The Provena™ Midline 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 Provena™ Midline Catheters are suitable for use with power injectors.

Device Description

Provena™ Midline Catheters are a family of peripherally placed catheters made from radiopaque body-softening polyurethane materials. Each Provena™ Midline Catheter is designed with kink-resistant, reverse taper design. Catheters are packaged in a tray with accessories for reliable short term (less than 30 days) vascular access. The Provena™ Midline Catheters are suitable for use with power-injectors.

AI/ML Overview

The provided FDA 510(k) summary for the Provena™ Midline Catheter does not describe a study involving an AI/Machine Learning device or an analysis of clinical images. Instead, it details a traditional medical device submission focused on demonstrating substantial equivalence to a predicate device through material, dimensional, and performance characteristic comparisons.

Therefore, many of the requested details regarding acceptance criteria and study design for an AI/ML device (e.g., sample size for test set, number of experts, MRMC studies, ground truth establishment) are not applicable to the content provided.

However, I can extract and present the device performance characteristics and the type of testing performed to demonstrate substantial equivalence, which serves as a form of "acceptance criteria" for a non-AI/ML device in this context.

Here's a breakdown based on the provided document, addressing the applicable points:

Device: Provena™ Midline Catheter (Non-AI/ML Device)

1. A Table of Acceptance Criteria and the Reported Device Performance (as demonstrated by testing against the predicate):

This table compares the characteristics of the subject device (Provena™ Midline Catheter) to the predicate device (PowerMidline™ Catheter) to demonstrate substantial equivalence, rather than defining specific statistical performance metrics against a clinical ground truth as would be done for an AI/ML device. The "reported device performance" is the equivalency shown through these characteristics and the results of specified performance tests.

Attribute	Subject Devices: Provena™ Midline Catheters	Predicate Devices: Dual Lumen PowerMidline™ Catheters	Acceptance Criterion (Implicit: Substantial Equivalence)	Reported Device Performance (as Compared to Predicate)
Indications for Use	Short term access to peripheral venous system for selected IV therapies, blood sampling, and power injection of contrast media. Suitable for power injectors.	Same as subject.	Same	Equivalent
Duration of Use	Short term (<30 days)	Short term (<30 days)	Same	Equivalent
Means of Insertion	Percutaneous, Modified Seldinger Technique and guidewire	Same as subject.	Same	Equivalent
Insertion Site	Peripheral	Same as subject.	Same	Equivalent
Tip Placement Location	Peripheral venous system, tip prior to axilla	Same as subject.	Same	Equivalent
Number of Lumens	3F Single Lumen: 1; 4F Dual Lumen: 2	4F Dual Lumen: 2	-	Different (new 3F SL option) but deemed not to raise new safety/effectiveness questions. 4F DL is same.
Lumen Size	3F SL: 18 Ga; 4F DL: 18 Ga (both lumens)	4F DL: 19 Ga (large), 21 Ga (small)	-	Different but deemed not to raise new safety/effectiveness questions.
Lumen Geometry	3F SL: Circular; 4F DL: Two identical D shaped lumens	4F DL: One large D shaped and one small D shaped lumen	-	Different but deemed not to raise new safety/effectiveness questions.
Catheter Base Materials	Polyurethane (modifications made)	Polyurethane	-	Similar material; specific modifications evaluated.
Power Injection Max Flow Rate	3F SL: 6 mL/sec; 4F DL: 6 mL/sec	4F DL: 3 mL/sec	-	Different (higher for subject device) but evaluated through performance testing.
Sterility	Provided Sterile (EO)	Same as subject.	Same	Equivalent
Key Performance Tests	Priming Volume, Particulate Matter, Assembly Burst, Catheter Assembly Leak, Catheter Assembly Tensile, Gravity Flow, Device Dimensional Characterization, Power Injection Testing, Biocompatibility Evaluation	Similar tests previously conducted on predicate device.	Passed specified tests and met predetermined acceptance criteria.	All tests passed and demonstrated substantial equivalence.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable in the context of clinical data for AI/ML. The "test set" here refers to the physical devices for engineering performance testing. Numbers of units tested for each engineering test (e.g., burst pressure, tensile strength) are not specified in this summary but would be part of the underlying design verification documentation.
Data Provenance: The 'data' for this submission is primarily engineering test results on newly manufactured devices. There is no mention of patient data (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is not an AI/ML device requiring clinical image interpretation or ground truth establishment by experts. The "ground truth" for this device's performance is established by engineering specifications and industry standards.

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

Not applicable as there is no human interpretation of data requiring adjudication for this device type.

