The Zenysis™ Short-Term Dialysis Catheter, 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.

Device Description

Zenysis™ Short-Term Dialysis Catheters are made of thermosensitive polyurethane, which softens when exposed to body temperature. The catheter is divided into two separate lumens permitting continuous blood flow. Both the venous (blue) and the arterial (red) lumens may be used for hemodialysis, hemoperfusion, and apheresis treatments. The Attachable Suture Wing and Attachable Suture Wing Fastener will be used to support the Zenysis™ Short-Term Dialysis Catheter, as securement devices to fixate the exposed portion of the catheter shaft to the patient's skin. The subject device included in this submission will be offered in varying French size and catheter configuration types, as summarized in the table below: Straight Extension Legs and Precurved Extension Legs with Insertion Lengths of 12.5 cm, 15 cm, 20 cm, and 24 cm. The subject catheters will be packaged with legally marketed components used in the placement procedure.

AI/ML Overview

The provided text describes the Zenysis™ Short-Term Dialysis Catheter and its substantial equivalence to a predicate device. However, it does not contain a study that proves the device meets specific acceptance criteria in the way a clinical or performance study with detailed statistical results would.

Instead, the document outlines the acceptance criteria by referencing various guidance documents and standards that the device was tested against. The study itself is a series of verification tests performed in accordance with Design Controls (21 CFR §820.30) and the listed standards. The "reported device performance" is simply stated as "The subject device met all predetermined acceptance criteria".

Here's the information extracted and formatted to answer your request, with "N/A" for information not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Derived from Standards/Guidance)	Referenced Standard/Guidance	Reported Device Performance
Mechanical/Physical Performance:
Priming Volumes	In-house protocols	Met all criteria
Assembly Leak Resistance	In-house protocols	Met all criteria
Tip Tensile	In-house protocols	Met all criteria
Shaft to Bifurcation Tensile	In-house protocols	Met all criteria
Shaft Stiffness	In-house protocols	Met all criteria
Catheter Shaft Outer Dimensions	In-house protocols	Met all criteria
Extension Leg to Bifurcation Tensile	In-house protocols	Met all criteria
Assembly Burst Strength	In-house protocols	Met all criteria
Axial Restraint	In-house protocols	Met all criteria
Functional Performance:
Recirculation	In-house protocols	Met all criteria
Dialysis Flow Testing and Collapse	In-house protocols	Met all criteria
Biocompatibility/Safety:
Hemolysis	ASTM F756:2013, ASTM F1841:1997 (R2013)	Met all criteria
Biological Evaluation	ISO 10993-1 CORR1:2010	Met all criteria
Material/Radiological Properties:
Radiopacity	ASTM F640:2012	Met all criteria
General Catheter Requirements:	ISO 10555-1:2013, ISO 10555-3:2013	Met all criteria

Note: The document states that the "subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device." It does not provide specific numerical results for each test.

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

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin). The testing would typically be performed in a laboratory setting by the manufacturer (Bard Access Systems, Inc. in Salt Lake City, UT).
Retrospective or Prospective: N/A (these are bench tests, not clinical studies on patients).

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

Number of Experts: N/A. Ground truth for these types of bench tests is established by adhering to widely accepted engineering and medical device standards (e.g., ISO, ASTM) and internal protocols, rather than expert consensus on medical images or diagnoses.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: N/A. The evaluation methods for these bench tests are typically predefined by the relevant standards and protocols, not requiring an adjudication process like clinical expert review.

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

N/A. This document describes a medical device (dialysis catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

N/A. This document describes a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: Established definitions and metrics based on engineering principles and international standards (e.g., ISO 10555, ASTM F640, ISO 10993-1) for device performance, safety, and material properties.

8. The Sample Size for the Training Set

N/A. This is a physical medical device; there is no "training set" in the context of machine learning or AI.

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

N/A. As there is no training set, this is not applicable.

