The Merit Centros and CentrosFLO Long-Term Hemodialysis Catheter for use in attaining long-tern vascular access for hemodialysis and apheresis. It may be insected percutaneously and is primarily placed in the internal jugular vein of an adult patient. This catheter is indicated for > 30 days, (long-term) placement.

Device Description

The Centros and CentrosFLO Long-Term Hemodialysis Catheters are dual lumen, 15FR catheters available in a straight configuration with multiple lengths. The catheter comes with a stiffening stylet that can be used for over-the-wire placement. The stiffening stylet has a female Luer which is over-molded on a nylon shaft with a tapered distal tip. Distal to the female Luer is a rotating male locking collar which can be used to attach the stylet to the catheter. The catheter lumens are D-shaped and made from radiopaque Carbothane. The distal end design is a fixed length pre-formed split-tip, with (CentrosFLO) or without (Centros) side-holes. The distal venous lumen extends past the arterial lumen, and includes a quide wire slit for insertion by the optional over-the-wire placement technique. The proximal device contains a fixed polyester cuff, an integrated bifurcation, suture wing, and extension legs with color coded occlusion clamps and Luer connectors (red and blue for the arterial and venous lumens respectively). The lumen priming volumes are printed on ID tags within the occlusion clamps. The trade name and cuff-to-tip length are printed on the catheter bifurcation. The procedure kits include the necessary accessories to correctly insert the catheter.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Merit Centros/CentrosFLO Long-Term Hemodialysis Catheter. It focuses on demonstrating substantial equivalence to a predicate device through conformity to recognized performance standards and bench testing.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of quantitative acceptance criteria with corresponding performance data. Instead, it states that a "battery of tests was performed based on the requirements of the below recognized performance standards and draft guidance, as well as biocompatibility, sterilization, and labeling standards and guidance."

The document generally states that the device "met the predetermined acceptance criteria applicable to the safety and efficacy of the device." No specific numerical values for acceptance criteria or performance are presented.

Here's an inferred list of the performance tests conducted, with the understanding that the acceptance criteria are implicitly derived from the referenced standards and guidance documents:

Test Performed	Implied Acceptance Criteria (from referenced standards)	Reported Device Performance
Dimensional Verification	Conformance to design specifications	Met
Stylet removal from catheter	Smooth removal without damage or excessive force	Met
Guidewire slit liquid leakage	No leakage or leakage within acceptable limits	Met
Stylet insertion in catheter	Smooth insertion without damage or excessive force	Met
Visual inspection	Absence of defects, conformance to visual standards	Met
Guidewire passage through stylet	Smooth passage without obstruction or damage	Met
Stylet Protrusion	Protrusion within specified limits	Met
Force at break stylet hub to shaft	Meets minimum strength requirements	Met
Stylet Luer gauging	Conformance to Luer taper standards (ISO 594-1/2)	Met
Stylet Luer separation force	Meets specified separation force requirements	Met
Stylet Luer unscrewing torque	Meets specified unscrewing torque requirements	Met
Stylet Luer ease of assembly	Easy and secure assembly	Met
Stylet Luer resistance to overriding	Resists overriding during assembly	Met
Stylet Luer stress cracking	No stress cracking observed	Met
Biocompatibility	Meets ISO 10993-1 requirements	Met
Sterilization	Meets ISO 11135-1 requirements	Met
Labeling	Conformance to FDA guidance	Met
General Requirements for Intravascular Catheters (ISO 10555-1)	Conformance to all applicable sections	Met
Central Venous Catheters Specific Requirements (ISO 10555-3)	Conformance to all applicable sections	Met
Intravascular Catheter Introducers (ISO 11070)	Conformance to all applicable sections	Met

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

The document does not specify the sample sizes used for any of the performance tests. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of medical device premarket notifications that rely on bench testing, it is generally assumed that these tests are conducted internally by the manufacturer (Merit Medical Systems, Inc., located in South Jordan, UT, USA) and are prospective experiments.

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

This information is not applicable and not provided in the document. The document describes bench testing against engineering standards and guidance documents, not a clinical study involving human assessment or expert consensus for "ground truth."

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies involving observer variability, which is not the case for the described bench tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable and not provided in the document. The filing describes a physical medical device (catheter) and its bench testing, not an AI or imaging diagnostic device. Therefore, no MRMC study, AI assistance, or effect size is discussed.

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

This information is not applicable and not provided in the document. As stated above, this is not an AI or algorithm-based device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the described bench tests, the "ground truth" is defined by the acceptance criteria established by the referenced international standards (e.g., ISO 10555-1, ISO 594-1/2, ISO 11135-1, ISO 10993-1, ISO 11070) and FDA guidance documents. The device's performance is compared against these predetermined, objective, and quantitative or qualitative benchmarks.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. This is not an AI or machine learning device that requires a training set.

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

This information is not applicable and not provided in the document. This is not an AI or machine learning device that requires a training set.

Summary

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Merit Centros/CentrosFLO Long-Term Hemodialysis Catheter Premarket Notification 510(k)

5.0 510(k) Summary

JUN 1 8 2014

Merit Medical Systems, Inc.

