 CFR §880.5965	21 CFR §880.5965	Same as Predicate
FDA ProductCode	LJT	LJT	Same as Predicate
Device Use
Intended Use	The PowerPort™ Implanted Port is atotally implantable vascular accessdevice designed to provide long-term,repeated access to the vascular system.	The PowerPort™ Implanted Port is atotally implantable vascular accessdevice designed to provide long-term,repeated access to the vascular system.	Same as Predicate
Indications forUse	The PowerPort® ClearVUE® SlimImplantable Port with 8F PolyurethaneCatheter is indicated for patienttherapies requiring repeated access tothe vascular system. The port systemcan be used for infusion ofmedications, I.V. fluids, parenteralnutrition solutions, blood products, andfor the withdrawal of blood samples.When used with a Powerloc® SafetyInfusion Set (SIS), the PowerPort®device is indicated for power injectionof contrast media. For power injectionof contrast media, the maximumrecommended infusion rate is 5 ml /s	The PowerPort™ Implanted Port isindicated for patient therapies requiringrepeated access to the vascular system.The port system can be used for infusionof medications including anti-cancermedicines (chemotherapy)1, I.V. fluids,parenteral nutrition solutions, bloodproducts, and for the withdrawal of bloodsamples.When used with the PowerLoc™ SafetyInfusion Set, the PowerPort™Implantable Port is indicated for powerinjection of contrast media. For powerinjection of contrast	Different than Predicate. The italicizedclarifying statement was cleared for allPowerPorts™ in K181446, clearancedate 07/08/2019.
Attribute	Predicate DevicePowerPort™ ClearVUE™ SlimImplantable (K122899)	Subject DevicePowerPort™ ClearVUE™ SlimImplantable Port	Discussion
		media, the maximum recommendedinfusion rate is 5 ml/s.
		1The italicized clarifying statement wascleared for all PowerPorts™ in K181446,clearance date 07/08/2019.
PatientPopulation	Patients requiring repeated access to thevascular system	Patients requiring repeated access to thevascular 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
VisualizationTechniques	Fluoroscopy	Fluoroscopy	Same as Predicate
Principle ofOperation	The device's primary components consistof a triangular injection port with self-sealing silicone septum and a radiopaquecatheter. A simple sliding lock collarsecures the catheter to the port's stem.The port can be identified through thepatient skin via the three palpation bumpsarranged in a triangle on the septum.Port access is performed bypercutaneous needle insertion using anon-coring needle.	The device's primary components consistof a triangular injection port with self-sealing silicone septum and a radiopaquecatheter. A simple sliding lock collarsecures the catheter to the port's stem.The port can be identified through thepatient skin via the three palpation bumpsarranged in a triangle on the septum.Port access is performed bypercutaneous needle insertion using anon-coring needle.	Same as Predicate
Catheter TipTerminationLocation	Central venous system - lower 1/3 ofsuperior vena cava preferred	Central venous system - lower 1/3 ofsuperior vena cava preferred	Same as Predicate
Design Characteristics
DeviceMeasurements	8 FPort Body:Height: 10.6 mmWidth: 21.6 mm x 25.5 mmReservoir Volume: 0.4 mL	8 FPort Body:Height: 10.4 mmWidth: 21.6 mm x 25.5 mmReservoir Volume: 0.4 mL6 FPort Body:Height: 10.4 mmWidth: 21.6 mm x 25.5 mmReservoir Volume: 0.4 mL	Different than PredicateThe change in product dimensions didnot change product performance.Labeling was updated for clarity only toensure safer or more effective use.There were no changes to theindications for use, warnings,precautions or contraindications for the
Attribute	Predicate DevicePowerPort™ ClearVUE™ SlimImplantable (K122899)	Subject DevicePowerPort™ ClearVUE™ SlimImplantable Port	Discussion
	Catheter:8 Fr x 46.4 cmChronoFlex, 1.6 mm ID	Catheter:8 Fr x 46.4 cmChronoFlex, 1.6 mm ID	Catheter:6 Fr x 46.4 cmChronoFlex, 1.3mm ID	PowerPort™ ClearVUE™ SlimImplantable Port. There was nochange in material composition,sterilization, or biocompatibility, sothere was no change in safety orefficacy of the device. Performancetesting was conducted on the to-be-marketed version of the subject deviceover the proposed shelf life todemonstrate the difference does notraise new questions of safety andeffectiveness.Different than PredicateThe change in product dimensions didnot change product performance.There were no changes to theindications for use, warnings,precautions or contraindications for thePowerPort™ ClearVUE™ SlimImplantable Port. There was nochange in material composition,sterilization, or biocompatibility, sothere was no change in safety orefficacy of the device. Performancetesting was conducted on the to-be-marketed version of the subject deviceover the proposed shelf life todemonstrate the difference does notraise new questions of safety andeffectiveness.
