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 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).

AI/ML Overview

The provided document is a 510(k) premarket notification summary from the FDA, and it does not contain the detailed acceptance criteria and study data typically found in a clinical trial report or a comprehensive performance study. Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and functional testing rather than clinical performance for an AI/ML component.

Therefore, for aspects related to an AI/ML device's performance, human reader studies, and AI-specific ground truth establishment, the information is not present in this document. This document describes a medical device (implantable port) with an enabling technology (ECG for tip positioning), but it doesn't describe an AI/ML-driven diagnostic or prognostic device that would require the typical performance metrics associated with AI.

However, I can extract information related to the performance testing that was conducted to support the substantial equivalence claim for the overall device, particularly for the new ECG-enabled feature.

Here's an attempt to answer your questions based on the provided text, highlighting where the requested information is absent or not applicable given the nature of the device and submission:

Device: PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port and related models.

Core Technology Change: The addition of ECG enablement for catheter tip placement confirmation using the BD Sherlock 3CG™ Tip Positioning System (TPS) stylet and BD Sherlock 3CG+™ Tip Confirmation System (TCS).

1. A table of acceptance criteria and the reported device performance

The document lists various performance tests conducted to demonstrate substantial equivalence, and states that "All testing passed the predetermined acceptance criteria." However, it does not provide a table with specific quantitative acceptance criteria or the numerical reported device performance for each test. It only lists the types of tests performed.

Test Category	Specific Tests Mentioned	Acceptance Criteria & Reported Performance
ECG Functionality	ECG Accuracy Verification	"facilitate accurate reproduction of source ECG signals" (Qualitative statement), "All testing passed the predetermined acceptance criteria." (General statement)
Mechanical/Physical	Catheter Air Leak, Catheter Air Burst, Catheter Flow Rate, Catheter Tensile Strength, Lateral Stem Tensile Strength, 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	"All testing passed the predetermined acceptance criteria." (General statement, no specific values given)
Compatibility	Magnetic Resonance Imaging Compatibility	(No specific criteria listed, assumed to meet MRI compatibility standards)
Packaging & Usability	Packaging Validation, Usability	"All testing passed the predetermined acceptance criteria." (General statement)
Shelf Life	(Implied by changes to shelf life, tested to ensure device performance met requirements after shelf life testing)	"All testing passed the predetermined acceptance criteria." (General statement), "the device performance met requirements after shelf life testing."

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated for any of the performance tests. The testing described appears to be laboratory/bench testing of the device components/full device, not human clinical trial data.
Data Provenance: This is not a clinical study involving human data in the traditional sense for evaluating the device's performance in a patient population (beyond basic "indications for use"). The testing described is pre-market validation conducted by the manufacturer, likely at their facilities or certified labs. Therefore, "country of origin of the data" and "retrospective or prospective" are not applicable in the context of clinical data for an AI/ML model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable: This device is a medical implant, not an AI/ML diagnostic or prognostic system that relies on expert consensus to establish ground truth for image interpretation or disease diagnosis. The "ground truth" for its performance is derived from engineering specifications, established medical device testing standards (e.g., ISO, ASTM), and the fundamental physics/physiology of ECG signals for tip placement.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: As this is not a study requiring expert readers or interpretation, there is no adjudication method.

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

Not Applicable: This filing is for an implantable port device, not an AI-based diagnostic tool that would typically undergo an MRMC study. The "ECG Enabled" feature is an alternative method for real-time tip placement (vs. fluoroscopy/X-ray), not an AI assisting human interpretation of images. The BD Sherlock 3CG+™ TCS (the system responsible for interpreting the ECG signals) has its own separate 510(k) and likely its own performance data (K180560 is referenced).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: The device itself (the port) does not have a standalone "algorithm only" performance. The ECG enablement relies on the separate BD Sherlock system. The performance tests evaluate the physical and electrical properties of the port that allow it to be used with the ECG system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Engineering/Physical Standards & Reference Data: The ground truth for the performance tests includes:
- Pre-determined acceptance criteria based on industry standards (e.g., ISO 11607-1, ASTM D4332, ASTM D4169, ISO 10555, NF S 94-370).
- Internal Risk Assessment procedures.
- FDA Guidance documents (e.g., "Guidance on 510(k) Submissions for Implanted Infusion Ports," "Applying Human Factors and Usability Engineering to Medical Devices").
- Functionality requirements (e.g., accurate reproduction of source ECG signals, no air leaks, appropriate flow rates).

8. The sample size for the training set

Not Applicable: This is not an AI/ML device that requires a training set. The device's function is mechanical and electrical, not data-driven learning.

9. How the ground truth for the training set was established

Not Applicable: As there is no training set for an AI/ML model, this question is not relevant to this submission.

