(266 days)
No
The device description and performance studies focus on the physical characteristics and material properties of an implantable port and catheter system, with no mention of AI or ML capabilities.
No.
The device facilitates the delivery of therapies (e.g., infusion of medications, parenteral nutrition), but it is not a therapy itself. Its function is to provide repeated vascular access.
No
Explanation: The device is described as an implanted port system used for infusion of medications, fluids, nutrition, blood products, and for withdrawal of blood samples. It facilitates access to the vascular system for therapeutic purposes, not for diagnosing medical conditions.
No
The device description clearly states it is an "Implantable Port" consisting of a "rigid housing and a self-sealing septum" and "catheters." These are physical hardware components, not software.
Based on the provided information, the PowerPort® implanted port is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "patient therapies requiring repeated access to the vascular system" for infusion and withdrawal of substances within the body.
- Device Description: The description details an implantable port system designed to be placed inside the body for vascular access.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are typically used to analyze samples like blood, urine, or tissue in a laboratory setting. The PowerPort® is a device implanted within the patient's body for direct access to the vascular system.
N/A
Intended Use / 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.
Product codes
LJT
Device Description
PowerPort® Implantable Ports are designed to provide repeated access to the vascular system without the need for repeated venipuncture or daily care of an external catheter. Long-Term Implantable Ports consist of a rigid housing and a self-sealing septum. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Polyurethane catheters are attached to the port by the physician during implantation.
PowerPort® Implantable Ports can be used for routine vascular access using a non-coring access needle. However, for power injection procedures, PowerPort® ports must be accessed with a Bard PowerLoc® Safety Infusion Set (SIS) to create a power-injectable system.
The ChronoFlex® Polyurethane Catheters maintain an average root mean square catheter surface profilometry of less than 0.5µm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Central venous system - lower 1/3 of superior vena cava preferred
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 activities were designed and performed in accordance with Design Controls as per 21 CFR §820.30. The following guidance documents and standards in conjunction with in-house protocols were used to determine appropriate methods for evaluating the performance of the device:
FDA Guidance - Guidance on 510(k) Submissions for Implanted Infusion Ports; October, 1990
FDA Guidance – Guidance on 510(k) Submissions for Short-Term and Long-Term Intravascular Catheters, March 16, 1990
FDA Guidance - General Considerations for Animal Studies for Cardiovascular Devices, dated July 29,2010
FDA Guidance – Good Laboratory Practices Questions and Answers, dated July, 2007
FDA Guidance - Bundling Multiple Devices or Multiple Indications in a single submission, dated June 22, 2007
FDA Guidance – Establishing safety and compatibility of passive implants in the magnetic resonance environment, dated August 21, 2008
ISO 10555-1 Second Edition 2013-07-01, Sterile, Single-Use Intravascular Catheters, Part 1: General Requirements
ISO 10555-3 Second Edition 2013-06-15, Sterile, Single-Use Intravascular Catheters, Part 3: Central Venous Catheters
AAMI/ANSI/ISO 11135-1: 2007, Sterilization of Healthcare Products – Ethylene Oxide
AAMI/ANSI/ISO 10993-1:2009/(R) 2013, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
ISO 10993-7 Second Edition 2008-10-15, Biological Evaluation for Medical Devices; Part 7 – Ethylene Oxide Sterilization Residuals
AAMI/ANSI/ISO 11607:2006/(R)2010, Packaging for Terminally Sterilized Medical Devices
AAMI / ANSI ST72:2011: Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing
ASTM F2503-13 (2014), Standard Practice for marketing Medical Devices and Other Items for Safety in the Magnetic Resonance (MR) Environment
The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate devices.
Key results: The results of the testing performed demonstrate the subject device performance is substantially equivalent to the predicate device.
