(58 days)
The PowerMidline™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerMidline™ Catheters are suitable for use with power injectors.
The dual lumen PowerMidline™ catheters are a family of peripherally placed catheters made from radiopaque body-softening polyurethane materials. Each dual lumen PowerMidline™ catheter is designed with kink-resistant, reverse taper design. The dual lumen PowerMidline™ catheters are offered in a 4 F dual lumen (DL) and 5 F dual lumen (DL) configuration for reliable short term (less than 30 days) vascular access. These catheters are offered in 20 cm trimmable lengths. The dual lumen PowerMidline™ catheters are suitable for use with power injectors.
This document is a 510(k) summary for the PowerMidline Catheter (K162900) by Bard Access Systems, Inc. It describes the device, its intended use, indications for use, and a comparison to its predicate device (K153393). The document primarily focuses on demonstrating substantial equivalence to a previously cleared device, rather than defining and proving new acceptance criteria for an innovative device feature or algorithm.
Therefore, the requested information about acceptance criteria and a study proving a device-specific, newly established acceptance criteria cannot be fully extracted from this document in the way it's usually applied to a new AI/medical device. The document explicitly states: "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." and "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 "acceptance criteria" here are essentially "meets the performance requirements of the predicate device" or "meets the requirements of the specified ISO/FDA guidance documents."
However, I can extract the types of performance tests conducted and the standards/guidances used, which implicitly define what was considered acceptable performance.
1. Table of Acceptance Criteria and Reported Device Performance
Instead of explicit numerical acceptance criteria, the document states that the device "met all predetermined acceptance criteria" derived from various performance tests. The "reported device performance" is the confirmation that these implicit criteria were met, leading to a determination of substantial equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Priming Volume: The priming volume of the dual lumen PowerMidline™ Catheter should be measured and reported in accordance with FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995, and BAS Internal Protocols/Procedures. (Implicit criterion: The device must have a measured priming volume that is safe and acceptable for its intended use, comparable to similar devices if applicable). | "Test and Report Priming Volume" - Met (as implied by the statement "the subject device met all predetermined acceptance criteria"). Specific values are not provided in this summary. |
| Shaft Tensile Strength: The catheter shaft must meet tensile strength requirements as specified in ISO 10555-1: 2013, Sterile, single-use intravascular catheters, Part 1: General requirements. (Implicit criterion: The catheter shaft must be strong enough to withstand anticipated tensile forces during clinical use without failure). | "Shaft Tensile" - Met (as implied by the statement "the subject device met all predetermined acceptance criteria"). |
| Modulus and Elongation: The device must meet modulus and elongation requirements as specified in FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995 (Implicit criterion: The material properties of the catheter must allow for flexibility and durability appropriate for intravascular use). | "Test and Report Modulus and Elongation Requirements" - Met (as implied by the statement "the subject device met all predetermined acceptance criteria"). |
| Assembly Burst (Burst Pressure with Power Injection): The catheter assembly must withstand burst pressure, particularly during power injection, within acceptable limits. (Implicit criterion: The catheter must not burst or leak under the pressures encountered during power injection). | "Assembly Burst (Burst Pressure with Power Injection)" - Met (as implied by the statement "the subject device met all predetermined acceptance criteria"). |
| Catheter Assembly Leak: The catheter assembly must be leak-proof. (Implicit criterion: No fluid leakage should occur from the catheter assembly under normal operating conditions). | "Catheter Assembly Leak" - Met (as implied by the statement "the subject device met all predetermined acceptance criteria"). |
| Catheter Assembly Tensile Strength: The catheter assembly must meet tensile strength requirements as specified in ISO 10555-1: 2013, Sterile, single-use intravascular catheters, Part 1: General requirements. (Implicit criterion: The assembled catheter must be strong enough to withstand anticipated tensile forces during clinical use without separation or failure). | "Catheter Assembly Tensile" - Met (as implied by the statement "the subject device met all predetermined acceptance criteria"). |
| Gravity Flow: The device must exhibit acceptable gravity flow characteristics. (Implicit criterion: The catheter must allow for adequate fluid flow rates under gravity). | "Test and Report Gravity Flow" - Met (as implied by the statement "the subject device met all predetermined acceptance criteria"). Specific values are not provided in this summary. |
| Device Dimensional Characterization: The dimensions of the device must be accurately characterized and meet design specifications. (Implicit criterion: The physical dimensions of the catheter, including French size, length, and lumen dimensions, must conform to engineering drawings and be suitable for its intended use). | "Device Dimensional Characterization" - Met (as implied by the statement "the subject device met all predetermined acceptance criteria"). Specific values are provided in the comparison table regarding 4 F DL x 20 cm and 5 F DL x 20 cm usable lengths, and Dual Lumen, two "D" shaped lumens. |
