(29 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.
The 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 an identical placement technique 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 subject PowerGlide Pro™ Midline Catheter features a catheter with a reinforced tip to support patency of the catheter during aspiration or blood draw. 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 describes the PowerGlide Pro™ Midline Catheter, which is an intravascular catheter intended for short-term use (<30 days) to sample blood or administer fluids intravenously. The submission is a 510(k) premarket notification, indicating substantial equivalence to a previously cleared predicate device (K153280). The key modification to the new device is a "reinforced catheter tip."
Here is an analysis of the acceptance criteria and the study performed, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document describes several performance tests conducted to demonstrate substantial equivalence of the modified PowerGlide Pro™ Midline Catheter to its predicate. The acceptance criteria are generally framed as "less than or equal to the predicate device," "not swell beyond twice the size of the labeled OD," "not collapse under a vacuum," "remains in the same orientation... and does not kink," and "be greater than maximum use pressure." The reported performance is summarized as the device "met all predetermined acceptance criteria." Specific numerical values for criteria or performance are not explicitly provided in this summary for most tests, but rather stated as meeting the internal standards or predicate performance.
| Performance Test | Acceptance Criteria (as stated or implied) | Reported Device Performance |
|---|---|---|
| Catheter Tip Adhesion Break Force | Force required to push catheter off needle after conditioning shall be less than or equal to the predicate device. (Bard internal standards and procedures) | Met all predetermined acceptance criteria |
| Catheter Swelling OD | Catheter does not swell beyond twice the size of the labeled OD during power injection. (Bard internal standards and procedures) | Met all predetermined acceptance criteria |
| Catheter Collapse | Catheter tip will not collapse under a vacuum during aspiration. (Bard internal standards and procedures, FDA guidance) | Met all predetermined acceptance criteria |
| Tip Location During and After Power Injection | Catheter tip remains in the same orientation during power injection (tip pointing in direction of venous flow) and does not kink following power injection when conducted at the maximum indicated flow rate. (Bard internal standards and procedures) | Met all predetermined acceptance criteria |
| Reinforced Tip Flexural Fatigue (Cyclic Kinking and Burst Test) | Burst pressure must be greater than maximum use pressure when the tip is occluded, following cyclical kink conditioning. (Bard internal standards and procedures, ISO 10555-1:2013) | Met all predetermined acceptance criteria |
| Reinforced Tip Separation Strength | Burst pressure must be greater than maximum use pressure when the tip is occluded. (ISO 10555-1:2013) | Met all predetermined acceptance criteria |
| Biocompatibility (Hemolysis, Coagulation, Complement Activation) | Tests conducted per ISO 10993-1:2009 and ISO 10993-4:2002 to demonstrate hemocompatibility. Specific criteria would be defined by these standards (e.g., non-hemolytic, no significant activation of coagulation/complement). | Met all predetermined acceptance criteria derived from the verification tests related to biocompatibility evaluation |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample sizes used for the test sets for any of the performance tests. It also does not provide information regarding the provenance of the data (country of origin, retrospective or prospective). These tests appear to be laboratory-based engineering performance tests rather than clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This type of information is not applicable to the studies described. The studies are engineering performance tests of a medical device, not clinical studies requiring expert interpretation or ground truth establishment in a medical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable to the studies described, as they are engineering performance tests and not clinical studies requiring adjudication of medical findings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device is an intravascular catheter, not an AI-powered diagnostic or assistive technology. No MRMC study or AI-related effectiveness study was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical instrument, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance tests listed are the established physical and mechanical properties (e.g., force, swelling, flow rate, kink resistance, burst pressure) as defined by Bard's internal standards, FDA guidance, and international standards (ISO 10555-1:2013, ISO 10993 series). These are objective measurements against defined standards, not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
This information is not applicable. There is no "training set" as this is not an algorithm or AI system being developed or evaluated.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set.
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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.
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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 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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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 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.
