The PowerPICC Catheter is 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. The maximum infusion flow rate is 5mL/second for power injection of contral venous pressure monitoring, it is recommended that a catheter lumen of 20gauge or larger be used.

Device Description

A family of peripherally inserted central catheters made from specially formulated and processed medical grade materials. Each PowerPICC® catheter has a kink resistant, reverse tapered design. Catheters are packaged in a tray with accessories for reliable long (greater than 30 days) or short (less than 30 days) term vascular access.

AI/ML Overview

The provided document is a 510(k) summary for the PowerPICC Catheter. It focuses on demonstrating substantial equivalence to a predicate device through various performance tests, rather than providing details of a study with acceptance criteria for an AI/ML powered device. Therefore, much of the requested information (sample sizes, ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable or available in this document.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful completion of the listed tests, indicating that the device performed as expected under the specified conditions. The document states that the performance tests were conducted "in determining substantial equivalence" and that "the subject PowerPICC Family Catheters have been demonstrated to be substantially equivalent to the cited predicate and reference devices." This implies that the device met the acceptance criteria derived from these tests.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility Testing	Free from biological hazard per ISO 10993-1.	Confirmed free from biological hazard; health-based risk assessment performed.
Leak Test	Catheter assembly will not leak when distal end is occluded.	Test confirmed non-leakage.
Dimensional Test	Compliance with dimensional specifications (OD/ID for single lumen, OD/lumen area for dual).	Ensured compliance with dimensional specifications.
Implantable Length	Compliance with dimensional specifications.	Ensured compliance with dimensional specifications.
Extension Leg Length	Compliance with dimensional specifications.	Confirmed compliance with dimensional specifications.
Catheter Collapse Test	Catheter will not collapse under a vacuum during aspiration.	Demonstrated non-collapse under vacuum.
Burst Test	Catheter burst pressure exceeds peak pressure at maximum flow conditions (distal end occluded).	Confirmed burst pressure exceeds peak pressure.
Hydraulic Catheter Burst Test	Catheter burst pressure exceeds peak pressure at maximum flow conditions (distal end occluded).	Confirmed burst pressure exceeds peak pressure.
Power Injection Conditioning	Catheter does not leak or burst during power injections at maximum indicated flow rate.	Confirmed no leakage or burst.
Gravity Flow	Acceptable gravity flow performance for a full-length catheter.	Demonstrated acceptable gravity flow.
Luer to Extension Leg Tensile Test	Peak tensile force exceeds minimum peak tensile force.	Demonstrated peak tensile force exceeds minimum.
Extension Leg to Trifurcation Tensile Test	Peak tensile force exceeds minimum peak tensile force.	Demonstrated peak tensile force exceeds minimum.
Trifurcation to Shaft Tensile Test	Peak tensile force exceeds minimum peak tensile force.	Demonstrated peak tensile force exceeds minimum.
Shaft Tensile Test	Evaluate maximum catheter strain and modulus at break.	Evaluated.
Radiopacity	Demonstrates catheter radio-detectability.	Demonstrated radio-detectability.
Tip Tensile	Peak tensile force exceeds minimum peak tensile force.	Demonstrated peak tensile force exceeds minimum.
Suture Wing Integrity Test	Measures maximum force suture wing can withstand prior to break.	Measured maximum force.
Priming Volume	Measures volume required to prime a full-length catheter.	Measured priming volume.
OD Swell	Catheter does not swell beyond twice the labeled OD during power injection.	Confirmed no excessive swelling.
Tip Stability Test	Catheter tip remains in the same orientation during power injection.	Confirmed tip stability.
Guidewire Drag Test	Guidewire can be removed without difficulty.	Ensured guidewire removal without difficulty.
Luer Testing	Luer connectors meet requirements for Stress Cracking, Resistance to Separation (Axial Load, Unscrewing, Overriding).	Confirmed compliance with luer connector requirements.
Particulate	Complies with USP 788 for particulate matter.	Demonstrated compliance with USP 788.

2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each test. It refers to "testing" in general. The data provenance is not mentioned, as these are in vitro and in vivo performance tests on the device itself, rather than studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are physical and biological performance tests, not clinical studies requiring expert ground truth for interpretation of outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is for physical and biological performance testing, not interpretation of data by 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
Not applicable. This is not an AI/ML device, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these tests are the established scientific and engineering principles, material properties, and regulatory standards (e.g., ISO 10993-1, ISO 10555-1, ASTM F640-12, ISO 10555-3, FDA Guidance on Premarket Notification for Intravascular Catheters, ISO 80369-7, USP 788). The device's performance is measured against these defined benchmarks.

8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.

