Provena(TM) Midline Catheter

K213203 · C.R. Bard, Inc. · PND · May 13, 2022 · General Hospital

Device Facts

• Record ID: K213203
• Device Name: Provena(TM) Midline Catheter
• Applicant: C.R. Bard, Inc.
• Product Code: PND · General Hospital
• Decision Date: May 13, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Provena™ Midline Catheters are intended for short term peripheral access for selected intravenous therapies, blood sampling, and power injection of contrast media.

Device Story

Provena Midline Catheter is a peripherally placed, radiopaque, body-softening polyurethane catheter; designed for short-term (less than 30 days) vascular access. Device features kink-resistant, reverse taper design; available in single and dual lumen configurations. Used in clinical settings for intravenous therapy, blood sampling, and power injection of contrast media. Inserted percutaneously via Modified Seldinger Technique with guidewire; tip placement in peripheral venous system prior to axilla. Healthcare providers use the device to provide reliable venous access; power injection capability allows for contrast media delivery during imaging procedures. Benefits include reduced need for repeated venipuncture and suitability for various patient populations based on vascular anatomy.

Clinical Evidence

Bench testing only. Performance testing included priming volume, particulate matter (USP 788), assembly burst/leak, tensile strength, gravity flow, dimensional characterization, and power injection testing (ISO 10555-1). Biocompatibility evaluated per ISO 10993-1. Risk management conducted per BS EN ISO 14971.

Technological Characteristics

Materials: Radiopaque body-softening polyurethane. Design: Kink-resistant, reverse taper, open-ended distal tip. Dimensions: 3F (single lumen) and 4F (dual lumen) variants, 20 cm length. Energy: None (passive). Connectivity: None. Sterilization: Ethylene Oxide (EO). Standards: ISO 10555-1, USP 788, ISO 10993-1, BS EN ISO 14971.

Indications for Use

Indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. May be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. Suitable for use with power injectors.

Regulatory Classification

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.

Predicate Devices

• Dual Lumen PowerMidline™ Catheters (K162900)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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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Image /page/3/Picture/0 description: The image shows the logo for BARD Access Systems. The word "BARD" is in large, bold, sans-serif font. Below the word "BARD" is the phrase "ACCESS SYSTEMS" in a smaller, sans-serif font.

# K213203 - 510(k) Summary
21 CFR 807.92(a)

| General<br>Provisions | Submitter Name:<br>Submitter Address:<br>Contact Person:<br>Telephone Number:<br>Fax Number:<br>Date of Preparation: | Bard Access Systems, Inc.<br>605 North 5600 West<br>Salt Lake City, UT 84116<br>Jeremy Kuyakana<br>Sr. Regulatory Affairs Specialist<br>[phone]<br>[phone]<br>April 13, 2022 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject<br>Device | Trade Name:<br>Common Name:<br>Classification Name:<br>Product Code:<br>Regulation:<br>Requlatory Class:<br>Classification Panel: | Provena™ Midline Catheter (SL, DL)<br>Intravascular Catheter<br>Intravascular Catheter<br>PND<br>21 CFR § 880.5200<br>Class II<br>General Hospital |
| Predicate<br>Device | Predicate Trade Name:<br>Common Name:<br>Classification Name:<br>Premarket Notification:<br>Manufacturer:<br>Product Code:<br>Regulation:<br>Regulatory Class:<br>Classification Panel: | PowerMidline™ Catheter (SL, DL)<br>Intravascular Catheter<br>Intravascular Catheter<br>K162900 (Cleared 12/14/2016)<br>Bard Access Systems, Inc.<br>PND<br>21 CFR § 880.5200<br>Class II<br>General Hospital |
| Device<br>Description | Provena™ Midline Catheters are a family of peripherally placed catheters made from<br>radiopaque body-softening polyurethane materials. Each Provena™ Midline Catheter is<br>designed with kink-resistant, reverse taper design. Catheters are packaged in a tray with<br>accessories for reliable short term (less than 30 days) vascular access. The Provena™<br>Midline Catheters are suitable for use with power-injectors. | |
| Intended Use | The Provena™ Midline Catheters are intended for short term peripheral access for<br>selected intravenous therapies, blood sampling, and power injection of contrast media. | |
| Indications for<br>Use | The Provena™ Midline Catheters are indicated for short term access to the<br>peripheral venous system for selected intravenous therapies, blood sampling,<br>and power injection of contrast media. These catheters may be used for any<br>patient population with consideration given to adequacy of vascular anatomy and<br>appropriateness of the procedure. The Provena™ Midline Catheters are suitable for use<br>with 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.
- 2. Materials
- Depending on subject catheter models:
- Modifications made to the base materials, colorants, and inks .