DeviceDescription andMaterials	Port Body:- Triangular hard plastic PEEK(polyetheretherketone) port cap andbase, including stem- One-piece silicone septum with 3 raisedpalpation bumps- 3 suture holes with or without siliconesuture plugs- Radiopaque bismuth trioxide(Bi2O3)/Delrin CT symbol capturedbetween the cap and base assembly	Port Body:- Triangular hard plastic PEEK(polyetheretherketone) port cap andbase, including stem- One-piece silicone septum with 3 raisedpalpation bumps- 3 suture holes with or without siliconesuture plugs- Radiopaque bismuth trioxide(Bi2O3)/Delrin CT symbol capturedbetween 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 DevicePowerPort™ ClearVUE™ SlimImplantable (K122899)	Subject DevicePowerPort™ ClearVUE™ SlimImplantable Port	Discussion
LockingSolution	To help prevent clot formation andcatheter blockage, each lumen of theimplanted ports with open-endedcatheters should be filled with sterileheparinized saline after each use. If theport remains unused for long periods oftime, the heparin lock should be changedat least once every four weeks.	To help prevent clot formation andcatheter blockage, each lumen of theimplanted ports with open-endedcatheters should be flushed with sterilenormal saline then filled with sterileheparinized saline, sterile normalsaline, or other approved lockingsolution per institutional protocol aftereach use. If the port remains unused forlong periods of time, the lock should bechanged at leastonce every 28 days.Warning: Alcohol should not be used tosoak or declot polyurethane cathetersbecause alcohol is known to degradepolyurethane catheters over time withrepeated or prolonged exposure.	Different from PredicateAdditional locking solutions to alignwith Infusion Therapy Standards ofPractice, 9th Edition (2024). The devicehas the same intended use and thischange does not raise questions ofsafety and effectiveness, so it isdeemed that there is no impact tosubstantial equivalence due to thischange.
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Same as Predicate
Shelf Life	1.5 years	2 years	Different from PredicateVerification testing demonstrated thatthe device performed as intended bymeeting product performancespecifications and controlling risks toan acceptable level following agingand exposure to ethylene oxidesterilization and simulated shipping.Testing activities that were performedfor the original 510(k) submission wereconducted for the port configurations,such as port assembly leak, portassembly tensile, port assembly burst,lateral stem tensile, septum coring(needle obturation), port-cathetersystem multiple power injection, and
Attribute	Predicate DevicePowerPort™ ClearVUE™ SlimImplantable (K122899)	Subject DevicePowerPort™ ClearVUE™ SlimImplantable Port	Discussion
			port system burst (power injection).There was no change to indications foruse, warnings, precautions,contraindications, sterilization, orbiocompatibility. As such, there was nochanges to device safety oreffectiveness.
