The PowerMidline™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerMidline™ Catheters are suitable for use with power injectors.

Device Description

Bard Access Systems, Inc.'s (BAS) PowerMidline™ catheters are a family of peripherally placed catheters made from radiopaque body-softening polyurethane materials. Each PowerMidline™ catheter is designed with kink-resistant, reverse taper design. The PowerMidline™ catheters are offered in a 3 F Single Lumen (SL) and 4 F Single Lumen (SL) configuration for reliable short term (less than 30 days) vascular access. These catheters are offered in 20 cm trimmable lengths. The PowerMidline™ catheters are suitable for use with power injectors.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the study that proves the device meets them.

Specifically, the text does not directly state:

A table of acceptance criteria and the reported device performance: While it lists performance tests, it does not provide the specific quantitative acceptance criteria or the results achieved.
Sample sized used for the test set and the data provenance: The document mentions performance tests were completed but does not specify the sample sizes used for these tests or the origin of any data (e.g., country, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present as the studies described are primarily engineering performance tests of the catheter itself, not clinical studies involving expert evaluation of outcomes or data.
Adjudication method: Not applicable to the type of performance tests described.
If a multi reader multi case (MRMC) comparative effectiveness study was done: The document does not describe any MRMC studies.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
The type of ground truth used: For the performance tests, the "ground truth" would be established by the test specifications and standards themselves (e.g., ISO, ASTM standards, BAS internal protocols), but not in the sense of clinical ground truth like pathology or expert consensus.
The sample size for the training set: Not applicable, as this is a physical medical device.
How the ground truth for the training set was established: Not applicable, as this is a physical medical device.

What the document does provide regarding performance:

The document states that "The subject device met all predetermined acceptance criteria derived from the above listed tests and demonstrated substantially equivalent performance as compared to the cited predicate and reference devices."

It lists the following Performance Tests that were completed on the subject device, along with the standards utilized:

Device Dimensional Characterization
Catheter Assembly Tensile (ISO 10555-1: 2013)
Catheter Assembly Leak
Burst Pressure Without Power Injection
Burst Pressure Post Power Injection Gravity Flow (ISO 10555-1: 2013)
Tensile, Modulus and Elongation Requirements (FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995)
Priming Volume (FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995)
Catheter Radiopacity (BAS Internal Protocols/Procedures, ASTM F640-79 (reapproved 2000))
Power Injection Testing (ISO 10555-1: 2013)
Tip Displacement During Power Injection (BAS Internal Protocols/Procedures)
Catheter Cyclic Kink (BAS Internal Protocols/Procedures)

Additionally, the following sterilization and biological tests were performed:

Sterilant Residual Testing (ISO 10993-7: 2008)
Cytotoxicity (ISO 10993-5: 2009)
Sensitization/Irritation (ISO 10993-10: 2010)

The document concludes that the device met these criteria and demonstrated substantially equivalent performance to predicate and reference devices. However, the specific quantitative values for the acceptance criteria and the device's performance are not detailed in this summary.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized image of an eagle with three heads, representing the department's commitment to health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

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

June 28, 2016

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

Re: K153393

Trade/Device Name: PowerMidline™ Catheters Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: PND Dated: May 26, 2016 Received: May 27, 2016

Dear Mr. Coombs:

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,

Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". There is also a number 5 present in the image. The signature is complex and illegible, consisting of a series of loops and lines.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K153393

Device Name PowerMidline™ Catheters

Indications for Use (Describe)

The PowerMidline™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerMidline™ Catheters are suitable for use with power injectors.

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.

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AC

510(k) Summary 21 CFR 807.92(a)

GeneralProvisions	Submitter Name:Address:	Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116
	Contact Person:Telephone Number:Fax Number:Date of Preparation:	Mr. Casey Coombs(801) 522-5869(801) 522-542527 June 2016
SubjectDevice	Trade Name:Common Name:Classification Name:Product Code:Regulation:	PowerMidline™ CatheterMidline CatheterIntravascular CatheterPND21 CFR §880.5200
Predicate/ReferenceDevices	Predicate Device:Classification:Premarket Notification:Manufacturer:	CT MidlineLJS, 21 CFR §880.5970, Percutaneous, implanted,long-term intravascular catheterK141151Medcomp (Medical Components, Inc.)
	Reference Device:Classification Name:Premarket Notification:Manufacturer:	4 F Single Lumen (SL) PowerPICC CatheterPercutaneous, implanted, long-term intravascularcatheterK070996Bard Access Systems, Inc.
	Reference Device:Classification Name:Premarket Notification:Manufacturer:	3 F Single Lumen (SL) PowerPICC SV CatheterPercutaneous, implanted, long-term intravascularcatheterK102159Bard Access Systems, Inc.
DeviceDescription		Bard Access Systems, Inc.'s (BAS) PowerMidline™ catheters are a family ofperipherally placed catheters made from radiopaque body-softeningpolyurethane materials. Each PowerMidline™ catheter is designed with kink-resistant, reverse taper design. The PowerMidline™ catheters are offered in a3 F Single Lumen (SL) and 4 F Single Lumen (SL) configuration for reliable

