BD PowerPiCC Catheter
Device Facts
| Record ID | K210264 |
|---|---|
| Device Name | BD PowerPiCC Catheter |
| Applicant | Bard Access Systems, Inc. |
| Product Code | LJS · General Hospital |
| Decision Date | Jul 30, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5970 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The PowerPICC catheter is intended to provide short-term access (< 30 days) and long-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.
Device Story
PowerPICC Catheter is a peripherally inserted central catheter (PICC) for vascular access; provides short or long-term access to central venous system. Used for IV therapy, blood sampling, parenteral nutrition, and power injection of contrast media. Features kink-resistant, reverse-tapered design; constructed from medical-grade polyurethane. Operated by clinicians in clinical settings. Device facilitates fluid administration and monitoring; power injection capability allows high-flow delivery of contrast media (up to 5 mL/sec). Benefits include reliable vascular access for various therapeutic needs.
Clinical Evidence
Bench testing only. No clinical data. Performance testing included biocompatibility (ISO 10993-1), leak testing, dimensional analysis, catheter collapse, burst pressure, power injection conditioning, gravity flow, tensile testing (ISO 10555-1), radiopacity (ASTM F640-12), suture wing integrity, priming volume, OD swell, tip stability, guidewire drag, luer testing (ISO 80369-7), and particulate matter (USP 788).
Technological Characteristics
Materials: Medical-grade polyurethane (shaft, luer, extension legs, junction). Design: Kink-resistant, reverse-tapered. Sterilization: Ethylene Oxide. Standards: ISO 10993-1 (biocompatibility), ISO 10555-1/3 (catheter requirements), ASTM F640-12 (radiopacity), ISO 80369-7 (luer connectors), USP 788 (particulates).
Indications for Use
Indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and central venous pressure monitoring. Maximum infusion flow rate is 5 mL/second for power injection. For central venous pressure monitoring, a catheter lumen of 20 gauge or larger is recommended.
Regulatory Classification
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.
Special Controls
*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
Predicate Devices
- PowerPICC SOLO Catheter (K072230)
Reference Devices
- 4 Fr Single Lumen PowerPICC Catheter (K070996)
- 6 Fr Triple Lumen PowerPICC Catheter (K053501)
- 5 Fr Dual Lumen PowerPICC Catheter (K051672)
Submission Summary (Full Text)
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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
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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
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### 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) |
|-----------------------------------------------------------------------------------------------------------------|
| <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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# 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<br>Salt Lake City, UT 84116 |
| | Contact Person: | Mary Strickland<br>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 |
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| 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<br>materials. Each PowerPICC® catheter has a kink resistant, reverse tapered design. Catheters are packaged in a tray<br>with accessories for reliable long (greater than 30 days) or short (less than 30 days) term vascular access. | | |
| Intended Use | PowerPICC Family Catheters:<br>The PowerPICC catheter is intended to provide short-term access (< 30 days) and long-term access (> 30 days) to the<br>central venous system. They are designed for administering I.V. fluids, blood products, drugs, and parenteral nutrition<br>solutions, as well as blood withdrawal, central venous pressure monitoring, and power injection of contrast media | | |
| Indications for Use | PowerPICC Family Catheters<br>The PowerPICC catheter is indicated for short- or long-term peripheral access to the central venous system for<br>intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure<br>monitoring. The maximum infusion flow rate is 5 mL/second for power injection of contrast media. For central venous<br>pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used. | | |
| Technological<br>Characteristics | Technological characteristics of the subject PowerPICC Family Catheters are substantially equivalent with respect to<br>basic design, function, and fundamental scientific technology to those of the cited predicate device. Changes<br>compared to the predicate device include a clarification to the indications for use statement, the addition of 5F Triple<br>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:<br>4F Single Lumen (SL), 55 cm Length<br>5F Dual Lumen (DL), 55 cm Length<br>5F Dual Lumen (DL) FT, 55 cm Length, (4F between 5 and 30cm mark) | PowerPICC SOLO Catheters:<br>4F Single Lumen (SL), 55 cm Length<br>5F Dual Lumen (DL), 55 cm Length<br>6F Triple Lumen (TL), 55 cm Length |
| | | | |
| | 5F Triple Lumen (TL) cm Length<br><br><i>PowerPICC Catheters:</i><br>4F Single Lumen (SL), 55 cm Length<br>5F Dual Lumen (DL), 55 cm Length<br>5F Dual Lumen (DL), FT 55 cm Length,<br>(4F between 5 and 30cm mark)<br>5F Triple Lumen (TL), 55 cm Length | | |
| Indications for use | The PowerPICC catheter is indicated for<br>short- or long-term peripheral access to the<br>central venous system for intravenous<br>therapy, blood sampling, power injection of<br>contrast media, and allows for central<br>venous pressure monitoring. The maximum<br>infusion flow rate is 5 mL/second for power<br>injection of contrast media. For central<br>venous pressure monitoring, it is<br>recommended that a catheter lumen of 20<br>gauge or larger be used. | The PowerPICC SOLO catheter is indicated<br>for short- or long-term peripheral access to<br>the central venous system for intravenous<br>therapy, power injection of contrast media,<br>and allows for central venous pressure<br>monitoring. For blood sampling, infusion, or<br>therapy use a 4 French or larger catheter.<br>The maximum recommended infusion rate<br>is 5 mL/sec for power injection of contrast<br>media. For central venous pressure<br>monitoring, it is recommended that a<br>catheter lumen of 20 gauge or larger be<br>used. | |
| Duration of use | Same | Short term (<30 days) or Long term (>30<br>days) | |
| Means of insertion | Same | Percutaneous | |
| Insertion site | Same | Peripheral | |
| Primary device<br>materials | Same | All Catheter Configurations Base Materials:<br>Shaft Tubing:<br>Polyurethane<br>Luer Connector:<br>Polyurethane | |
| | | | |
| | | | Extension Legs: |
| | | | Polyurethane |
| | | | Junction: |
| | | | Polyurethane |
| | Power injection<br>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<br>Catheter, K053501: 6 Fr Triple Lumen PowerPICC Catheter, K051672: 5 Fr Dual Lumen PowerPICC Catheter. The<br>technological differences and changes to the indications for use statement listed above were evaluated using industry<br>consensus standards, and as defined in the Risk Assessment. These differences in technological characteristics<br>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<br>the predicate devices. | | |
| | Reference Standard: ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1:<br>Evaluation and testing within a risk management process | | |
| | Biocompatibility<br>Testing | Tests to confirm that the catheter is free from biological hazard per testing. A<br>health-based risk assessment per ISO 10993-1 was performed for<br>determining the acceptability of the material for the intended purpose.<br><br>Testing Performed includes:<br>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.…
