(236 days)
The PowerPICC Provena Catheters with SOLO² Valve Technology 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 with SOLO² Valve Technology are sterile, single use devices designed to provide access to the patient's vascular system. The devices are intended for long or short-term use, as clinically indicated, 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 device. The subject devices include a silicone valve on the proximal end. 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
Catheter Configuration | French size (Number of Lumens)
PowerPICC Provena Catheters with SOLO² Valve Technology | 3 French Single Lumen (SL)
PowerPICC Provena Catheters with SOLO² Valve Technology | 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 incorporate a silicone valve on the proximal end;
● 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;
● Catheter extension legs, luer hubs, and junction are printed with markings to identify the catheter as PowerPICC Provena Catheters with SOLO² Valve Technology, and include information to facilitate proper use of the device.
The subject devices are provided sterile in basic interventional radiology (IR) kits, 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 text describes specific performance tests conducted for the PowerPICC Provena Catheters with SOLO² Valve Technology to demonstrate substantial equivalence to predicate devices, rather than an AI/ML medical device. Therefore, the information provided does not align with the request to describe acceptance criteria and a study proving an AI/ML device meets those criteria.
However, based on the provided text, I can infer the "acceptance criteria" from the "Risk Acceptability Criteria (Acceptance Criteria of Test)" column and the reported performance from the "Verification / Validation Method" column. The study described is a series of in-house and standard-based performance tests, not an MRMC or standalone AI study.
Here's an interpretation based on the provided content, acknowledging its limitations regarding AI/ML:
This document describes the testing and verification of a medical catheter, not an AI/ML-driven device. Therefore, many of the requested criteria specific to AI/ML systems (sample size for test/training sets, data provenance, expert ground truth, MRMC studies, effect size, standalone performance) are not applicable or cannot be extracted from the provided text.
However, I can extract the acceptance criteria and stated performance for the catheter device as presented:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Risk Acceptability Criteria) | Reported Device Performance (Verification / Validation Method) |
|---|---|
| Mechanical Hemolysis Test: Testing to determine the hemolytic properties when blood is aspirated through the catheter assembly. • Bard internal standards and procedures | Testing to determine the hemolytic properties when blood is aspirated through the catheter assembly. (Implies satisfactory performance as per the concluding statement: "The subject devices 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 - Part 1: General requirements | 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. (Implies satisfactory performance as per the concluding statement: "The subject devices 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 FDA guidance, Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters (March 16, 1995) | Test to measure the flow rate of aspiration and demonstrate that the catheter will not collapse under a vacuum. (Implies satisfactory performance as per the concluding statement: "The subject devices met all predetermined acceptance criteria...") |
| Luer to Extension Leg Tensile Test: Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force. • ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters - Part 1: General requirements | Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force. (Implies satisfactory performance as per the concluding statement: "The subject devices 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) | Test to measure the volume required to prime a full length catheter. (Implies satisfactory performance as per the concluding statement: "The subject devices 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 | Test to determine the maximum pressure generated by the catheter when infusing water through it at a maximum pump flow rate. (Implies satisfactory performance as per the concluding statement: "The subject devices met all predetermined acceptance criteria...") |
| Gravity Flow: Test to measure the gravity flow rate. • 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) • ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters - Part 1: General requirements | Test to measure the gravity flow rate. (Implies satisfactory performance as per the concluding statement: "The subject devices met all predetermined acceptance criteria...") |
The document 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."
AI/ML Specific Questions (Cannot be answered from the provided text as it's not an AI/ML device)
- Sample sizes used for the test set and data provenance: Not applicable. This is a physical device.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for a physical device is established through physical and mechanical testing against standards.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this physical device is established through meeting material, mechanical, and functional performance specifications defined by internal standards, ISO standards (e.g., ISO 10555-1:2013), and FDA guidance documents.
- The sample size for the training set: Not applicable. This is a physical device, not an AI model.