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510(k) Summary
21 CFR 807.92(a)
| GeneralProvisions | Submitter Name:Submitter Address:Contact Person:Telephone Number:Fax Number:Date of Preparation: | Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116Jacob LeeRegulatory Affairs Specialist(801) 522-5823(801) 522-5425September 14, 2016 |
|---|---|---|
| SubjectDevice | Trade Name:Common Name:Regulation Name:Product Code:Regulation:Regulatory Class:Classification Panel: | PowerGlide Pro™ Midline CatheterIntravascular CatheterIntravascular CatheterFOZ21 CFR § 880.5200IIGeneral Hospital |
| PredicateDevice | Predicate Trade Name:Premarket Notification:Manufacturer:Common Name:Regulation Name:Product Code:Regulation:Regulatory Class:Classification Panel: | PowerGlide Pro™ Midline CatheterK153280 (cleared June 2, 2016)Bard Access Systems, Inc.Intravascular CatheterIntravascular CatheterFOZ21 CFR § 880.5200IIGeneral Hospital |
| DeviceDescription | The PowerGlide Pro™ Midline Catheter is a sterile, single use devicedesigned to provide access to the patient's vascular system. The device isintended for short term use (<30 days) to sample blood and administer fluidsintravenously, and employs an identical placement technique to the citedpredicate device. The subject device consists of an introducer needle with apassive safety mechanism, guidewire, and single lumen catheter rated forpower injection. The subject PowerGlide Pro™ Midline Catheter features acatheter with a reinforced tip to support patency of the catheter duringaspiration or blood draw.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 thepatient's vascular system for short term use (less than 30 days) to sample | blood or administer fluids intravenously. |
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| Indications ForUse | 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. | |||
|---|---|---|---|---|
| The technological characteristics of the subject PowerGlide Pro™ MidlineCatheter are substantially equivalent with respect to basic design, materialsand function to those of the cited predicate device. The differences are notcritical to the intended use of the device and do not raise any new or differentquestions of safety and effectiveness. | ||||
| Key modifications made to the subject device when compared to the predicatedevice are as follows: | ||||
| Reinforced catheter tip - Integration of material to the inner diameter●of the catheter tip. | ||||
| Labeling modifications - The content description of the unit label will●be revised to identify the catheter with reinforced tip. All other typesof device labeling (case labels, IFU, inserts, etc.) will remain the sameas the predicate device. | ||||
| The following table provides a comparison between the technologicalcharacteristics of the subject and predicate device. | ||||
| Subject and Predicate Device Comparison Table | ||||
| Technological | ||||
| Characteristics | Attribute | Subject Device:PowerGlide Pro™ MidlineCatheter | Predicate Device:PowerGlide Pro™ MidlineCatheter (K153280) | |
| Owner | Same as predicate | Bard Access Systems, Inc. | ||
| Classification | Same as predicate | FOZ - 21 CFR 880.5200 - Short-term - Intravascular Catheter | ||
| 510(k) Status | Subject of this PremarketNotification | K153280 - Clearance dateJune 2, 2016 | ||
| Indications forUse | Same as predicate | The PowerGlide Pro™ MidlineCatheter is inserted into apatient's vascular system forshort-term use (<30 days) tosample blood or administer fluidsintravenously. These cathetersmay be used for any patientpopulation with considerationqiven to adequacy of vascularanatomy and appropriateness ofthe procedure. The PowerGlidePro™ Midline Catheter issuitable for use with powerinjectors. | ||
| Subject and Predicate Device Comparison Table | ||||
| Attribute | Subject Device:PowerGlide Pro™ MidlineCatheter | Predicate Device:PowerGlide Pro™ MidlineCatheter (K153280) | ||
| TechnologicalCharacteristics | CatheterDimensions | Same as predicate | Length: 8 and 10 cmDiameter: 18, 20, 22* Gauge*22Ga is 8cm length only | |
| Duration ofUse | Same as predicate | Short term (<30 days) | ||
| Primary DeviceComponents | Same as predicate | Catheter● Needle● Guidewire | ||
| Means ofInsertion | Same as predicate | Percutaneous, Over a Guidewire | ||
| Insertion Site | Same as predicate | Peripheral | ||
