(55 days)
The PowerPICC Provena Catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
Bard Access Systems, Inc.'s PowerPICC Provena Catheters are sterile, single use devices designed to provide access to the patient's vascular system. The devices are intended for short- or long-term use (>30 days) to sample blood and administer fluids intravenously. The catheters are capable of central venous pressure monitoring, and can withstand power injection of contrast media. The catheters are peripherally inserted central catheters (PICC) and utilize the same placement technique as the predicate devices.
The subject devices included in this notification are of varying French size and catheter configuration types, as summarized in the table below.
Summary of Subject Devices
French size (Number of Lumens)
Catheter Configuration
PowerPICC Provena Catheters
3 French Single Lumen (SL)
4 French Dual Lumen (DL)
The following device descriptors apply to all French sizes and configurations of the subject catheters:
- Catheters are open-ended, radiopaque polyurethane;
- Catheters have a reverse taper design;
- Catheter shaft tubing is marked with depth indicators, with "0" indicated to serve as a reference for the catheter insertion point;
- Purple colorant is included in the catheter material to provide the catheter with an appearance that allows the end user to differentiate Bard's power injectable catheters from other manufacturers' power injectable catheters; and
- Catheter extension leg, luer hub, junction, and clamp ID tags are printed with markings to identify the catheter as PowerPICC Provena Catheters, and include information to facilitate proper use of the device.
The subject devices are provided sterile in basic interventional radiology (IR) as well as basic, full, and max barrier nursing PICC kits with legally marketed components to assist in the placement procedure. These kits are available in both standard and small patient versions.
The provided document describes the acceptance criteria and a detailed study for the C.R. Bard, Inc. PowerPICC Provena Catheters (K162443). This is a medical device, and the study involves a series of performance tests to demonstrate substantial equivalence to a predicate device, rather than a clinical study evaluating AI performance.
Here's the information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a comprehensive list of verification/validation methods and their corresponding risk acceptability criteria. The reported performance for all these tests is a general statement that the device met all predetermined acceptance criteria.
| Verification / Validation Method | Risk Acceptability Criteria (Acceptance Criteria of Test) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Tests to confirm that the catheter is free from biological hazard. Bard internal standards and procedures and ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters – 1: General requirements. Testing Performed includes: Sensitization, Cytotoxicity, Irritation/Intracutaneous Reactivity, Acute Systemic Injection, Material-mediated Pyrogenicity, Subacute 14 day IV toxicity (Saline), Subacute 14 day IP toxicity (Cottonseed oil), Ames Genotoxicity, Mouse Lymphoma, Rodent Blood Micronucleus, 2 week and 6 week implantation, Hemolysis, Complement Activation. | Met all predetermined acceptance criteria |
| Cantilever Stiffness Test | Test to characterize the catheter shaft stiffness at the distal section using a cantilever bend technique. Bard internal standards and procedures. | Met all predetermined acceptance criteria |
| Clamp Engagement | Test to confirm that the catheter assembly will not leak when the clamp is engaged. Bard internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – 1: General requirements. | Met all predetermined acceptance criteria |
| Mechanical Hemolysis Test | Testing to determine the hemolytic properties when blood is aspirated through the catheter assembly. Bard internal standards and procedures. | Met all predetermined acceptance criteria |
| Leak Test | Test to confirm that the catheter assembly will not leak when the distal end of the catheter is occluded. Bard internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – 1: General requirements. | Met all predetermined acceptance criteria |
| Dimensional Test | Test to measure OD and ID for single lumen catheters and OD and lumen area for dual lumen catheters to ensure compliance with dimensional specification. Bard internal standards and procedures and ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - 1: General requirements. | Met all predetermined acceptance criteria |
| Implantable Length | Test to measure useful length for catheters to ensure compliance with dimensional specification. Bard internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – 1: General requirements. | Met all predetermined acceptance criteria |
| Extension Leg Length | Test to measure and confirm extension leg length compliance with dimensional specification. Bard internal standards and procedures. | Met all predetermined acceptance criteria |
| Catheter Collapse Test | Test to measure the flow rate of aspiration and demonstrate that the catheter will not collapse under a vacuum. Bard internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – 1: General requirements. | Met all predetermined acceptance criteria |