| Catheter Cyclic Kink: The catheter must resist kinking under cyclic stress. (Implicit criterion: The catheter must maintain patency and functionality when subjected to bending forces encountered during patient movement or catheter placement). | "Catheter Cyclic Kink" - Met (as implied by the statement "the subject device met all predetermined acceptance criteria"). |
| Tip Displacement During Power Injection: The catheter tip displacement during power injection must remain within acceptable limits. (Implicit criterion: The catheter tip should not migrate excessively or pose a risk of vascular damage during high-pressure contrast injection). | "Tip Displacement During Power Injection" - Met (as implied by the statement "the subject device met all predetermined acceptance criteria"). |
| Power Injection Testing (Maximum Flow Rate): The device must safely accommodate specified maximum power injection flow rates per ISO 10555-1: 2013 and BAS Internal Protocols/Procedures. (Implicit criterion: The device must be able to withstand power injection at specified flow rates without failure or compromise to patient safety. Specific flow rates are stated as 4 F DL = 4 mL/s and 5 F DL = 7 mL/s). | "Power Injection Testing" - Met, specifically: - 4 F DL = 4 mL/s - 5 F DL = 7 mL/s (as implied by the statement "the subject device met all predetermined acceptance criteria" and the values provided in the comparison table.) |
| Biocompatibility: The device materials must be biocompatible as per ISO 10993-1:2009. (Implicit criterion: The device must not cause adverse biological reactions when in contact with the body). | "Per ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process, a biocompatibility evaluation was performed based upon the modifications made to develop the subject device." - Met. |
| Risk Management: The device must comply with risk management procedures as per BS EN ISO 14971:2012. (Implicit criterion: Identified risks must be acceptably managed and mitigated). | "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." - Met. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify an exact "sample size" for the performance tests in terms of number of catheters tested for each criterion. It simply states that "performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence."
- Sample Size: Not explicitly stated as a numerical count for each test. The tests were performed on "the subject device" which includes 4 F DL and 5 F DL configurations.
- Data Provenance: The tests were conducted internally by Bard Access Systems, Inc. ("BAS Internal Protocols/Procedures"). This implies the data is prospective in nature, generated specifically for this submission, rather than retrospective clinical data. The country of origin is implicitly the USA, where the manufacturer is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable in the context of this device. This is a physical medical device (catheter), and the "ground truth" for its performance is established through objective engineering and biological performance testing against recognized standards (ISO, FDA guidance). There is no "ground truth" derived from expert interpretation of data in the way one would for an AI diagnostic algorithm.
4. Adjudication Method for the Test Set
Not applicable. This concept is relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. Performance testing of a physical device against standards does not typically involve adjudication in this sense. The acceptance relies on the measured performance meeting the predefined (or implicitly defined by the standard) thresholds.
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
Not applicable. This is a physical medical device (catheter), not an AI algorithm intended for interpretation by human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by:
- Compliance with recognized international standards (e.g., ISO 10555-1:2013, ISO 10993-1:2009, BS EN ISO 14971:2012).
- Compliance with FDA Guidance documents (e.g., "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995").
- Internal protocols and procedures developed by the manufacturer, which would be designed to ensure the device meets its design specifications and is safe and effective for its intended use.
Essentially, the "ground truth" is adherence to established engineering, materials, and biological performance specifications and regulatory requirements.
8. The sample size for the training set
Not applicable. This is a physical device submission; there is no "training set" in the context of machine learning or AI models. The design and manufacturing processes are analogous to a training process, leading to the final device design.
9. How the ground truth for the training set was established
Not applicable. As there is no training set in the AI sense, there is no ground truth establishment for it. The development of the device's design (analogous to "training") is guided by medical necessity, engineering principles, material science, regulatory requirements, and feedback from previous predicate devices. The "ground truth" for the predicate device would have been its demonstrated safety and effectiveness in previous clearances.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2016
C.R. Bard, Inc. % Casey Coombs Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116
Re: K162900
Trade/Device Name: PowerMidline Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: PND Dated: November 17, 2016 Received: November 18, 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
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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) K162900
Device Name PowerMidline Catheter
Indications for Use (Describe)
The PowerMidline™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerMidline™ Catheters are 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 shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font, with each letter outlined in black. Below the word "BARD" is the phrase "ACCESS SYSTEMS" in a smaller, sans-serif font.