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:

No, an MRMC study was not done as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

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

The "ground truth" for this device's substantial equivalence is based on:
- Engineering Specifications: Defined physical and performance characteristics.
- Industry Standards: Compliance with standards like ISO 10555-1 (Sterile, single-use intravascular catheters) and USP 788 (Particulate Matter Testing).
- Risk Analysis: Performed in accordance with BS EN ISO 14971 (Risk Management for Medical Devices).

8. The sample size for the training set:

Not applicable as this is not an AI/ML device that requires a training set.

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

Not applicable as this is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

May 13, 2022

C. R. Bard, Inc. Jeremy Kuyakana Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116

Re: K213203

Trade/Device Name: Provena Midline Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: PND Dated: April 13, 2022 Received: April 14, 2022

Dear Jeremy Kuyakana:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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.

Payal Patel 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) K213203

Device Name Provena™ Midline Catheter

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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K213203 - 510(k) Summary

21 CFR 807.92(a)

GeneralProvisions	Submitter Name:Submitter Address:Contact Person:Telephone Number:Fax Number:Date of Preparation:	Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116Jeremy KuyakanaSr. Regulatory Affairs Specialist(801) 800-6474(801) 565-2390April 13, 2022
SubjectDevice	Trade Name:Common Name:Classification Name:Product Code:Regulation:Requlatory Class:Classification Panel:	Provena™ Midline Catheter (SL, DL)Intravascular CatheterIntravascular CatheterPND21 CFR § 880.5200Class IIGeneral Hospital
PredicateDevice	Predicate Trade Name:Common Name:Classification Name:Premarket Notification:Manufacturer:Product Code:Regulation:Regulatory Class:Classification Panel:	PowerMidline™ Catheter (SL, DL)Intravascular CatheterIntravascular CatheterK162900 (Cleared 12/14/2016)Bard Access Systems, Inc.PND21 CFR § 880.5200Class IIGeneral Hospital
DeviceDescription	Provena™ Midline Catheters are a family of peripherally placed catheters made fromradiopaque body-softening polyurethane materials. Each Provena™ Midline Catheter isdesigned with kink-resistant, reverse taper design. Catheters are packaged in a tray withaccessories for reliable short term (less than 30 days) vascular access. The Provena™Midline Catheters are suitable for use with power-injectors.
Intended Use	The Provena™ Midline Catheters are intended for short term peripheral access forselected intravenous therapies, blood sampling, and power injection of contrast media.
Indications forUse	The Provena™ Midline 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 anatomy andappropriateness of the procedure. The Provena™ Midline Catheters are suitable for usewith power injectors.

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The technological characteristics of the subject Provena™ Midline Catheters are substantially equivalent with respect to basic design, materials and function to those of the cited predicate device. The differences are not critical and do not raise any new or different questions of safety and effectiveness.

Key modifications made to the subject device when compared to the predicate device are as follows:

1. Labelling
- Modification made to the product name to introduce the Provena™ Midline . Catheters. The new name is reflected in the indications for use as well as throughout the device labeling.
1. Materials
- Depending on subject catheter models:
  - Modifications made to the base materials, colorants, and inks .

3. Technology

Depending on subject catheter models:
- . Dimensional modifications
1. Performance
- Modification to the power injection flow rate. .

Technological Characteristics

The following table provides a comparison between the technological characteristics of the subject and predicate devices.