| Burst Test | Burst pressure test to confirm the catheter burst pressure exceeds the peak pressure present in the catheter at maximum flow conditions when the distal end is occluded. Bard internal standards and procedures and ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - Part 1: General requirements. | Met all predetermined acceptance criteria |
| OD Swell | Test to confirm that the 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 |
| Hydraulic Catheter Burst Test | Burst pressure test to confirm the catheter burst pressure exceeds the peak pressure present in the catheter at maximum flow conditions when the distal end is occluded. Bard internal standards and procedures and ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - Part 1: General requirements. | Met all predetermined acceptance criteria |
| Extension Leg Burst Test | Burst pressure test to confirm the extension leg burst pressure exceeds the peak pressure present in the catheter at maximum flow conditions when the extension leg is occluded. Bard internal standards and procedures and ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - Part 1: General requirements. | Met all predetermined acceptance criteria |
| Power Injection Conditioning | Test to confirm the catheter does not leak or burst as a result of power injections at maximum indicated flow rate. Bard internal standards and procedures and ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - Part 1: General requirements. | Met all predetermined acceptance criteria |
| Tip Stability Test | Test to confirm that the catheter tip remains in the same orientation during power injection (tip pointing in direction of venous flow) at the maximum indicated flow rate. Bard internal standards and procedures. | Met all predetermined acceptance criteria |
| Assembly Tensile Test | Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force. | Met all predetermined acceptance criteria |
| Shaft Tensile Test Luer to Extension Leg Tensile Test | ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – Part 1: General requirements. | Met all predetermined acceptance criteria |
| Shaft Tensile Test | Test to evaluate the maximum catheter strain and modulus at break. Bard internal standards and procedures and FDA guidance, Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters (March 16, 1995). | Met all predetermined acceptance criteria |
| Radiopacity | Test to demonstrate catheter radio-detectability. Bard internal standards and procedures and ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - Part 1: General requirements. | Met all predetermined acceptance criteria |
| Suture Wing Integrity Test | Test to measure the maximum force a catheter junction suture wing can withstand prior to break. Bard internal standards and procedures and FDA guidance, Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters (March 16, 1995). | Met all predetermined acceptance criteria |
| Priming Volume | Test to measure the volume required to prime a full length catheter. FDA guidance, Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters (March 16, 1995). | Met all predetermined acceptance criteria |
| Gravity Flow | Test to measure the gravity flow performance of a full length catheter. Bard internal standards and procedures and ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - Part 1: General requirements. | Met all predetermined acceptance criteria |
| Pump Flow | Test to determine the maximum pressure generated by the catheter when infusing water through it at a maximum pump flow rate. Bard internal standards and procedures. | Met all predetermined acceptance criteria |
| Kink Diameter Test | Test to quantitatively evaluate kink characteristics associated with the catheter shafts. Bard internal standards and procedures. | Met all predetermined acceptance criteria |
| Stylet Drag Test | Test to ensure that the stylets used to place the catheter can be removed without difficulty. Bard internal standards and procedures. | Met all predetermined acceptance criteria |
| StatLock Compatibility | Test to ensure the catheter is compatible with StatLock for catheter securement. Bard internal standards and procedures. | Met all predetermined acceptance criteria |
| Taper Length | Test to measure and confirm taper length compliance with dimensional specification. Bard internal standards and procedures. | Met all predetermined acceptance criteria |
| Catheter Printing | Test is to confirm ink on the catheter exhibits proper adherence. Bard internal standards and procedures. | Met all predetermined acceptance criteria |
The document explicitly states: "The subject devices met all predetermined acceptance criteria derived from the above listed references and demonstrated substantial equivalence as compared to the cited predicate device."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices tested) for each individual test. It generally references "Bard internal standards and procedures" and relevant ISO standards (e.g., ISO 10555-1:2013) for the testing methodology. These standards typically define acceptable sample sizes for device testing.