- How the ground truth for the training set was established: Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 24, 2017
C.R. Bard, Inc. Bryan Stone Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116
Re: K162441
Trade/Device Name: PowerPICC Provena Catheters with SOLO2 Valve Technology Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: March 15, 2017 Received: March 17, 2017
Dear Bryan 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 with SOLO2 Valve Technology
Indications for Use (Describe)
The PowerPICC Provena Catheters with SOLO² Valve Technology 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: K162441 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 StoneAssociate Manager, Regulatory Affairs | |
| Telephone Number: | (801) 522-5876 | |
| Fax Number: | (801) 522-5425 | |
| Date of Preparation: | April 17, 2017 | |
| Subject Device | Trade Name(s): | PowerPICC Provena Catheters with SOLO² ValveTechnology |
| Common Name: | Peripherally Inserted Central Catheter (PICC) | |
| Classification Name: | percutaneous, implanted, long-term intravascularcatheter | |
| ProductCode/Regulation/Class: | LJS/21 CFR §880.5970/Class II | |
| PredicateDevice | Predicate Trade Name: | PowerPICC Provena Catheter |
| Classification Name: | percutaneous, implanted, long-term intravascularcatheter | |
| ProductCode/Regulation/Class: | LJS/21 CFR §880.5970/Class II | |
| Premarket Notification: | K162443 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| ReferenceDevice | Reference Trade Name: | PowerPICC SOLO Catheter |
| Classification Name: | percutaneous, implanted, long-term intravascularcatheter | |
| ProductCode/Regulation/Class: | LJS/21 CFR §880.5970/Class II | |
| Premarket Notification: | K072230 | |
| Manufacturer: | Bard Access Systems, Inc. |
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| Bard Access Systems, Inc.'s PowerPICC Provena Catheters with SOLO ValveTechnology are sterile, single use devices designed to provide access to the patient'svascular system. The devices are intended for long or short-term use, as clinicallyindicated, to sample blood and administer fluids intravenously. The catheters arecapable of central venous pressure monitoring, and can withstand power injection ofcontrast media. The catheters are peripherally inserted central catheters (PICC) andutilize the same placement technique as the predicate device. The subject devicesinclude a silicone valve on the proximal end.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 | ||||
| Catheter Configuration | French size (Number of Lumens) | |||
| PowerPICC Provena Catheters | 3 French Single Lumen (SL) | |||
| with SOLO² Valve Technology | 4 French Dual Lumen (DL) | |||
| Device | The following device descriptors apply to all French sizes and configurations of thesubject catheters: | |||
| Description | Catheters are open-ended, radiopaque polyurethane;● | |||
| Catheters incorporate a silicone valve on the proximal end;● | ||||
| 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; | ||||
| Catheter extension legs, luer hubs, and junction are printed with markings to●identify the catheter as PowerPICC Provena Catheters with SOLO- ValveTechnology, and include information to facilitate proper use of the device. | ||||
| The subject devices are provided sterile in basic interventional radiology (IR) kits, aswell as basic, full, and max barrier nursing PICC kits with legally marketed componentsto assist in the placement procedure. These kits are available in both standard and smallpatient versions. | ||||
| Intended Use | The PowerPICC Provena Catheters with SOLO~ Valve Technology are intended forshort- or long-term peripheral access to the central venous system for intravenoustherapy and blood sampling. |
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| Indications For | The PowerPICC Provena Catheters with SOLO~ Valve Technology are indicated forshort or long-term use when clinically indicated and for peripheral access to the centralvenous system for intravenous therapy, blood sampling, power injection of contrastmedia, and allows for central venous pressure monitoring. For central venous pressuremonitoring, it is recommended that a catheter lumen of 20 gauge or larger be used. | |||
|---|---|---|---|---|
| Use | Catheter Size | Maximum Flow Rate | ||
| 3F Single Lumen | 3 mL/sec | |||
| 4F Dual Lumen | 5 mL/sec | |||
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Technological characteristics of the subject Povena Catheters with SOLO Valve Technology are substantially equivalent with respect to basic design and function to those of the cited primary predicate device.
