(179 days)
No
The summary describes a physical medical device (a catheter) and its performance characteristics, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for "intravenous therapy," which is a form of medical treatment. Additionally, it allows for "central venous pressure monitoring," which is related to managing a patient's physiological state.
No
Explanation: The device is a catheter designed for intravenous therapy, blood sampling, power injection of contrast media, and central venous pressure monitoring, which are all interventional or monitoring functions, not diagnostic ones.
No
The device description clearly states it is a family of peripherally inserted central catheters made from medical grade materials, indicating a physical, hardware-based device. The performance studies also focus on physical properties and tests of the catheter itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for accessing the central venous system for therapeutic purposes (intravenous therapy, power injection of contrast media, central venous pressure monitoring) and blood sampling. These are all procedures performed in vivo (within the body).
- Device Description: The description details a catheter designed for insertion into the vascular system.
- Lack of IVD Indicators: There is no mention of the device being used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic purposes. The performance studies focus on the physical and biological properties of the catheter itself, not on the analysis of biological samples.
Therefore, the PowerPICC Catheter is a medical device used for in vivo procedures, not an IVD.
N/A
Intended Use / Indications for Use
The PowerPICC 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. The maximum infusion flow rate is 5mL/second for power injection of contral venous pressure monitoring, it is recommended that a catheter lumen of 20gauge or larger be used.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
A family of peripherally inserted central catheters made from specially formulated and processed medical grade materials. Each PowerPICC® catheter has a kink resistant, reverse tapered design. Catheters are packaged in a tray with accessories for reliable long (greater than 30 days) or short (less than 30 days) term vascular access.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
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)
The following performance tests were conducted in determining substantial equivalence of the PowerPICC Catheter to the predicate devices.
Reference Standard: ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process
Biocompatibility Testing: Tests to confirm that the catheter is free from biological hazard per testing. A health-based risk assessment per ISO 10993-1 was performed for determining the acceptability of the material for the intended purpose. Testing Performed includes: Cytotoxicity Sensitization Irritation or Intracutaneous Reactivity Acute Systemic Toxicity Pyrogenicity Subchronic Systemic Toxicity Genotoxicity Chronic toxicity Hemocompatibility Implantation
Reference Standard: ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – Part 1: General requirements
Leak Test: Test to confirm that the catheter assembly will not leak when the distal end of the catheter is occluded.
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.
Implantable Length: Test to measure useful length for catheters to ensure compliance with dimensional specification.
Extension Leg Length: Test to measure and confirm extension leg length compliance with dimensional specification.
Catheter Collapse Test: Test to measure the flow rate of aspiration and demonstrate that the catheter will not collapse under a vacuum.
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.
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.
Power Injection Conditioning: Test to confirm the catheter does not leak or burst as a result of power injections at maximum indicated flow rate.
Gravity Flow: Test to measure the gravity flow performance of a full-length catheter.
Luer to Extension Leg Tensile Test: Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force.
Extension Leg to Trifurcation Tensile Test
Trifurcation to Shaft Tensile Test
Shaft Tensile Test
Reference Standard: ASTM F640-12 – Standard Test Methods for Radiopacity of Plastics for Medical Use
Radiopacity: Test to demonstrate catheter radio-detectability.
Reference Standard: ISO 10555-3:2013 - Intravascular catheters – Sterile and single-use catheters - Part 3: Central venous catheters
Tip Tensile: Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force.
Reference Standard: FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, 1995
Shaft Tensile Test: Test to evaluate the maximum catheter strain and modulus at break.
Suture Wing Integrity Test: Test to measure the maximum force a catheter junction suture wing can withstand prior to break.
Priming Volume: Test to measure the volume required to prime a full-length catheter.
OD Swell: Test to confirm that the catheter does not swell beyond twice the size of the labeled OD during power injection.
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.
Guidewire Drag Test: Test to ensure that the guidewire used to place the catheter can be removed without difficulty.
Reference Standard: ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
Luer Testing: Testing to ensure that luer connectors meet requirements for Stress Cracking, Resistance to Separation from Axial Load, Resistance to Separation from Unscrewing, and Resistance to Overriding.
Reference Standard: USP 788 Particulate Matter in Injections
Particulate: Particulate matter is defined in the USP as extraneous, mobile, undissolved substances, other than gas bubbles, unintentionally present in a solution (or in/on a device).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.”