In summary, the provided document is a regulatory submission for a physical medical device (an implantable port) that has been modified to be compatible with an existing ECG-based tip positioning system. The "performance data" presented is primarily a list of engineering and functional tests to demonstrate that the new design maintains safety and effectiveness and is substantially equivalent to predicate devices, not data from a clinical study on an AI/ML model.

Summary

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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 (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

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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)

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, Inc1625 West 3rd StreetTempe, 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 EnabledImplantable Port;PowerPort™ ClearVUE™ isp ECG EnabledImplantable Port;PowerPort™ isp M.R.I.™ ECG EnabledImplantable 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 ImplantablePort (K122899, cleared 11/15/2012)	PowerPort™ ClearVUE™ Slim ECG EnabledImplantable Port
PowerPort™ Implanted Polymeric Port(K063377, cleared 1/25/2007)	PowerPort™ ClearVUE™ isp ECG EnabledImplantable Port;PowerPort™ isp M.R.I.™ ECG EnabledImplantable Port
Titanium PowerPort™ isp Implanted Port(K072549, cleared 11/14/2007)	PowerPort™ Slim ECG Enabled ImplantablePort

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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 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
TechnologicalCharacteristic	PowerPort™ ClearVUE™Slim Implantable Port(K122899)	PowerPort™ ClearVUE™Slim ECG EnabledImplantable Port	Discussion
	PowerPort™ ImplantedPolymeric Port (K063377)	PowerPort™ClearVUE™ isp ECGEnabled ImplantablePort;
		PowerPort™ isp M.R.I.™ECG EnabledImplantable Port
	Titanium PowerPort™ ispImplanted Port (K072549)	PowerPort™ Slim ECGEnabled Implantable Port
Intended use	The PowerPort™Implanted Port is a totallyimplantable vascularaccess device designedto provide long-term,repeated access to thevascular system.	Same	Same as Predicate
Indications foruse	The PowerPort™ ImplantedPort is indicated for patienttherapies requiringrepeated access to thevascular system. The portsystem can be used forinfusion of medications, I.Vfluids, parenteral nutritionsolutions, blood products,and for the withdrawal ofblood samples.	The PowerPort™Implanted Port isindicated for patienttherapies requiringrepeated access to thevascular system. The portsystem can be used forinfusion of medicationsincluding anti-cancermedicines(chemotherapy) , I.V.fluids, parenteral nutritionsolutions, blood products,and for the withdrawal ofblood samples.	The addition of "anti-cancer medicines(chemotherapy)," wascleared under K181446.
	When used with thePowerLoc™ SafetyInfusion Set, thePowerPort™ device isindicated for powerinjection of contrastmedia. For powerinjection of contrastmedia, the maximumrecommended infusionrate is 5 ml/s.	When used with thePowerLoc™ SafetyInfusion Set, thePowerPort™ device isindicated for powerinjection of contrastmedia. For powerinjection of contrastmedia, the maximumrecommended infusionrate is 5 ml/s.
Patientpopulation	Patients requiringrepeated access to thevascular system	Same	Same as Predicate
	Predicate Device	Subject Device
TechnologicalCharacteristic	PowerPort™ ClearVUE™Slim Implantable Port(K122899)PowerPort™ ImplantedPolymeric Port (K063377)Titanium PowerPort™ ispImplanted Port (K072549)	PowerPort™ ClearVUE™Slim ECG EnabledImplantable PortPowerPort™ClearVUE™ isp ECGEnabled ImplantablePort;PowerPort™ isp M.R.I.™ECG EnabledImplantable PortPowerPort™ Slim ECGEnabled Implantable Port	Discussion
Principle ofoperation	The device's primarycomponents consist of atriangular injection portwith self-sealing siliconeseptum and a radiopaquecatheter. A simple slidinglock collar secures thecatheter to the port'sstem. The port can beidentified through thepatient skin via the threepalpation bumps arrangedin a triangle on theseptum.Port access is performedby percutaneous needleinsertion using a non-coring needle.	Same	Same as Predicate
