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.

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.

AI/ML Overview

This document describes the premarket notification for the "PowerFlow™ Implantable Apheresis IV Port" and its substantial equivalence to a predicate device. Below is an analysis of the acceptance criteria and the studies performed.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a direct table of acceptance criteria with quantitative thresholds for each test, followed by the reported device performance against those specific thresholds. Instead, it lists various performance tests and then states a general conclusion for each section.

However, based on the information provided, we can infer the acceptance criteria was that the device must meet the requirements of the listed standards and guidance documents, and demonstrate performance "substantially equivalent" to the predicate device.

Here's an inferred summary:

Test/Characteristic	Inferred Acceptance Criteria	Reported Device Performance
Mechanical/Physical Performance	Meet standards/guidance for:	"The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device." This applies to: 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.
Biocompatibility	Compliance with ISO 10993-1 and FDA Guidance for biocompatibility.	"All biological tests were conducted by Bard or by independent testing contract laboratories in accordance with Good Laboratory Practice (GLP) standards." All recommended tests (Cytotoxicity, Sensitization, Irritation/intracutaneous reactivity, Acute systemic toxicity, Subchronic systemic toxicity, Genotoxicity, Hemocompatibility, Pyrogenicity, Subcutaneous implantation, Extractables and leachates) were conducted and evaluated.
Clinical Performance (Apheresis)	Safe and effective for long-term apheresis, comparable to predicate.	Clinical data from three studies on the predicate device (CATHLINK 20) are presented, showing: - Low complication rates (e.g., thrombotic occlusion rate of 0.16 per 1,000 catheter patient days). - Median length of continuous port use of 45 months. - Successful access by apheresis personnel (1.23 ± 0.6 attempts per port). - Adequate whole blood and plasma flow rates. - No adverse effects from use and no hospitalizations for plasma exchange. The report concludes that "Significant design similarities... suggest that this clinical data can provide reasonable expectations for the safety and effectiveness of the PowerFlow™ device."
Power Injectability	Meet safety and functionality for power injection.	"The same test methods and acceptance criteria utilized for the Bard Titanium PowerPort ISP Implanted Port cleared through K072215 was used." This implies the PowerFlow device met these criteria, specifically mentioning a maximum recommended infusion rate of 5 mL/s.
Substantial Equivalence	Device is substantially equivalent to the predicate device.	"Based on the indications for use, technological characteristics, performance testing and biocompatibility testing the subject PowerFlow Implantable Apheresis IV Port... demonstrates that the subject device is substantially equivalent to the predicate device."

2. Sample Sizes Used for the Test Set and Data Provenance

Test Set (Bench Testing/Non-Clinical): The document does not specify exact sample sizes for each of the numerous performance and biocompatibility tests. It broadly states that "Final, finished, sterile samples of the subject Bard PowerFlow Implantable Apheresis IV Port assembly were used for all recommended biocompatibility tests." For other tests (e.g., flow rates, tensile strength), standard engineering and quality control practices typically involve specific sample sizes to ensure statistical significance, but these are not enumerated in this summary.
Data Provenance (Clinical - for Predicate Device):
- The clinical data presented is for the predicate device, CATHLINK 20, not the subject device (PowerFlow).
- The studies were retrospective or prospective clinical observations.
- Country of Origin: Not explicitly stated, but the referenced academic journals often span international research. The institutions involved in the studies (e.g., Pediatry Blood Cancer, J Clin Apher) suggest clinical settings, likely within professional healthcare systems.
- Study 1 (Raj et al.): 18 CATHLINK 20 ports implanted in 15 patients.
- Study 2 (Pertine et al.): Six patients.
- Study 3 (Gonzalez et al.): Four patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For Non-Clinical Tests (Performance & Biocompatibility): The "ground truth" for these tests are the established international standards and FDA guidance documents (e.g., ISO 10555-1, ISO 10993-1, ASTM standards, FDA guidances). The experts involved would be the engineers, scientists, and technicians at Bard Access Systems (or independent contract laboratories) who designed, performed, and interpreted these tests according to the specified methodologies. Their qualifications are not individually listed but are implied by their adherence to GLP standards and relevant regulatory frameworks.
For Clinical Data (Predicate Device): The "ground truth" here is the clinical outcomes reported by the studies. The experts are the medical professionals (e.g., physicians, nurses, apheresis personnel) involved in conducting the studies, implanting the devices, performing procedures, and collecting data. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed in this summary, but they are implied to be clinical specialists in relevant fields (e.g., hematology, neurology, apheresis).