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 30, 2021
Bard Access Systems, Inc. Mary Strickland Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116
Re: K210264
Trade/Device Name: PowerPICC Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: June 28, 2021 Received: June 30, 2021
Dear Mary Strickland:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210264
Device Name
PowerPICC Catheter
Indications for Use (Describe)
The PowerPICC 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. The maximum infusion flow rate is 5mL/second for power injection of contral venous pressure monitoring, it is recommended that a catheter lumen of 20gauge or larger be used.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K210381 510(k) Summary for PowerPICC Catheters
21 CFR §807.92(a)
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part(1)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is presented in the following table:
| Submitter Name: | Bard Access Systems, Inc. (Bard has joined BD) | |
|---|---|---|
| General Provisions | Submitter Address: | 605 North 5600 West |
| Salt Lake City, UT 84116 | ||
| Contact Person: | Mary Strickland | |
| Regulatory Affairs Specialist | ||
| Telephone Number: | 801.522.5031 | |
| Fax Number: | 801.522.5425 | |
| Date of Preparation: | 7/30/2021 | |
| Trade Name(s): | PowerPICC Catheter | |
| Subject Device | Common Name: | Catheter, Intravascular, Therapeutic, Long-term Greater than 30 days |
| Classification Name: | Percutaneous, Implanted, Long-term Intravascular Catheter | |
| Class: | Class 2 | |
| Regulation Number: | 21 CFR §880.5970 | |
| Product Code: | LJS | |
| Classification Panel | General Hospital | |
| Trade Name(s): | PowerPICC SOLO Catheter | |
| Predicate Device | Common Name: | Catheter, Intravascular, Therapeutic, Long-term Greater than 30 days |
| Classification Name: | Percutaneous, Implanted, Long-term Intravascular Catheter | |
| Premarket Notification # | K072230 | |
| Class: | Class 2 | |
| Regulation Number: | 21 CFR §880.5970 |
4
| Product Code: | LJS | ||
|---|---|---|---|
| Classification Panel | General Hospital | ||
| Concurrence Date: | November 18, 2008 | ||
| Device Description | A family of peripherally inserted central catheters made from specially formulated and processed medical grade | ||
| materials. Each PowerPICC® catheter has a kink resistant, reverse tapered design. Catheters are packaged in a tray | |||
| with accessories for reliable long (greater than 30 days) or short (less than 30 days) term vascular access. | |||
| Intended Use | PowerPICC Family Catheters: | ||
| The PowerPICC catheter is intended to provide short-term access ( 30 days) to the | |||
| central venous system. They are designed for administering I.V. fluids, blood products, drugs, and parenteral nutrition | |||
| solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media | |||
| Indications for Use | PowerPICC Family Catheters | ||
| The PowerPICC 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. The maximum infusion flow rate is 5 mL/second for power injection of contrast media. For central venous | |||
| pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used. | |||
| Technological | |||
| Characteristics | Technological characteristics of the subject PowerPICC Family Catheters are substantially equivalent with respect to | ||
| basic design, function, and fundamental scientific technology to those of the cited predicate device. Changes | |||
| compared to the predicate device include a clarification to the indications for use statement, the addition of 5F Triple | |||
| Lumen and 5Fr Dual Lumen FT catheter configurations, and other minor changes to product instructions for use. | |||
| The following table provides a summary comparison between the subject and predicate device: | |||
| Attribute | Subject Device | Predicate device | |
| Owner | Bard Access Systems, Inc. | Same | |
| 510(k) status | Subject of this 510(k) | K072230 | |
| Device Configuration | PowerPICC SOLO Catheters: | ||
| 4F Single Lumen (SL), 55 cm Length | |||
| 5F Dual Lumen (DL), 55 cm Length | |||
| 5F Dual Lumen (DL) FT, 55 cm Length, (4F between 5 and 30cm mark) | PowerPICC SOLO Catheters: | ||
| 4F Single Lumen (SL), 55 cm Length | |||
| 5F Dual Lumen (DL), 55 cm Length | |||
| 6F Triple Lumen (TL), 55 cm Length | |||
| 5F Triple Lumen (TL) cm Length |
PowerPICC Catheters:
4F Single Lumen (SL), 55 cm Length
5F Dual Lumen (DL), 55 cm Length
5F Dual Lumen (DL), FT 55 cm Length,
(4F between 5 and 30cm mark)
5F Triple Lumen (TL), 55 cm Length | | |
| Indications for use | The PowerPICC 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. The maximum
infusion flow rate is 5 mL/second for power
injection of contrast media. For central
venous pressure monitoring, it is
recommended that a catheter lumen of 20
gauge or larger be used. | The PowerPICC SOLO catheter is indicated
for short- or long-term peripheral access to
the central venous system for intravenous
therapy, power injection of contrast media,
and allows for central venous pressure
monitoring. For blood sampling, infusion, or
therapy use a 4 French or larger catheter.