Insertion site	Most commonly on upperchest	Same	Same as Predicate
Catheter tipterminationlocation	Central venous system -lower 1/3 of superior venacava preferred	Same	Same as Predicate
Duration of use	Long term (>30 days)	Same	Same as Predicate
Method ofsterilizationandsterilityassurancelevel	Ethylene Oxide, 10-6	Same	Same as Predicate
Visualizationtechnique	Fluoroscopy	Fluoroscopy or ECG	The subject devicesfacilitate accuratereproduction of sourceECG signals as shown byECG Accuracy VerificationTesting. Therefore, whenused with the BD Sherlock3CG+™ TCS, the subjectdevices can be used to
	Predicate Device	Subject Device
TechnologicalCharacteristic	PowerPort™ ClearVUE™Slim Implantable Port(K122899)PowerPort™ ImplantedPolymeric Port (K063377)Titanium PowerPort™ ispImplanted Port (K072549)	PowerPort™ ClearVUE™Slim ECG EnabledImplantable PortPowerPort™ClearVUE™ isp ECGEnabled ImplantablePort;PowerPort™ isp M.R.I.™ECG EnabledImplantable PortPowerPort™ Slim ECGEnabled Implantable Port	Discussion
			facilitate catheteradvancement and tiplocation confirmation usingpatient ECG. No new ordifferent questions of safetyand effectiveness areraised because the devicecan be accuratelyvisualized usingfluoroscopy or ECG.
ECG-compatiblecomponents	None	Included, such as styletthat is used duringcatheter placement	In addition to ECGAccuracy Verificationtesting, Catheter Air Leakand Usability testing wereconducted to evaluate thefunctionality andacceptability of stylet usewith the port catheter. Alltesting passed thepredetermined acceptancecriteria. No new or differentquestions of safety andeffectiveness are raisedbecause the device can beaccurately placed using thestylet.
Packagingconfiguration	Triple tray packaging; twosterilebarriers in the form ofnested, sealed trays	Organizational tray andretainer lid sealed insidea header bag	Packaging validationtesting evaluated thefunctionality andacceptability of the finalproduct. All testing passedthe predeterminedacceptance criteria.
DeviceDimensions			Changes to dimensionswere qualified through thefollowing performancetests. All testing passed thepredetermined acceptancecriteria. No new or differentquestions of safety andeffectiveness are raised
	Predicate Device	Subject Device
TechnologicalCharacteristic	PowerPort™ ClearVUE™Slim Implantable Port(K122899)PowerPort™ ImplantedPolymeric Port (K063377)Titanium PowerPort™ isp	PowerPort™ ClearVUE™Slim ECG EnabledImplantable PortPowerPort™ClearVUE™ isp ECGEnabled ImplantablePort;PowerPort™ isp M.R.I. ™ECG EnabledImplantable PortPowerPort™ Slim ECG	Discussion
	Implanted Port (K072549)	Enabled Implantable Port
			because the dimensionalchanges do not affect thedevice performance.
	PowerPort™ ClearVUE™Slim:Height: 10.6 mmWidth: 21.6 mm x 25.5 mmReservoir Volume: 0.4 mLCatheter:8 Fr x 46.4 cm, 1.6 mm ID	PowerPort™ ClearVUE™Slim:Height: 10.4 mmWidth: 21.6 mm x 25.5mmReservoir Volume: 0.4 mLCatheter:8 Fr x 46.4 cm, 1.6 mm ID6 Fr x 46.4 cm, 1.3 mmID	PowerPort™ ClearVUE™Slim:● Stem Catheter Leak● Stem Connection● Tensile● Stem Catheter Burst● Port Subassembly Air● Leak● Lateral Stem TensileStrength● Port SubassemblyTensile Strength● Multiple PowerInjections● Port System Burst,Power Injection● Port Subassembly AirBurst● Catheter Flow Rate
	PowerPort™ ImplantedPolymeric Port:Height: 13.7 mmWidth: 30.0 mm x 28.8 mmReservoir Volume: 0.6 mLCatheter:8 Fr x 46.4 cm, 1.6 mm ID	PowerPort™ ClearVUE™isp:Height: 11.9 mmWidth: 24.4 mm x 25.9mmReservoir Volume: 0.6 mLCatheter:8 Fr x 46.4 cm, 1.6 mm ID6 Fr x 46.4 cm, 1.3 mmID	PowerPort™ ClearVUE™isp:● Stem Catheter Leak● Stem Connection● Tensile● Stem Catheter Burst● Port Subassembly Air● Leak● Port System Burst,Power Injection● Port SubassemblyTensile Strength● Multiple PowerInjections● Port Subassembly Air
	Predicate Device	Subject Device
TechnologicalCharacteristic	PowerPort™ ClearVUE™Slim Implantable Port(K122899)PowerPort™ ImplantedPolymeric Port (K063377)Titanium PowerPort™ ispImplanted Port (K072549)	PowerPort™ ClearVUE™Slim ECG EnabledImplantable PortPowerPort™ ClearVUE™ isp ECGEnabled ImplantablePort;PowerPort™ isp M.R.I.™ECG EnabledImplantable PortPowerPort™ Slim ECGEnabled Implantable Port	Discussion
