POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER

K133456 · C.R. Bard, Inc. · NIE · Sep 24, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133456
• Device Name: POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: NIE · Gastroenterology, Urology
• Decision Date: Sep 24, 2014
• Decision: SEKD
• Submission Type: Traditional
• Regulation: 21 CFR 876.5540
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Power-TrialysisTM Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

Device Story

Thermosensitive polyurethane triple-lumen catheter; designed for short-term (<30 days) vascular access. Two lumens (venous/arterial) facilitate hemodialysis, hemoperfusion, and apheresis; third independent distal lumen supports intravenous therapy, power injection of contrast media (max 5 mL/sec), and central venous pressure monitoring. Inserted via Seldinger or percutaneous technique into central veins (SVC preferred). Used in clinical settings by healthcare professionals. Provides stable vascular access; enables simultaneous dialysis and infusion/monitoring; reduces need for multiple access sites. Benefits include procedural efficiency and patient comfort.

Clinical Evidence

Bench testing only. Performed hemolysis (ASTM F1841:1997), leak (ISO 10555-1), burst, tensile, dialysis flow, recirculation, gravity flow, catheter collapse, guidewire fit, and central venous pressure monitoring. Sterilization validation per ISO 10993-7:2008. All tests met predetermined acceptance criteria.

Technological Characteristics

Thermosensitive polyurethane; triple-lumen design; atraumatic tapered tip. Lengths: 12.5, 15, 20, 24 cm. Features Alphacurve shaft tubing and side holes. Sterilization validation per ISO 10993-7. No electronic components; mechanical device.

Indications for Use

Indicated for patients requiring short-term (<30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments via jugular, femoral, or subclavian vein insertion.

Regulatory Classification

Identification

A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device. (2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle). (3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).

Special Controls

*Classification.* (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided. (ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated. (B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided. (C) Priming volumes must be established. (D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use. (E) Air leakage testing and liquid leakage testing must be conducted. (F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage. (G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern. (H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established. (iii) Performance data must demonstrate the sterility of the device. (iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing. (v) Labeling of implanted blood access devices for hemodialysis must include the following: (A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated. (B) Labeling must specify the forward and reverse recirculation rates. (C) Labeling must provide the arterial and venous priming volumes. (D) Labeling must specify an expiration date. (E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device. (F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient. (G) Labeling must include a patient implant card. (H) The labeling must contain comprehensive instructions for the following: ( *1* ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;( *2* ) Proper care and maintenance of the device and device exit site;( *3* ) Removal of the device;( *4* ) Anticoagulation;( *5* ) Management of obstruction and thrombus formation; and( *6* ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following: (A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port. (B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device. (C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use. (vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following: (A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied. (B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties. (C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens. (D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness. (viii) The following must be included for A-V shunt cannulae (with vessel tips): (A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply. (B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation. (C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use. (2) Class II (performance standards) for the nonimplanted blood access device. (3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section. (4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Power-Trialysis Short-Term Dialysis Catheter (K083675)

Submission Summary (Full Text)

{0}------------------------------------------------

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, representing health and human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 24, 2014

Bard Access Systems, Inc. Elizabeth U. Peterson Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, UT 84116

Re: K133456

> Trade/Device Name: Power-Trialysis Short-Term Dialysis Catheter Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: NIE Dated: August 26, 2014 Received: August 28, 2014

Dear Elizabeth U. Peterson,

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 Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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

{1}------------------------------------------------

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 device-related 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.

In addition, we have determined that your device kit contains Lidocaine and ChloraPrep which are subject to regulation as drugs.

Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:

Director, Division of Drug Labeling Compliance Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville. Marvland 20857 [phone]

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

{2}------------------------------------------------

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

## Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font, with each letter being a solid black color. Below the word "BARD" is the phrase "ACCESS SYSTEMS" in a smaller, sans-serif font, also in black. The logo has a clean and professional appearance.

## Indications for Use

K133456

510(k) Number (if known):

Device Name:

Power-Trialysis Short-Term Dialysis Catheter

Indications for Use:

The Power-Trialysis Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power iniection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the juqular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

V Prescription Use (Part 21 CFR §801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR §801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for BARD Access Systems. The word "BARD" is in large, bold, sans-serif font. Below the word "BARD" is the phrase "ACCESS SYSTEMS" in a smaller, bold, sans-serif font. The logo is black and white.

