(171 days)
No
The device description and performance studies focus on the mechanical design and clinical use of an implantable port system, with no mention of AI or ML technologies.
Yes
The device (Bard PowerFlow™ Implantable Apheress IV Port) is a therapeutic device because its intended use includes "patient therapies requiring repeated access to the vascular system" such as "long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, I.V. fluids, parenteral nutrition solutions, blood and blood products." These are all therapeutic applications.
No
Explanation: The device is an implantable port used for repeated vascular access for therapies, blood withdrawal, and infusions, not for diagnosing conditions.
No
The device description clearly details a physical, implantable port system with a catheter, septum, and other hardware components. It is not solely software.
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 vascular system for therapeutic apheresis, blood withdrawal, fluid/medication infusion, and power injection of contrast media. These are all procedures performed on the patient, not on a sample taken from the patient for diagnostic purposes.
- Device Description: The description details an implantable port system designed to provide repeated vascular access. This is a medical device used for treatment and administration, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health. The device facilitates the delivery or withdrawal of substances to or from the body.
In summary, the Bard PowerFlow™ Implantable Apheresis IV Port is a medical device used for vascular access and administration of therapies, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Bard PowerFlow™ Implantable Apheresis IV Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, I.V. fluids, parenteral nutrition solutions, blood and blood products.
The Bard PowerFlow™ Implantable Apheresis IV Port 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
PTD
Device Description
The PowerFlow Implantable Apheresis IV Port with 9.6 Fr. ChronoFlex Catheter is designed to provide repeated access to the vascular system without the need for repeated venipuncture or the daily care of an external catheter. The Bard PowerFlow Apheresis IV Port is a low profile totally implantable, angled access titanium port based design and is accessed through an angled opening which consists of a funnel shaped entrance designed to guide the peripheral intravenous (P.I.V.) access needle and catheter into the subject device. The PowerFlow Apheresis IV Port comes with a number of kit components to aid in the implantation procedure and/or access of the device once implanted. The PowerFlow Apheresis IV Port and necessary kit components are provided sterile (EtO).
The overall implanted system consists of three primary components: the port body with a silicone layered septum, an attachable radiopaque polyurethane catheter lock which secures the catheter to the port body stem. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Once implanted, the method of accessing the subject Bard PowerFlow Apheresis IV Port is the exact same as the predicate Bard CathLink 20 Titanium Port device. After the implanted device has been identified and access is prepped per institutional policy, the user palpates the uniquely shaped angled entry funnel. Once the funnel is palpated, providing the location of the introducer needle access path, the 14 or 16Ga introducer needle is inserted into the funnel. After the Introducer Needle Stop is reached, the Introducer Needle is pulled back slightly and the P.I.V. Catheter is advanced forward. The P.I.V. Catheter is then advanced through the silicone layered septum and the Introducer Needle is removed. After needle removal, the Peripheral IV Catheter is attached to the appropriate extension set and secured for the necessary infusion or withdrawal procedure.
The PowerFlow Implantable Apheresis IV Port can be used for routine vascular access infusion or withdrawal using a BD Insyte Autoguard Shielded IV Catheter. For power injection infusion procedures, the subject device can be accessed with a power injection rated IV catheter to create a power-injectable system.
The kit components provided to aid in the implantation procedure and/or access of the device once implanted include:
Intermediate Implantation Placement Kit
- . 16 Gauge Insyte Autoquard Shielded IV Catheter
- . 17 Ga Flushing Connector
- . Syringe, 12 cc with Luer Slip
- . 9.5 Fr. Barbed Malleable Tunneler
- . Introducer Needle, Echogenic 18 Gauge x 7cm
- . StruXure Guidewire "J" Tip with Straightener, 0.035 inch OD x 70 cm length
- . AirGuard Valved Introducer. Peel-Apart Sheath. 10 Fr. with Vessel Dilator
IV Port Access Kit
- . 14 or 16 Gauge Insyte Autoguard Shielded IV Catheter
- . Prep Pad. Skin
- Absorbent Towel
- ChloraPrep, 3mL .
