Who is the manufacturer of PowerGlide Pro Midline Catheter?

C.R. Bard, Inc. filed the 510(k) submission for PowerGlide Pro Midline Catheter (K153280).

What is the FDA product code for PowerGlide Pro Midline Catheter?

FOZ. It is classified under 21 CFR 880.5200 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for PowerGlide Pro Midline Catheter?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PowerGlide Pro Midline Catheter?

PowerGlide™ Midline Catheter (K133856).

Who can help prepare an FDA 510(k) submission like PowerGlide Pro Midline Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PowerGlide Pro Midline Catheter

K153280 · C.R. Bard, Inc. · FOZ · Jun 2, 2016 · General Hospital

Device Facts

Record ID	K153280
Device Name	PowerGlide Pro Midline Catheter
Applicant	C.R. Bard, Inc.
Product Code	FOZ · General Hospital
Decision Date	Jun 2, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5200
Device Class	Class 2

Intended Use

The PowerGlide Pro Midline Catheter is inserted into a patient's vascular system for short-term use (<30 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide Pro Midline Catheter is suitable for use with power injectors.

Device Story

PowerGlide Pro Midline Catheter is a sterile, single-use intravascular catheter for short-term (<30 days) peripheral vascular access. Device components include an introducer needle with a passive safety mechanism, a guidewire, and a single-lumen catheter. The device is inserted percutaneously over a guidewire. It is designed for power injection of fluids. The device is used in clinical settings by healthcare professionals. The catheter allows for blood sampling and fluid administration, facilitating patient treatment. The passive safety guard locks over the needle tip upon withdrawal to prevent needlestick injuries.

Clinical Evidence

Bench testing only. Performance testing included burst pressure (with/without power injection), effective needle/guidewire length, and tensile strength (needle-to-hub and guidewire bond) per ISO 10555-1:2013 and ISO 11070:2014. Biological testing included cytotoxicity (ISO 10993-5:2009) and sensitization/irritation (ISO 10993-10:2010). All tests met predetermined acceptance criteria.

Technological Characteristics

Materials: Stainless steel needle, Nitinol guidewire, polyurethane catheter/hub. Design: Single-lumen, open-ended, 18/20/22 gauge sizes. Features: Passive safety needle-shield mechanism. Sterilization: Provided sterile. Standards: ISO 10555-1:2013, ISO 11070:2014, ISO 10993-5:2009, ISO 10993-10:2010, BS EN ISO 14971:2012.

Indications for Use

Indicated for any patient population requiring short-term (<30 days) vascular access for blood sampling or intravenous fluid administration, provided vascular anatomy is adequate. 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

PowerGlide™ Midline Catheter (K133856)

Reference Devices

PowerGlide™ Midline Catheter (K121073)