Key modifications made to the subject device when compared to the predicate device are as follows:
- The luer hub of the subject catheters has been modified by adding a proximal valve is identical to the valve used in the ● reference device - the PowerPICC SOLO Catheter, K072230.
- Labeling and packaging modifications due to the commercial name change have been made. .
The following table provides a comparison between the subject and predicate device.
| Subject and Predicate Device Comparison Table | ||||
|---|---|---|---|---|
| Attribute | Subject Device - PowerPICC ProvenaCatheter With SOLO2 ValveTechnology | Predicate Device - PowerPICCProvena Catheters (K162443) | Reference Device - PowerPICC SOLOCatheters (K072230) | |
| TechnologicalCharacteristics | Owner | Same | Bard Access Systems, Inc. | Bard Access Systems, Inc. |
| Classification | Same | LJS - 21 CFR 880.5970 – Long-Term -Intravascular Catheter | LJS - 21 CFR 880.5970 – Long-Term -Intravascular Catheter | |
| 510(k) Status | Subject of this Premarket Notification | K162443 – Concurrence date October 25,2016 | K072230 - Concurrence dateOctober 05, 2007 | |
| Attribute | Subject Device – PowerPICC ProvenaCatheter With SOLO2 ValveTechnology | Predicate Device – PowerPICCProvena Catheters (K162443) | Reference Device – PowerPICC SOLOCatheters (K072230) | |
| Indications forUse | The PowerPICC Provena Catheters withSOLO2 Valve Technology are indicatedfor short or long-term use when clinicallyindicated and for peripheral access to thecentral venous system for intravenoustherapy, blood sampling, power injectionof contrast media, and allows for centralvenous pressure monitoring. For centralvenous pressure monitoring, it isrecommended that a catheter lumen of 20gauge or larger be used. | The PowerPICC Provena Catheters areindicated for short or long-term peripheralaccess to the central venous system forintravenous therapy, blood sampling,power injection of contrast media, andallows for central venous pressuremonitoring. For central venous pressuremonitoring, it is recommended that acatheter lumen of 20 gauge or larger beused. | The PowerPICC SOLO catheters areindicated for short- or long-term peripheralaccess to the central venous system forintravenous therapy, power injection ofcontrast media, and allows for centralvenous pressure monitoring. For bloodsampling, infusion, or therapy, use a 4F orlarger catheter. The maximumrecommended infusion rate is 5mL/sec forpower injection of contrast media. Forcentral venous pressure monitoring, it isrecommended that a catheter lumen of 20gauge or larger be used. | |
| Catheter SizeMaximum Flow Rate3F Single Lumen 3 mL/sec4F Dual Lumen 5 mL/sec | Catheter SizeMaximum Flow Rate3F Single Lumen 3 mL/sec4F Dual Lumen 5 mL/sec | |||
| CommercialName | PowerPICC Provena Catheters withSOLO2 Valve Technology | PowerPICC Provena Catheters | PowerPICC SOLO Catheter | |
| CatheterDimensions | Same as Predicate | 3F Single Lumen x 55 cm4F Dual Lumen x 55 cm | 4F Single Lumen x 55 cm5F Dual Lumen x 55 cm | |
| Duration ofUse | Same | Short (<30 days) or long-term(>30 days) | Short (<30 days) or long-term(>30 days) | |
| Subject and Predicate Device Comparison Table | ||||
| Attribute | Subject Device - PowerPICC ProvenaCatheter With SOLO2 Valve Technology | Predicate Device - PowerPICCProvena Catheters (K162443) | Reference Device - PowerPICC SOLOCatheters (K072230) | |
| Means ofInsertion | Same | Percutaneous using a peel-away sheathIntroducer | Percutaneous using a peel-away sheathIntroducer | |
| Insertion Site | Same | Peripheral | Peripheral | |
| PrimaryDeviceMaterials | Catheter Base Materials | Catheter Base Materials | Catheter Base Materials | |
| Shaft Tubing: | Shaft Tubing: | Shaft Tubing: | ||
| Same as Predicate | Polycarbonate Polyurethane | Polyether Polyurethane | ||
| Luer Connector: | Luer Connector: | Luer Connector: | ||
| Same as Reference | Polyurethane | Polyurethane with Silicone Valve | ||
| Extension Legs: | Extension Legs: | Extension Legs: | ||
| Same as Predicate | Polycarbonate Polyurethane | Polyether Polyurethane | ||
| Junction | Junction: | Junction: | ||
| Same as Predicate | Polycarbonate Polyurethane | Polyether Polyurethane | ||
| CatheterProximalConfiguration | Luer Connection with ValveThe subject device differs from its primarypredicate in terms of the luer hub with valveconfiguration on the subject device. Thisdifference in the luer does not alter theintended use of the subject device, nor doesit raise different questions of equivalence.The luer hub on the subject device isidentical to that of the reference device | Luer Connection | Luer Connection with Valve |
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equivalence.
