The PowerPICC Provena Catheters with SOLO² Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

Catheter Size Maximum Flow Rate
3 F Single Lumen 3 mL/sec
4 F Dual Lumen 5 mL/sec

The PowerPICC Provena Catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

Catheter Size Maximum Flow Rate
3 F Single Lumen 3 mL/sec
4 F Dual Lumen 5 mL/sec

Device Description

The PowerPICC Provena Catheters and PowerPICC Provena Catheters with SOLO2 Valve Technology are sterile, single use devices designed to provide access to the patient's vascular system. The devices are intended for short- or long-term use, as clinically indicated, to sample blood and administer fluids intravenously. The catheters are capable of central venous pressure monitoring, and can withstand power injection of contrast media. The catheters are peripherally inserted central catheters (PICC) and utilize the same placement technique as the predicate device. The SOLO2 versions of the subject devices include a silicone valve on the proximal end.
The subject devices are provided sterile in basic interventional radiology (IR) as well as basic, full, and max barrier nursing PICC kits with legally marketed components to assist in the placement procedure. These kits are available in both standard and small patient versions.

AI/ML Overview

This document, K180548, is a 510(k) premarket notification for a medical device, specifically PowerPICC Provena Catheters and PowerPICC Provena Catheters with SOLO2 Valve Technology. The purpose of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials like a PMA. Therefore, the information provided focuses on comparative testing against established standards and the predicate device, rather than a clinical study with human patients, AI integration, or expert consensus on a test set in the traditional sense of an AI/ML clinical study.

Given the nature of this 510(k) submission for a non-AI/ML device, many of the requested criteria regarding AI/ML performance studies, such as multi-reader multi-case studies, ground truth establishment for clinical data, and training/test set sizes for algorithms, are not applicable.

However, we can extract information regarding acceptance criteria for the device's physical and functional performance and the study (testing) methods used to demonstrate that the device meets these criteria as part of the substantial equivalence determination.

Here's an interpretation based on the provided document:

Acceptance Criteria and Device Performance for PowerPICC Provena Catheters

Since this is a physical medical device (catheter) and not an AI/ML diagnostic or therapeutic system, the "acceptance criteria" listed here are for the device's physical and functional performance specifications. The "study" refers to the engineering and bench testing performed to verify these specifications, primarily comparing them to predicate devices and relevant ISO standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance tests conducted due to a material change in the extension leg (from Polycarbonate Polyurethane to Polyether Polyurethane). The acceptance criteria are generally "Risk Acceptability Criteria" as defined by internal standards (BAS) and ISO standards. The reported device performance is that the "subject devices met design requirements and demonstrated substantial equivalence." Specific numerical results are not provided in this summary, but the type of performance demonstrated is indicated.

Acceptance Criteria (Risk Acceptability Criteria)	Reported Device Performance (Summary)
Assembly Tensile Testing - Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force. - Standard: ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – Part 1: General requirements	Device "met design requirements and demonstrated substantial equivalence" to predicate device, implying the tensile strength criteria were met.
Dimensional Characterization - Test to demonstrate that the new material formulation conforms correctly to design tolerances of the extension legs. - Standard: BAS internal standards and procedures	Device "met design requirements and demonstrated substantial equivalence," implying dimensional conformity.
Leak Decay Testing - Testing performed to evaluate that the catheter assembly will not leak when the distal end of the catheter is occluded. - Standard: BAS internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters - Part 1: General requirements	Device "met design requirements and demonstrated substantial equivalence," implying no leaks or leaks within acceptable limits.
Hydraulic Burst Testing - Testing performed to evaluate that the catheter burst pressure exceeds the peak use pressure at maximum flow conditions. - Standard: BAS internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters - Part 1: General requirements	Device "met design requirements and demonstrated substantial equivalence," implying burst pressure exceeded requirements.
Biocompatibility Evaluation - Evaluation conducted based upon the specific modification per ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process. - Utilized information from reference device PowerPICC SOLO (K072230) which uses the same material for extension legs as subject devices.	Biocompatibility evaluation concluded device "met design requirements and demonstrated substantial equivalence."
Risk Management - Conducted in accordance with BS EN ISO 14971:2012, Medical Devices – Application of Risk Management to Medical Devices.	Risk management activities confirmed substantial equivalence.

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

Sample Size for Test Set: The document does not specify the exact number of units/parts tested for each performance test (e.g., Assembly Tensile Testing, Leak Decay Testing). Standard engineering practices for medical devices typically involve statistically significant sample sizes, but these are not disclosed in the 510(k) summary.
Data Provenance: The testing appears to be in-house bench testing conducted by the manufacturer, Bard Access Systems, Inc. The document does not indicate country of origin for test data beyond the manufacturer's location in Salt Lake City, UT, USA. The testing is prospective in the sense that it was conducted specifically for this regulatory submission to demonstrate performance of the modified device.

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

This question is not applicable in the context of this device. "Ground truth" in this scenario refers to established engineering specifications and compliance with ISO standards (e.g., tensile strength minimums, leak limits). These are determined by published standards and internal design requirements, not by expert human interpretation of data in the way radiologists interpret images.