### 3. Technology

- Depending on subject catheter models:
- . Dimensional modifications
- 4. 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:<br>ProvenaTM Midline Catheters | Predicate Devices:<br>Dual Lumen PowerMidlineTM<br>Catheters | |
| Owner | Same as predicate | Bard Access Systems, Inc. | |
| Classification | Same as predicate | PND - 21 CFR 880.5200 - Short-term -<br>Intravascular Catheter | |
| 510(k) Status | Subject of this Premarket<br>Notification | K162900 – Dual Lumen<br>PowerMidlineTM Catheters (Clearance<br>date December 14, 2016) | |
| Commercial<br>Name | ProvenaTM Midline Catheter | PowerMidlineTM Catheter | |
| | Indications for<br>Use | Same as predicate | The PowerMidline™ Catheters are<br>indicated for short term access to the<br>peripheral venous system for selected<br>intravenous therapies, blood sampling,<br>and power injection of contrast media.<br>These catheters may be used for any<br>patient population with consideration<br>given to adequacy of vascular<br>anatomy and appropriateness of the<br>procedure. The PowerMidline™<br>Catheters are suitable for use with<br>power injectors. |
| | Duration of Use | Same as predicate | Short term (<30 days) |
| Technological<br>Characteristics | Means of<br>Insertion | Same as predicate | Percutaneous, using Modified<br>Seldinger Technique and guidewire |
| | Insertion Site | Same as predicate | Peripheral |
| | Tip Placement<br>Location | Same as predicate | Peripheral venous system, with<br>catheter tip terminating prior to the<br>axilla |
| | Number of<br>Lumens | 3F Single Lumen Provena™<br>Midline Catheter: 1<br>4F Dual Lumen Provena™ Midline<br>Catheter: Same as predicate | 4F Dual Lumen PowerMidline™<br>Catheter: 2 |
| | Lumen Size | 3F Single Lumen Provena™<br>Midline Catheter: 18 Ga<br>4F Dual Lumen Provena™ Midline<br>Catheter: 18 Ga (both lumens) | 4F Dual Lumen PowerMidline™<br>Catheter: 19 Ga (large power<br>injectable lumen), 21 Ga (small lumen) |
| | Lumen<br>Geometry | 3F Single Lumen Provena™<br>Midline Catheter: Circular lumen<br>4F Dual Lumen Provena™ Midline<br>Catheter: Two identical D shaped<br>lumens | 4F Dual Lumen PowerMidline™<br>Catheter: One large D shaped lumen<br>and one small D shaped lumen |
| | Catheter Base<br>Materials | Catheter Base Materials<br>Shafts Tubing<br>Same as predicate<br>Catheter Junctions<br>Same as predicate<br>Extension Legs<br>Same as predicate<br>Luer Hubs<br>Same as predicate<br>Extension Leg Clamps | Catheter Base Materials<br>Shafts Tubing<br>Polyurethane<br>Catheter Junctions<br>Polyurethane<br>Extension Legs<br>Polyurethane<br>Luer Hubs<br>Polyurethane<br>Extension Leg Clamps |
| Catheter<br>Proximal<br>Configuration | Same as predicate | Luer Connection | |
| Catheter Distal<br>Configuration | Same as predicate | Open Ended | |
| Catheter<br>Dimensions | 3F Single Lumen Provena™<br>Midline Catheter: 3 French Single<br>lumen x 20 cm usable length | 4F Dual Lumen PowerMidline™<br>Catheter: 4 French Dual lumen x 20<br>cm usable length | |
| | 4F Dual Lumen Provena™ Midline<br>Catheter: Same as predicate | | |
| Power Injection<br>Maximum Flow<br>Rate (mL/sec) | 3F Single Lumen Provena™<br>Midline Catheter: 6 | 4F Dual Lumen PowerMidline™<br>Catheter: 3 | |
| | 4F Dual Lumen Provena™ Midline<br>Catheter: 6 | | |
| Depth Markings | Same as predicate | "0" depth indicator located 1 cm from<br>catheter junction on reverse taper<br>shaft tubing; catheter marked every 1<br>cm, with numeric indicators every 5<br>cm. | |
| 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<br>[510(k)] Submission for Short-Term and<br>Long-Term Intravascular Catheters, March<br>16, 1995 |
| Particulate Matter Testing | USP 788 |
| Assembly Burst (Burst Pressure<br>with Power Injection) | ISO 10555-1: 2013, Sterile, single-use<br>intravascular catheters, Part 1: General<br>requirements |
| Catheter Assembly Leak | |

#### Performance Tests

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| | Catheter Assembly Tensile | ISO 10555-1: 2013, Sterile, single-use<br>intravascular catheters, Part 1: General<br>requirements |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | Gravity Flow | |
| | Device Dimensional<br>Characterization | |
| Performance<br>Tests | Power Injection Testing | ISO 10555-1: 2013, Sterile, single-use<br>intravascular catheters, Part 1: General<br>requirements |
| | Per ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and<br>Testing Within a Risk Management Process, a biocompatibility evaluation was performed<br>based 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 all<br>predetermined acceptance criteria derived from the above listed tests and demonstrated<br>substantial equivalence as compared to the cited predicate devices. | |
| | Risk management, including a failure modes and effects analysis (FMEA), of the subject<br>devices was conducted in accordance with BS EN ISO 14971:2012, Medical Devices –<br>Application of Risk Management to Medical Devices. | |
| Technological<br>Comparison to<br>Predicate<br>Device | Technological characteristics of the subjects Provena™ Midline Catheters are<br>substantially equivalent with regard to the basic design and function of the predicate<br>device: Dual Lumen PowerMidline™ Catheters (K162900). | |
| | The size, number, and geometry of the lumens in the subject devices, as well as the flow<br>rates differ from the predicate devices. However, these differences do not alter the<br>intended use of the subject devices, and do not raise any new or different questions<br>regarding safety or effectiveness when compared to the predicate devices. | |
| Summary of<br>Substantial<br>Equivalence | The subject Provena Midline Catheters have the same intended use and fundamental<br>technological characteristics as the cited predicate device cleared under K162900. Based<br>on the intended use, technological characteristics, and results of performance testing, the<br>subject Provena™ Midline Catheters are considered substantially equivalent to the cited<br>predicate device. | |