The data provenance is implied to be from in-house testing conducted by Bard Access Systems, Inc. There is no mention of country of origin for data if it were to be from external sources, nor does it specify if the data is retrospective or prospective, as this is a device performance study rather than a clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts) is not relevant for this device performance study. The ground truth for these tests is established by objective, measurable engineering and material science standards and physical properties, not by expert interpretation.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1, none) are typically used in clinical studies or studies involving human assessment of data. This document describes a battery of engineering and material science tests. Therefore, no adjudication method as described for clinical data interpretation is applicable or mentioned. The "adjudication" is inherent in the objective measurement against established criteria.
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
No, a multi-reader multi-case comparative effectiveness study was not done. This document describes the safety and performance testing of a medical device (intravascular catheter), not an AI system. Therefore, there is no mention of human readers, AI assistance, or effect sizes related to AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This document pertains to the physical performance of a medical catheter, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests described is based on objective, measurable engineering and material properties, and established industry standards. Examples include:
- Physical measurements: OD, ID, length, flow rates, burst pressure, tensile strength.
- Reference: Dimensional Test, Implantable Length, Extension Leg Length, Burst Test, Hydraulic Catheter Burst Test, Extension Leg Burst Test, Power Injection Maximum Flow Rate, Assembly Tensile Test, Shaft Tensile Test, Suture Wing Integrity Test, Priming Volume, Gravity Flow, Pump Flow, Kink Diameter Test, Taper Length.
- Chemical/Biological properties: Biocompatibility outcomes (e.g., absence of biological hazard, lack of sensitization, cytotoxicity, irritation, hemolysis).
- Reference: Biocompatibility Testing, Mechanical Hemolysis Test.
- Functional performance: Absence of leaks, tip stability during power injection, ability to remove stylets easily, adherence of printing.
- Reference: Clamp Engagement, Leak Test, Catheter Collapse Test, Power Injection Conditioning, Tip Stability Test, Stylet Drag Test, Catheter Printing.
- Compliance with published standards: ISO 10555-1:2013 and FDA guidance documents.
8. The sample size for the training set
This is not applicable. This is a device performance study, not an AI model development or validation study. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI model in this document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 25, 2016
C.R. Bard, Inc. Mr. Bryan Stone Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116
Re: K162443
Trade/Device Name: PowerPICC Provena Catheters Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: September 28, 2016 Received: September 30, 2016
Dear Mr. Stone:
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)
Device Name PowerPICC Provena Catheters
Indications for Use (Describe)
The PowerPICC Provena Catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
| Catheter Size | Maximum Flow Rate |
|---|---|
| 3 F Single Lumen | 3 mL/sec |
| 4 F Dual Lumen | 5 mL/sec |
| 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: | Bard Access Systems, Inc. |
|---|---|---|
| Submitter Address: | 605 North 5600 WestSalt Lake City, UT 84116 | |
| Contact Person: | Bryan StoneRegulatory Affairs Specialist, II | |
| Telephone Number: | (801) 522-5876 | |
| Fax Number: | (801) 522-5425 | |
| Date of Preparation: | September 29, 2016 | |
| Subject Device | Trade Name(s): | PowerPICC Provena Catheters |
| Common Name: | Peripherally Inserted Central Catheter (PICC) | |
| Classification Name: | Percutaneous, Implanted, Long-term IntravascularCatheter | |
| Product Code/Regulation: | LJS/21 CFR §880.5970 | |
| PredicateDevices | Predicate Trade Name: | PowerPICC SV Catheter |
| Classification Name: | Percutaneous, Implanted, Long-term IntravascularCatheter | |