- . GuardIVa
- Sentrinex 3D Port Dressing
- . Extension Set, Macro, 9 inch Hex Luer Lock w/ Valve
- . Face Mask
- Alcohol Wipe
- . Pre-Filled Saline Svringe
- . 2" x 2" Gauze
- . Medical Adhesive Tape
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The port system can be used for patient therapies requiring repeated access to the vascular system. Catheter Insertion Site: external jugular, internal jugular, or subclavian veins. Catheter Tip Placement Location: lower 1/3 of the superior vena cava.
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 inhouse protocols were used to determine appropriate methods for evaluating the performance of the device:
- . FDA Guidance on 510(k) Submissions for Implanted Infusion Ports, October 1990
- FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term . Intravascular Catheters, March 16, 1995
- FDA Guidance Medical Devices with Sharps Injury Prevention Features, August 9, 2005 .
- FDA Guidance Implanted Blood Access Devices for Hemodialysis, January 21, 2016 .
- FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices, February 3. 2016
- FDA Guidance Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Device Labeled as Sterile, 21 January 2016
- FDA Guidance Establishing safety and compatibility of passive implants in the magnetic . resonance environment, August 21, 2008
- FDA Draft Guidance Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
- ISO 10555-1:2009, Sterile, single-use intravascular catheters, Part 1. General requirements .
- ISO 10555-6: 2015, Intravascular catheters - Sterile and single use catheters Part 6: . Subcutaneous implanted ports
- AAMI/ANSI/ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluations and Testing, and the FDA Modified ISO 10993 Test Profile
- AAMI/ANSI/ISO 10993-7:2008, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide . Sterilization Residuals
- AAMI/ANSI/ISO 11135:2007, Medical Devices - Validation and Routine Control of Ethylene . Oxide Sterilization
- BS EN ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: . Requirements for development, validation and routine control of a sterilization process for medical devices
- BS EN 556-1: 2001. Sterilization of medical devices - Requirements for medical devices to be . designated "STERILE" – Part 1: Requirements for terminally sterilized medical devices
- AAMI ST72:2011, Bacterial endotoxins-Test methodologies, routine monitoring, and alternatives to batch testing (LAL)
- USP:2012, Bacterial Endotoxins Test .
- USP:2009, Transfusion and Infusion Assemblies and Similar Medical Devices (define LAL . limits for devices)
- ISTA 1G:2001, Packaged Products 150lb (68kg) or less Random Vibration .
- ASTM D4332:2013, Standard practice for conditioning containers, packages, or packing . components for testing
- ASTM F1980:2011, Standard quide for accelerated aging of sterile barrier systems for medical . devices
- BS EN ISO 11607-1:2010, Packaging for terminally sterilized medical devices Part 1: . Requirements for materials, sterile barrier systems and packaging systems
- ASTM F136:2012. Standard specification for wrought titanium- aluminum-4 vanadium ELI alloy for surgical implant applications
- ASTM F86: 2013, Standard practice for surface preparation and marking of metallic surgical . implants
- ASTM F640: 2012, Standard test methods for determining radiopacity for medical use
- ASTM F756:2008, Standard practice for assessment of haemolytic properties of materials
- ASTM F1841:2013, Standard practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
- IEC 62366:2007, Medical devices - Application of usability engineering to medical devices -. Edition 1.0
- ISO 15223-1:2012, Medical devices – Symbols to be used with medical device labeling . and information to be supplied - Part 1: General requirements
- KDOQI 2006: Clinical Practice Guidelines and Recommendations .