4. Adjudication Method for the Test Set

This question is not applicable. As the "test set" involves physical and functional performance testing against objective criteria (e.g., burst pressure, tensile strength), there is no need for human adjudication of results in the way image interpretation might require. The results are quantitative measurements compared against predefined thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This question is not applicable. This device is a physical catheter, not an AI-assisted diagnostic or therapeutic system. Therefore, an MRMC study related to human reader performance with or without AI assistance was not performed.

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

This question is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

International Standards: e.g., ISO 10555-1:2013 (for intravascular catheters), ISO 10993-1:2009 (for biocompatibility), BS EN ISO 14971:2012 (for risk management).
Internal Manufacturer Specifications and Procedures: ("BAS internal standards and procedures").
Comparison to Predicate Device Performance: The primary method for 510(k) clearance is demonstrating substantial equivalence to a predicate device that has previously met these standards.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of a physical medical device. This is not an AI/ML product.

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

This question is not applicable. As there is no training set, there is no ground truth for it.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 26, 2018

C.R. Bard, Inc (Bard has joined BD) Brvan Stone Associate Manager, Regulatory Affairs 605 North 5600 West Salt Lake City, Utah 84116

Re: K180548

Trade/Device Name: PowerPICC Provena Catheters PowerPICC Provena Catheters with SOLO2 Valve Technology Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: February 27, 2018 Received: March 1, 2018

Dear Bryan Stone:

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.

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 803); good

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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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting 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)

K180548

Device Name

PowerPICC Provena Catheters with SOLO2 Valve Technology

Indications for Use (Describe)

Catheter Size	Maximum Flow Rate
3 F Single Lumen	3 mL/sec
4 F Dual Lumen	5 mL/sec

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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Indications for Use

510(k) Number (if known)

K180548

Device Name PowerPICC Provena Catheters

Indications for Use (Describe)

Catheter Size	Maximum Flow Rate
3 F Single Lumen	3 mL/sec
4 F Dual Lumen	5 mL/sec

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary K180548

21 CFR 807.92(a)

	Submitter Name:	Bard Access Systems, Inc. (Bard has joined BD)
	Submitter Address:	605 North 5600 WestSalt Lake City, UT 84116
GeneralProvisions	Contact Person:	Bryan StoneAssociate Manager, Regulatory Affairs
	Telephone Number:	(801) 522-5876
	Fax Number:	(801) 522-5425
	Date of Preparation:	April 19, 2018
	Trade Name(s):	PowerPICC Provena CathetersPowerPICC Provena Catheters with SOLO2 Valve Technology
Subject Devices	Common Name:	Catheter, Intravascular, Therapeutic, Long-term Greater than 30 days
	Classification Name:	Percutaneous, Implanted, Long-term intravascular catheter
	Product Code/Regulation:	LJS/21 CFR §880.5970
	Class	2
	Classification Panel	General Hospital
		Predicate Trade Name:
Predicate Devices	Classification Name:	Percutaneous, Implanted, Long-term intravascular catheter
	Product Code/Regulation:	LJS/21 CFR §880.5970
	Premarket Notification #:	K162443 (PowerPICC Provena)K162441 (PowerPICC Provena Catheters with SOLO2 Valve Technology)
	Manufacturer:	Bard Access Systems, Inc.
Reference Device	Reference Trade Name:	PowerPICC SOLO Catheter
	Classification Name:	Percutaneous, Implanted, Long-term intravascular catheter
	Product Code/Regulation:	LJS/21 CFR §880.5970
	Premarket Notification:	K072230
	Manufacturer:	Bard Access Systems, Inc.

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DeviceDescription	The PowerPICC Provena Catheters and PowerPICC Provena Catheters with SOLO2 Valve Technology are sterile, single usedevices designed to provide access to the patient's vascular system. The devices are intended for short- or long-term use, asclinically indicated, to sample blood and administer fluids intravenously. The catheters are capable of central venous pressuremonitoring, and can withstand power injection of contrast media. The catheters are peripherally inserted central catheters(PICC) and utilize the same placement technique as the predicate device. The SOLO2 versions of the subject devices includea silicone valve on the proximal end.The subject devices are provided sterile in basic interventional radiology (IR) as well as basic, full, and max barrier nursingPICC kits with legally marketed components to assist in the placement procedure. These kits are available in both standardand small patient versions.
Intended Use	The PowerPICC Provena Catheters and PowerPICC Provena Catheters with SOLO2 Valve Technology are intended forshort- or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
Indications ForUse	The PowerPICC Provena Catheters are indicated for short or long-term peripheral access to the central venous system forintravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring.For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
	Catheter Size Maximum Flow Rate 3F Single Lumen 3 mL/sec 4F Dual Lumen 5 mL/sec	Catheter Size Maximum Flow Rate 3F Single Lumen 3 mL/sec 4F Dual Lumen 5 mL/sec
	The PowerPICC Provena Catheters with SOLO2 Valve Technology are indicated for short or long-term peripheral access tothe central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for centralvenous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gaugeor larger be used.

