(134 days)
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.
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.
This document describes the premarket notification for a medical device, the PowerGlide ST™ Midline Catheter. It focuses on demonstrating substantial equivalence to a predicate device, not on proving clinical effectiveness through novel AI or diagnostic algorithms. Therefore, many of the requested criteria related to AI performance, ground truth establishment, expert readers, and MRMC studies are not applicable to this type of regulatory submission.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests and states that the "subject device met all predetermined acceptance criteria". However, the specific quantitative acceptance criteria values and the exact reported performance results for each test are not disclosed in this summary. It only indicates that the device passed.
| Performance Test | Acceptance Criteria (Not Explicitly Stated) | Reported Performance |
|---|---|---|
| Dilator Outer Diameter | Within design specifications (Bard internal stds) | Met criteria |
| Dilator Effective Length | Within design specifications (BS EN ISO 11070:2014) | Met criteria |
| Dilator Luer Connector | Comply with ISO 594-1 and 594-2 (6% luer taper) | Met criteria |
| Catheter/Dilator Tip Adhesion Break Force | Force required to remove dilator (Bard internal stds) | Met criteria |
| Dilator Assembly Tensile | Does not fail in tension (BS EN ISO 11070:2014) | Met criteria |
| Catheter/Dilator Assembly Burst Pressure | Greater than maximum use pressure (ISO 10555-1:2013) | Met criteria |
Biocompatibility Tests:
| Biological Test | Acceptance Criteria (Not Explicitly Stated) | Reported Performance |
|---|---|---|
| Cytotoxicity | Per ISO 10993-5 (2009) | Met criteria |
| Sensitization | Per ISO 10993-10 (2010) | Met criteria |
| Intracutaneous Reactivity | Per ISO 10993-10 (2010) | Met criteria |
| Acute Systemic Toxicity | Per ISO 10993-11 (2006) | Met criteria |
| Pyrogenicity | Per ISO 10993-11 (2006) | Met criteria |
| Hemocompatibility | Per ISO 10993-4 (2002, amended 2006) | Met criteria |
| Genotoxicity | Per ISO 10993-3 (2014), ISO/TR 10993-33 (2015) | Met criteria |
| Sterilization Residuals | Per ISO 10993-7 | Met criteria |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the described physical and biological performance tests. It also does not discuss data provenance (e.g., country of origin, retrospective/prospective) as these are non-clinical, in-vitro/bench tests on device components, not clinical data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The "ground truth" for this medical device submission is based on engineering specifications, physical/chemical properties, and biological safety standards (ISO standards). It does not involve expert interpretations of medical images or diagnoses that would require human expert consensus.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic accuracy, where there's a need to resolve discrepancies between human readers or between AI and human reads. This document describes bench testing and biocompatibility assessments which do not involve this type of adjudication.
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 question is not applicable. This submission is for a physical medical device (catheter) and does not involve AI or human readers for diagnostic purposes. Therefore, an MRMC study and effects on human reader performance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical medical catheter, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's acceptance is based on:
- Engineering design specifications: The physical dimensions and properties of the dilator and catheter.
- Industry Standards (ISO/BS EN ISO): Established international and national standards for medical devices, specifically for intravascular catheters, luer connectors, and biocompatibility.
- Bard internal standards and procedures: Proprietary testing methods and acceptance criteria used by the manufacturer.
8. The sample size for the training set
This question is not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
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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.