PackagingConfiguration	Triple tray packaging; two sterile barriersin the form of nested, sealed trays	Triple tray packaging; two sterile barriersin the form of nested, sealed trays	Same as Predicate
	Predicate Device	Subject Device	Discussion
Attribute	PowerPort™ ImplantedPolymeric Port (K063377)	PowerPort™ ClearVUE™ ispImplantable Port
Note	1. Bold Font indicates a difference between the subject device and predicate devices2. 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 ClassificationName	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 Portis a totally implantable vascularaccess device designed toprovide long-term, repeatedaccess to the vascular system.	The PowerPort™ Implanted Port isa totally implantable vascularaccess device designed to providelong-term, repeated access to thevascular system.	Same as Predicate
Indications for Use	The PowerPort™ Implanted Portis indicated for patient therapiesrequiring repeated access to thevascular system. The portsystem can be used for infusionof medications I.V. fluids,parenteral nutrition solutions,blood products, and for thewithdrawal of blood samples.When used with the PowerLoc™Safety Infusion Set, thePowerPort™ device is indicatedfor power injection of contrastmedia. For power injection ofcontrast media, the maximum	The PowerPort™ Implanted Port isis indicated for patient therapiesrequiring repeated access to thevascular system. The port systemcan be used for infusion ofmedications including anti-cancermedicines (chemotherapy)1, I.V.fluids, parenteral nutrition solutions,blood products, and for thewithdrawal of blood samples.When used with the PowerLoc™Safety Infusion Set, the PowerPort™Implantable Port is indicated forpower injection of contrast media.For power injection of contrastmedia, the maximum recommendedinfusion rate is 5 ml/s.	Different than Predicate. The italicizedclarifying statement wascleared for all PowerPorts™ in K181446,clearance date 07/08/2019.
Attribute	Predicate DevicePowerPort™ ImplantedPolymeric Port (K063377)	Subject DevicePowerPort™ ClearVUE™ ispImplantable Port	Discussion
	recommended infusion rate is 5 ml/s.	¹The italicized clarifying statementwas cleared for all PowerPorts™ inK181446, 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
VisualizationTechniques	Fluoroscopy	Fluoroscopy	Same as Predicate
Principle of Operation	The device's primary components consist of atriangular injection port with self-sealing silicone septum and aradiopaque catheter. A simple sliding lock collar secures thecatheter to the port's stem. The port can be identified through thepatient skin via the three palpation bumps arranged in atriangle on the septum.Port access is performed bypercutaneous needle insertion using a non-coring needle.	The device's primary componentsconsist of a triangular injection portwith self-sealing silicone septumand a radiopaque catheter. A simplesliding lock collar secures thecatheter to the port's stem. The portcan be identified through the patientskin via the three palpation bumpsarranged in a triangle on theseptum.Port access is performed bypercutaneous needle insertionusing a non-coring needle.	Same as Predicate
Catheter TipTermination Location	Central venous system - lower1/3 of superior vena cava preferred	Central venous system - lower 1/3of superior vena cava preferred	Same as Predicate
Design Characteristics
Device Measurements	PowerPort M.R.I 8 F	ClearVUE™ isp 8 FPort Body:	Different than PredicateThe change in product dimensions did notchange product performance. Labeling
		ClearVUE™ isp 6 FPort Body:
Attribute	Predicate DevicePowerPort™ ImplantedPolymeric Port (K063377)	Subject DevicePowerPort™ ClearVUE™ ispImplantable Port		Discussion
Height: 13.7mmWidth: 30.0mm x Length:28.8mmReservoir Volume: 0.6mL	Height: 11.9mmWidth: 24.4 mm25.9 mmReservoirVolume: 0.6 mL	Height: 11.9mmWidth: 24.4mmx 25.9 mmReservoirVolume: 0.6 mL	was updated for clarity only to insure saferor more effective use. There were nochanges to the indications for use,warnings, precautions or contraindicationsfor the PowerPort™ ClearVUE™ ispImplantable Port. There was no change inmaterial composition, sterilization, orbiocompatibility, so there was no change insafety or efficacy of the device.Performance testing was conducted on theto-be-marketed version of the subjectdevice over the proposed shelf life todemonstrate the difference does not raisenew questions of safety and effectiveness.
Catheter:8Fr x 45cm ChronoFlex	Catheter:8 Fr x 46.4 cmChronoFlex,1.6 mm ID	Catheter:6 Fr x 46.4 cmChronoFlex,1.3 mm ID	Different than PredicateThe change in product dimensions did notchange product performance. Labelingwas updated for clarity only to insure saferor more effective use. There were nochanges to the indications for use,warnings, precautions or contraindicationsfor the PowerPort™ ClearVUE™ ispImplantable Port. There was no change inmaterial composition, sterilization, orbiocompatibility, so there was no change insafety or efficacy of the device.Performance testing was conducted on theto-be-marketed version of the subjectdevice over the proposed shelf life todemonstrate the difference does not raisenew questions of safety and effectiveness.