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TechnologicalCharacteristics	Technological characteristics of the subject PowerPICC Provena Catheters and PowerPICC Provena Catheters with SOLO²Valve Technology are substantially equivalent with respect to basic design, function and fundamental scientific technology tothose of the cited primary predicate devices.Key modifications made to the subject devices when compared to the predicate devices are as follows:• The material formulation of the extension leg has been changed from Polycarbonate Polyurethane to PolyetherPolyurethane.The following table provides a comparison between the subject and predicate devices.
	Attribute	Subject Devices – PowerPICC ProvenaCatheters and PowerPICC Provena CathetersWith SOLO² Valve Technology
	Owner	Same
	Classification	Same
510(k) Status	Subjects of this Premarket Notification	K162443 – Concurrence date October 25, 2016K162441 – Concurrence date April 24, 2017

Indications for Use	Same	The PowerPICC Provena Catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
		Catheter Size	Maximum Flow Rate
		3F Single Lumen	3 mL/sec
		4F Dual Lumen	5 mL/sec
		The PowerPICC Provena Catheters with SOLO2 Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
		Catheter Size	Maximum Flow Rate
		3F Single Lumen	3 mL/sec
		4F Dual Lumen	5 mL/sec
Commercial Name	Same	PowerPICC Provena CathetersPowerPICC Provena Catheters with SOLO2 Valve Technology
Catheter	Same	3F Single Lumen x 55 cm
Duration of Use	Same	Short (<30 days) or long-term (>30 days)
Means ofInsertion	Same	Percutaneous using a peel-away sheathIntroducer
Insertion Site	Same	Peripheral
Primary DeviceMaterials	Catheter Base Materials	Catheter Base Materials
	Shaft Tubing:	Shaft Tubing:
	Same	Polycarbonate Polyurethane
	Luer Connector:	Luer Connector:
	Same	Polyurethane
	Extension Legs:	Extension Legs:
	Polyether Polyurethane	Polycarbonate Polyurethane
	Junction:	Junction:
	Same	Polycarbonate Polyurethane (inner)Polyether Polyurethane (outer)
	Valve (SOLO2 Only):	Valve (SOLO2 Only):
	Same	Silicone
CatheterProximalConfiguration	Same	Luer ConnectionLuer Connection with Valve (SOLO2)
Catheter DistalConfiguration	Same	Open Ended
Number ofLumens	Same	Single LumenDual Lumen
	Power InjectionMaximum Flow Rate	Same	Catheter Size3F Single Lumen	Maximum Flow Rate3 mL/sec
			4F Dual Lumen	5 mL/sec
	Sterility	Same	Provided Sterile
	PackagingConfigurations	Same	Both Standard and Small Patient versions of the following configurations: Basic Configuration Full Configuration Max Barrier Configuration IR Configuration
	The technological differences listed above were evaluated using the same test requirements as the predicate devices, as defined in the Risk Assessment. Therefore, these differences in technological characteristics between the subject and predicate devices do not raise different questions of safety or effectiveness.
PerformanceTests	Based on a risk analysis, the performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate device. In addition, when technological characteristics between the subject and predicate device were found to be identical, results of the performance testing conducted on the predicate device were applied to the subject device. The following table identifies the performance tests completed on the subject device based upon the specific modification to the extension leg material, including a test description and applicable standard associated with each test.
	Verification /Validation Method	Risk Acceptability Criteria (Acceptance Criteria of Test)
	Assembly TensileTesting	Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force. ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – Part 1: General requirements

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	DimensionalCharacterization	Test to demonstrate that the new material formulation conforms correctly to design tolerances of the extensionlegs.BAS internal standards and procedures
	Leak DecayTesting	Testing performed to evaluate that the catheter assembly will not leak when the distal end of the catheter isoccluded.BAS internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use IntravascularCatheters - Part 1: General requirements
	Hydraulic BurstTesting	Testing performed to evaluate that the catheter burst pressure exceeds the peak use pressure at maximumflow conditions.BAS internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use IntravascularCatheters - Part 1: General requirements
	A biocompatibility evaluation was also conducted based upon the specific modification to the subject device per ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process.According to this evaluation, and the tests and references mentioned above, the subject devices met design requirementsand demonstrated substantial equivalence as compared to the cited predicate devices. This biocompatibility evaluation alsoutilized the information from the reference device PowerPICC SOLO (K072230), which uses the same material for theextension legs as the subject devices.Risk management, including a failure modes and effects analysis (FMEA), of the subject devices was conducted inaccordance with BS EN ISO 14971:2012, Medical Devices – Application of Risk Management to Medical Devices.
Summary ofSubstantialEquivalence	Based on the risk management activities, the subject PowerPICC Provena Catheters and PowerPICC Provena Catheterswith SOLO2 Valve Technology have been demonstrated to be substantially equivalent to the cited predicate devices.

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”