Based upon the evaluation of the methods provided in the guidance and standards, the following verification tests were conducted:
- Port Subassembly Inspection
- Port Subassembly MR Compatibility
- Port Subassembly Radiopacity
- Stem-Catheter Connection Air Leak
- Peripheral IV Insertion Force
- Peripheral IV Retention Force
- Stem-Catheter Connection Tensile Strength
- Stem-Catheter Connection Hydraulic Burst
- Catheter Inspection
- Catheter Radiopacity
- Catheter Dimensions
- Catheter Vacuum Collapse
- Catheter Tensile Strength / Catheter Elongation
- Catheter Hydraulic Burst
- Tunneler-Catheter Connection Tensile
- Gravity Flow Rate
- Clearance Kinetics
- Apheresis Flow Rate
- Multiple Power Injection
- Device System Burst, Power Injection
- Recirculation
- Hemolysis
- Packaging Ship Testing
- Silicone Boot Retention
- Suture Retention
- Stem Tensile Strength
- Corrosion Resistance
- Peripheral IV Catheter Duration
The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device.
Biocompatibility Testing:
The subject device has different materials than the predicate device; however, all materials present in the subject device are used with the same patient contact in other Bard implantable vascular access ports. The biocompatibility evaluation was compliance to ISO 10993-1;2009. Biological Evaluation of Medical Devices Part 1 – Evaluation and Testing within a Risk Management Process and the FDA Guidance for Industry and FDA- Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", as applicable to the device type. All biological tests were conducted by Bard or by independent testing contract laboratories in accordance with Good Laboratory Practice (GLP) standards.
The ISO 10993-1:2009 stangard defines the Bard PowerFloys mayantable Apheresis IV Port as: Implant
The subject device does not contain any colorants. Final, finished, sterile samples of the subject Bard PowerFlow Implantable Apheresis IV Port assembly were used for all recommended biocompatibility tests. The tests listed below were conducted and evaluated per ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile.
- . Cytotoxicity
- . Sensitization
- . Irritation or intracutaneous reactivity
- . Acute systemic toxicity
- . Subchronic systemic toxicity
- Genotoxicity
- . Hemocompatibility
- . Pyrogenicity
- . Subcutaneous implantation (2, 8, 26 week) with histopathology
- . Extractables and leachates
Clinical Data:
Clinical data with the predicate device, CATHLINK 20, used in the theresis population have been reported in three studies. Significant design similarities between the predicate device and the subject PowerFlow™ Implantable Apheresis IV Port suggest that this clinical data can provide reasonable expectations for the safety and effectiveness of the PowerFlow™ device.
-
In one study, 18 CATHLINK 20 ports were implanted in 15 patients with sickle cell disease for 19,230 catheter patient days. No peri-operative complications were observed. Three episodes of catheter occlusion required port replacement in two patients; one required port replacement after 23 months of continuous use; a second patient had their port replaced after continuous use for 16 months and then again 21 months after the first replacement. The observed rate for thrombotic occlusion was 0.16 per 1,000 catheter patient days. In the other 13 out of 15 patients, the median length of continuous port use was 45 months (range 30-64 months). Patients received erythrocytapheresis therapy on a monthly basis through their ports. The authors state that their experience indicates the CATHLINK 20 represents an effective, reliable, and safe means of establishing and maintaining venous access for patients requiring long-term erythrocytapheresis.
-
In a second study of six patients, three started with a single device (using an antecubital or other peripheral vein for the second access point) and three started with two CATHLINK 20 devices. By the end of the study, 5 of 6 patients had two devices. Apheresis personnel were able to access the ports in 1.23 ± 0.6 attempts per port per procedure. Six of the 70 planned apheresis procedures were aborted. Of these, three were due to failure of the antecubital vein return site and three were because of catheter occlusion, which was resolved using a thrombotic agent. The other 64 therapeutic plasma exchange procedures were performed successfully. Two adverse surgical events occurred during the study: one was an infected skin suture site that required the replacement of another CATHLINK 20 at a different location and the other was a malpositioned catheter that required a return to the operating room for repositioning. No patient required hospitalization during the study. The authors state that the CATHLINK 20 provides adequate whole blood and plasma flow rates, is easy for apheresis personnel to access and manage, and does not burden the patient with lifestyle restrictions or exit site care.