Device Description andMaterials	PowerPort M.R.I.	ClearVUE™ isp8	ClearVUE™ isp6	Different than PredicateThe "C T" symbol changed from titanium to
Port Body:- Purple Triangular Delrin plasticport- radiopaque identifying featuredisplaying power injectionsymbol and the letters "C T"- one piece silicone septum- septum with 3 raised palpationbumps	Port Body:- TriangularDelrin plasticport (with nocolorant)- radiopaquenon-metallicidentifyingfeaturedisplayingpower injectionsymbol and theletters "C T"	Port Body:- TriangularDelrin plasticport (with nocolorant)- radiopaqueidentifyingfeaturedisplayingpower injectionsymbol and theletters "C T"	Delrin 500 NC-010 with 25% BismuthTrioxide (Bi2O3); however, the newmaterial is encapsulated and does notcontact tissue or fluid. Encapsulation isachieved by dipping the CT symbol in amixture of silicone thinned with hexane tocreate a thin skim-coat. The symbol is thenassembled onto the port reservoir and theentire subassembly is over-molded insilicone. There was no change insterilization and biocompatibility, and assuch, there were no introduction or
Attribute	Predicate Device	Subject Device	Discussion
	PowerPort™ ImplantedPolymeric Port (K063377)	PowerPort™ ClearVUE™ ispImplantable Port
		- Integralmolded Delrinstem with twodistal barbs- one piecesilicone septum- septum with 3raised palpationbumps- base isencapsulated	- one piecesilicone septum- septum with 3raised palpationbumps	modification of risks associated with thefinal product.
	Catheter:- ChronoFlex polyurethane (withno colorant)- open-ended- single lumen- attachable	Catheter:- ChronoFlexpolyurethane(with nocolorant)- open-ended- single lumen- attachable	Catheter:- ChronoFlexpolyurethane(with nocolorant)- open-ended- single lumen- attachable	Same as Predicate
	Cathlock:- Polycarbonate	Cathlock:- Polycarbonate		Same as Predicate
Locking Solution	To help prevent clot formationand catheter blockage, eachlumen of the implanted ports withopen-ended catheters should befilled with sterile heparinizedsaline after each use. If the portremains unused for long periodsof time, the heparin lock shouldbe changed at least once everyfour weeks.	To help prevent clot formation andcatheter blockage, each lumen ofthe implanted ports with open-ended catheters should be flushedwith sterile normal saline thenfilled with sterile heparinizedsaline, sterile normal saline, orother approved locking solutionper institutional protocol aftereach use. If the port remainsunused for long periods of time, thelock should be changed at leastonce every 28 days.		Different from PredicateAdditional locking solutions to align withInfusion Therapy Standards of Practice, 9thEdition (2024). The device has the sameintended use and this change does notraise questions of safety and effectiveness,so it is deemed that there is no impact tosubstantial equivalence due to this change.
Attribute	Predicate DevicePowerPort™ ImplantedPolymeric Port (K063377)	Subject DevicePowerPort™ ClearVUE™ ispImplantable Port	Discussion
		Warning: Alcohol should not beused to soak or declot polyurethanecatheters because alcohol is knownto degrade polyurethane cathetersover time with repeated orprolonged exposure.
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Same as Predicate
Shelf Life	1 year	2 years	Different than PredicateVerification testing demonstrated that thedevice performed as intended by meetingproduct performance specifications andcontrolling risks to an acceptable levelfollowing aging and exposure to ethyleneoxide sterilization and simulated shipping.Testing activities that were performed forthe original 510(k) submission wereconducted for the port configurations,including port assembly leak, portassembly tensile, port assembly burst,lateral stem tensile, septum coring (needleobturation), port-catheter system multiplepower injection, and port system burst(power injection). As such, there was nochanges to device safety or effectiveness.
PackagingConfiguration	Triple tray packaging; two sterilebarriers in the form of nested,sealed trays	Triple tray packaging; two sterilebarriers in the form of nested,sealed trays	Same as Predicate

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Table 2. Subject and Predicate Device Comparison – PowerPort™ ClearVUE™ isp Implantable Port

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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)

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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.

Regulation Number and Section

§ 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.