| Premarket Notification: | K102159 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| ReferencesDevices | Reference Trade Name: | PowerPICC EtOH Catheter |
| Classification Name: | Percutaneous, Implanted, Long-term IntravascularCatheter | |
| Premarket Notification: | K151985 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| Reference Trade Name: | PowerPICC Catheter | |
| Classification Name: | Percutaneous, Implanted, Long-term IntravascularCatheter | |
| Premarket Notification: | K053501 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| DeviceDescription | Bard Access Systems, Inc.'s PowerPICC Provena Catheters are sterile, single usedevices designed to provide access to the patient's vascular system. The devices are |
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| intended for short- or long-term use (>30 days) to sample blood and administer fluidsintravenously. The catheters are capable of central venous pressure monitoring, andcan withstand power injection of contrast media. The catheters are peripherallyinserted central catheters (PICC) and utilize the same placement technique as thepredicate devices. | |||||||
|---|---|---|---|---|---|---|---|
| The subject devices included in this notification are of varying French size andcatheter configuration types, as summarized in the table below. | |||||||
| Summary of Subject Devices | |||||||
| French size (Number of Lumens)Catheter Configuration | |||||||
| PowerPICC Provena Catheters | 3 French Single Lumen (SL) | ||||||
| 4 French Dual Lumen (DL) | |||||||
| The following device descriptors apply to all French sizes and configurations of thesubject catheters: | |||||||
| ● | Catheters are open-ended, radiopaque polyurethane; | ||||||
| ● | Catheters have a reverse taper design; | ||||||
| Catheter shaft tubing is marked with depth indicators, with "0" indicated to●serve as a reference for the catheter insertion point; | |||||||
| Purple colorant is included in the catheter material to provide the catheter with●an appearance that allows the end user to differentiate Bard's powerinjectable catheters from other manufacturers' power injectable catheters; and | |||||||
| Catheter extension leg, luer hub, junction, and clamp ID tags are printed with●markings to identify the catheter as PowerPICC Provena Catheters, andinclude information to facilitate proper use of the device. | |||||||
| The subject devices are provided sterile in basic interventional radiology (IR) as wellas basic, full, and max barrier nursing PICC kits with legally marketed components toassist in the placement procedure. These kits are available in both standard and smallpatient versions. | |||||||
| Intended Use | The PowerPICC Provena Catheters are intended for short- or long-term peripheralaccess to the central venous system for intravenous therapy and blood sampling. | ||||||
| Indications For | The PowerPICC Provena Catheters are indicated for short or long-term peripheralaccess to the central venous system for intravenous therapy, blood sampling, powerinjection of contrast media, and allows for central venous pressure monitoring. Forcentral venous pressure monitoring, it is recommended that a catheter lumen of 20gauge or larger be used. | ||||||
| Use | Catheter Size | Maximum Flow Rate | |||||
| 3F Single Lumen | 3 mL/sec | ||||||
| 4F Dual Lumen | 5 mL/sec | ||||||
| TechnologicalCharacteristics | predicate device. | Technological characteristics of the subject PowerPICC Provena Catheters aresubstantially equivalent with respect to basic design and function to those of the cited |
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Key modifications made to the subject device when compared to the predicate device are as follows:
- . Dimensional modifications to the catheter shaft including the reverse taper length and wall thickness of the catheter lumens;
- o Material formulation changes have been made to the subject devices compared to the predicate devices (refer to Comparison Table below);
- . Labeling and packaging modifications due to changes to the commercial name, maximum flow rate, and the addition of small patient packaging kit configurations.
The following table provides a comparison between the subject and predicate device.