			Burst Catheter Flow Rate Magnetic Resonance Imaging Compatibility
		PowerPort™ isp M.R.I.™:Height: 11.7 mmWidth: 23.7 mm x 26.6mmReservoir Volume: 0.6 mLCatheter:8 Fr x 46.4 cm, 1.6 mm ID6 Fr x 46.4 cm, 1.3 mmID	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™ ispImplanted Port:Height: 11.2 mmWidth: 24.1 mm x 27.3 mmReservoir Volume: 0.6 mLCatheter:6.0 Fr x 45 cm, 1.3 mm ID	PowerPort™ Slim:Height: 9.8 mmBase Width: 21.2 mm x25.5 mmReservoir Volume: 0.5 mLCatheter: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
DeviceMaterials	PowerPort™ ClearVUE™Slim:PEEK, silicone,Bi2O3/acetyl polymer	PowerPort™ ClearVUE™Slim:Same	Same as Predicate
	Predicate Device	Subject Device
TechnologicalCharacteristic	PowerPort™ ClearVUE™Slim Implantable Port(K122899)PowerPort™ ImplantedPolymeric Port (K063377)	PowerPort™ ClearVUE™Slim ECG EnabledImplantable PortPowerPort™ClearVUE™ isp ECGEnabled ImplantablePort;PowerPort™ isp M.R.I.™ECG EnabledImplantable Port	Discussion
	Titanium PowerPort™ ispImplanted Port (K072549)	PowerPort™ Slim ECGEnabled Implantable Port
	PowerPort™ ImplantedPolymeric Port:Delrin, silicone, titanium	PowerPort™ ClearVUE™isp:Delrin, silicone,Bi2O3/acetyl polymer	Changes to PowerPort™ClearVUE™ isp materialswere qualified through thefollowing performancetests. All testing passed thepredetermined acceptancecriteria. No new or differentquestions of safety andeffectiveness are raisedbecause the materialchanges do not affect thedevice 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™ ispImplanted Port:Titanium, silicone	PowerPort™ Slim:Same	Same as Predicate
	Catheter:Chronoflex (purple) forTitanium PowerPort™ isp;Chronoflex (white) for allother ports	Catheter (all ports):Chronoflex (white)	The PowerPort™ Slim portcatheter change wasqualified through thefollowing performancetests. All testing passed the
	Predicate Device	Subject Device
TechnologicalCharacteristic	PowerPort™ ClearVUE™Slim Implantable Port(K122899)PowerPort™ ImplantedPolymeric Port (K063377)Titanium PowerPort™ ispImplanted Port (K072549)	PowerPort™ ClearVUE™Slim ECG EnabledImplantable PortPowerPort™ClearVUE™ isp ECGEnabled ImplantablePort;PowerPort™ isp M.R.I.™ECG EnabledImplantable PortPowerPort™ Slim ECGEnabled 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 werequalified through thefollowing performancetests. All testing passed thepredetermined acceptancecriteria. No new or differentquestions of safety andeffectiveness are raisedbecause the deviceperformance metrequirements after shelf lifetesting.
			PowerPort™ ClearVUE™Slim:• Port System Burst,Power Injection• Septum Obturation• Needle Retention• Tensile Strength• Port SubassemblyTensile Strength• Port Subassembly Air
	Predicate Device	Subject Device
TechnologicalCharacteristic	PowerPort™ ClearVUE™Slim Implantable Port(K122899)PowerPort™ ImplantedPolymeric Port (K063377)Titanium PowerPort™ ispImplanted Port (K072549)	PowerPort™ ClearVUE™Slim ECG EnabledImplantable PortPowerPort™ClearVUE™ isp ECGEnabled ImplantablePort;PowerPort™ isp M.R.I.™ECG EnabledImplantable PortPowerPort™ Slim ECGEnabled Implantable Port	Discussion
			Port Subassembly Air Burst Stem Catheter Leak Stem Catheter Burst Stem Connection Tensile Multiple Power Injections Catheter Flow Rate
	PowerPort™ ImplantedPolymeric Port:1 year	PowerPort™ ClearVUE™isp:2 yearsPowerPort™ isp M.R.I.™:2 years	PowerPort™ ClearVUE™isp/PowerPort™ ispM.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™ ispImplanted Port:1 year	PowerPort™ Slim:2 years	PowerPort™ Slim:Port System Injection Rate Multiple Power Injections
	Predicate Device	Subject Device
TechnologicalCharacteristic	PowerPort™ ClearVUE™Slim Implantable Port(K122899)	PowerPort™ ClearVUE™Slim ECG EnabledImplantable Port	Discussion
	PowerPort™ ImplantedPolymeric Port (K063377)	PowerPort™ClearVUE™ isp ECGEnabled ImplantablePort;PowerPort™ isp M.R.I.™ECG EnabledImplantable Port
	Titanium PowerPort™ ispImplanted Port (K072549)	PowerPort™ Slim ECGEnabled 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 ●

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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.

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.