510(k) Summary
21 CFR 807.92(a)
| GeneralProvisions | Submitter Name: | Bard Access Systems, Inc. |
|---|---|---|
| Submitter Address: | 605 North 5600 WestSalt Lake City, UT 84116 | |
| Contact Person: | Mr. Casey CoombsRegulatory Affairs Specialist | |
| Telephone Number: | (801) 522-5869 | |
| Fax Number: | (801) 522-4969 | |
| Date of Preparation: | November 27, 2016 | |
| SubjectDevice | Trade Name: | PowerMidline™ Catheter |
| Common Name: | Intravascular Catheter | |
| Regulation Name: | Intravascular Catheter | |
| Product Code: | PND | |
| Regulation: | 21 CFR § 880.5200 | |
| Regulatory Class: | Class II | |
| Classification Panel: | General Hospital | |
| PredicateDevice | Predicate Trade Name: | PowerMidline™ Catheter |
| Common Name: | Intravascular Catheter | |
| Regulation Name: | Intravascular Catheter | |
| Premarket Notification: | K153393 (cleared June 28, 2016) | |
| Manufacturer: | Bard Access Systems, Inc. | |
| Product Code: | PND | |
| Regulation: | 21 CFR § 880.5200 | |
| Regulatory Class: | Class II | |
| Classification Panel: | General Hospital | |
| ReferenceDevice | Reference Trade Name: | PowerPICCT™ SV Catheter |
| Common Name: | Peripherally Inserted Central Catheter (PICC) | |
| Regulation Name: | Percutaneous, implanted, long-term intravascularcatheter | |
| Premarket Notification: | K102159 (cleared November 17, 2010) | |
| Manufacturer: | Bard Access Systems, Inc. | |
| Product Code: | LJS | |
| Regulation: | 21 CFR § 880.5970 | |
| Regulatory Class: | Class II | |
| Classification Panel: | General Hospital |
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| ReferenceDevice | Reference Trade Name: 6 F Triple Lumen PowerPICCT™ CatheterCommon Name: Peripherally Inserted Central Catheter (PICC)Regulation Name: Percutaneous, implanted, long-term intravascularcatheterPremarket Notification: K053501 (cleared January 13, 2006)Manufacturer: Bard Access Systems, Inc.Product Code: LJSRegulation: 21 CFR § 880.5970Regulatory Class: Class IIClassification Panel: General Hospital |
|---|---|
| DeviceDescription | The dual lumen PowerMidline™ catheters are a family of peripherally placedcatheters made from radiopaque body-softening polyurethane materials. Eachdual lumen PowerMidline™ catheter is designed with kink-resistant, reversetaper design. The dual lumen PowerMidline™ catheters are offered in a 4 Fdual lumen (DL) and 5 F dual lumen (DL) configuration for reliable short term(less than 30 days) vascular access. These catheters are offered in 20 cmtrimmable lengths. The dual lumen PowerMidline™ catheters are suitable foruse with power injectors. |
| Intended Use | The PowerMidline™ Catheter is intended for short term peripheral access forselected intravenous therapies, blood sampling, and power injection ofcontrast media. |
| Indications ForUse | The PowerMidline™ Catheters are indicated for short term access to theperipheral venous system for selected intravenous therapies, blood sampling,and power injection of contrast media. These catheters may be used for anypatient population with consideration given to adequacy of vascular anatomyand appropriateness of the procedure. The PowerMidline™ Catheters aresuitable for use with power injectors. |
| TechnologicalCharacteristics | The technological characteristics of the subject PowerMidline™ Catheters aresubstantially equivalent with respect to basic design, materials and function tothose of the cited predicate device.Key modifications made to the subject device when compared to the predicatedevice are as follows:Modifications made to the number of lumens and extension legs tointroduce the dual lumen configurations Dimensional modifications made to introduce a 5 French size duallumen catheter Modifications made to the catheter junctions to accommodate the duallumen configurations Material modifications to the extension leg, luer hub, and catheterjunction components to introduce the dual lumen configurations Labeling modifications to reflect the dual lumen configurations The following table provides a comparison between the subject and predicatedevice. |
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| Subject and Predicate Device Comparison Table | |||
|---|---|---|---|
| Attribute | Subject Device:Dual LumenPowerMidline™ Catheter | Predicate Device:Single LumenPowerMidline™ Catheter(K153393) | |
| TechnologicalCharacteristics | Owner | Same as predicate | Bard Access Systems, Inc. |