4. Adjudication Method for the Test Set

For Non-Clinical Tests: Adjudication is not typically performed by external experts in this context. The results are evaluated against predetermined acceptance criteria specified by the standards and internal protocols. Any discrepancies or failures would lead to further investigation and potentially design changes, followed by re-testing.
For Clinical Data (Predicate Device): The document does not describe adjudication methods for the clinical studies of the predicate device. Clinical studies generally involve independent verification of data and outcomes, but specific adjudication processes (like 2+1 reads for imaging) are not mentioned as these were clinical outcome studies, not diagnostic device studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed for this device. This type of study is primarily relevant for diagnostic imaging devices where different readers evaluate the same cases with and without AI assistance to measure reader performance improvement. The PowerFlow™ Implantable Apheresis IV Port is a medical device for vascular access, and its evaluation centers on physical performance, biocompatibility, and clinical outcomes for the intended use, not diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm-only) performance study was not done. This concept is not applicable to an implantable vascular access port, which is a physical medical device and not an AI algorithm.

7. The Type of Ground Truth Used

For Performance Tests (Mechanical, Flow Rates, etc.): The ground truth is based on objective measurements against engineering specifications and industry and regulatory standards.
For Biocompatibility Tests: The ground truth is determined by the biological responses observed in standardized in-vitro and in-vivo tests, evaluated against established toxicity, irritation, and sensitization profiles defined by ISO 10993.
For Clinical Data (Predicate Device): The ground truth is based on clinical outcomes data (e.g., complication rates, duration of use, successful access attempts, flow rates, patient-reported experiences) observed during the actual use of the predicate device in a patient population.

8. The Sample Size for the Training Set

This product is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The design and validation of the device rely on engineering principles, materials science, and conformity to established standards and clinical performance of predicate devices.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the AI/ML sense for this device, this question is not applicable. The "ground truth" for the device's design and validation is established through:
* Literature review and understanding of clinical needs (for indications).
* Engineering design specifications.
* Compliance with recognized national and international standards (e.g., ISO, ASTM).
* Performance data from similar legally marketed predicate devices.

Summary

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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.

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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™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 WestSalt 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.

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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

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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 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(PowerFlowApheresis IV Port)	Primary Predicate(CathLink 20 TitaniumPort)	Impact on Safety	Impact on Effectivenessfor Apheresis
Port CatheterSize	9.6 Fr polyurethane	6 Fr polyurethane	None - same outer diameteras existing port catheters	Same and/or higher flowrates possible to facilitateapheresis
IV Size	16 or 14 Gauge	20 Gauge	None – 16 Gauge needlesare used for apheresis today;14 Gauge needles are usedto access fistulas today	Same and/or higher flowrates possible to facilitateapheresis
Silicone Valve	Single layer valve	Two layer valve	None - result is still a valvefor use with an IV access	Single layer valve tofacilitate multipleaccesses
Entry Funnel	2.82 in² target area	2.46 in² target area	None - same size asintermediate size portseptum	Larger and thus easier tofind and identify
Port BodyMaterials	Titanium covered withsilicone	Titanium	None - titanium and siliconeare both biocompatiblematerials	Softer for patient comfort,provides multiple optionsfor suture sites

Same Technological Elements:

Feature	Subject Device(PowerFlowApheresis IV Port)	Primary Predicate(CathLink 20 TitaniumPort)	Impact on Safety	Impact on Effectivenessfor Apheresis
Long-termDuration of Use	repeated access	repeated access	Same for the predicatedevice and the subjectdevice	Same for the predicatedevice and the subjectdevice
ImplantedSubcutaneously	tunneled and insertedinto the blood vessel	tunneled and insertedinto the blood vessel	Same for the predicatedevice and the subjectdevice	Same for the predicatedevice and the subjectdevice
CatheterInsertion Site	external jugular,internal jugular, orsubclavian veins	external jugular,internal jugular, orsubclavian veins	Same for the predicatedevice and the subjectdevice	Same for the predicatedevice and the subjectdevice
Catheter TipPlacementLocation	lower 1/3 of thesuperior vena cava	lower 1/3 of thesuperior vena cava	Same for the predicatedevice and the subjectdevice	Same for the predicatedevice and the subjectdevice
Catheter Tip	Opened endedintravascular cathetertip design	Opened endedintravascular cathetertip design	Same for the predicatedevice and the subjectdevice	Same for the predicatedevice and the subjectdevice
Port System	Peripheral IV catheteraccessed implantableport system	Peripheral IV catheteraccessed implantableport system	Same for the predicatedevice and the subjectdevice	Same for the predicatedevice and the subjectdevice
Septum	Silicone valve andseal combination forlayered septum	Silicone valve and sealcombination for layeredseptum	Same for the predicatedevice and the subjectdevice	Same for the predicatedevice and the subjectdevice
Port Entry	Angled entry funnelwith an introducerneedle stop featurefor port systemaccess	Angled entry funnelwith an introducerneedle stop feature forport system access	Same for the predicatedevice and the subjectdevice	Same for the predicatedevice and the subjectdevice

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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:

. 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<85>:2012, Bacterial Endotoxins Test .

USP<161>: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

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.

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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 <150 min (mean 120 ± 28min). There were no adverse effects resulting from the use of the CATHLINK 20 and no hospitalizations were needed for plasma exchange. The authors state that their follow-up experience indicates that the CATHLINK 20 could be conveniently used for long-term outpatient plasma exchange.

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.

Regulation Number and Section

§ 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.