Related Devices

K162377 — PowerGlide Pro Midline Catheter · C.R. Bard, Inc. · Sep 22, 2016
K121073 — POWERGLIDE MIDLINE CATHETER · C.R. Bard, Inc. · Jun 1, 2012
K133856 — POWERGLIDE MIDLINE CATHETER · C.R. Bard, Inc. · Jan 16, 2014
K252402 — Midline Catheter · Terumo Medical Products (Hangzhou) Co., Ltd. · Dec 18, 2025
K250292 — OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) · Skydance Vascular, Inc. · May 2, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three intertwined figures representing human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 2, 2016 C. R. Bard, Inc. Mr. Casey Coombs Regulatory Affairs Specialist II Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, Utah 84116 Re: K153280 Trade/Device Name: PowerGlide Pro™ Midline Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: April 29, 2016 Received: May 2, 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. {1}------------------------------------------------ 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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, Tina Kiang - 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K153280 Device Name PowerGlide Pro Midline Catheter #### Indications for Use (Describe) The PowerGlide Pro Midline Catheter is inserted into a patient's vascular system for short-term use (<30 days) to sample blood or administer fluids intravenously. These cathers may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the PowerGlide Pro Midline Catheter is 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. 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.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font, with a stylized "A" that resembles an upside-down "V". Below "BARD" is the text "ACCESS SYSTEMS" in a smaller, sans-serif font. The logo is black and white. ## 510(k) Summary 21 CFR 807.92(a) | | Submitter Name: Address: | Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, UT 84116 | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | General Provisions | Contact Person: Telephone Number: Fax Number: Date of Preparation: | Mr. Casey Coombs (801) 522-5869 (801) 522-5425 1 June 2016 | | Subject Device | Trade Name: Common Name: Classification Name: Product Code: Regulation: | PowerGlide Pro™ Midline Catheter Intravascular Catheter Intravascular Catheter FOZ 21 CFR § 880.5200 | | Predicate Device | Predicate Trade Name: Classification Name: Premarket Notification: Manufacturer: | PowerGlide™ Midline Catheter Intravascular Catheter K133856 Bard Access Systems, Inc. | | Reference Device | Reference Trade Name: Classification Name: Premarket Notification: Manufacturer: | PowerGlide™ Midline Catheter Intravascular Catheter K121073 Bard Access Systems, Inc. | | Device Description | Bard Access Systems, Inc.'s PowerGlide Pro™ Midline Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device is intended for short term use (<30 days) to sample blood and administer fluids intravenously, and employs a placement technique similar to the cited predicate device. The subject device consists of an introducer needle with a passive safety mechanism, guidewire, and single lumen catheter rated for power injection. The PowerGlide Pro™ Midline Catheter features device housings and insertion mechanisms that are different from the predicate device. | | | | The PowerGlide Pro™ Midline Catheter is offered in 18, 20, and 22 gauge sizes. The 18 and 20 gauge devices are offered in 8 cm or 10 cm lengths. The 22 gauge device is offered in only an 8 cm length. | | | Intended Use | The PowerGlide Pro™ Midline Catheter is intended to be inserted in the patient's vascular system for short term use (less than 30 days) to sample blood or administer fluids intravenously. | | {4}------------------------------------------------ | Indications For Use | The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascular system for short-term use (<30 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide Pro™ Midline Catheter is suitable for use with power injectors. | | | | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Technological characteristics of the subject PowerGlide Pro™ Midline Catheter are substantially equivalent with respect to basic design and function to those of the predicate PowerGlide™ Midline Catheters. The differences are not critical to the intended use of the device and do not raise any new 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. | | | | | | Attribute | Subject Device – PowerGlide Pro™ Midline Catheter | Predicate Device – PowerGlide™ Midline Catheter (K133856) | Reference Device – PowerGlide™ Midline Catheter (K121073) | | Technological Characteristics | Device Class | Same | FOZ 21 CFR 880.5200 Short-term Intravascular Catheter | FOZ 21 CFR 880.5200 Short-term Intravascular Catheter | | | Indications for Use | Same – with exception of trade name | The PowerGlide™ Midline Catheter is inserted into a patient's vascular system for short- term use (<30 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide™ Midline Catheter is suitable for use with power injectors. | The PowerGlide™ Midline Catheter is inserted into a patient's vascular system for short- term use (<30 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerGlide™ Midline Catheter is suitable for use with power injectors. | | | Duration of Use | Same | Short term (<30 days) | Short term (<30 days) | | | Primary Device Components | Same | Needle Guidewire Catheter | Needle Guidewire Catheter | | | Means of Insertion | Same | Percutaneous, over a guidewire | Percutaneous, over a guidewire | | | Insertion Site | Same | Peripheral | Peripheral | | | Catheter, Needle, Guidewire Materials | Catheter Base Materials | Catheter Base Materials | Catheter Base Materials | | | Needle • Same | Shaft Tubing: • Same Luer Hub: • Same | Shaft Tubing: • Polyurethane Luer Hub: • Polyurethane | Shaft Tubing: • Polyurethane Luer Hub: • Polyurethane | | | Guidewire • Same as Predicate (K133856) | Needle • Stainless Steel | Needle • Stainless Steel | Guidewire • Stainless Steel | | | | Guidewire • Nitinol | | | | | Catheter Proximal Configuration | Same | Luer Connection | Luer Connection | | al cs | Catheter Distal Configuration | Same | Open Ended | Open Ended | | | Catheter Dimensions | 18/20/22 gauge catheter Same as predicate/ reference device based on gauge size | 18 gauge catheter • Length: 8 and 10 cm • Diameter: 18 gauge 22 gauge catheter • Length: 8 cm • Diameter: 22 gauge | 20 gauge catheter • Length: 8 and 10 cm • Diameter: 20 gauge | | | Number of Lumens | Same | Single Lumen | Single Lumen | | | Catheter Labeling | 18/20/22 gauge catheter Same as predicate/ reference device based on gauge size | The luer hub is labeled with: 18 gauge catheter • Bard • PowerGlide • 7 mL/s max • 10 cm or 8 cm 22 gauge catheter • Bard • PowerGlide • 2 mL/s max • 8 cm | The luer hub is labeled with: 20 gauge catheter • Bard • PowerGlide • 5 mL/s max • 10 cm or 8 cm | | | Power Injection Maximum Flow Rate | Same as predicate/ reference device based on gauge size | 18 gauge catheter = 7 mL/s 22 gauge catheter = 2 mL/s | 20 gauge catheter = 5 mL/s | | | Needle Dimensions | Same as predicate/ reference device based on catheter gauge size | 18 gauge device = Needle OD: 21 gauge 22 gauge device = Needle OD: 24 gauge | 20 gauge device = Needle OD: 22 gauge | | | Needle Bevel | Same | B Bevel | B Bevel | | Technological Characteristics | Needle-shield feature | Same | The PowerGlide® Midline Catheter includes a passive safety guard mechanism. The safety guard locks over the needle tip as the needle is withdrawn from the vein. | The PowerGlide® Midline Catheter includes a passive safety guard mechanism. The safety guard locks over the needle tip as the needle is withdrawn from the vein. | | | Guidewire OD | Same as predicate/ reference device based on catheter gauge size | 18 gauge device = Guidewire OD: 0.018" 22 gauge device = Guidewire OD: 0.010" | 20 gauge device = Guidewire OD: 0.014" | | | Guidewire Tip Type | Same | Soft Tip | Soft Tip | | | Sterility | Same | Provided Sterile | Provided Sterile | {5}------------------------------------------------ # Technologica Characteristics {6}------------------------------------------------ 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. Additionally, when technological characteristics between the subject and predicate device were found to be identical, results of 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, including the standards associated to each test. | Performance Tests Completed | ISO Standard Utilized | |----------------------------------------|------------------------------------------------------------------------------------------------| | Burst Pressure Post Power Injection | ISO 10555 - 1: 2013, Sterile, single use intravascular catheters, Part 1: General requirements | | Burst Pressure Without Power Injection | - use intravascular catheters, Part 1: General requirements | | Effective Needle Length | ISO 11070: 2014, Sterile, single use intravascular catheter introducer | | Effective Guidewire Length | Coronary and Cerebrovascular | | Needle to Hub Tensile Strength | Guidewire Guidance, January 1995 | | Guidewire Bond Tensile Strength | | The following biological tests were also performed on the subject device: - 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 Performance Tests {7}------------------------------------------------ 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 device. Risk management, including a failure modes and effects analysis (FMEA), of the subject device was conducted in accordance with BS EN ISO 14971:2012, Medical Devices – Application of Risk Management to Medical Devices. Based on the intended use, technological characteristics, and performance Summary of testing, the subject PowerGlide Pro™ Midline Catheter met the requirements Substantial that are considered sufficient for its intended use and is therefore substantially Equivalence equivalent to the predicate device cited.