-
The third study followed four patients for approximately 1.5-2.5 years. Three of the patients had two devices and one patient had one CATHLINK 20 and used an antecubital vein for the second access point. For the 190 therapeutic plasma exchange procedures performed, the CATHLINK 20 device was accessed in 1.45 ± 0.86 attempts per device. Ninety-one percent (91%) of plasma exchange procedures were completed in
§ 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 and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three figures intertwined to represent people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2017
C.R. Bard, Inc. Christoph Wagner Von Hoff Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116
Re: K163001
Trade/Device Name: PowerFlow™ Implantable Apheresis IV Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port And Catheter Regulatory Class: Class II Product Code: PTD Dated: March 13, 2017 Received: March 14, 2017
Dear Christoph Wagner Von Hoff:
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.
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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,
Michael J. Ryan -S
for 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
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Indications for Use
510(k) Number (if known) K163001
Device Name PowerFlowTM Implantable Apheresis IV Port
Indications for Use (Describe)
The Bard PowerFlow™ Implantable Apheress IV Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, I.V. fluids, parenteral nutrition solutions, blood and blood products.
The Bard PowerFlow™M Implantable Apheresis IV Port 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: K163001 21 CFR 807.92
PowerFlow™ Implantable Apheresis IV Port with 9.6 Fr. ChronoFlex™ Catheter
1. General Provisions
| Submitter Name: | Bard Access Systems, Inc. |
|---|---|
| Address: | 605 North 5600 West |
| Salt Lake City, UT 84116 | |
| Contact Person: | Christoph Wagner von Hoff |
| Sr. Regulatory Affairs Program Manager | |
| Christoph.Wagnervonhoff@crbard.com | |
| Phone: | 480.638.2925 |
| Fax: | 480.449.2546 |
| Date of Preparation: | 14 April 2017 |
2. Subject Device
| Trade Name: | PowerFlow TM Implantable Apheresis IV Port with 9.6 Fr. ChronoFlexTM Catheter |
|---|---|
| Common/Usual Name: | Subcutaneous implanted apheresis port |
| Classification Name: | Subcutaneous, implanted, intravascular infusion port and catheter |
| Regulatory Class: | II |
| Product Code: | PTD |
| Regulation: | 21 CFR 880.5965 |
3. Predicate Device
| Trade Name: | Bard CathLink 20 Titanium Port with Attachable Polyurethane Cathete |
|---|---|
| Classification Name: | Subcutaneous, Implanted, Intravascular Infusion Port and Catheter |
| Premarket Notification: | K926139 |
| Manufacturer: | Bard Access Systems, Inc. |
This predicate has not been subject to a design-related recall.
4
4. Reference Devices
| Trade Name: | TriFusion, Model 0609190/0659350 (Hickman TriFusion Catheter) |
|---|---|
| Classification Name: | Percutaneous, Implanted, Long-term Intravascular Catheter |
| Premarket Notification: | K041088 |
| Manufacturer: | Bard Access Systems, Inc. |
| Trade Name: | Titanium PowerPort ISP Implanted Port |
| Classification Name: | Subcutaneous, Implanted, Intravascular Infusion Port and Catheter |
| Premarket Notification: | K072215 |
| Manufacturer: | Bard Access Systems, Inc. |
5. Reference Devices Justification
Therapeutic Apheresis Reference Device
To support the use of the subject device for patients requiring therapeutic apheresis. The Hickman TriFusion Triple Lumen Long-Term Central Venous Catheter (TriFusion Catheter) cleared by the General Hospital Branch through K041088 is utilized as a reference predicate device. The TriFusion Catheter is a long-term intravascular catheter that is currently indicated for apheresis use. The means of inserting the catheter as well as the catheter tip location during clinical use are the same as what is utilized for the subject Bard PowerFlow Apheresis IV Port.
Power Iniection Reference Device
The subject device will also have within the indications for use the power injection of contrast media when used with a power injection rated peripheral IV catheter. To substantiate the subject device for this use, the same test methods and acceptance criteria utilized for the Bard Titanium PowerPort ISP Implanted Port cleared through K072215 was used. The Bard Titanium PowerPort ISP Implanted Port has the same anatomical location when implanted as well as the same infusion capabilities as the subject device.