| Attribute | Subject Device – PowerPICC ProvenaCatheter With SOLO² Valve Technology | Predicate Device – PowerPICCProvena Catheters (K162443) | Reference Device – PowerPICC SOLOCatheters (K072230) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Catheter DistalConfiguration | Same | Open Ended | Open Ended | ||||||||||||
| Number ofLumens | Same | Single LumenDual Lumen | Single LumenDual Lumen | ||||||||||||
| PowerInjectionMaximum FlowRate | Same as Predicate | Catheter Size MaximumFlow Rate 3F Single Lumen 3 mL/sec 4F Dual Lumen 5 mL/sec | Catheter Size MaximumFlow Rate 4F Single Lumen 5 mL/sec 5F Dual Lumen 5 mL/sec | ||||||||||||
| Sterility | Same | Provided Sterile | Provided Sterile | ||||||||||||
| PackagingConfigurations | Same as Predicate | Both Standard and Small Patientversions of the following configurations:Basic Configuration Full Configuration Max Barrier Configuration IR Configuration | Standard Kits:Basic Configuration Full Configuration Max Barrier Configuration IR Configuration |
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Verification and validation tests were designed and performed in accordance with Design Controls per 21 CFR §820.30. The following tests were conducted per guidance documents and standards in conjunction with in-house protocols to establish the performance of the device.
| Verification /Validation Method | Risk Acceptability Criteria (Acceptance Criteria of Test) | |
|---|---|---|
| MechanicalHemolysis Test | Testing to determine the hemolytic properties when blood is aspiratedthrough the catheter assembly.• Bard internal standards and procedures | |
| 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 - Part 1:General requirements | |
| PerformanceTests | Catheter CollapseTest | Test to measure the flow rate of aspiration and demonstrate that thecatheter will not collapse under a vacuum.• Bard internal standards and procedures and FDA guidance,Guidance on Premarket Notification [510(k)] Submission forShort-Term and Long-Term Intravascular Catheters (March16, 1995) |
| Luer to ExtensionLeg Tensile Test | Test to demonstrate the peak tensile force of each test piece exceedsthe minimum peak tensile force.• ISO 10555-1:2013 – Sterile Single-Use IntravascularCatheters - Part 1: General requirements | |
| 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 IntravascularCatheters (March 16, 1995) | |
| Pump Flow | Test to determine the maximum pressure generated by the catheterwhen infusing water through it at a maximum pump flow rate.• Bard internal standards and procedures | |
| Gravity Flow | Test to measure the gravity flow rate.• Bard internal standards and procedures and FDA guidance,Guidance on Premarket Notification [510(k)] Submission forShort-Term and Long-Term Intravascular Catheters (March16, 1995)• ISO 10555-1:2013 – Sterile Single-Use IntravascularCatheters - Part 1: General requirements | |
| 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 the subjectdevices was conducted in accordance with BS EN ISO 14971:2012, Medical Devices -Application of Risk Management to Medical Devices. | ||
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and results of performancetesting, the subject PowerPICC Provena Catheters with SOLO2 Valve Technology meetthe requirements that are considered sufficient for its intended use and demonstratesubstantial equivalence to the cited predicate device. |
§ 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.”