PowerGlide Pro Midline Catheter

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three human profiles facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 22, 2016 C. R. Bard, Inc. Mr. Jacob Lee Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116 Re: K162377 Trade/Device Name: PowerGlide Pro™ Midline Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: August 22, 2016 Received: August 24, 2016 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 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 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/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 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, Tina Kiang -S 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 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K162377 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 catheters may 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 shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font. Below that, the words "ACCESS SYSTEMS" are in a smaller, sans-serif font. K162377 ## 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>Jacob Lee<br>Regulatory Affairs Specialist<br>(801) 522-5823<br>(801) 522-5425<br>September 14, 2016 | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Subject<br>Device | Trade Name:<br>Common Name:<br>Regulation Name:<br>Product Code:<br>Regulation:<br>Regulatory Class:<br>Classification Panel: | PowerGlide Pro™ Midline Catheter<br>Intravascular Catheter<br>Intravascular Catheter<br>FOZ<br>21 CFR § 880.5200<br>II<br>General Hospital | | Predicate<br>Device | Predicate Trade Name:<br>Premarket Notification:<br>Manufacturer:<br>Common Name:<br>Regulation Name:<br>Product Code:<br>Regulation:<br>Regulatory Class:<br>Classification Panel: | PowerGlide Pro™ Midline Catheter<br>K153280 (cleared June 2, 2016)<br>Bard Access Systems, Inc.<br>Intravascular Catheter<br>Intravascular Catheter<br>FOZ<br>21 CFR § 880.5200<br>II<br>General Hospital | | Device<br>Description | The PowerGlide Pro™ Midline Catheter is a sterile, single use device<br>designed to provide access to the patient's vascular system. The device is<br>intended for short term use (<30 days) to sample blood and administer fluids<br>intravenously, and employs an identical placement technique to the cited<br>predicate device. The subject device consists of an introducer needle with a<br>passive safety mechanism, guidewire, and single lumen catheter rated for<br>power injection. The subject PowerGlide Pro™ Midline Catheter features a<br>catheter with a reinforced tip to support patency of the catheter during<br>aspiration or blood draw.<br>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.<br>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<br>patient's vascular system for short term use (less than 30 days) to sample | blood or administer fluids intravenously. | {4}------------------------------------------------ | Indications For<br>Use | The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascular<br>system for short-term use (<30 days) to sample blood or administer fluids<br>intravenously. These catheters may be used for any patient population with<br>consideration given to adequacy of vascular anatomy and appropriateness of<br>the procedure. The PowerGlide Pro™ Midline Catheter is suitable for use with<br>power injectors. | | | | |-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | The technological characteristics of the subject PowerGlide Pro™ Midline<br>Catheter are substantially equivalent with respect to basic design, materials<br>and function to those of the cited predicate device. The differences are not<br>critical to the intended use of the device and do not raise any new or different<br>questions of safety and effectiveness. | | | | | | Key modifications made to the subject device when compared to the predicate<br>device are as follows: | | | | | | Reinforced catheter tip - Integration of material to the inner diameter<br>●<br>of the catheter tip. | | | | | | Labeling modifications - The content description of the unit label will<br>●<br>be revised to identify the catheter with reinforced tip. All other types<br>of device labeling (case labels, IFU, inserts, etc.) will remain the same<br>as the predicate device. | | | | | The following table provides a comparison between the technological<br>characteristics of the subject and predicate device. | | | | | | | Subject and Predicate Device Comparison Table | | | | | Technological | | | | | | Characteristics | Attribute | Subject Device:<br>PowerGlide Pro™ Midline<br>Catheter | Predicate Device:<br>PowerGlide Pro™ Midline<br>Catheter (K153280) | | | | Owner | Same as predicate | Bard Access Systems, Inc. | | | | Classification | Same as predicate | FOZ - 21 CFR 880.5200 - Short-<br>term - Intravascular Catheter | | | | 510(k) Status | Subject of this Premarket<br>Notification | K153280 - Clearance date<br>June 2, 2016 | | | | Indications for<br>Use | Same as predicate | The PowerGlide Pro™ Midline<br>Catheter is inserted into a<br>patient's vascular system for<br>short-term use (<30 days) to<br>sample blood or administer fluids<br>intravenously. These catheters<br>may be used for any patient<br>population with consideration<br>qiven to adequacy of vascular<br>anatomy and appropriateness of<br>the procedure. The PowerGlide<br>Pro™ Midline Catheter is<br>suitable for use with power<br>injectors. | | | | | Subject and Predicate Device Comparison Table | | | | | Attribute | Subject Device:<br>PowerGlide Pro™ Midline<br>Catheter | Predicate Device:<br>PowerGlide Pro™ Midline<br>Catheter (K153280) | | | Technological<br>Characteristics | Catheter<br>Dimensions | Same as predicate | Length: 8 and 