| Subject and Predicate Device Comparison Table | ||
|---|---|---|
| Attribute | Subject Device – PowerPICC Provena Catheters | Predicate Device – PowerPICC SV Catheters (K102159) |
| Owner | Same | Bard Access Systems, Inc. |
| Classification | Same | LJS - 21 CFR 880.5970 - Long-Term - Intravascular Catheter |
| 510(k) Status | Subject of this Premarket Notification | K102159 - Concurrence date November 17, 2010 |
| Indications for Use | The PowerPICC Provena catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used. | The PowerPICC SV catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used. |
| Catheter Size | Maximum Flow Rate | |
| 3F Single Lumen | 3 mL/sec | |
| 4F Dual Lumen | 5 mL/sec | |
| Catheter Size | Maximum Flow Rate | |
| 3F Single Lumen | 1 mL/sec | |
| 4F Dual Lumen | 2.5 mL/sec | |
| Commercial Name | PowerPICC Provena Catheters | PowerPICC SV Catheters |
| Catheter Dimensions | 3F Single Lumen x 55 cm | 3F Single Lumen x 45 cm |
| 4F Dual Lumen x 55 cm | 4F Dual Lumen x 55 cm | |
| Duration of Use | Same | Short (<30 days) or long-term (≥30 days) |
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| Means ofInsertion | Same | Percutaneous using a peel-away sheath Introducer | |||||
|---|---|---|---|---|---|---|---|
| Insertion Site | Same | Peripheral | |||||
| Catheter Base MaterialsShaft Tubing: | Catheter Base Materials | ||||||
| Shaft Tubing: | |||||||
| Polycarbonate Polyurethane | Polyether Polyurethane | ||||||
| PrimaryDeviceMaterials | Luer Connector: | Luer Connector: | |||||
| Same | Polyurethane | ||||||
| Extension Legs: | Extension Legs: | ||||||
| Polycarbonate Polyurethane | Polyether Polyurethane | ||||||
| Junction | Junction | ||||||
| Same | Polyether Polyurethane | ||||||
| CatheterProximalConfiguration | Same | Luer Connection | |||||
| Catheter DistalConfiguration | Open Ended | ||||||
| Number ofLumens | Single Lumen | ||||||
| Dual Lumen | |||||||
| PowerInjectionMaximum FlowRate | Catheter Size | MaximumFlow Rate | Catheter Size | MaximumFlow Rate | |||
| 3F SingleLumen | 3 mL/sec | 3F Single Lumen | 1 mL/sec | ||||
| 4F Dual Lumen | 5 mL/sec | 4F Dual Lumen | 2.5mL/sec | ||||
| Sterility | Same | Provided Sterile | |||||
| Both Standard and SmallPatient versions in: | Standard Kits: | ||||||
| PackagingConfigurations | Basic ConfigurationFull ConfigurationMax Barrier ConfigurationIR Configuration | Basic ConfigurationFull ConfigurationMax Barrier ConfigurationIR Configuration | |||||
| The technological differences listed above, including differences in materialformulation and dimensional design, were evaluated using the same testrequirements as the predicate devices, as defined in the Risk Assessment. Therefore,these differences in technological characteristics between the subject and predicatedevices do not raise different questions of equivalence. | |||||||
| PerformanceTests | Verification and validation tests were designed and performed in accordance withDesign Controls per 21 CFR §820.30. The following tests were conducted perguidance documents and standards in conjunction with in-house protocols to |
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| Verification /Validation Method | Risk Acceptability Criteria (Acceptance Criteria of Test) | |
|---|---|---|
| BiocompatibilityTesting | Tests to confirm that the catheter is free from biological hazard.Bard internal standards and procedures and ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters –1: General requirements Testing Performed includes: Sensitization Cytotoxicity Irritation/Intracutaneous Reactivity Acute Systemic Injection Material-mediated Pyrogenicity Subacute 14 day IV toxicity (Saline) Subacute 14 day IP toxicity (Cottonseed oil) Ames Genotoxicity Mouse Lymphoma Rodent Blood Micronucleus 2 week and 6 week implantation Hemolysis Complement Activation | |
| Cantilever StiffnessTest | Test to characterize the catheter shaft stiffness at the distal sectionusing a cantilever bend technique. Bard internal standards and procedures | |
| Clamp Engagement | Test to confirm that the catheter assembly will not leak when theclamp is engaged. Bard internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters –1: General requirements | |
| MechanicalHemolysis Test | Testing to determine the hemolytic properties when blood isaspirated through the catheter assembly. Bard internal standards and procedures | |
| Leak Test | Test to confirm that the catheter assembly will not leak when thedistal end of the catheter is occluded. Bard internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters –1: General requirements | |
| Dimensional Test | Test to measure OD and ID for single lumen catheters and OD andlumen area for dual lumen catheters to ensure compliance withdimensional specification. Bard internal standards and procedures and ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters -1: General requirements | |
| Implantable Length | Test to measure useful length for catheters to ensure compliancewith dimensional specification. Bard internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters –1: General requirements | |