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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 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
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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)
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510(k) Summary
21 CFR 807.92(a)
| GeneralProvisions | Submitter Name: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) 522-4969May 26, 2017 |
|---|---|---|
| SubjectDevice | Trade Name:Common Name:Regulation Name:Product Code:Regulation:Regulatory Class:Classification Panel: | PowerGlide ST™ Midline CatheterIntravascular CatheterIntravascular CatheterPND21 CFR § 880.5200IIGeneral Hospital |
| Predicate Device | Predicate Trade Name:Premarket Notification:Manufacturer:Common Name:Regulation Name:Product Code:Regulation:Regulatory Class:Classification Panel: | PowerGlide Pro™ Midline CatheterK162377 (cleared September 22, 2016)Bard Access Systems, Inc.Intravascular CatheterIntravascular CatheterFOZ21 CFR § 880.5200IIGeneral Hospital |
| DeviceDescription | 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. |
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| Indications For Use | The PowerGlide ST™ Midline Catheter is inserted into a patient's vascularsystem for short term use to sample blood or administer fluids intravenously.These catheters may be used for any patient population with considerationgiven to adequacy of vascular anatomy and appropriateness of the procedure.The PowerGlide ST™ Midline Catheter is suitable for use with powerinjectors. | ||
|---|---|---|---|
| The technological characteristics of the subject PowerGlide ST™ MidlineCatheters are substantially equivalent with respect to basic design andfunction to those of the predicate PowerGlide Pro™ Midline Catheter. Thecatheter assemblies (catheter shaft, luer hub and strain relief) used in both thesubject and predicate devices are identical. The differences between thesubject and predicate devices are not critical to the intended use of the deviceand do not impact the substantial equivalence determination. The keydifferences between the subject and predicate device include the following: | |||
| • | The subject device catheter insertion procedure uses the SeldingerTechnique (ST) and is different than the all in one catheter insertiontechnique of the predicate device. However, both the subject andpredicate devices are inserted into the vasculature over a guidewire. | ||
| • | The subject device does not include the predicate device housing orinsertion mechanism components. The predicate device housing andinsertion mechanism components are required to facilitate the all inone catheter placement technique. Rather, the subject device will beaccompanied by legally marketed procedural kit components (e.g.introducer needle and guidewire) that are necessary when insertingthe subject device using the ST. | ||
| TechnologicalCharacteristics | • | The subject device includes a dilator assembly (dilator shaft, hub andlocking collar) that is integrated into the catheter assembly to assistcatheter insertion using the ST. The predicate device catheter ispreloaded over an introducer needle and does not include a dilatorcomponent. | |
| The following table provides a comparison of the technological characteristicsbetween the subject and predicate devices in sufficient detail to provide anunderstanding 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™ MidlineCatheter | Predicate Device:PowerGlide Pro™ MidlineCatheter (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 PremarketNotification | K162377 - Clearance dateSeptember 22, 2016 |
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| Indications forUse | Same as the predicate with theexception of the subject devicetrade name and the removal of"(<30 days)":The PowerGlide STTM MidlineCatheter is inserted into apatient's vascular system forshort term use to sample bloodor administer fluidsintravenously. These cathetersmay be used for any patientpopulation with considerationgiven to adequacy of vascularanatomy and appropriatenessof the procedure. ThePowerGlide STTM MidlineCatheter is suitable for use withpower injectors. | The PowerGlide ProTM MidlineCatheter is inserted into apatient's vascular system forshort-term use (<30 days) tosample blood or administerfluids intravenously. Thesecatheters may be used for anypatient population withconsideration given toadequacy of vascular anatomyand appropriateness of theprocedure. The PowerGlideProTM Midline Catheter issuitable for use with powerinjectors. |
|---|---|---|
| CommercialName | PowerGlide STTM MidlineCatheter | PowerGlide ProTM MidlineCatheter |
| CatheterDimensions | Same as predicate | Length: 8 and 10 cmDiameter: 18, 20, 22* Gauge*22Ga is 8 cm length only |
| Duration ofUse | Same as predicate | Short term |
| Primary DeviceComponents | • Catheter• Dilator (18 & 20 Ga only) | • Catheter• Needle• Guidewire |
| Means ofInsertion | Same as predicate | Percutaneous, Over aGuidewire |
| Insertion Site | Same as predicate | Peripheral |
| Primary DeviceMaterials | 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 |
| CatheterProximalConfiguration | Same as predicate | Luer Connection |
| Catheter DistalConfiguration | Same as predicate | Open Ended |
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| 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 |
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 | ||
|---|---|---|
| PerformanceTests | Test Description | Standard Utilized |
| Dilator OuterDiameter | Test to confirm that the ODof the dilator is withindesign specifications. | Bard internal standards andprocedures |
| Dilator EffectiveLength | Test to confirm that thelength of the dilator iswithin designspecifications. | BS EN ISO 11070:2014 -Sterile single-useintravascular introducers,dilators, and guidewires |
| Dilator LuerConnector | Tests to confirm that all 6%luer fittings and connectorscomply with ISO 594-1 and594-2 | ISO 594-1:1986 - Conicalfittings with 6% luer taper forsyringes, needles and certainother medical equipment -Part 1: GeneralRequirementsISO 594-2: 1998 - Conicalfittings with 6% luer taper forsyringes, needles and certainother medical equipment - |
| Catheter/DilatorTip AdhesionBreak Force | Test to demonstrate theforce required to removethe dilator from thecatheter when the lockingcollar has been removed. | Part 2: Lock FittingsBard internal standards andprocedures |
| Dilator AssemblyTensile | Test to verify that thedilator assembly does notfail in tension with forcesbelow the predetermined | BS EN ISO 11070:2014 -Sterile single-useintravascular introducers,dilators, and guidewires |
Performance Tests
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| acceptance criteria. | ||
|---|---|---|
| Catheter/DilatorAssembly BurstPressure | Test to verify that the burstpressure is greater thanmaximum use pressure. | ISO 10555-1:2013 – SterileSinqle-Use IntravascularCatheters – Part 1: Generalrequirements |
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.
§ 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).