Subject and Predicate Devices Comparison Table
Attribute	Subject Devices:ProvenaTM Midline Catheters	Predicate Devices:Dual Lumen PowerMidlineTMCatheters
Owner	Same as predicate	Bard Access Systems, Inc.
Classification	Same as predicate	PND - 21 CFR 880.5200 - Short-term -Intravascular Catheter
510(k) Status	Subject of this PremarketNotification	K162900 – Dual LumenPowerMidlineTM Catheters (Clearancedate December 14, 2016)
CommercialName	ProvenaTM Midline Catheter	PowerMidlineTM Catheter
	Indications forUse	Same as predicate	The PowerMidline™ Catheters areindicated for short term access to theperipheral venous system for selectedintravenous therapies, blood sampling,and power injection of contrast media.These catheters may be used for anypatient population with considerationgiven to adequacy of vascularanatomy and appropriateness of theprocedure. The PowerMidline™Catheters are suitable for use withpower injectors.
	Duration of Use	Same as predicate	Short term (<30 days)
TechnologicalCharacteristics	Means ofInsertion	Same as predicate	Percutaneous, using ModifiedSeldinger Technique and guidewire
	Insertion Site	Same as predicate	Peripheral
	Tip PlacementLocation	Same as predicate	Peripheral venous system, withcatheter tip terminating prior to theaxilla
	Number ofLumens	3F Single Lumen Provena™Midline Catheter: 14F Dual Lumen Provena™ MidlineCatheter: Same as predicate	4F Dual Lumen PowerMidline™Catheter: 2
	Lumen Size	3F Single Lumen Provena™Midline Catheter: 18 Ga4F Dual Lumen Provena™ MidlineCatheter: 18 Ga (both lumens)	4F Dual Lumen PowerMidline™Catheter: 19 Ga (large powerinjectable lumen), 21 Ga (small lumen)
	LumenGeometry	3F Single Lumen Provena™Midline Catheter: Circular lumen4F Dual Lumen Provena™ MidlineCatheter: Two identical D shapedlumens	4F Dual Lumen PowerMidline™Catheter: One large D shaped lumenand one small D shaped lumen
	Catheter BaseMaterials	Catheter Base MaterialsShafts TubingSame as predicateCatheter JunctionsSame as predicateExtension LegsSame as predicateLuer HubsSame as predicateExtension Leg Clamps	Catheter Base MaterialsShafts TubingPolyurethaneCatheter JunctionsPolyurethaneExtension LegsPolyurethaneLuer HubsPolyurethaneExtension Leg Clamps
CatheterProximalConfiguration	Same as predicate	Luer Connection
Catheter DistalConfiguration	Same as predicate	Open Ended
CatheterDimensions	3F Single Lumen Provena™Midline Catheter: 3 French Singlelumen x 20 cm usable length	4F Dual Lumen PowerMidline™Catheter: 4 French Dual lumen x 20cm usable length
	4F Dual Lumen Provena™ MidlineCatheter: Same as predicate
Power InjectionMaximum FlowRate (mL/sec)	3F Single Lumen Provena™Midline Catheter: 6	4F Dual Lumen PowerMidline™Catheter: 3
	4F Dual Lumen Provena™ MidlineCatheter: 6
Depth Markings	Same as predicate	"0" depth indicator located 1 cm fromcatheter junction on reverse tapershaft tubing; catheter marked every 1cm, with numeric indicators every 5cm.
Sterility	Same as predicate	Provided Sterile (EO)

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As part of Bard Access Systems, Inc.'s design controls, a risk analysis was conducted to assess the impact of the proposed device modifications. Based upon the results of the risk analysis, design control activities were identified to ensure that specified design requirements were met. The performance tests completed on the subject devices were limited to those tests required to support a determination of substantial equivalence to the predicate devices. In addition, when technological characteristics between the subject and predicate devices were found to be identical, results of the performance testing conducted on the predicate devices were applied to the subject devices. As required by the risk analysis, the following table identifies the performance tests completed on the subject devices based upon the specific modifications made to develop the subject devices. The table below includes a description of testing completed and the standard(s) followed for each test.

Testing Completed	Standard(s) Followed
Priming Volume	Guidance on Premarket Notification[510(k)] Submission for Short-Term andLong-Term Intravascular Catheters, March16, 1995
Particulate Matter Testing	USP 788
Assembly Burst (Burst Pressurewith Power Injection)	ISO 10555-1: 2013, Sterile, single-useintravascular catheters, Part 1: Generalrequirements
Catheter Assembly Leak

Performance Tests

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	Catheter Assembly Tensile	ISO 10555-1: 2013, Sterile, single-useintravascular catheters, Part 1: Generalrequirements
	Gravity Flow
	Device DimensionalCharacterization
PerformanceTests	Power Injection Testing	ISO 10555-1: 2013, Sterile, single-useintravascular catheters, Part 1: Generalrequirements
	Per ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation andTesting Within a Risk Management Process, a biocompatibility evaluation was performedbased upon the device modifications and the device classification of the subject devices.
	Per design control requirements as specified in 21 CFR 820.30, the subject devices met allpredetermined acceptance criteria derived from the above listed tests and demonstratedsubstantial equivalence as compared to the cited predicate devices.
	Risk management, including a failure modes and effects analysis (FMEA), of the subjectdevices was conducted in accordance with BS EN ISO 14971:2012, Medical Devices –Application of Risk Management to Medical Devices.
TechnologicalComparison toPredicateDevice	Technological characteristics of the subjects Provena™ Midline Catheters aresubstantially equivalent with regard to the basic design and function of the predicatedevice: Dual Lumen PowerMidline™ Catheters (K162900).
	The size, number, and geometry of the lumens in the subject devices, as well as the flowrates differ from the predicate devices. However, these differences do not alter theintended use of the subject devices, and do not raise any new or different questionsregarding safety or effectiveness when compared to the predicate devices.
Summary ofSubstantialEquivalence	The subject Provena Midline Catheters have the same intended use and fundamentaltechnological characteristics as the cited predicate device cleared under K162900. Basedon the intended use, technological characteristics, and results of performance testing, thesubject Provena™ Midline Catheters are considered substantially equivalent to the citedpredicate device.

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).