6. Device Description
The PowerFlow Implantable Apheresis IV Port with 9.6 Fr. ChronoFlex Catheter is designed to provide repeated access to the vascular system without the need for repeated venipuncture or the daily care of an external catheter. The Bard PowerFlow Apheresis IV Port is a low profile totally implantable, angled access titanium port based design and is accessed through an angled opening which consists of a funnel shaped entrance designed to guide the peripheral intravenous (P.I.V.) access needle and catheter into the subject device. The PowerFlow Apheresis IV Port comes with a number of kit components to aid in the implantation procedure and/or access of the device once implanted. The PowerFlow Apheresis IV Port and necessary kit components are provided sterile (EtO).
The overall implanted system consists of three primary components: the port body with a silicone layered septum, an attachable radiopaque polyurethane catheter lock which secures the catheter to the port body stem. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Once implanted, the method of accessing the subject Bard PowerFlow Apheresis IV Port is the exact same as the predicate Bard CathLink 20 Titanium Port device. After the implanted device has been identified and access is prepped per institutional policy, the user palpates the uniquely shaped angled entry funnel. Once the funnel is palpated, providing the location of the introducer needle access path, the 14 or 16Ga introducer needle is inserted into the funnel. After the Introducer Needle Stop is reached, the Introducer Needle is pulled
5
back slightly and the P.I.V. Catheter is advanced forward. The P.I.V. Catheter is then advanced through the silicone layered septum and the Introducer Needle is removed. After needle removal, the Peripheral IV Catheter is attached to the appropriate extension set and secured for the necessary infusion or withdrawal procedure.
The PowerFlow Implantable Apheresis IV Port can be used for routine vascular access infusion or withdrawal using a BD Insyte Autoguard Shielded IV Catheter. For power injection infusion procedures, the subject device can be accessed with a power injection rated IV catheter to create a power-injectable system.
The kit components provided to aid in the implantation procedure and/or access of the device once implanted include:
Intermediate Implantation Placement Kit
- . 16 Gauge Insyte Autoquard Shielded IV Catheter
- . 17 Ga Flushing Connector
- . Syringe, 12 cc with Luer Slip
- . 9.5 Fr. Barbed Malleable Tunneler
- . Introducer Needle, Echogenic 18 Gauge x 7cm
- . StruXure Guidewire "J" Tip with Straightener, 0.035 inch OD x 70 cm length
- . AirGuard Valved Introducer. Peel-Apart Sheath. 10 Fr. with Vessel Dilator
IV Port Access Kit
- . 14 or 16 Gauge Insyte Autoguard Shielded IV Catheter
- . Prep Pad. Skin
- Absorbent Towel
- ChloraPrep, 3mL .
- . GuardIVa
- Sentrinex 3D Port Dressing
- . Extension Set, Macro, 9 inch Hex Luer Lock w/ Valve
- . Face Mask
- Alcohol Wipe
- . Pre-Filled Saline Svringe
- . 2" x 2" Gauze
- . Medical Adhesive Tape
7. Intended Use
PowerFlow Implantable Apheresis IV Ports are intended to be implanted vascular access devices designed to provide long-term, repeated access to the vascular system.
8. Indications for Use
The Bard PowerFlow™ Implantable Apheresis IV Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, IV fluids, parenteral nutrition solutions, blood and blood products.
The Bard PowerFlow™ Implantable Apheresis IV Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.
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9. Technological Characteristics with Comparison to Predicate Device
The technological characteristics of the subject PowerFlow Implantable Apheresis IV Port with 9.6 Fr. ChronoFlex Catheter is substantially equivalent with respect to design and function to those of the predicate Bard CathLink 20 Titanium Port device is designed to be accessed with a 14 or 16Ga BD Insyte Autoguard Shielded IV catheter and has a 9.6 Fr. ChronoFlex Catheter intended to provide optimal flow rates for patients requiring therapeutic apheresis.
An Implantable Port System with a valved silicone layered septum that is accessed with a peripheral IV catheter is the primary technological principle for both the subject and predicate device. Both port systems have the same three primary components which include a port body with a valved silicone layered septum, an attachable radiopaque polyurethane catheter lock which secures the catheter to the port body stem.
