(203 days)
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.
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.
The provided document is a 510(k) premarket notification for the C. R. Bard, Inc. PowerGlide Pro™ Midline Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria in the manner typically seen for novel diagnostic or AI devices.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details, ground truth types) are not applicable or derivable from this type of regulatory submission. The document emphasizes mechanical and biological performance tests that are standard for this class of medical device.
Here's the information that can be extracted or deduced from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "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." However, the exact numerical acceptance criteria for each test are not explicitly detailed. The tests performed are as follows:
| Performance Test Completed | ISO Standard Utilized | Reported Device Performance |
|---|---|---|
| Burst Pressure Post Power Injection | ISO 10555 - 1: 2013, Sterile, single use intravascular catheters, Part 1: General requirements | Met all predetermined acceptance criteria |
| Burst Pressure Without Power Injection | ISO 10555 - 1: 2013, Sterile, single use intravascular catheters, Part 1: General requirements | Met all predetermined acceptance criteria |
| Effective Needle Length | ISO 11070: 2014, Sterile, single use intravascular catheter introducer | Met all predetermined acceptance criteria |
| Effective Guidewire Length | Coronary and Cerebrovascular Guidewire Guidance, January 1995 | Met all predetermined acceptance criteria |
| Needle to Hub Tensile Strength | Not explicitly stated | Met all predetermined acceptance criteria |
| Guidewire Bond Tensile Strength | Not explicitly stated | Met all predetermined acceptance criteria |
| Cytotoxicity | ISO 10993-5: 2009 | Met all predetermined acceptance criteria |
| Sensitization/Irritation | ISO 10993-10: 2010 | Met all predetermined acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for this type of device and regulatory submission. The document describes engineering and biological performance tests, not a clinical study on a patient test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth as typically defined for diagnostic or AI algorithm studies is not relevant here. The "ground truth" for these performance tests would be the established engineering and biocompatibility standards.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is not relevant for the performance testing of an intravascular catheter to demonstrate substantial equivalence based on mechanical and biological properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an intravascular catheter, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's acceptable performance is based on International Organization for Standardization (ISO) standards for sterile, single-use intravascular catheters and biological evaluation of medical devices, along with internal predetermined acceptance criteria for mechanical and biocompatibility tests.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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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.
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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
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Indications for Use
510(k) Number (if known)
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)
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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 WestSalt Lake City, UT 84116 | |
|---|---|---|
| GeneralProvisions | Contact Person:Telephone Number:Fax Number:Date of Preparation: | Mr. Casey Coombs(801) 522-5869(801) 522-54251 June 2016 |
| SubjectDevice | Trade Name:Common Name:Classification Name:Product Code:Regulation: | PowerGlide Pro™ Midline CatheterIntravascular CatheterIntravascular CatheterFOZ21 CFR § 880.5200 |
| PredicateDevice | Predicate Trade Name:Classification Name:Premarket Notification:Manufacturer: | PowerGlide™ Midline CatheterIntravascular CatheterK133856Bard Access Systems, Inc. |
| ReferenceDevice | Reference Trade Name:Classification Name:Premarket Notification:Manufacturer: | PowerGlide™ Midline CatheterIntravascular CatheterK121073Bard Access Systems, Inc. |
| DeviceDescription | 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 andadminister fluids intravenously, and employs a placement technique similar tothe cited predicate device. The subject device consists of an introducerneedle with a passive safety mechanism, guidewire, and single lumencatheter rated for power injection. The PowerGlide Pro™ Midline Catheterfeatures device housings and insertion mechanisms that are different from thepredicate device. | |