10 cm<br>Diameter: 18, 20, 22* Gauge<br>*22Ga is 8cm length only | | | | Duration of<br>Use | Same as predicate | Short term (<30 days) | | | | Primary Device<br>Components | Same as predicate | Catheter<br>● Needle<br>● Guidewire | | | | Means of<br>Insertion | Same as predicate | Percutaneous, Over a Guidewire | | | | Insertion Site | Same as predicate | Peripheral | | | | Primary Device<br>Materials | Catheter Base Materials:<br>● Shaft Tubing:<br>Same as predicate<br>● Luer Hub:<br>Same as predicate<br>● Catheter Tip (Inner<br>Diameter):<br>Isoplast Polyurethane<br>(same as Luer Hub)<br>Needle<br>● Same as predicate<br>Guidewire<br>● Same as predicate | Catheter Base Materials:<br>● Shaft Tubing:<br>Polyurethane<br>● Luer Hub:<br>Isoplast Polyurethane<br>Needle<br>● Stainless Steel<br>Guidewire<br>● Nitinol | | | | Catheter<br>Proximal<br>Configuration | Same as predicate | Luer Connection | | | | Catheter Distal<br>Configuration | Same as predicate | Open Ended | | | | Number of<br>Lumens | Same as predicate | Single Lumen | | | | Power Injection<br>Maximum Flow<br>Rate | Same as predicate | 18 Gauge = 7 mL/s max<br>20 Gauge = 5 mL/s max<br>22 Gauge = 2 mL/s max | | | | Sterility | Same as predicate | Provided Sterile (EO) | | | | Packaging<br>Configurations | Same as predicate | Basic Configuration<br>Full Configuration<br>Max Configuration | | {5}------------------------------------------------ {6}------------------------------------------------ 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, the necessary design control activities were identified to ensure that specified design requirements were met. 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. As required by the risk analysis, the following table identifies the performance tests completed on the subject device based upon the specific modification to the catheter tip, including a test description and applicable standard associated with each test. | | Performance Tests | Test Description / Standard Utilized | |----------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Performance<br>Tests | Catheter Tip Adhesion<br>Break Force | Test to demonstrate the force required to push the<br>catheter off the needle after potential adhesion due to<br>conditioning. The force required shall be less than or<br>equal to the predicate device.<br>Bard internal standards and procedures | | | Catheter Swelling OD | Test to confirm that the catheter does not swell beyond<br>twice the size of the labeled OD during power injection.<br>Bard internal standards and procedures | | | Catheter Collapse | Test to measure the flow rate of aspiration and<br>demonstrate that the catheter tip will not collapse under a<br>vacuum.<br>Bard internal standards and procedures and FDA<br>guidance, Guidance on Premarket Notification<br>[510(k)] Submission for Short-Term and Long-Term<br>Intravascular Catheters (March 16, 1995) | | | Tip Location During<br>and After Power<br>Injection | Test to confirm that the catheter tip remains in the same<br>orientation during power injection (tip pointing in direction<br>of venous flow) and does not kink following power<br>injection when conducted at the maximum indicated flow<br>rate.<br>Bard internal standards and procedures | | | Reinforced Tip<br>Flexural Fatigue<br>(Cyclic Kinking and<br>Burst Test) | Burst pressure test to confirm the reinforced tip material<br>will not separate from the catheter shaft under maximum<br>use pressure conditions following cyclical kink<br>conditioning of the catheter tip. The burst pressure must<br>be greater than maximum use pressure when the tip is<br>occluded.<br>Bard internal standards and procedures and ISO<br>10555-1:2013 – Sterile Single-Use Intravascular<br>Catheters - Part 1: General requirements | | | Reinforced Tip<br>Separation Strength | Burst pressure test to confirm the reinforced tip material<br>will not separate from the catheter shaft under maximum<br>use pressure conditions. The burst pressure must be<br>greater than maximum use pressure when the tip is<br>occluded.<br>ISO 10555-1:2013 – Sterile Single-Use Intravascular<br>Catheters - Part 1: General requirements | {7}------------------------------------------------ | Performance<br>Tests | A biocompatibility evaluation was conducted based upon the specific<br>modification to the subject device per ISO 10993-1:2009, Biological<br>Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk<br>Management Process. According to this evaluation the following<br>hemocompatibility tests were conducted per ISO 10993-4:2002, Biological<br>Evaluation of Medical Devices - Part 4: Selection of tests for interaction with<br>blood:<br>• Hemolysis<br>• Coagulation (UPTT & PT)<br>• Compliment Activation<br>Per design control requirements as specified in 21 CFR 820.30, the subject<br>device met all predetermined acceptance criteria derived from the above listed<br>verification tests and demonstrated substantial equivalence as compared to<br>the cited predicate device. | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Risk management, including a failure modes and effects analysis (FMEA), of<br>the subject device was conducted in accordance with BS EN ISO 14971:2012,<br>Medical Devices - Application of Risk Management to Medical Devices. | | Summary of<br>Substantial<br>Equivalence | The subject PowerGlide Pro™ Midline Catheter has the same intended use<br>and fundamental technological characteristics as the cited predicate device<br>cleared under K153280. Based on the intended use, technological<br>characteristics, and results of performance testing, the subject PowerGlide<br>Pro™ Midline Catheter is considered substantially equivalent to the cited<br>predicate device. |