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Different Technological Elements:
| Feature | Subject Device
(PowerFlow
Apheresis IV Port) | Primary Predicate
(CathLink 20 Titanium
Port) | Impact on Safety | Impact on Effectiveness
for Apheresis |
|------------------------|----------------------------------------------------|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Port Catheter
Size | 9.6 Fr polyurethane | 6 Fr polyurethane | None - same outer diameter
as existing port catheters | Same and/or higher flow
rates possible to facilitate
apheresis |
| IV Size | 16 or 14 Gauge | 20 Gauge | None – 16 Gauge needles
are used for apheresis today;
14 Gauge needles are used
to access fistulas today | Same and/or higher flow
rates possible to facilitate
apheresis |
| Silicone Valve | Single layer valve | Two layer valve | None - result is still a valve
for use with an IV access | Single layer valve to
facilitate multiple
accesses |
| Entry Funnel | 2.82 in² target area | 2.46 in² target area | None - same size as
intermediate size port
septum | Larger and thus easier to
find and identify |
| Port Body
Materials | Titanium covered with
silicone | Titanium | None - titanium and silicone
are both biocompatible
materials | Softer for patient comfort,
provides multiple options
for suture sites |
Same Technological Elements:
| Feature | Subject Device
(PowerFlow
Apheresis IV Port) | Primary Predicate
(CathLink 20 Titanium
Port) | Impact on Safety | Impact on Effectiveness
for Apheresis |
|---------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|
| Long-term
Duration of Use | repeated access | repeated access | Same for the predicate
device and the subject
device | Same for the predicate
device and the subject
device |
| Implanted
Subcutaneously | tunneled and inserted
into the blood vessel | tunneled and inserted
into the blood vessel | Same for the predicate
device and the subject
device | Same for the predicate
device and the subject
device |
| Catheter
Insertion Site | external jugular,
internal jugular, or
subclavian veins | external jugular,
internal jugular, or
subclavian veins | Same for the predicate
device and the subject
device | Same for the predicate
device and the subject
device |
| Catheter Tip
Placement
Location | lower 1/3 of the
superior vena cava | lower 1/3 of the
superior vena cava | Same for the predicate
device and the subject
device | Same for the predicate
device and the subject
device |
| Catheter Tip | Opened ended
intravascular catheter
tip design | Opened ended
intravascular catheter
tip design | Same for the predicate
device and the subject
device | Same for the predicate
device and the subject
device |
| Port System | Peripheral IV catheter
accessed implantable
port system | Peripheral IV catheter
accessed implantable
port system | Same for the predicate
device and the subject
device | Same for the predicate
device and the subject
device |
| Septum | Silicone valve and
seal combination for
layered septum | Silicone valve and seal
combination for layered
septum | Same for the predicate
device and the subject
device | Same for the predicate
device and the subject
device |
| Port Entry | Angled entry funnel
with an introducer
needle stop feature
for port system
access | Angled entry funnel
with an introducer
needle stop feature for
port system access | Same for the predicate
device and the subject
device | Same for the predicate
device and the subject
device |
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10. 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 inhouse protocols were used to determine appropriate methods for evaluating the performance of the device:
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. FDA Guidance on 510(k) Submissions for Implanted Infusion Ports, October 1990
FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term . Intravascular Catheters, March 16, 1995 -
FDA Guidance Medical Devices with Sharps Injury Prevention Features, August 9, 2005 .
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FDA Guidance Implanted Blood Access Devices for Hemodialysis, January 21, 2016 .
. FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices, February 3. 2016
. FDA Guidance Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Device Labeled as Sterile, 21 January 2016
FDA Guidance Establishing safety and compatibility of passive implants in the magnetic . resonance environment, August 21, 2008
. FDA Draft Guidance Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
ISO 10555-1:2009, Sterile, single-use intravascular catheters, Part 1. General requirements .
