The PowerPort® implanted port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

When used with a 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

PowerPort® Implantable Ports are designed to provide repeated access to the vascular system without the need for repeated venipuncture or daily care of an external catheter. Long-Term Implantable Ports consist of a rigid housing and a self-sealing septum. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Polyurethane catheters are attached to the port by the physician during implantation.

PowerPort® Implantable Ports can be used for routine vascular access using a non-coring access needle. However, for power injection procedures, PowerPort® ports must be accessed with a Bard PowerLoc® Safety Infusion Set (SIS) to create a power-injectable system.

The ChronoFlex® Polyurethane Catheters maintain an average root mean square catheter surface profilometry of less than 0.5µm.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Catheter Surface Profilometry (RMS Value)	≤ 0.5µm
Maximum Recommended Infusion Rate for Power Injection of Contrast Media	5 mL/s
Compliance with FDA Guidance Documents and ISO Standards	Met all pre-determined acceptance criteria
Biocompatibility	Met all pre-determined acceptance criteria
Sterilization	Met all pre-determined acceptance criteria
Packaging	Met all pre-determined acceptance criteria
Bacterial Endotoxins	Met all pre-determined acceptance criteria
MRI Safety	Met all pre-determined acceptance criteria
Overall Substantial Equivalence to Predicate Device	Demonstrated substantial equivalence

Study Details

Sample sizes used for the test set and the data provenance:
- The document does not explicitly state specific sample sizes for the test set or the number of units tested for each criterion. It mentions "Verification and validation activities were designed and performed in accordance with Design Controls as per 21 CFR §820.30."
- Data Provenance: Not specified, but given it's a submission to the US FDA by a US-based company (Bard Access Systems, Inc. in Salt Lake City, Utah), it's highly likely the pre-clinical testing was conducted in the US. The document does not indicate if the data is retrospective or prospective, but as it pertains to device performance testing before market approval, it would be considered prospective data generation for the purpose of the submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The document describes engineering and performance testing based on standards, not studies involving human interpretation or clinical ground truth establishment in the typical sense of AI/reader studies.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable and therefore not provided. The testing described is for physical device performance and adherence to standards, not for expert-based assessment that would require adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for AI diagnostic or decision support tools, where human readers interact with AI. The device in question is a physical medical device (implantable port and catheter), not an AI system.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. The device is a physical product, not an algorithm. The "standalone" performance here refers to the device's physical and functional attributes.
The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering specifications, validated measurement methods, and compliance with recognized industry standards and FDA guidance documents for medical devices (e.g., ISO 10555, AAMI/ANSI/ISO 10993, ASTM F2503). The listed performance tests (e.g., surface profilometry, infusion rate, biocompatibility) are measured against these pre-defined, objective standards.
The sample size for the training set:
- Not applicable. The device is a physical medical device, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As the device is not an AI algorithm, there is no "training set" or corresponding ground truth establishment in that context.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 20, 2015

C.R. Bard, Inc. Mr. James Davis Regulatory Affairs Specialist Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, Utah 84116

Re: K150514

Trade/Device Name: Power-injectable Implantable Ports with Chronoflex® Polyurethane Catheters Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: October 22, 2015 Received: October 23, 2015

Dear Mr. Davis:

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 (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. 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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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Tina Kiang S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150514

Device Name

Power-Injectable Implantable Ports with ChronoFlex® Polyurethane Catheters

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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510(k) Summary 21 CFR 807.92

Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters

	Submitter Name:	Bard Access Systems, Inc.
	Address:	605 North 5600 WestSalt Lake City, UT 84116
GeneralProvisions	Contact Person	James R. DavisRegulatory Affairs SpecialistJames.R.Davis@crbard.com801.522.5000 ext 5456801.522.5425
	Date of Preparation:	22 October 2015
SubjectDevice	Trade Name:	Power-Injectable Implantable Ports with ChronoFlex®Polyurethane Catheters
	Common/Usual Name:	Implanted Infusion Port & Catheter
	Classification Name:	Subcutaneous, Implanted, Intravascular Infusion Portand Catheter
	Product Code:	LJT
	Regulation:	21 CFR 880.5965
PredicateDevice	Trade Name:	PowerPort® ClearVUE® Slim Implantable Port
	Classification Name:	Subcutaneous, Implanted, Intravascular Infusion Portand Catheter
	Premarket Notification:	K122899
	Manufacturer:	Bard Access Systems, Inc.
ReferenceDevices	Trade Name:	Titanium PowerPort® ISP Implanted Port with 6 Fr.ChronoFlex® Polyurethane Catheter
	Classification Name:	Subcutaneous, Implanted, Intravascular Infusion Portand Catheter
	Premarket Notification:	K072549
	Manufacturer:	Bard Access Systems, Inc.
	Trade Name:	PowerPort® Polymeric Port with 8 F S/L ChronoFlex®Catheters
	Classification Name:	Subcutaneous, Implanted, Intravascular Infusion Portand Catheter
	Premarket Notification:	K063377
	Manufacturer:	Bard Access Systems, Inc.

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Reference Devices Justification

The references devices are provided because a bundled 510(k) submission is appropriate for the subject device since the scientific and regulatory issues are most efficiently addressed during one review. Additionally, the performance data is the same for the subject devices, only the General Hospital review branch is involved with the review process and the devices have the same indications for use.

