Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters
Device Facts
| Record ID | K150514 |
|---|---|
| Device Name | Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters |
| Applicant | C.R. Bard, Inc. |
| Product Code | LJT · General Hospital |
| Decision Date | Nov 20, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5965 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The PowerPort® implanted port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a PowerLoc® safety infusion set, the PowerPort® device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.
Device Story
Implantable vascular access port; consists of rigid housing, self-sealing septum, and ChronoFlex polyurethane catheter. Physician implants port subcutaneously; tunnels catheter into central venous system (preferred lower 1/3 of superior vena cava). Used for long-term, repeated vascular access; avoids repeated venipuncture. For power injection of contrast media, clinician must use Bard PowerLoc safety infusion set. Device facilitates delivery of medications, fluids, nutrition, and blood products; enables blood sampling. Benefits patient by providing reliable, long-term access point for therapies.
Clinical Evidence
Bench testing only. No clinical data presented. Performance evaluated via verification and validation activities including catheter surface profilometry, biocompatibility (ISO 10993), sterilization validation (AAMI/ANSI/ISO 11135), and MR environment safety (ASTM F2503).
Technological Characteristics
Implantable port with PEEK body/stem, silicone suture plugs, and ChronoFlex polyurethane catheter. Catheter surface profilometry RMS ≤0.5µm. Sterilization via ethylene oxide per AAMI/ANSI/ISO 11135-1. Passive implant; no energy source. No software component.
Indications for Use
Indicated for patients requiring repeated vascular access for infusion of medications, IV fluids, parenteral nutrition, blood products, and blood withdrawal. When used with PowerLoc safety infusion set, indicated for power injection of contrast media at max rate 5 mL/s.
Regulatory Classification
Identification
A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.
Special Controls
*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
Predicate Devices
- PowerPort® ClearVUE® Slim Implantable Port (K122899)
Reference Devices
- Titanium PowerPort® ISP Implanted Port with 6 Fr. ChronoFlex® Polyurethane Catheter (K072549)
- PowerPort® Polymeric Port with 8 F S/L ChronoFlex® Catheters (K063377)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2015
C.R. Bard, Inc. Mr. James Davis Regulatory Affairs Specialist Bard Access Systems, Inc. 605 North 5600 West Salt Lake City, Utah 84116
Re: K150514
Trade/Device Name: Power-injectable Implantable Ports with Chronoflex® Polyurethane Catheters Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: October 22, 2015 Received: October 23, 2015
Dear Mr. Davis:
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 (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 yours, Tina Kiang S
for Erin I. Keith, M.S. 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) K150514
Device Name
Power-Injectable Implantable Ports with ChronoFlex® Polyurethane Catheters
Indications for Use (Describe)
The PowerPort® implanted port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
When used with a PowerLoc® safety infusion set, the PowerPort® device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.
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
# Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters
| | Submitter Name: | Bard Access Systems, Inc. |
|-----------------------|-------------------------|----------------------------------------------------------------------------------------------------------------------|
| | Address: | 605 North 5600 West<br>Salt Lake City, UT 84116 |
| General<br>Provisions | Contact Person | James R. Davis<br>Regulatory Affairs Specialist<br>James.R.Davis@crbard.com<br>801.522.5000 ext 5456<br>801.522.5425 |
| | Date of Preparation: | 22 October 2015 |
| Subject<br>Device | Trade Name: | Power-Injectable Implantable Ports with ChronoFlex®<br>Polyurethane Catheters |
| | Common/Usual Name: | Implanted Infusion Port & Catheter |
| | Classification Name: | Subcutaneous, Implanted, Intravascular Infusion Port<br>and Catheter |
| | Product Code: | LJT |
| | Regulation: | 21 CFR 880.5965 |
| Predicate<br>Device | Trade Name: | PowerPort® ClearVUE® Slim Implantable Port |
| | Classification Name: | Subcutaneous, Implanted, Intravascular Infusion Port<br>and Catheter |
| | Premarket Notification: | K122899 |
| | Manufacturer: | Bard Access Systems, Inc. |
| Reference<br>Devices | Trade Name: | Titanium PowerPort® ISP Implanted Port with 6 Fr.<br>ChronoFlex® Polyurethane Catheter |
| | Classification Name: | Subcutaneous, Implanted, Intravascular Infusion Port<br>and Catheter |
| | Premarket Notification: | K072549 |
| | Manufacturer: | Bard Access Systems, Inc. |
| | Trade Name: | PowerPort® Polymeric Port with 8 F S/L ChronoFlex®<br>Catheters |
| | Classification Name: | Subcutaneous, Implanted, Intravascular Infusion Port<br>and Catheter |
| | Premarket Notification: | K063377 |
| | Manufacturer: | Bard Access Systems, Inc. |
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### Reference Devices Justification
The references devices are provided because a bundled 510(k) submission is appropriate for the subject device since the scientific and regulatory issues are most efficiently addressed during one review. Additionally, the performance data is the same for the subject devices, only the General Hospital review branch is involved with the review process and the devices have the same indications for use.