| Primary DeviceMaterials | Catheter Base Materials:● Shaft Tubing:Same as predicate● Luer Hub:Same as predicate● Catheter Tip (InnerDiameter):Isoplast Polyurethane(same as Luer Hub)Needle● Same as predicateGuidewire● Same as predicate | Catheter Base Materials:● Shaft Tubing:Polyurethane● Luer Hub:Isoplast PolyurethaneNeedle● Stainless SteelGuidewire● Nitinol | ||
| CatheterProximalConfiguration | Same as predicate | Luer Connection | ||
| Catheter DistalConfiguration | Same as predicate | Open Ended | ||
| Number ofLumens | Same as predicate | Single Lumen | ||
| Power InjectionMaximum FlowRate | Same as predicate | 18 Gauge = 7 mL/s max20 Gauge = 5 mL/s max22 Gauge = 2 mL/s max | ||
| Sterility | Same as predicate | Provided Sterile (EO) | ||
| PackagingConfigurations | Same as predicate | Basic ConfigurationFull ConfigurationMax Configuration |
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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, 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 | |
|---|---|---|
| PerformanceTests | Catheter Tip AdhesionBreak Force | Test to demonstrate the force required to push thecatheter off the needle after potential adhesion due toconditioning. The force required shall be less than orequal to the predicate device.Bard internal standards and procedures |
| Catheter Swelling OD | Test to confirm that the catheter does not swell beyondtwice the size of the labeled OD during power injection.Bard internal standards and procedures | |
| Catheter Collapse | Test to measure the flow rate of aspiration anddemonstrate that the catheter tip will not collapse under avacuum.Bard internal standards and procedures and FDAguidance, Guidance on Premarket Notification[510(k)] Submission for Short-Term and Long-TermIntravascular Catheters (March 16, 1995) | |
| Tip Location Duringand After PowerInjection | Test to confirm that the catheter tip remains in the sameorientation during power injection (tip pointing in directionof venous flow) and does not kink following powerinjection when conducted at the maximum indicated flowrate.Bard internal standards and procedures | |
| Reinforced TipFlexural Fatigue(Cyclic Kinking andBurst Test) | Burst pressure test to confirm the reinforced tip materialwill not separate from the catheter shaft under maximumuse pressure conditions following cyclical kinkconditioning of the catheter tip. The burst pressure mustbe greater than maximum use pressure when the tip isoccluded.Bard internal standards and procedures and ISO10555-1:2013 – Sterile Single-Use IntravascularCatheters - Part 1: General requirements | |
| Reinforced TipSeparation Strength | Burst pressure test to confirm the reinforced tip materialwill not separate from the catheter shaft under maximumuse pressure conditions. The burst pressure must begreater than maximum use pressure when the tip isoccluded.ISO 10555-1:2013 – Sterile Single-Use IntravascularCatheters - Part 1: General requirements |
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| PerformanceTests | A biocompatibility evaluation was conducted based upon the specificmodification to the subject device per ISO 10993-1:2009, BiologicalEvaluation of Medical Devices - Part 1: Evaluation and Testing Within a RiskManagement Process. According to this evaluation the followinghemocompatibility tests were conducted per ISO 10993-4:2002, BiologicalEvaluation of Medical Devices - Part 4: Selection of tests for interaction withblood:• Hemolysis• Coagulation (UPTT & PT)• Compliment ActivationPer design control requirements as specified in 21 CFR 820.30, the subjectdevice met all predetermined acceptance criteria derived from the above listedverification tests and demonstrated substantial equivalence as compared tothe cited predicate device. |
|---|---|
| Risk management, including a failure modes and effects analysis (FMEA), ofthe subject device was conducted in accordance with BS EN ISO 14971:2012,Medical Devices - Application of Risk Management to Medical Devices. | |
| Summary ofSubstantialEquivalence | The subject PowerGlide Pro™ Midline Catheter has the same intended useand fundamental technological characteristics as the cited predicate devicecleared under K153280. Based on the intended use, technologicalcharacteristics, and results of performance testing, the subject PowerGlidePro™ Midline Catheter is considered substantially equivalent to the citedpredicate device. |
§ 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).