ISO 10555-6: 2015, Intravascular catheters - Sterile and single use catheters Part 6: . Subcutaneous implanted ports
AAMI/ANSI/ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluations and Testing, and the FDA Modified ISO 10993 Test Profile
AAMI/ANSI/ISO 10993-7:2008, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide . Sterilization Residuals
AAMI/ANSI/ISO 11135:2007, Medical Devices - Validation and Routine Control of Ethylene . Oxide Sterilization
BS EN ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: . Requirements for development, validation and routine control of a sterilization process for medical devices
BS EN 556-1: 2001. Sterilization of medical devices - Requirements for medical devices to be . designated "STERILE" – Part 1: Requirements for terminally sterilized medical devices
. AAMI ST72:2011, Bacterial endotoxins-Test methodologies, routine monitoring, and alternatives to batch testing (LAL)
USP:2012, Bacterial Endotoxins Test .
USP:2009, Transfusion and Infusion Assemblies and Similar Medical Devices (define LAL . limits for devices)
ISTA 1G:2001, Packaged Products 150lb (68kg) or less Random Vibration .
ASTM D4332:2013, Standard practice for conditioning containers, packages, or packing . components for testing
ASTM F1980:2011, Standard quide for accelerated aging of sterile barrier systems for medical . devices
BS EN ISO 11607-1:2010, Packaging for terminally sterilized medical devices Part 1: . Requirements for materials, sterile barrier systems and packaging systems
. ASTM F136:2012. Standard specification for wrought titanium- aluminum-4 vanadium ELI alloy for surgical implant applications
ASTM F86: 2013, Standard practice for surface preparation and marking of metallic surgical . implants
. ASTM F640: 2012, Standard test methods for determining radiopacity for medical use
. ASTM F756:2008, Standard practice for assessment of haemolytic properties of materials
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- . ASTM F1841:2013, Standard practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
IEC 62366:2007, Medical devices - Application of usability engineering to medical devices -. Edition 1.0
ISO 15223-1:2012, Medical devices – Symbols to be used with medical device labeling . and information to be supplied - Part 1: General requirements
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KDOQI 2006: Clinical Practice Guidelines and Recommendations .
Based upon the evaluation of the methods provided in the guidance and standards, the following verification tests were conducted: -
Port Subassembly Inspection .
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Port Subassembly MR Compatibility .
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. Port Subassembly Radiopacity
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. Stem-Catheter Connection Air Leak
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. Peripheral IV Insertion Force
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. Peripheral IV Retention Force
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Stem-Catheter Connection Tensile Strength
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Stem-Catheter Connection Hydraulic Burst
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Catheter Inspection
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Catheter Radiopacity
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Catheter Dimensions
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Catheter Vacuum Collapse
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. Catheter Tensile Strength / Catheter Elongation
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Catheter Hydraulic Burst
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Tunneler-Catheter Connection Tensile
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. Gravity Flow Rate
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Clearance Kinetics
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Apheresis Flow Rate
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Multiple Power Injection
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Device System Burst, Power Injection
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Recirculation
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Hemolysis
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Packaging Ship Testing ●
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Silicone Boot Retention .
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Suture Retention
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Stem Tensile Strength
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Corrosion Resistance
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Peripheral IV Catheter Duration
The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device.
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11. Biocompatibility Testing
The subject device has different materials than the predicate device; however, all materials present in the subject device are used with the same patient contact in other Bard implantable vascular access ports. The biocompatibility evaluation was compliance to ISO 10993-1;2009. Biological Evaluation of Medical Devices Part 1 – Evaluation and Testing within a Risk Management Process and the FDA Guidance for Industry and FDA- Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", as applicable to the device type. All biological tests were conducted by Bard or by independent testing contract laboratories in accordance with Good Laboratory Practice (GLP) standards.
The ISO 10993-1:2009 stangard defines the Bard PowerFloys mayantable Apheresis IV Port as: Implant
The subject device does not contain any colorants. Final, finished, sterile samples of the subject Bard PowerFlow Implantable Apheresis IV Port assembly were used for all recommended biocompatibility tests. The tests listed below were conducted and evaluated per ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile.