## 510(k) Summary
21 CFR 807.92(a)

| | Submitter Name:<br>Submitter Address: | Bard Access Systems, Inc.<br>605 North 5600 West<br>Salt Lake City, UT 84116 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General<br>Provisions | Contact Person:<br>Telephone Number:<br>Fax Number:<br>Date of Preparation: | Elizabeth U. Peterson<br>Regulatory Affairs Specialist<br>[phone]<br>[phone]<br>September 22, 2014 |
| Subject Device | Trade Name:<br>Common Name:<br>Classification Name:<br>Product Code:<br>Classification<br>Regulation: | Power-Trialysis™ Short-Term Dialysis Catheter<br>Short-Term Hemodialysis Catheter<br>Catheter, Hemodialysis, Triple Lumen, Non-Implanted<br>NIE<br>21 CFR §876.5540 |
| Predicate<br>Device | Trade Name:<br>Common Name:<br>Classification Name:<br>Product Code:<br>Classification<br>Regulation:<br>Premarket Notification:<br>Concurrence Date: | Power-Trialysis™ Short-Term Dialysis Catheter<br>Short-Term Hemodialysis Catheter<br>Catheter, Hemodialysis, Triple Lumen, Non-Implanted<br>NIE<br>21 CFR §876.5540<br>K083675<br>March 19, 2009 |
| Device<br>Description | | Power-Trialysis™ Short-Term Dialysis catheters are made of thermosensitive<br>polyurethane, which softens when exposed to body temperature. The catheter<br>is divided into three separate lumens permitting continuous blood flow. Both<br>the venous (blue) and the arterial (red) lumens may be used for hemodialysis,<br>hemoperfusion, and apheresis treatments. The distal (purple) lumen is<br>completely independent from the two dialysis lumens and may be used for<br>intravenous therapy, power injection of contrast media, and central venous<br>pressure monitoring. The distal lumen can also be accessed for blood draws |
| Intended Use /<br>Indications For<br>Use | The Power-TrialysisTM Short-Term Dialysis Catheter, with a third internal lumen<br>for intravenous therapy, power injection of contrast media, and central venous<br>pressure monitoring, is indicated for use in attaining short-term (less than 30<br>days) vascular access for hemodialysis, hemoperfusion, and apheresis<br>treatments. The catheter is intended to be inserted in the jugular, femoral, or<br>subclavian vein as required. The maximum recommended infusion rate is 5<br>mL/sec for power injection of contrast media. | |
| Technological<br>Characteristics | Vascular access for hemodialysis, hemoperfusion, and apheresis treatments<br>with the additional power injectable third lumen is the technological principle for<br>both the subject and predicate devices.<br>At a high level, the subject and predicate devices are based on the following<br>same technological elements:<br>Short term use (<30 days). Insertion technique- Seldinger (over-the-guidewire) or percutaneous<br>procedure into one of the large central veins to place the catheter. Catheter is intended to be inserted in the jugular, femoral, or<br>subclavian vein as required. Catheter tip placement is in the central venous system with the<br>Superior Vena Cava (SVC) preferred. Catheter length 12.5 cm, 15 cm, 20 cm, and 24 cm. The tip configuration of the Power-TrialysisTM is an atraumatic tapered<br>tip. The catheter is skived to create the venous and arterial lumen<br>openings. The power-injectable lumen opening is distal to the venous<br>and arterial lumen openings. The following technological differences exist between the subject and<br>predicate devices: Addition of side holes for venous and arterial flows Addition of Alphacurve to catheter shaft tubing For Alphacurve configurations only: additional catheter markings to<br>indicate effective (insertable) catheter length and suture wing<br>placement. The differences are not critical to the intended use of the device and do not<br>raise any new questions regarding safety or effectiveness. | |
| Safety and<br>Performance<br>Testing | Verification and validation activities were designed and performed in<br>accordance with Design Controls as per 21 CFR §820.30.<br>The following performance data were provided in support of the substantial<br>equivalence determination.<br>Hemolysis testing was performed by infusing and aspirating blood through the<br>catheters. The evaluation was conducted in accordance with ASTM<br>F1841:1997 (R 2005).<br>Chemical conditioning of the catheters before testing for leak, static burst,<br>tensile testing, and shaft to hub tensile testing was performed to ensure the<br>performance of the device was not adversely affected following exposure to<br>chemicals generally used during hemodialysis. Leak testing was conducted<br>in accordance with ISO 10555-1: 1995/Amd 1: 1999/Amd 2: 2004. | |
| Safety and<br>Performance<br>Testing<br>(Continued) | Occluded Power Injection and Assembly Leak Post Occluded Power<br>Injection testing were performed to resolve equivalence issues related to the<br>lower static burst threshold of the modified device. | |
| | Assembly Burst testing was performed post power injection to ensure<br>multiple power injection conditioning did not cause the material of the test<br>articles to weaken. | |
| | Dialysis Flow testing was performed to ensure the catheter configurations<br>satisfy established flow rate requirements under labeled dialysis procedural<br>pressures. | |
| | Shaft to Hub Tensile testing was performed to evaluate the integrity of the<br>shaft to hub bond. | |
| | Dialysis Lumen Recirculation testing was performed to determine the<br>percentage of recirculation in forward and reverse flow configurations. | |
| | Gravity Flow testing was performed to determine the flow rate of normal<br>saline through the power injectable lumen. | |
| | Catheter Collapse for Dialysis Lumens testing was performed to ensure the<br>catheter lumens will not collapse at established pressure requirements that<br>could be achieved during hemodialysis procedures. | |
| | Catheter Collapse for Power Injectable Lumen testing was performed to<br>determine the flow rate through the power injectable lumen at a vacuum<br>pressure. | |
| | Guidewire Fit testing was performed to ensure use compatibility between the<br>catheters and guidewires. | |
| | Central Venous Pressure Monitoring testing was performed to verify the<br>capabilities of the catheters in a simulated environment. | |
| | Sterilization Validation was performed to verify the added length of the<br>Power Trialysis Alphacurve Catheter does not adversely impact sterilant<br>residual levels following sterilization. This testing is done in accordance with<br>ISO 10993-7: 2008. | |
| | The subject device met all predetermined acceptance criteria derived from the<br>above listed testing and demonstrated substantially equivalent performance as<br>compared to the cited predicate device. | |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, technological characteristics, and safety and<br>performance testing, the subject Power-TrialysisTM Short-Term Dialysis<br>Catheter meets the requirements that are considered sufficient for its intended<br>use and demonstrates that the subject device is substantially equivalent to the<br>predicate device cited. | |

and infusion of medications.

{5}------------------------------------------------

{6}------------------------------------------------