| Classification | Same as predicate | PND - 21 CFR 880.5200 -Short-term - IntravascularCatheter | |
| 510(k) Status | Subject of this PremarketNotification | K153393 - Clearance dateJune 28, 2016 | |
| Indicationsfor Use | Same as predicate | The PowerMidline™Catheters are indicated forshort term access to theperipheral venous system forselected intravenoustherapies, blood sampling,and power injection ofcontrast media. Thesecatheters may be used forany patient population withconsideration given toadequacy of vascularanatomy andappropriateness of theprocedure. ThePowerMidline™ Cathetersare suitable for use withpower injectors. | |
| Duration ofUse | Same as predicate | Short term (<30 days) | |
| Means ofInsertion | Same as predicate | Percutaneous, usingModified SeldingerTechnique and guidewire | |
| Insertion Site | Same as predicate | Peripheral | |
| TipPlacementLocation | Same as predicate | Peripheral venous system,with catheter tip terminatingprior to the axilla | |
| CatheterBaseMaterials | Same as predicate | Shaft TubingPolyurethaneCatheter JunctionPolyurethaneExtension LegPolyurethaneLuer HubPolyurethane | |
| Extension Leg ClampAcetal Resin | |||
| TechnologicalCharacteristics | CatheterProximalConfiguration | Same as predicate | Luer Connection |
| CatheterDistalConfiguration | Same as predicate | Open Ended | |
| CatheterDimensions | 4 F DL x 20 cm usablelength | 3 F SL x 20 cm usablelength | |
| 5 F DL x 20 cm usablelength | 4 F SL x 20 cm usablelength | ||
| Number,Shape ofLumens | Dual Lumen, two "D" shapedlumens | Single Lumen, round | |
| DepthMarkings | Same as predicate | "0" depth indicator located 1cm from catheter junction onreverse taper shaft tubing;catheter marked every 1 cm,with numeric indicatorsevery 5 cm. | |
| Pre-insertedStyletConfiguration | Same as predicate | Stiffening stylet | |
| PowerInjectionMaximumFlow Rate | 4 F DL = 4 mL/s | 3 F SL = 3 mL/s | |
| MaximumFlow Rate | 5 F DL = 7 mL/s | 4 F SL = 7 mL/s | |
| Sterility | Same as predicate | Provided Sterile (EO) |
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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 modifications made to develop the subject device. The table includes a description of testing completed and the standard(s) utilized with each test.
| Testing Completed | ISO Standard / FDA Guidance /BAS Protocols Utilized | |
|---|---|---|
| Test and Report Priming Volume | Guidance on Premarket Notification[510(k)] Submission for Short-Termand Long-Term IntravascularCatheters, March 16, 1995 | |
| BAS Internal Protocols/Procedures | ||
| PerformanceTests | Shaft Tensile | ISO 10555-1: 2013, Sterile, single-use intravascular catheters, Part 1:General requirements |
| Test and Report Modulus andElongation Requirements | Guidance on Premarket Notification[510(k)] Submission for Short-Termand Long-Term IntravascularCatheters, March 16, 1995 | |
| Assembly Burst (Burst Pressurewith Power Injection) | ||
| Catheter Assembly Leak | ||
| Catheter Assembly Tensile | ISO 10555-1: 2013, Sterile, single-use intravascular catheters, Part 1:General requirements | |
| Test and Report Gravity Flow | ||
| Device DimensionalCharacterization | ||
| Catheter Cyclic Kink | ||
| Tip Displacement During PowerInjection | BAS Internal Protocols/Procedures | |
| Power Injection Testing | ISO 10555-1: 2013, Sterile, single-use intravascular catheters, Part 1:General requirements | |
| BAS Internal Protocols/Procedures | ||
| Per ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing Within a Risk Management Process, a biocompatibilityevaluation was performed based upon the modifications made to develop thesubject device. | ||
| Per design control requirements as specified in 21 CFR 820.30, the subjectdevice met all predetermined acceptance criteria derived from the above listedtests and demonstrated substantial equivalence as compared to the citedpredicate 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 dual lumen PowerMidline™ Catheter has the same intended useand fundamental technological characteristics as the cited predicate devicecleared under K153393. Based on the intended use, technologicalcharacteristics, and results of performance testing, the subject dual lumenPowerMidline™ Catheter is considered substantially equivalent to the citedpredicate device. |
Performance Tests
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§ 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).