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
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
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.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
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 | |
| Salt Lake City, UT 84116 | ||
| General | ||
| Provisions | Contact Person | James R. Davis |
| Regulatory Affairs Specialist | ||
| James.R.Davis@crbard.com | ||
| 801.522.5000 ext 5456 | ||
| 801.522.5425 | ||
| Date of Preparation: | 22 October 2015 | |
| Subject | ||
| Device | Trade Name: | Power-Injectable Implantable Ports with ChronoFlex® |
| Polyurethane Catheters | ||
| Common/Usual Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | Subcutaneous, Implanted, Intravascular Infusion Port | |
| and Catheter | ||
| Product Code: | LJT | |
| Regulation: | 21 CFR 880.5965 | |
| Predicate | ||
| Device | Trade Name: | PowerPort® ClearVUE® Slim Implantable Port |
| Classification Name: | Subcutaneous, Implanted, Intravascular Infusion Port | |
| and Catheter | ||
| Premarket Notification: | K122899 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| Reference | ||
| Devices | Trade Name: | Titanium PowerPort® ISP Implanted Port with 6 Fr. |
| ChronoFlex® Polyurethane Catheter | ||
| Classification Name: | Subcutaneous, Implanted, Intravascular Infusion Port | |
| and Catheter | ||
| Premarket Notification: | K072549 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| Trade Name: | PowerPort® Polymeric Port with 8 F S/L ChronoFlex® | |
| Catheters | ||
| Classification Name: | Subcutaneous, Implanted, Intravascular Infusion Port | |
| 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 | ||
| ChronoFlex® Polyurethane Catheters | PowerPort® ClearVUE® Slim Implantable Port | |
| (K122899) | ||
| Note | Bold red font 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 |
| Concurrence Date: | ||
| November 15th, 2012 | ||
| Classification | Same | 21 CFR 880.5965 – Class II |
| 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. |
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 vena cava preferred |
| Significant Device Dimensions | 8 Fr. & 6 Fr. Catheter Surface Profilometry
RMS Value: ≤0.5µm | 8 Fr. & 6 Fr. Catheter Surface Profilometry
N/A |
| Catheter Body Materials | Same | Polyurethane |
| Port Body Materials | Same | Polyetheretherketone (Body/Stem)
Silicone (Suture Plugs) |
| Catheter Lock Materials | Same | Polycarbonate |
| Device
Description | PowerPort® Implantable Ports are designed to provide repeated access to the
vascular system without the need for repeated venipuncture or daily care of an
external catheter. Long-Term Implantable Ports consist of a rigid housing and a
self-sealing septum. The catheters used with infusion ports are essentially the
same design as externalized, stand-alone intravascular catheters. Polyurethane
catheters are attached to the port by the physician during implantation. | |
| | PowerPort® Implantable Ports can be used for routine vascular access using a
non-coring access needle. However, for power injection procedures, PowerPort®
ports must be accessed with a Bard PowerLoc® Safety Infusion Set (SIS) to
create a power-injectable system. | |
| | The ChronoFlex® Polyurethane Catheters maintain an average root mean square
catheter surface profilometry of less than 0.5µm. | |
| Intended Use | 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 | 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. | |
| Technological
Characteristics | The technological characteristics of the subject Power-Injectable Ports with
ChronoFlex® Polyurethane Catheters are substantially equivalent with respect to
design and function to those of the predicate devices. | |
| Performance
Tests | Verification and validation activities were designed and performed in accordance
with Design Controls as per 21 CFR §820.30. The following guidance
documents and standards in conjunction with in-house protocols were used to
determine appropriate methods for evaluating the performance of the device:
FDA Guidance - Guidance on 510(k) Submissions for Implanted Infusion
Ports; October, 1990 FDA Guidance – Guidance on 510(k) Submissions for Short-Term and Long-
Term Intravascular Catheters, March 16, 1990 FDA Guidance - General Considerations for Animal Studies for Cardiovascular
Devices, dated July 29,2010 FDA Guidance – Good Laboratory Practices Questions and Answers, dated
July, 2007 FDA Guidance - Bundling Multiple Devices or Multiple Indications in a single
submission, dated June 22, 2007 FDA Guidance – Establishing safety and compatibility of passive implants in
the magnetic resonance environment, dated August 21, 2008 ISO 10555-1 Second Edition 2013-07-01, Sterile, Single-Use Intravascular
Catheters, Part 1: General Requirements ISO 10555-3 Second Edition 2013-06-15, Sterile, Single-Use Intravascular
Catheters, Part 3: Central Venous Catheters AAMI/ANSI/ISO 11135-1: 2007, Sterilization of Healthcare Products –
Ethylene Oxide AAMI/ANSI/ISO 10993-1:2009/(R) 2013, Biological Evaluation of Medical
Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test
Profile ISO 10993-7 Second Edition 2008-10-15, Biological Evaluation for Medical
Devices; Part 7 – Ethylene Oxide Sterilization Residuals AAMI/ANSI/ISO 11607:2006/(R)2010, Packaging for Terminally Sterilized
Medical Devices AAMI / ANSI ST72:2011: Bacterial Endotoxins—Test Methodologies, Routine
Monitoring, and Alternatives to Batch Testing ASTM F2503-13 (2014), Standard Practice for marketing Medical Devices and
Other Items for Safety in the Magnetic Resonance (MR) Environment The subject device met all pre-determined acceptance criteria and demonstrated
substantial equivalence as compared to the predicate devices. | |
| Testing
Conclusion | The results of the testing performed demonstrate the subject device performance
is substantially equivalent to the predicate device. | |
| Summary of
Substantial
Equivalence | Based on the indications for use, technological characteristics, and performance
testing, the subject Power-Injectable Ports with ChronoFlex® Polyurethane Catheters
meets the requirements that are considered sufficient for its intended use and
demonstrates that the subject devices are substantially equivalent to the
predicate devices cited. | |
Subject and Predicate Device Comparison
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