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Power-Injectable Implantable Ports with<br>ChronoFlex® Polyurethane Catheters | PowerPort® ClearVUE® Slim Implantable Port<br>(K122899) |
| Note | <b>Bold red font</b> indicates a difference between the subject device and the current regulatory predicate baseline of the predicate device.Plain type indicates that the attribute of the subject device is the same as that of the current regulatory baseline of the predicate device. | |
| Owner | Same | Bard Access Systems, Inc. |
| 510(k) Status | Subject of this Premarket Notification | K122899<br>Concurrence Date:<br>November 15th, 2012 |
| Classification | Same | 21 CFR 880.5965 – Class II<br>LJT – Subcutaneous, implanted, intravascular infusion port and catheter |
| Intended Use | Same | Power-Injectable Implantable Ports are intended to be an implanted vascular access device designed to provide long-term, repeated access to the vascular system. |
| Indications for Use | Same | The PowerPort® implanted port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.<br><br>When used with a PowerLoc® safety infusion set, the PowerPort® device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s. |
| Duration of Use | Same | Long term (>30 days) |
| Insertion Site | Same | Port is implanted subcutaneously with catheter tunneled and inserted in blood vessel |
| Catheter Tip Location | Same | Central venous system - lower 1/3 of superior <i>vena cava</i> preferred |
| Significant Device Dimensions | 8 Fr. & 6 Fr. Catheter Surface Profilometry<br>RMS Value: ≤0.5µm | 8 Fr. & 6 Fr. Catheter Surface Profilometry<br>N/A |
| Catheter Body Materials | Same | Polyurethane |
| Port Body Materials | Same | Polyetheretherketone (Body/Stem)<br>Silicone (Suture Plugs) |
| Catheter Lock Materials | Same | Polycarbonate |
| Device<br>Description | PowerPort® Implantable Ports are designed to provide repeated access to the<br>vascular system without the need for repeated venipuncture or daily care of an<br>external catheter. Long-Term Implantable Ports consist of a rigid housing and a<br>self-sealing septum. The catheters used with infusion ports are essentially the<br>same design as externalized, stand-alone intravascular catheters. Polyurethane<br>catheters are attached to the port by the physician during implantation. | |
| | PowerPort® Implantable Ports can be used for routine vascular access using a<br>non-coring access needle. However, for power injection procedures, PowerPort®<br>ports must be accessed with a Bard PowerLoc® Safety Infusion Set (SIS) to<br>create a power-injectable system. | |
| | The ChronoFlex® Polyurethane Catheters maintain an average root mean square<br>catheter surface profilometry of less than 0.5µm. | |
| Intended Use | Power-Injectable Implantable Ports are intended to be an implanted vascular<br>access device designed to provide long-term, repeated access to the vascular<br>system. | |
| Indications for<br>Use | The PowerPort® implanted port is indicated for patient therapies requiring<br>repeated access to the vascular system. The port system can be used for<br>infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products,<br>and for the withdrawal of blood samples. | |
| | When used with a PowerLoc® safety infusion set, the PowerPort® device is<br>indicated for power injection of contrast media. For power injection of contrast<br>media, the maximum recommended infusion rate is 5 mL/s. | |
| Technological<br>Characteristics | The technological characteristics of the subject Power-Injectable Ports with<br>ChronoFlex® Polyurethane Catheters are substantially equivalent with respect to<br>design and function to those of the predicate devices. | |
| Performance<br>Tests | Verification and validation activities were designed and performed in accordance<br>with Design Controls as per 21 CFR §820.30. The following guidance<br>documents and standards in conjunction with in-house protocols were used to<br>determine appropriate methods for evaluating the performance of the device:<br>FDA Guidance - Guidance on 510(k) Submissions for Implanted Infusion<br>Ports; October, 1990 FDA Guidance – Guidance on 510(k) Submissions for Short-Term and Long-<br>Term Intravascular Catheters, March 16, 1990 FDA Guidance - General Considerations for Animal Studies for Cardiovascular<br>Devices, dated July 29,2010 FDA Guidance – Good Laboratory Practices Questions and Answers, dated<br>July, 2007 FDA Guidance - Bundling Multiple Devices or Multiple Indications in a single<br>submission, dated June 22, 2007 FDA Guidance – Establishing safety and compatibility of passive implants in<br>the magnetic resonance environment, dated August 21, 2008 ISO 10555-1 Second Edition 2013-07-01, Sterile, Single-Use Intravascular<br>Catheters, Part 1: General Requirements ISO 10555-3 Second Edition 2013-06-15, Sterile, Single-Use Intravascular<br>Catheters, Part 3: Central Venous Catheters AAMI/ANSI/ISO 11135-1: 2007, Sterilization of Healthcare Products –<br>Ethylene Oxide AAMI/ANSI/ISO 10993-1:2009/(R) 2013, Biological Evaluation of Medical<br>Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test<br>Profile ISO 10993-7 Second Edition 2008-10-15, Biological Evaluation for Medical<br>Devices; Part 7 – Ethylene Oxide Sterilization Residuals AAMI/ANSI/ISO 11607:2006/(R)2010, Packaging for Terminally Sterilized<br>Medical Devices AAMI / ANSI ST72:2011: Bacterial Endotoxins—Test Methodologies, Routine<br>Monitoring, and Alternatives to Batch Testing ASTM F2503-13 (2014), Standard Practice for marketing Medical Devices and<br>Other Items for Safety in the Magnetic Resonance (MR) Environment The subject device met all pre-determined acceptance criteria and demonstrated<br>substantial equivalence as compared to the predicate devices. | |
| Testing<br>Conclusion | The results of the testing performed demonstrate the subject device performance<br>is substantially equivalent to the predicate device. | |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, technological characteristics, and performance<br>testing, the subject Power-Injectable Ports with ChronoFlex® Polyurethane Catheters<br>meets the requirements that are considered sufficient for its intended use and<br>demonstrates that the subject devices are substantially equivalent to the<br>predicate devices cited. | |
#### Subject and Predicate Device Comparison
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