The maximum recommended infusion rate
is 5 mL/sec for power injection of contrast
media. For central venous pressure
monitoring, it is recommended that a
catheter lumen of 20 gauge or larger be
used. | |
| Duration of use | Same | Short term (30
days) | |
| Means of insertion | Same | Percutaneous | |
| Insertion site | Same | Peripheral | |
| Primary device
materials | Same | All Catheter Configurations Base Materials:
Shaft Tubing:
Polyurethane
Luer Connector:
Polyurethane | |
| | | | |
| | | | Extension Legs: |
| | | | Polyurethane |
| | | | Junction: |
| | | | Polyurethane |
| | Power injection
maximum flow rate | Same | 5 ml/sec |
| | Sterility | Same | Ethylene Oxide |
| Reference devices used for specific technological characteristics include, K070996: 4 Fr Single Lumen PowerPICC
Catheter, K053501: 6 Fr Triple Lumen PowerPICC Catheter, K051672: 5 Fr Dual Lumen PowerPICC Catheter. The
technological differences and changes to the indications for use statement listed above were evaluated using industry
consensus standards, and as defined in the Risk Assessment. These differences in technological characteristics
between the subject and predicate devices do not raise new or different questions of safety or effectiveness. | | | |
| Performance Tests | The following performance tests were conducted in determining substantial equivalence of the PowerPICC Catheter to
the predicate devices. | | |
| | Reference Standard: ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1:
Evaluation and testing within a risk management process | | |
| | Biocompatibility
Testing | Tests to confirm that the catheter is free from biological hazard per testing. A
health-based risk assessment per ISO 10993-1 was performed for
determining the acceptability of the material for the intended purpose.
Testing Performed includes:
Cytotoxicity Sensitization Irritation or Intracutaneous Reactivity Acute Systemic Toxicity Pyrogenicity Subchronic Systemic Toxicity | |
| | Genotoxicity Chronic toxicity Hemocompatibility Implantation Reference Standard: ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – Part 1: | | |
| | General requirements | | |
| | Leak Test | Test to confirm that the catheter assembly will not leak when the distal end of the catheter is occluded. | |
| | 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. | |
| | Implantable Length | Test to measure useful length for catheters to ensure compliance with dimensional specification. | |
| | Extension Leg Length | Test to measure and confirm extension leg length compliance with dimensional specification. | |
| | Catheter Collapse Test | Test to measure the flow rate of aspiration and demonstrate that the catheter will not collapse under a vacuum. | |
| | 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. | |
| | 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. | |
| | Power Injection Conditioning | Test to confirm the catheter does not leak or burst as a result of power injections at maximum indicated flow rate. | |
| | Gravity Flow | Test to measure the gravity flow performance of a full-length catheter. | |
| | Luer to Extension Leg Tensile Test | Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force. | |
5
6
7
8
| Extension Leg to
Trifurcation Tensile
| Test | ||
|---|---|---|
| Trifurcation to Shaft | ||
| Tensile Test | ||
| Shaft Tensile Test | ||
| Reference Standard: ASTM F640-12 – Standard Test Methods for Radiopacity of Plastics | ||
| for Medical Use | ||
| Radiopacity | Test to demonstrate catheter radio-detectability. | |
| Reference Standard: ISO 10555-3:2013 - Intravascular catheters – Sterile and single-use | ||
| catheters - Part 3: Central venous catheters | ||
| Tip Tensile | Test to demonstrate the peak tensile force of each test piece exceeds the | |
| minimum peak tensile force. | ||
| Reference Standard: FDA Guidance on Premarket Notification [510(k)] Submission for Short- | ||
| Term | ||
| and Long-Term Intravascular Catheters, 1995 | ||
| Shaft Tensile Test | Test to evaluate the maximum catheter strain and modulus at break. | |
| Suture Wing Integrity | ||
| Test | Test to measure the maximum force a catheter junction suture wing can | |
| withstand prior to break. | ||
| Priming Volume | Test to measure the volume required to prime a full-length catheter. | |
| OD Swell | Test to confirm that the catheter does not swell beyond twice the size of the | |
| labeled OD during power injection. | ||
| 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. | ||
| Guidewire Drag Test | Test to ensure that the guidewire used to place the catheter can be removed | |
| without difficulty. | ||
| Reference Standard: ISO 80369-7: Small-bore connectors for liquids and gases in healthcare | ||
| applications - Part 7: Connectors for intravascular or hypodermic applications | ||
| Luer Testing | Testing to ensure that luer connectors meet requirements for Stress | |
| Cracking, Resistance to Separation from Axial Load, Resistance to | ||
| Separation from Unscrewing, and Resistance to Overriding. | ||
| Reference Standard: USP 788 Particulate Matter in Injections | ||
| Particulate | Particulate matter is defined in the USP as extraneous, mobile, undissolved | |
| substances, other than gas bubbles, unintentionally present in a solution (or | ||
| in/on a device). | ||
| Technological | ||
| Comparison to | ||
| Predicate and | ||
| Reference Devices | Technological characteristics of the subject PowerPICC Family (PowerPICC, PowerPICC SOLO, PowerPICC FT and | |
| PowerPICC Provena, PowerPICC Provena SOLO) Catheters are substantially equivalent with regard to the basic | ||
| design and function of the predicate device, PowerPICC SOLO, K072230, Concurrence date November 18, 2008. It is | ||
| known that the predicate and reference devices are made from grades of polyurethane typically used in catheters (and | ||
| permitted, by 21 CFR §880.5970). | ||
| Summary of | ||
| Substantial | ||
| Equivalence | Based on the risk management activities and testing, the subject PowerPICC Family Catheters have been | |
| demonstrated to be substantially equivalent to the cited predicate and reference devices. |
9