Attribute	SUBJECT DEVICE	PREDICATE DEVICE
	Power-Injectable Implantable Ports withChronoFlex® Polyurethane Catheters	PowerPort® ClearVUE® Slim Implantable Port(K122899)
Note	Bold red font indicates a difference between the subject device and the current regulatory predicate baseline of the predicate device.Plain type indicates that the attribute of the subject device is the same as that of the current regulatory baseline of the predicate device.
Owner	Same	Bard Access Systems, Inc.
510(k) Status	Subject of this Premarket Notification	K122899Concurrence Date:November 15th, 2012
Classification	Same	21 CFR 880.5965 – Class IILJT – Subcutaneous, implanted, intravascular infusion port and catheter
Intended Use	Same	Power-Injectable Implantable Ports are intended to be an implanted vascular access device designed to provide long-term, repeated access to the vascular system.
Indications for Use	Same	The PowerPort® implanted port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.When used with a 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.
Duration of Use	Same	Long term (>30 days)
Insertion Site	Same	Port is implanted subcutaneously with catheter tunneled and inserted in blood vessel
Catheter Tip Location	Same	Central venous system - lower 1/3 of superior vena cava preferred
Significant Device Dimensions	8 Fr. & 6 Fr. Catheter Surface ProfilometryRMS Value: ≤0.5µm	8 Fr. & 6 Fr. Catheter Surface ProfilometryN/A
Catheter Body Materials	Same	Polyurethane
Port Body Materials	Same	Polyetheretherketone (Body/Stem)Silicone (Suture Plugs)
Catheter Lock Materials	Same	Polycarbonate
DeviceDescription	PowerPort® Implantable Ports are designed to provide repeated access to thevascular system without the need for repeated venipuncture or daily care of anexternal catheter. Long-Term Implantable Ports consist of a rigid housing and aself-sealing septum. The catheters used with infusion ports are essentially thesame design as externalized, stand-alone intravascular catheters. Polyurethanecatheters are attached to the port by the physician during implantation.
	PowerPort® Implantable Ports can be used for routine vascular access using anon-coring access needle. However, for power injection procedures, PowerPort®ports must be accessed with a Bard PowerLoc® Safety Infusion Set (SIS) tocreate a power-injectable system.
	The ChronoFlex® Polyurethane Catheters maintain an average root mean squarecatheter surface profilometry of less than 0.5µm.
Intended Use	Power-Injectable Implantable Ports are intended to be an implanted vascularaccess device designed to provide long-term, repeated access to the vascularsystem.
Indications forUse	The PowerPort® implanted port is indicated for patient therapies requiringrepeated access to the vascular system. The port system can be used forinfusion of medications, I.V. fluids, parenteral nutrition solutions, blood products,and for the withdrawal of blood samples.
	When used with a PowerLoc® safety infusion set, the PowerPort® device isindicated for power injection of contrast media. For power injection of contrastmedia, the maximum recommended infusion rate is 5 mL/s.
TechnologicalCharacteristics	The technological characteristics of the subject Power-Injectable Ports withChronoFlex® Polyurethane Catheters are substantially equivalent with respect todesign and function to those of the predicate devices.
PerformanceTests	Verification and validation activities were designed and performed in accordancewith Design Controls as per 21 CFR §820.30. The following guidancedocuments and standards in conjunction with in-house protocols were used todetermine appropriate methods for evaluating the performance of the device:FDA Guidance - Guidance on 510(k) Submissions for Implanted InfusionPorts; October, 1990 FDA Guidance – Guidance on 510(k) Submissions for Short-Term and Long-Term Intravascular Catheters, March 16, 1990 FDA Guidance - General Considerations for Animal Studies for CardiovascularDevices, dated July 29,2010 FDA Guidance – Good Laboratory Practices Questions and Answers, datedJuly, 2007 FDA Guidance - Bundling Multiple Devices or Multiple Indications in a singlesubmission, dated June 22, 2007 FDA Guidance – Establishing safety and compatibility of passive implants inthe magnetic resonance environment, dated August 21, 2008 ISO 10555-1 Second Edition 2013-07-01, Sterile, Single-Use IntravascularCatheters, Part 1: General Requirements ISO 10555-3 Second Edition 2013-06-15, Sterile, Single-Use IntravascularCatheters, Part 3: Central Venous Catheters AAMI/ANSI/ISO 11135-1: 2007, Sterilization of Healthcare Products –Ethylene Oxide AAMI/ANSI/ISO 10993-1:2009/(R) 2013, Biological Evaluation of MedicalDevices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 TestProfile ISO 10993-7 Second Edition 2008-10-15, Biological Evaluation for MedicalDevices; Part 7 – Ethylene Oxide Sterilization Residuals AAMI/ANSI/ISO 11607:2006/(R)2010, Packaging for Terminally SterilizedMedical Devices AAMI / ANSI ST72:2011: Bacterial Endotoxins—Test Methodologies, RoutineMonitoring, and Alternatives to Batch Testing ASTM F2503-13 (2014), Standard Practice for marketing Medical Devices andOther Items for Safety in the Magnetic Resonance (MR) Environment The subject device met all pre-determined acceptance criteria and demonstratedsubstantial equivalence as compared to the predicate devices.
TestingConclusion	The results of the testing performed demonstrate the subject device performanceis substantially equivalent to the predicate device.
Summary ofSubstantialEquivalence	Based on the indications for use, technological characteristics, and performancetesting, the subject Power-Injectable Ports with ChronoFlex® Polyurethane Cathetersmeets the requirements that are considered sufficient for its intended use anddemonstrates that the subject devices are substantially equivalent to thepredicate devices cited.

Subject and Predicate Device Comparison

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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.