GeneralProvisions	Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number:	Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 208-4789(801) 253-6919Susan ChristensenMay 22, 20141721504
Subject Device	Trade Name:Common/Usual Name:Classification Name:	Merit Centros® and CentrosFLO® Long-TermHemodialysis CatheterImplanted Hemodialysis CatheterCatheter, Hemodialysis, Implanted
PredicateDevice	Trade Name:Classification Name:Premarket Notification:Manufacturer:	Merit Centros® Long-Term HemodialysisCatheterCatheter, Hemodialysis, ImplantedK092597Merit Medical Systems, Inc.
Classification	Class21 CFR §FDA Product Code:Review Panel:	III876.5540MSDGastroenterology/Urology
Intended Use	The Merit Centros and CentrosFLO Long-Term Hemodialysis Catheterare indicated for use in attaining long-term vascular access forhemodialysis and apheresis. It may be inserted percutaneously and isprimarily placed in the internal jugular vein of an adult patient. Thiscatheter is indicated for > 30 days, (long-term) placement.
DeviceDescription	The Centros and CentrosFLO Long-Term Hemodialysis Catheters aredual lumen, 15FR catheters available in a straight configuration withmultiple lengths. The catheter comes with a stiffening stylet that can beused for over-the-wire placement. The stiffening stylet has a femaleLuer which is over-molded on a nylon shaft with a tapered distal tip.Distal to the female Luer is a rotating male locking collar which can beused to attach the stylet to the catheter. The catheter lumens are D-shaped and made from radiopaque Carbothane. The distal end designis a fixed length pre-formed split-tip, with (CentrosFLO) or without(Centros) side-holes. The distal venous lumen extends past the arteriallumen, and includes a quide wire slit for insertion by the optional over-the-wire placement technique. The proximal device contains a fixedpolyester cuff, an integrated bifurcation, suture wing, and extensionlegs with color coded occlusion clamps and Luer connectors (red andblue for the arterial and venous lumens respectively). The lumenpriming volumes are printed on ID tags within the occlusion clamps.The trade name and cuff-to-tip length are printed on the catheterbifurcation. The procedure kits include the necessary accessories tocorrectly insert the catheter.
Comparison toPredicateDevice	The technological characteristics including design, intended use, materials, kit components, packaging, and labeling of the subject Centros and CentrosFLO Long-Term Hemodialysis Catheter are substantially equivalent to those of the predicate device. Both the Centros and CentrosFLO catheters now come with a stiffening stylet for use in placing the catheter using the over-the-wire placement method.
	FDA guidance and recognized performance standards have been established for Implanted Blood Access Devices for Hemodialysis under Section 514 of the Food, Drug and Cosmetic Act. A battery of tests was performed based on the requirements of the below recognized performance standards and draft guidance, as well as biocompatibility, sterilization, and labeling standards and guidance. Conformity to these standards demonstrates that the proposed Merit Centros/CentrosFLO Long-Term Hemodialysis Catheters met the standards' established acceptance criteria applicable to the safety and efficacy of the device. Performance testing was conducted based on the risk analysis and based on the requirements of the following international standards/documents:
Safety &PerformanceTests	FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, 1995 FDA Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document Implanted Blood Access devices for Hemodialysis June 28, 2013 ISO 10555-1:2013, Sterile, Single-Use Intravascular Catheters, Part 1: General Requirements. ISO 10555-3:2013, Sterile, Single-Use Intravascular Catheters, Part 3: Central Venous Catheters. ISO 594-1:1986, Conical Fittings with 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirements. ISO 594-2:1998, Conical Fittings with 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock fittings ISO 11070: Sterile Single Use Intravascular Catheter Introducers ISO 11135-1:2007, Sterilization of health care products - routine control of a sterilization process for medical device ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and FDA guidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995
	Performance Testing-Bench
Safety &PerformanceTests cont.	• Dimensional Verification• Stylet removal from catheter .• Guidewire slit liquid leakage• Stylet insertion in catheter• Visual inspection• Guidewire passage through stylet• Stylet Protrusion• Force at break stylet hub to shaft• Stylet Luer gauging• Stylet Luer separation force• Stylet Luer unscrewing torque• Stylet Luer ease of assembly• Stylet Luer resistance to overriding• Stylet Luer stress crackingThe results of the testing demonstrated that the subject MeritCentros/CentrosFLO Long-Term Hemodialysis Catheter met thepredetermined acceptance criteria applicable to the safety andefficacy of the device.
Summary ofSubstantialEquivalence	Based on the indications for use, design, safety and performancetesting, the subject Merit Centros/CentrosFLO Long-Term HemodialysisCatheter meets the requirements that are considered essential for itsintended use and is substantially equivalent to the predicate device, theCentros Long-Term Hemodialysis Catheter, K092597 manufactured byMerit Medical Systems, Inc.

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Merit Centros/CentrosFLO Long-Term Hemodialysis Catheter Premarket Notification 510(k)

Merit Medical Systems, Inc.

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Merit Centros/CentrosFLO Long-Term Hemodialysis Catheter Premarket Notification 510(k)

Merit Medical Systems, Inc.

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

June 18, 2014

Merit Medical Systems, Inc. Susan Christensen Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095

Re: K141363

Trade/Device Name: Merit Centros® and CentrosFLO® Long-Term Hemodialysis Catheter Regulation Number: 21 CFR$ 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: May 22, 2014 Received: May 23, 2014

Dear Susan Christensen,

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. 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 legally 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, and 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

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Page 2 - Susan Christensen

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.

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 (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" (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.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/7 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The letters are black against a white background. The letters "P." are smaller than the other letters in the name.

for

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K141363

Device Name

Merit Centros® and CentrosFLO® Long-Term Hemodialysis Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Herbert P. Lerner -S 2014.06.18 12:13:31 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Regulation Number and Section

§ 876.5540 Blood access device and accessories.

(a)
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).
(b)
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.