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DeviceDescription	short term (less than 30 days) vascular access. These catheters are offered in20 cm trimmable lengths. The PowerMidline™ catheters are suitable for usewith power injectors.
Intended Use	The PowerMidline™ Catheter is intended for short term peripheral access forselected intravenous therapies, blood sampling, and power injection ofcontrast media.
Indications ForUse	The PowerMidline™ Catheters are indicated for short term access to theperipheral venous system for selected intravenous therapies, blood sampling,and power injection of contrast media. These catheters may be used for anypatient population with consideration given to adequacy of vascular anatomyand appropriateness of the procedure. The PowerMidline™ Catheters aresuitable for use with power injectors.

DeviceDescription

short term (less than 30 days) vascular access. These catheters are offered in20 cm trimmable lengths. The PowerMidline™ catheters are suitable for usewith power injectors.

Intended Use

The PowerMidline™ Catheter is intended for short term peripheral access forselected intravenous therapies, blood sampling, and power injection ofcontrast media.

Indications ForUse

The PowerMidline™ Catheters are indicated for short term access to theperipheral venous system for selected intravenous therapies, blood sampling,and power injection of contrast media. These catheters may be used for anypatient population with consideration given to adequacy of vascular anatomyand appropriateness of the procedure. The PowerMidline™ Catheters aresuitable for use with power injectors.

Technological characteristics of the subject PowerMidline™ Catheters are substantially equivalent with respect to basic design and function to those of the cited predicate and reference devices. The differences are not critical to the intended use of the device and do not raise new or different questions regarding safety or effectiveness.

The following table provides a comparison of the technological characteristics between the subject and predicate/reference devices in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.

	Subject and Predicate/Reference Device Comparison Table
	Attribute	Subject DevicePowerMidline™Catheter	PredicateDevice - CTMidline(K141151)	ReferenceDevice - 3 F SLPowerPICC SVCatheter(K102159)	ReferenceDevice - 4 F SLPowerPICCCatheter(K070996)
TechnologicalCharacteristics	Intended Use	Same aspredicate/referencedevices	The CT Midlineis intended toaccess thevascular systemforadministrationof fluidsintravenously,blood sampling,and powerinjection ofcontrast media.	The 3 F SLPowerPICC SVCatheter isintended toaccess thevascular systemforadministrationof fluidsintravenously,blood sampling,and powerinjection ofcontrast media.	The 4 F SLPowerPICCCatheter isintended toaccess thevascular systemforadministrationof fluidsintravenously,blood sampling,and powerinjection ofcontrast media.
	Duration ofUse	Same aspredicate CTMidline	Short term (<30days)	Short term(<30days) orlong term(>30days)	Short term(<30days) orlong term(>30days)
	Means ofInsertion	Same aspredicate/referencedevices	Percutaneous,using ModifiedSeldingerTechnique andguidewire	Percutaneous,using ModifiedSeldingerTechnique andguidewire	Percutaneous,using ModifiedSeldingerTechnique andguidewire
Subject and Predicate/Reference Device Comparison Table
	Attribute	Subject DevicePowerMidline™Catheter	PredicateDevice - CTMidline(K141151)	ReferenceDevice - 3 F SLPowerPICC SVCatheter(K102159)	ReferenceDevice - 4 F SLPowerPICCCatheter(K070996)
TechnologicalCharacteristics	Tip PlacementLocation	Same aspredicate CTMidline	Peripheralvenous system,with catheter tipterminating priorto the axilla	Central venoussystem, withlower 1/3 of theSuperior VenaCava (SVC)preferred	Central venoussystem, withlower 1/3 of theSuperior VenaCava (SVC)preferred
	Insertion Site	Same aspredicate/referencedevices	Peripheral	Peripheral	Peripheral
	Catheter BaseMaterials	Same aspredicate/referencedevices	Shaft TubingPolyurethane	Shaft TubingPolyurethane	Shaft TubingPolyurethane
			CatheterJunctionPolyurethane	CatheterJunctionPolyurethane	CatheterJunctionPolyurethane
			Extension LegPolyurethane	Extension LegPolyurethane	Extension LegPolyurethane
			Luer HubPolyurethane	Luer HubPolyurethane	Luer HubPolyurethane
			Extension LegClampAcetal Resin	Extension LegClampAcetal Resin	Extension LegClampAcetal Resin
	CatheterProximalConfiguration	Same aspredicate/referencedevices	LuerConnection	LuerConnection	LuerConnection
	CatheterDistalConfiguration	Same aspredicate/referencedevices	Open Ended	Open Ended	Open Ended
	CatheterDimensions	3 F SL x 20 cmusable length4 F SL x 20 cmusable length	4 F SL x 20 cmusable length5 F DL x 20 cmusable length	3 F SL x 45 cmusable length	4 Fr SL x 55 cmusable length
	Number,Shape ofLumens	Same as singlelumen predicate/referencedevices	Single Lumen,roundDouble Lumen,double D	Single Lumen,round	Single Lumen,round
	Subject and Predicate/Reference Device Comparison Table
TechnologicalCharacteristics	Attribute	Subject DevicePowerMidline™Catheter	PredicateDevice - CTMidline(K141151)	ReferenceDevice - 3 F SLPowerPICC SVCatheter(K102159)	ReferenceDevice - 4 F SLPowerPICCCatheter(K070996)
	DepthMarkings	Same asreferencedevices	Number every 5cm and depthmark every cm	"0" depthindicator located1 cm fromcatheterjunction onreverse tapershaft tubing;catheter markedevery 1 cm, withnumericindicators every5 cm.	"0" depthindicator located1 cm fromcatheterjunction onreverse tapershaft tubing;catheter markedevery 1 cm, withnumericindicators every5 cm.
	Pre-insertedStyletConfiguration	Same aspredicate/referencedevices	Stiffening stylet	Stiffening stylet	Stiffening stylet
	PowerInjectionMaximumFlow Rate	3 F SL = 3 mL/s4 F SL = 7 mL/s	4 Fr SL = 5mL/sec5 Fr DL = 7mL/sec	1 mL/s	5 mL/s
	Sterility	Same aspredicate/referencedevices	100% EthyleneOxide, SAL of10-6	100% EthyleneOxide, SAL of10-6	100% EthyleneOxide, SAL of10-6

