(55 days)
No
The document describes a standard medical device (PICC catheter) and its physical characteristics and performance testing. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device facilitates intravenous therapy, which is a therapeutic intervention.
No
Explanation: The device is a catheter used for intravenous therapy, blood sampling, power injection of contrast media, and central venous pressure monitoring. While it assists in obtaining information (blood samples, pressure monitoring), its primary function is not to diagnose conditions itself, but rather to facilitate procedures that may lead to a diagnosis by other means.
No
The device is a physical catheter, a hardware component, and the summary describes extensive hardware verification and validation testing.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to diagnose, monitor, or screen for diseases.
- Device Function: The PowerPICC Provena Catheters are devices inserted into the body to provide access to the central venous system for administering fluids, drawing blood, power injecting contrast media, and monitoring central venous pressure.
- Lack of Diagnostic Testing: The device itself does not perform any diagnostic tests on samples. It is a tool for accessing the body to facilitate various medical procedures, some of which might involve collecting samples for subsequent in vitro diagnostic testing, but the catheter itself is not the diagnostic device.
The description clearly outlines its function as a vascular access device, not a diagnostic test.
N/A
Intended Use / 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.
Product codes
LJS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system, peripheral access
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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.
- Cantilever Stiffness Test: Test to characterize the catheter shaft stiffness at the distal section using a cantilever bend technique. Bard internal standards and procedures.
- 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.
- Mechanical Hemolysis Test: Testing to determine the hemolytic properties when blood is aspirated through the catheter assembly. Bard internal standards and procedures.
- 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.
- 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.
- 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.
- Extension Leg Length: Test to measure and confirm extension leg length compliance with dimensional specification. Bard internal standards and procedures.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Assembly Tensile Test: Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force.
- Shaft Tensile Test Luer to Extension Leg Tensile Test: ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – Part 1: General requirements.
- 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).
- 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.
- 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).
- 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).
- 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.
- 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.
- Kink Diameter Test: Test to quantitatively evaluate kink characteristics associated with the catheter shafts. Bard internal standards and procedures.
- Stylet Drag Test: Test to ensure that the stylets used to place the catheter can be removed without difficulty. Bard internal standards and procedures.
- StatLock Compatibility: Test to ensure the catheter is compatible with StatLock for catheter securement. Bard internal standards and procedures.
- Taper Length: Test to measure and confirm taper length compliance with dimensional specification. Bard internal standards and procedures.
- Catheter Printing: Test is to confirm ink on the catheter exhibits proper adherence. Bard internal standards and procedures.
Key Results: 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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Image /page/0/Picture/1 description: The image is a logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of three human profiles facing to the right, with a stylized design below them that could represent water or fabric.
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.
1
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
2
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)
| General
| Provisions | Submitter Name: | Bard Access Systems, Inc. |
|---|---|---|
| Submitter Address: | 605 North 5600 West | |
| Salt Lake City, UT 84116 | ||
| Contact Person: | Bryan Stone | |
| Regulatory 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 Intravascular | |
| Catheter | ||
| Product Code/Regulation: | LJS/21 CFR §880.5970 | |
| Predicate | ||
| Devices | Predicate Trade Name: | PowerPICC SV Catheter |
| Classification Name: | Percutaneous, Implanted, Long-term Intravascular | |
| Catheter | ||
| Premarket Notification: | K102159 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| References | ||
| Devices | Reference Trade Name: | PowerPICC EtOH Catheter |
| Classification Name: | Percutaneous, Implanted, Long-term Intravascular | |
| Catheter | ||
| Premarket Notification: | K151985 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| Reference Trade Name: | PowerPICC Catheter | |
| Classification Name: | Percutaneous, Implanted, Long-term Intravascular | |
| Catheter | ||
| Premarket Notification: | K053501 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| Device | ||
| Description | 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 |
4
| | 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. | | | | | | |
| Intended Use | The PowerPICC Provena Catheters are intended for short- or long-term peripheral
access to the central venous system for intravenous therapy and blood sampling. | | | | | | |
| Indications For | 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. | | | | | | |
| Use | | Catheter Size | | Maximum Flow Rate | | | |
| | | 3F Single Lumen | | 3 mL/sec | | | |
| | | 4F Dual Lumen | | 5 mL/sec | | | |
| Technological
Characteristics | predicate device. | | | Technological characteristics of the subject PowerPICC Provena Catheters are
substantially equivalent with respect to basic design and function to those of the cited | | | |
5
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 ( |