Who is the manufacturer of PowerGlide ST Midline Catheter?

C.R. Bard, Inc. filed the 510(k) submission for PowerGlide ST Midline Catheter (K170158).

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

PND. 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 ST Midline Catheter?

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

What are the predicate devices for PowerGlide ST Midline Catheter?

PowerGlide Pro™ Midline Catheter (K162377).

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

K170158 · C.R. Bard, Inc. · PND · Jun 1, 2017 · General Hospital

Device Facts

Record ID	K170158
Device Name	PowerGlide ST Midline Catheter
Applicant	C.R. Bard, Inc.
Product Code	PND · General Hospital
Decision Date	Jun 1, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5200
Device Class	Class 2

Intended Use

The PowerGlide ST™ Midline Catheter is intended to be inserted in the patient's vascular system for short term use to sample blood or administer fluids intravenously.

Device Story

PowerGlide ST Midline Catheter is a sterile, single-use, single-lumen, radiopaque, body-softening polyurethane catheter. It facilitates vascular access for short-term blood sampling and intravenous fluid administration. The device is inserted percutaneously into the peripheral vasculature using the Seldinger Technique (ST) over a guidewire. It includes an integrated dilator assembly (dilator shaft, hub, and locking collar) for 18 and 20 gauge models to assist insertion. The device is compatible with power injectors for contrast media delivery. It is used in clinical settings by healthcare professionals. The output is the established vascular access path, which allows for the delivery of fluids or withdrawal of blood samples, benefiting patients by providing a reliable, short-term venous access route.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included dilator dimensions, luer connector compliance (ISO 594-1/2), tip adhesion, assembly tensile strength, and burst pressure (ISO 10555-1). Biocompatibility testing conducted per ISO 10993-1 included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, hemocompatibility, genotoxicity, and sterilization residuals.

Technological Characteristics

Materials: Polyurethane (shaft), Isoplast polyurethane (hub/dilator), Polycarbonate (locking collar). Sensing/Actuation: None (mechanical). Energy: None. Dimensions: 18, 20, 22 gauge; 8-10 cm lengths. Connectivity: None. Sterilization: Ethylene Oxide (EO). Standards: ISO 594-1/2 (luer), ISO 10555-1 (catheter), BS EN ISO 11070 (introducers/dilators), ISO 10993 (biocompatibility).

Indications for Use

Indicated for any patient population requiring short-term intravenous fluid administration or blood sampling, subject to vascular anatomy and procedural appropriateness. 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 Pro™ Midline Catheter (K162377)