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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 30, 2021

Bard Access Systems, Inc. Mary Strickland Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116

Re: K210264

Trade/Device Name: PowerPICC Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: June 28, 2021 Received: June 30, 2021

Dear Mary Strickland:

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. 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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 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,

CAPT Alan M. Stevens 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) K210264

Device Name

PowerPICC Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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K210381 510(k) Summary for PowerPICC Catheters

21 CFR §807.92(a)

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part(1)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is presented in the following table:

	Submitter Name:	Bard Access Systems, Inc. (Bard has joined BD)
General Provisions	Submitter Address:	605 North 5600 WestSalt Lake City, UT 84116
	Contact Person:	Mary StricklandRegulatory Affairs Specialist
	Telephone Number:	801.522.5031
	Fax Number:	801.522.5425
	Date of Preparation:	7/30/2021
	Trade Name(s):	PowerPICC Catheter
Subject Device	Common Name:	Catheter, Intravascular, Therapeutic, Long-term Greater than 30 days
	Classification Name:	Percutaneous, Implanted, Long-term Intravascular Catheter
	Class:	Class 2
	Regulation Number:	21 CFR §880.5970
	Product Code:	LJS
	Classification Panel	General Hospital
	Trade Name(s):	PowerPICC SOLO Catheter
Predicate Device	Common Name:	Catheter, Intravascular, Therapeutic, Long-term Greater than 30 days
	Classification Name:	Percutaneous, Implanted, Long-term Intravascular Catheter
	Premarket Notification #	K072230
	Class:	Class 2
	Regulation Number:	21 CFR §880.5970

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Product Code:	LJS
Classification Panel	General Hospital
Concurrence Date:	November 18, 2008
Device Description	A family of peripherally inserted central catheters made from specially formulated and processed medical gradematerials. Each PowerPICC® catheter has a kink resistant, reverse tapered design. Catheters are packaged in a traywith accessories for reliable long (greater than 30 days) or short (less than 30 days) term vascular access.
Intended Use	PowerPICC Family Catheters:The PowerPICC catheter is intended to provide short-term access (< 30 days) and long-term access (> 30 days) to thecentral venous system. They are designed for administering I.V. fluids, blood products, drugs, and parenteral nutritionsolutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media
Indications for Use	PowerPICC Family CathetersThe PowerPICC catheter is 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 pressuremonitoring. The maximum infusion flow rate is 5 mL/second for power injection of contrast media. For central venouspressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
TechnologicalCharacteristics	Technological characteristics of the subject PowerPICC Family Catheters are substantially equivalent with respect tobasic design, function, and fundamental scientific technology to those of the cited predicate device. Changescompared to the predicate device include a clarification to the indications for use statement, the addition of 5F TripleLumen and 5Fr Dual Lumen FT catheter configurations, and other minor changes to product instructions for use.
	The following table provides a summary comparison between the subject and predicate device:
	Attribute	Subject Device	Predicate device
	Owner	Bard Access Systems, Inc.	Same
	510(k) status	Subject of this 510(k)	K072230
	Device Configuration	PowerPICC SOLO Catheters:4F Single Lumen (SL), 55 cm Length5F Dual Lumen (DL), 55 cm Length5F Dual Lumen (DL) FT, 55 cm Length, (4F between 5 and 30cm mark)	PowerPICC SOLO Catheters:4F Single Lumen (SL), 55 cm Length5F Dual Lumen (DL), 55 cm Length6F Triple Lumen (TL), 55 cm Length

	5F Triple Lumen (TL) cm LengthPowerPICC Catheters:4F Single Lumen (SL), 55 cm Length5F Dual Lumen (DL), 55 cm Length5F Dual Lumen (DL), FT 55 cm Length,(4F between 5 and 30cm mark)5F Triple Lumen (TL), 55 cm Length
Indications for use	The PowerPICC catheter is indicated forshort- or long-term peripheral access to thecentral venous system for intravenoustherapy, blood sampling, power injection ofcontrast media, and allows for centralvenous pressure monitoring. The maximuminfusion flow rate is 5 mL/second for powerinjection of contrast media. For centralvenous pressure monitoring, it isrecommended that a catheter lumen of 20gauge or larger be used.	The PowerPICC SOLO catheter is indicatedfor short- or long-term peripheral access tothe central venous system for intravenoustherapy, power injection of contrast media,and allows for central venous pressuremonitoring. For blood sampling, infusion, ortherapy use a 4 French or larger catheter.The maximum recommended infusion rateis 5 mL/sec for power injection of contrastmedia. For central venous pressuremonitoring, it is recommended that acatheter lumen of 20 gauge or larger beused.
Duration of use	Same	Short term (<30 days) or Long term (>30days)
Means of insertion	Same	Percutaneous
Insertion site	Same	Peripheral
Primary devicematerials	Same	All Catheter Configurations Base Materials:Shaft Tubing:PolyurethaneLuer Connector:Polyurethane