| The PowerGlide Pro™ Midline Catheter is offered in 18, 20, and 22 gaugesizes. 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 thepatient's vascular system for short term use (less than 30 days) to sampleblood or administer fluids intravenously. |
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| Indications For Use | The PowerGlide Pro™ Midline Catheter is inserted into a patient's vascularsystem for short-term use (<30 days) to sample blood or administer fluidsintravenously. These catheters may be used for any patient population withconsideration given to adequacy of vascular anatomy and appropriateness ofthe procedure. The PowerGlide Pro™ Midline Catheter is suitable for use withpower injectors. | |||
|---|---|---|---|---|
| Technological characteristics of the subject PowerGlide Pro™ MidlineCatheter are substantially equivalent with respect to basic design and functionto those of the predicate PowerGlide™ Midline Catheters. The differences arenot critical to the intended use of the device and do not raise any newquestions regarding safety or effectiveness.The following table provides a comparison of the technological characteristicsbetween the subject and predicate/reference devices in sufficient detail toprovide an understanding of the basis for a determination of substantialequivalence. | ||||
| Attribute | Subject Device –PowerGlidePro™ MidlineCatheter | Predicate Device –PowerGlide™Midline Catheter(K133856) | Reference Device –PowerGlide™Midline Catheter(K121073) | |
| TechnologicalCharacteristics | Device Class | Same | FOZ21 CFR 880.5200Short-termIntravascularCatheter | FOZ21 CFR 880.5200Short-termIntravascularCatheter |
| Indicationsfor Use | Same – withexception of tradename | The PowerGlide™Midline Catheter isinserted into apatient's vascularsystem for short-term use (<30 days)to sample blood oradminister fluidsintravenously. Thesecatheters may beused for any patientpopulation withconsideration givento adequacy ofvascular anatomyand appropriatenessof the procedure.The PowerGlide™Midline Catheter issuitable for use withpower injectors. | The PowerGlide™Midline Catheter isinserted into apatient's vascularsystem for short-term use (<30 days)to sample blood oradminister fluidsintravenously. Thesecatheters may beused for any patientpopulation withconsideration givento adequacy ofvascular anatomyand appropriatenessof the procedure.The PowerGlide™Midline Catheter issuitable for use withpower injectors. | |
| Duration ofUse | Same | Short term (<30days) | Short term (<30days) | |
| PrimaryDeviceComponents | Same | NeedleGuidewireCatheter | NeedleGuidewireCatheter | |
| Means ofInsertion | Same | Percutaneous, overa guidewire | Percutaneous, overa guidewire | |
| Insertion Site | Same | Peripheral | Peripheral | |
| Catheter, Needle, Guidewire Materials | Catheter Base Materials | Catheter Base Materials | Catheter Base Materials | |
| Needle• Same | Shaft Tubing:• SameLuer Hub:• Same | Shaft Tubing:• PolyurethaneLuer Hub:• Polyurethane | Shaft Tubing:• PolyurethaneLuer 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 | |
| alcs | Catheter Distal Configuration | Same | Open Ended | Open Ended |
| Catheter Dimensions | 18/20/22 gauge catheterSame as predicate/ reference device based on gauge size | 18 gauge catheter• Length: 8 and 10 cm• Diameter: 18 gauge22 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 catheterSame 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 cm22 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/s22 gauge catheter = 2 mL/s | 20 gauge catheter = 5 mL/s | |
| NeedleDimensions | Same aspredicate/reference devicebased on cathetergauge size | 18 gauge device =Needle OD: 21gauge22 gauge device =Needle OD: 24gauge | 20 gauge device =Needle OD: 22gauge | |
| Needle Bevel | Same | B Bevel | B Bevel | |
| TechnologicalCharacteristics | Needle-shieldfeature | Same | The PowerGlide®Midline Catheterincludes a passivesafety guardmechanism. Thesafety guard locksover the needle tipas the needle iswithdrawn from thevein. | The PowerGlide®Midline Catheterincludes a passivesafety guardmechanism. Thesafety guard locksover the needle tipas the needle iswithdrawn from thevein. |
| Guidewire OD | Same aspredicate/reference devicebased on cathetergauge size | 18 gauge device =Guidewire OD:0.018"22 gauge device =Guidewire OD:0.010" | 20 gauge device =Guidewire OD:0.014" | |
| Guidewire TipType | Same | Soft Tip | Soft Tip | |
| Sterility | Same | Provided Sterile | Provided Sterile |
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Technologica
Characteristics
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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
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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.
§ 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).