| Extension LegLength | Test to measure and confirm extension leg length compliance withdimensional specification. Bard internal standards and procedures | |
| Catheter CollapseTest | Test to measure the flow rate of aspiration and demonstrate thatthe catheter will not collapse under a vacuum. Bard internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters –1: General requirements | |
| Burst Test | Burst pressure test to confirm the catheter burst pressure exceedsthe peak pressure present in the catheter at maximum flowconditions when the distal end is occluded. Bard internal standards and procedures and ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - Part1: General requirements | |
| OD Swell | Test to confirm that the catheter does not swell beyond twice thesize of the labeled OD during power injection. Bard internal standards and procedures | |
| Hydraulic CatheterBurst Test | Burst pressure test to confirm the catheter burst pressure exceedsthe peak pressure present in the catheter at maximum flowconditions when the distal end is occluded. Bard internal standards and procedures and ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - Part1: General requirements | |
| Extension Leg BurstTest | Burst pressure test to confirm the extension leg burst pressureexceeds the peak pressure present in the catheter at maximumflow conditions when the extension leg is occluded. Bard internal standards and procedures and ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - Part1: General requirements | |
| Power InjectionConditioning | Test to confirm the catheter does not leak or burst as a result ofpower injections at maximum indicated flow rate. Bard internal standards and procedures and ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - Part1: General requirements | |
| Tip Stability Test | Test to confirm that the catheter tip remains in the same orientationduring power injection (tip pointing in direction of venous flow) atthe maximum indicated flow rate. Bard internal standards and procedures | |
| Assembly TensileTest | Test to demonstrate the peak tensile force of each test pieceexceeds the minimum peak tensile force. | |
| Shaft Tensile TestLuer to ExtensionLeg Tensile Test | ISO 10555-1:2013 – Sterile Single-Use IntravascularCatheters – Part 1: General requirements | |
| Shaft Tensile Test | Test to evaluate the maximum catheter strain and modulus atbreak. Bard internal standards and procedures and FDAguidance, Guidance on Premarket Notification [510(k)]Submission for Short-Term and Long-Term IntravascularCatheters (March 16, 1995) | |
| Radiopacity | Test to demonstrate catheter radio-detectability. Bard internal standards and procedures and ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - Part1: General requirements | |
| Suture WingIntegrity Test | Test to measure the maximum force a catheter junction suturewing can withstand prior to break. Bard internal standards and procedures and FDAguidance, Guidance on Premarket Notification [510(k)]Submission for Short-Term and Long-Term IntravascularCatheters (March 16, 1995) | |
| Priming Volume | Test to measure the volume required to prime a full length catheter. FDA guidance, Guidance on Premarket Notification[510(k)] Submission for Short-Term and Long-TermIntravascular Catheters (March 16, 1995) | |
| Gravity Flow | Test to measure the gravity flow performance of a full lengthcatheter. Bard internal standards and procedures and ISO 10555-1:2013 - Sterile Single-Use Intravascular Catheters - Part1: General requirements | |
| Pump Flow | Test to determine the maximum pressure generated by thecatheter when infusing water through it at a maximum pump flowrate.• Bard internal standards and procedures | |
| Kink Diameter Test | Test to quantitatively evaluate kink characteristics associated withthe catheter shafts.• Bard internal standards and procedures | |
| Stylet Drag Test | Test to ensure that the stylets used to place the catheter can beremoved without difficulty.• Bard internal standards and procedures | |
| StatLock Compatibility | Test to ensure the catheter is compatible with StatLock for cathetersecurement.• Bard internal standards and procedures | |
| Taper Length | Test to measure and confirm taper length compliance withdimensional specification.• Bard internal standards and procedures | |
| Catheter Printing | Test is to confirm ink on the catheter exhibits proper adherence.• Bard internal standards and procedures | |
| The subject devices met all predetermined acceptance criteria derived from the abovelisted references and demonstrated substantial equivalence as compared to the citedpredicate device.Risk management, including a failure modes and effects analysis (FMEA), of thesubject device was conducted in accordance with BS EN ISO 14971:2012, MedicalDevices - Application of Risk Management to Medical Devices. | ||
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and results ofperformance testing, the subject PowerPICC Provena Catheters meet therequirements that are considered sufficient for its intended use and demonstratesubstantial equivalence to the cited predicate device. |
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§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”