			Extension Legs:
			Polyurethane
			Junction:
			Polyurethane
	Power injectionmaximum flow rate	Same	5 ml/sec
	Sterility	Same	Ethylene Oxide
Reference devices used for specific technological characteristics include, K070996: 4 Fr Single Lumen PowerPICCCatheter, K053501: 6 Fr Triple Lumen PowerPICC Catheter, K051672: 5 Fr Dual Lumen PowerPICC Catheter. Thetechnological differences and changes to the indications for use statement listed above were evaluated using industryconsensus standards, and as defined in the Risk Assessment. These differences in technological characteristicsbetween the subject and predicate devices do not raise new or different questions of safety or effectiveness.
Performance Tests	The following performance tests were conducted in determining substantial equivalence of the PowerPICC Catheter tothe predicate devices.
	Reference Standard: ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1:Evaluation and testing within a risk management process
	BiocompatibilityTesting	Tests to confirm that the catheter is free from biological hazard per testing. Ahealth-based risk assessment per ISO 10993-1 was performed fordetermining the acceptability of the material for the intended purpose.Testing Performed includes:Cytotoxicity Sensitization Irritation or Intracutaneous Reactivity Acute Systemic Toxicity Pyrogenicity Subchronic Systemic Toxicity
	Genotoxicity Chronic toxicity Hemocompatibility Implantation Reference Standard: ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – Part 1:
	General requirements
	Leak Test	Test to confirm that the catheter assembly will not leak when the distal end of the catheter is occluded.
	Dimensional Test	Test to measure OD and ID for single lumen catheters and OD and lumen area for dual lumen catheters to ensure compliance with dimensional specification.
	Implantable Length	Test to measure useful length for catheters to ensure compliance with dimensional specification.
	Extension Leg Length	Test to measure and confirm extension leg length compliance with dimensional specification.
	Catheter Collapse Test	Test to measure the flow rate of aspiration and demonstrate that the catheter will not collapse under a vacuum.
	Burst Test	Burst pressure test to confirm the catheter burst pressure exceeds the peak pressure present in the catheter at maximum flow conditions when the distal end is occluded.
	Hydraulic Catheter Burst Test	Burst pressure test to confirm the catheter burst pressure exceeds the peak pressure present in the catheter at maximum flow conditions when the distal end is occluded.
	Power Injection Conditioning	Test to confirm the catheter does not leak or burst as a result of power injections at maximum indicated flow rate.
	Gravity Flow	Test to measure the gravity flow performance of a full-length catheter.
	Luer to Extension Leg Tensile Test	Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force.

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Extension Leg toTrifurcation TensileTest
Trifurcation to ShaftTensile Test
Shaft Tensile Test
	Reference Standard: ASTM F640-12 – Standard Test Methods for Radiopacity of Plasticsfor Medical Use
Radiopacity	Test to demonstrate catheter radio-detectability.
	Reference Standard: ISO 10555-3:2013 - Intravascular catheters – Sterile and single-usecatheters - Part 3: Central venous catheters
Tip Tensile	Test to demonstrate the peak tensile force of each test piece exceeds theminimum peak tensile force.
	Reference Standard: FDA Guidance on Premarket Notification [510(k)] Submission for Short-Termand Long-Term Intravascular Catheters, 1995
Shaft Tensile Test	Test to evaluate the maximum catheter strain and modulus at break.
Suture Wing IntegrityTest	Test to measure the maximum force a catheter junction suture wing canwithstand prior to break.
Priming Volume	Test to measure the volume required to prime a full-length catheter.
OD Swell	Test to confirm that the catheter does not swell beyond twice the size of thelabeled OD during power injection.
Tip Stability Test	Test to confirm that the catheter tip remains in the same orientation duringpower injection (tip pointing in direction of venous flow) at the maximumindicated flow rate.
Guidewire Drag Test	Test to ensure that the guidewire used to place the catheter can be removedwithout difficulty.
Reference Standard: ISO 80369-7: Small-bore connectors for liquids and gases in healthcareapplications - Part 7: Connectors for intravascular or hypodermic applications
	Luer Testing	Testing to ensure that luer connectors meet requirements for StressCracking, Resistance to Separation from Axial Load, Resistance toSeparation from Unscrewing, and Resistance to Overriding.
Reference Standard: USP 788 Particulate Matter in Injections
	Particulate	Particulate matter is defined in the USP as extraneous, mobile, undissolvedsubstances, other than gas bubbles, unintentionally present in a solution (orin/on a device).
TechnologicalComparison toPredicate andReference Devices	Technological characteristics of the subject PowerPICC Family (PowerPICC, PowerPICC SOLO, PowerPICC FT andPowerPICC Provena, PowerPICC Provena SOLO) Catheters are substantially equivalent with regard to the basicdesign and function of the predicate device, PowerPICC SOLO, K072230, Concurrence date November 18, 2008. It isknown that the predicate and reference devices are made from grades of polyurethane typically used in catheters (andpermitted, by 21 CFR §880.5970).
Summary ofSubstantialEquivalence	Based on the risk management activities and testing, the subject PowerPICC Family Catheters have beendemonstrated to be substantially equivalent to the cited predicate and reference devices.

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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.”