- . Cytotoxicity
- . Sensitization
- . Irritation or intracutaneous reactivity
- . Acute systemic toxicity
- . Subchronic systemic toxicity
- Genotoxicity
- . Hemocompatibility
- . Pyrogenicity
- . Subcutaneous implantation (2, 8, 26 week) with histopathology
- . Extractables and leachates
12. Testing Conclusion
The results of the testing performed successfully demonstrate that the subject device's performance is substantially equivalent to the predicate device and the scientific methods utilized from the reference devices are appropriate.
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13. Clinical Data
Clinical data with the predicate device, CATHLINK 20, used in the theresis population
have been reported in three studies'-3- Significant design similarities between the pred nate beer roler of the subject PowerFlow™ Implantable Apheresis IV Port suggest that this clinical data can provide reasonable expectations for the safety and effectiveness of the PowerFlow" " device.
In one study , 18 CATHLINK 20 ports were implanted in 15 patients with sickle cell disease for 19,230 catheter patient days. No peri-operative complications were observed. Three episodes of catheter occlusion required port replacement in two patient required port replacement after 23 months of continuous use; a second patient had their port replaced after continuous use for 16 months and then again 21 months after the first replacement. The observed rate for thrombotic occlusion was 0.16 per 1,000 catheter patient days. In the other 13 out of 15 patients, the median length of continuous port use was 45 months (range 30-64 months). Patients received erythrocytapheresis therapy on a monthly basis through their ports. The authors state that their experience indicates the CATHLINK 20 represents an effective, reliable, and safe means of establishing and maintaining venous access for patients requiring long-term erythrocytapheresis.
In a second study of six patients, three started with a single device (using an antecubital or other peripheral vein for the second access point) and three started with two CATHLINK 20 devices. By the end of the study, 5 of 6 patients had two devices. Apheresis personnel were able to access the ports in 1.23 ± 0.6 attempts per port per procedure. Six of the 70 planned apheresis procedures were aborted. Of these, three were due to failure of the antecubital vein return site and three were because of catheter occlusion, which was resolved using a thrombotic agent. The other 64 therapeutic plasma exchange procedures were performed successfully. Two adverse surgical events occurred during the study: one was an infected skin suture site that required the replacement of another CATHLINK 20 at a different location and the other was a malpositioned catheter that required a return to the operating room for repositioning. No patient required hospitalization during the study. The authors state that the CATHLINK 20 provides adequate whole blood and plasma flow rates, is easy for apheresis personnel to access and manage, and does not burden the patient with lifestyle restrictions or exit site care.
The third study followed four patients for approximately 1.5-2.5 years. Three of the patients had two devices and one patient had one CATHLINK 20 and used an antecubital vein for the second access point. For the 190 therapeutic plasma exchange procedures performed, the CATHLINK 20 device was accessed in 1.45 ± 0.86 attempts per device. Ninety-one percent (91%) of plasma exchange procedures were completed in 1 Raj A, Bertolone S, Bond S, et al. Cathlink® 20: A Subcutaneous Implanted Central Venous Access Device Used in Children With Sickle Cell Disease on Long-Term Erythrocytapheresis - A Report of Low Complication Rates. Pediatr Blood Cancer 2005 Jun 15: 44(7): 669-72.
2 Pertine B. Razvi S. Weinstein R. Prospective investigation of a subcutaneous, implantable central venous access device for therapeutic plasma exchange in adults with neurological disorders. J Clin Apher 2002; 17:1-6.
3 Gonzalez A, Sodano D, Flanagan J et al. Long-term therapeutic plasma exchange in the outpatient setting using an implantable central venous access device. J Clin Apher 2004; 19:180-184.
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14. Summary of Substantial Equivalence
Based on the indications for use, technological characteristics, performance testing and biocompatibility testing the subject PowerFlow Implantable Apheresis IV Port with 9.6 Fr. ChronoFlex Catheter meets the requirements that are considered sufficient for its intended use and demonstrates that the subject device is substantially equivalent to the predicate device.