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The indications for use statement is different between the subject device and predicate device. Specifically, the subject device indications for use includes a statement indicating that the device may be used with any patient population when consideration is given to adequacy of vascular anatomy and appropriateness of the procedure, whereas the predicate device indications for use does not include this statement. This difference in the indications for use does not alter the intended use of the device (i.e., access to the vascular system for administration of fluids intravenously, blood sampling, and power injection of contrast media). The purpose of this information is to specify that prior to use of the subject device, the user should consider the patient's vascular anatomy and appropriateness of using the subject device for the intended procedure. The statement does not prescribe a different general purpose or function of the device, nor does it prescribe a different patient population, therapeutic or diagnostic use of the subject device compared to the predicate device. Therefore, this difference in indications for use between the subject and predicate devices does not raise different questions of equivalence.

Performance Tests

The performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate/reference devices. Additionally, when technological characteristics between the subject and predicate/reference devices were found to be identical, results of performance testing conducted on the predicate/reference devices were applied to the subject device. The following table identifies the performance tests completed on the subject device, including the standards associated to each test.

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	Testing Completed	ISO Standard / FDA Guidance /BAS Protocols Utilized
PerformanceTests	Device DimensionalCharacterization
	Catheter Assembly Tensile	ISO 10555-1: 2013, Sterile, single-use intravascular catheters, Part 1:General requirements
	Catheter Assembly Leak
	Burst Pressure Without PowerInjection
	Burst Pressure Post Power InjectionGravity Flow	ISO 10555-1: 2013, Sterile, single-use intravascular catheters, Part 1:General requirements
	Tensile, Modulus and ElongationRequirements	Guidance on Premarket Notification[510(k)] Submission for Short-Termand Long-Term IntravascularCatheters, March 16, 1995
	Priming Volume	Guidance on Premarket Notification[510(k)] Submission for Short-Termand Long-Term IntravascularCatheters, March 16, 1995
	Catheter Radiopacity	BAS Internal Protocols/ProceduresASTM F640-79 (reapproved 2000),Standard Test Methods forRadiopacity of Plastics for MedicalUse
	Power Injection Testing	ISO 10555-1: 2013, Sterile, single-use intravascular catheters, Part 1:General requirements
	Tip Displacement During PowerInjection	BAS Internal Protocols/Procedures
	Catheter Cyclic Kink	BAS Internal Protocols/Procedures

The following sterilization and biological tests were also performed on the subject device:

. Sterilant Residual Testing - ISO 10993-7: 2008, Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals
. Cytotoxicity - ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Sensitization/Irritation ISO 10993-10: 2010, Biological evaluation of . medical devices – Part 10: Tests for irritation and skin sensitization

The subject device met all predetermined acceptance criteria derived from the above listed tests and demonstrated substantially equivalent performance as compared to the cited predicate and reference devices.

Risk management, including a failure modes and effects analysis (FMEA), of the subject devices was conducted in accordance with BS EN ISO 14971:2012, Medical Devices - Application of risk management to medical devices.

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Summary of Substantial Equivalence

Based on the intended use, technological characteristics, and performance testing, the subject PowerMidline™ Catheters meet the requirements that are considered sufficient for the intended use and are therefore substantially equivalent to the predicate and reference devices cited.

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).