Related Devices

K121073 — POWERGLIDE MIDLINE CATHETER · C.R. Bard, Inc. · Jun 1, 2012
K153280 — PowerGlide Pro Midline Catheter · C.R. Bard, Inc. · Jun 2, 2016
K162900 — PowerMidline Catheter · C.R. Bard, Inc. · Dec 14, 2016
K173114 — primeMidline Catheters · Pfm Medical, Inc. · Mar 7, 2018
K162377 — PowerGlide Pro Midline Catheter · C.R. Bard, Inc. · Sep 22, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 1, 2017 C. R. Bard. Inc. Jacob Lee Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116 Re: K170158 Trade/Device Name: PowerGlide STTM Midline Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: PND Dated: May 4, 2017 Received: May 5, 2017 Dear Mr. Jacob Lee: 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 devicerelated 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 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, Image /page/1/Picture/9 description: The image contains a signature followed by the name "Tina Kiang" and the number "-5". The signature is a complex series of loops and curves, with a prominent loop on the left side. The name "Tina Kiang" is written in a simple, sans-serif font, and the number "-5" is located directly below the name. Tina Kiang, Ph.D. Acting 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) K170158 Device Name PowerGlide ST Midline Catheter #### Indications for Use (Describe) The PowerGlide ST Midline Catheter is inserted into a patient's vascular system for short term use 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 PowerGlide ST 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}------------------------------------------------ K170158 Image /page/3/Picture/1 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. # 510(k) Summary 21 CFR 807.92(a) | General Provisions | Submitter Name: Address: Contact Person: Telephone Number: Fax Number: Date of Preparation: | Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, UT 84116 Jacob Lee Regulatory Affairs Specialist (801) 522-5823 (801) 522-4969 May 26, 2017 | |-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Subject Device | Trade Name: Common Name: Regulation Name: Product Code: Regulation: Regulatory Class: Classification Panel: | PowerGlide ST™ Midline Catheter Intravascular Catheter Intravascular Catheter PND 21 CFR § 880.5200 II General Hospital | | Predicate Device | Predicate Trade Name: Premarket Notification: Manufacturer: Common Name: Regulation Name: Product Code: Regulation: Regulatory Class: Classification Panel: | PowerGlide Pro™ Midline Catheter K162377 (cleared September 22, 2016) Bard Access Systems, Inc. Intravascular Catheter Intravascular Catheter FOZ 21 CFR § 880.5200 II General Hospital | | Device Description | Bard Access Systems, Inc.'s PowerGlide ST™ 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. The subject device consists of a single lumen, radiopaque, body softening polyurethane catheter rated for power injection, and a dilator (when applicable). Additional procedural kit accessories (e.g. introducer needle and guidewire) are included to facilitate catheter placement. The PowerGlide ST™ 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 with an integrated dilator. The 22 gauge device is offered in only an 8 cm length and does not include a dilator. | | | Intended Use | The PowerGlide ST™ Midline Catheter is intended to be inserted in the patient's vascular system for short term use to sample blood or administer fluids intravenously. | | {4}------------------------------------------------ | Indications For Use | The PowerGlide ST™ Midline Catheter is inserted into a patient's vascular system for short term use 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 ST™ Midline Catheter is suitable for use with power injectors. | | | |-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------| | | The technological characteristics of the subject PowerGlide ST™ Midline Catheters are substantially equivalent with respect to basic design and function to those of the predicate PowerGlide Pro™ Midline Catheter. The catheter assemblies (catheter shaft, luer hub and strain relief) used in both the subject and predicate devices are identical. The differences between the subject and predicate devices are not critical to the intended use of the device and do not impact the substantial equivalence determination. The key differences between the subject and predicate device include the following: | | | | | • | The subject device catheter insertion procedure uses the Seldinger Technique (ST) and is different than the all in one catheter insertion technique of the predicate device. However, both the subject and predicate devices are inserted into the vasculature over a guidewire. | | | | • | The subject device does not include the predicate device housing or insertion mechanism components. The predicate device housing and insertion mechanism components are required to facilitate the all in one catheter placement technique. Rather, the subject device will be accompanied by legally marketed procedural kit components (e.g. introducer needle and guidewire) that are necessary when inserting the subject device using the ST. | | | Technological Characteristics | • | The subject device includes a dilator assembly (dilator shaft, hub and locking collar) that is integrated into the catheter assembly to assist catheter insertion using the ST. The predicate device catheter is preloaded over an introducer needle and does not include a dilator component. | | | | The following table provides a comparison of the technological characteristics between the subject and predicate devices in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. | | | | Subject and Predicate Device Comparison Table | | | | | | Attribute | Subject Device: PowerGlide ST™ Midline | Predicate Device: PowerGlide Pro™ Midline | | Attribute | Subject Device: PowerGlide ST™ Midline Catheter | Predicate Device: PowerGlide Pro™ Midline Catheter (K162377) | |----------------|-------------------------------------------------------|--------------------------------------------------------------------| | Owner | Same as predicate | Bard Access Systems, Inc. | | Classification | PND - 21 CFR 880.5200 - Intravascular Catheter | FOZ - 21 CFR 880.5200 - Intravascular Catheter | | 510(k) Status | Subject of this Premarket Notification | K162377 - Clearance date September 22, 2016 | {5}------------------------------------------------ | Indications for Use | Same as the predicate with the exception of the subject device trade name and the removal of "(<30 days)": The PowerGlide STTM Midline Catheter is inserted into a patient's vascular system for short term use 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 STTM Midline Catheter is suitable for use with power injectors. | The PowerGlide ProTM 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 ProTM Midline Catheter is suitable for use with power injectors. | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Commercial Name | PowerGlide STTM Midline Catheter | PowerGlide ProTM Midline Catheter | | Catheter Dimensions | Same as predicate | Length: 8 and 10 cm Diameter: 18, 20, 22* Gauge *22Ga is 8 cm length only | | Duration of Use | Same as predicate | Short term | | Primary Device Components | • Catheter • Dilator (18 & 20 Ga only) | • Catheter • Needle • Guidewire | | Means of Insertion | Same as predicate | Percutaneous, Over a Guidewire | | Insertion Site | Same as predicate | Peripheral | | Primary Device Materials | Catheter Base Materials Shaft Tubing: Same as predicate Luer Hub: Same as predicate Catheter Tip: Same as predicate Dilator Hub: Isoplast Polyurethane Locking Collar: Polycarbonate Shaft: Isoplast Polyurethane | Catheter Base Materials Shaft Tubing: Polyurethane Luer Hub: Isoplast Polyurethane Catheter Tip: Isoplast Polyurethane Needle Stainless Steel Guidewire Nitinol | | Catheter Proximal Configuration | Same as predicate | Luer Connection | | Catheter Distal Configuration | Same as predicate | Open Ended | {6}------------------------------------------------ | Number of Lumens | Same as predicate | Single Lumen | |-----------------------------------------|-------------------|-------------------------------------------------------------------------| | Power Injection Maximum Flow Rate | Same as predicate | 18 Gauge = 7 mL/s max 20 Gauge = 5 mL/s max 22 Gauge = 2 mL/s max | | Sterility | Same as predicate | Provided Sterile (EO) | | Packaging Configurations | Same as predicate | Basic Configuration Full Configuration Max Configuration | Verification and validation tests have been performed in accordance with Design Controls as per 21 CFR § 820.30. 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. In addition, when technological characteristics between the subject and predicate device were found to be identical, results of the 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 a test description and applicable standard associated with each test. | Subject Device Verification Testing | | | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance Tests | Test Description | Standard Utilized | | Dilator Outer Diameter | Test to confirm that the OD of the dilator is within design specifications. | Bard internal standards and procedures | | Dilator Effective Length | Test to confirm that the length of the dilator is within design specifications. | BS EN ISO 11070:2014 - Sterile single-use intravascular introducers, dilators, and guidewires | | Dilator Luer Connector | Tests to confirm that all 6% luer fittings and connectors comply with ISO 594-1 and 594-2 | ISO 594-1:1986 - Conical fittings with 6% luer taper for syringes, needles and certain other medical equipment - Part 1: General Requirements ISO 594-2: 1998 - Conical fittings with 6% luer taper for syringes, needles and certain other medical equipment - | | Catheter/Dilator Tip Adhesion Break Force | Test to demonstrate the force required to remove the dilator from the catheter when the locking collar has been removed. | Part 2: Lock Fittings Bard internal standards and procedures | | Dilator Assembly Tensile | Test to verify that the dilator assembly does not fail in tension with forces below the predetermined | BS EN ISO 11070:2014 - Sterile single-use intravascular introducers, dilators, and guidewires | ### Performance Tests {7}------------------------------------------------ | | acceptance criteria. | | |------------------------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | Catheter/Dilator Assembly Burst Pressure | Test to verify that the burst pressure is greater than maximum use pressure. | ISO 10555-1:2013 – Sterile Sinqle-Use Intravascular Catheters – Part 1: General requirements | A biocompatibility evaluation was conducted on the subject device per ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process. According to the evaluation, the biological tests in the table below were conducted. #### Performance Tests | Biological Test | Test Standard | |---------------------------|-------------------------------------------| | Cytotoxicity | ISO 10993-5 (2009) | | Sensitization | ISO 10993-10 (2010) | | Intracutaneous Reactivity | ISO 10993-10 (2010) | | Acute Systemic Toxicity | ISO 10993-11 (2006) | | Pyrogenicity | ISO 10993-11 (2006) | | Hemocompatibility | ISO 10993-4 (2002, amended 2006) | | Genotoxicity | ISO 10993-3 (2014) ISO/TR 10993-33 (2015) | | Sterilization Residuals | ISO 10993-7 | 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. Summary of Substantial Equivalence The subject PowerGlide STTM Midline Catheter has the same intended use as the cited predicate device. The catheter assemblies utilized in both the subject and predicate devices are identical; therefore, the technological characteristics are the same with respect to the catheter assembly. The dilator assembly component of the subject device introduces different technological characteristics from the cited predicate device. The results of performance and biological tests conducted on the subject PowerGlide STTM Midline Catheter met all predetermined acceptance criteria and demonstrated that the differences in technological characteristics do not impact the substantial equivalence determination. Therefore, the proposed subject PowerGlide STTM Midline Catheter is considered substantially equivalent to the cited predicate device.