Summary

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Re:

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

April 4, 2017

C.R. Bard. Inc. Silvia De La Barra Associate Manager, Regulatory Affairs 605 North 5600 West Salt Lake City, UT 84116

K163458 Trade/Device Name: Zenysis™ Short-Term Dialysis Catheter Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood Access Device and Accessories Regulatory Class: II Product Code: MPB Dated: March 22, 2017 Received: March 23, 2017

Dear Silvia De La Barra:

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 Zenysis " Short-Term Dialysis Catheter 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/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

In addition, we have determined that your device kit contains ChloraPrep® (NDA 020832) and Lidocaine HCl 1% (ANDA 080408), 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, Maryland 20857 (301) 594-0101

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 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.

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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,

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

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Indications for Use

510(k) Number (if known)

K163458

Device Name Zenysis™ Short-Term Dialysis Catheter

Indications for Use (Describe)

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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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 that, the words "ACCESS SYSTEMS" are in a smaller, sans-serif font.

510(k) Summary

21 CFR 807.92(a)

GeneralProvisions	Submitter Name:Address:	Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116
Contact Person:Telephone Number:Fax Number:Date of Preparation:	Silvia De La Barra(801) 522-5909(801) 522-49698 December 2016
SubjectDevice	Trade Name:Common Name:Classification Name:Product Code/Regulation:	Zenysis™ Short-Term Dialysis CatheterShort-Term Dialysis CatheterCatheter, Hemodialysis, Non-ImplantedMPB - 21 CFR §876.5540
PredicateDevices	Trade Name:Classification Name:Premarket Notification:Manufacturer:	Niagara™ Slim-Cath Short-Term Dialysis CathetersShort-Term Hemodialysis CatheterK010778Bard Access Systems, Inc.
ReferenceDevice	Trade Name:Classification Name:Premarket Notification:Manufacturer:	Power-Trialysis™ Slim-Cath™ Short-Term DialysisCatheterShort-Term Hemodialysis CatheterK141531Bard Access Systems, Inc.

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	Zenysis™ Short-Term Dialysis Catheters are made of thermosensitivepolyurethane, which softens when exposed to body temperature. The catheteris divided into two separate lumens permitting continuous blood flow. Both thevenous (blue) and the arterial (red) lumens may be used for hemodialysis,hemoperfusion, and apheresis treatments.The Attachable Suture Wing and Attachable Suture Wing Fastener will be
	used to support the Zenysis™ Short-Term Dialysis Catheter, as securementdevices to fixate the exposed portion of the catheter shaft to the patient's skin.
DeviceDescription	The subject device included in this submission will be offered in varyingFrench size and catheter configuration types, as summarized in the tablebelow:
		Straight Extension	Precurved Extension
		Legs	Legs
	Insertion Length		12.5 cm
		15 cm	15 cm
		20 cm24 cm	20 cm24 cm
	The subject catheters will be packaged with legally marketed componentsused in the placement procedure.
Intended Use	Zenysis™ Short-Term Dialysis Catheters are recommended for use inattaining short term vascular access for hemodialysis, apheresis, andhemoperfusion treatments. This device is intended for insertion in the internaljugular, femoral, or subclavian vein as required.
Indications ForUse	The Zenysis™ Short-Term Dialysis Catheter, is indicated for use in attainingshort-term (less than 30 days) vascular access for hemodialysis,hemoperfusion, and apheresis treatments. The catheter is intended to beinserted in the jugular, femoral, or subclavian vein as required.

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Both the subject and predicate devices are intended for vascular access for hemodialysis, hemoperfusion, and apheresis treatments.

The subject and predicate devices are based on the following same technological elements:

Short term use (<30 days) ●
. Insertion technique-Seldinger (over-the-guidewire) or percutaneous procedure into one of the large central veins to place the catheter
Catheter is intended to be inserted in the jugular, femoral, or ● subclavian vein as required
Catheter tip placement is in the central venous system with the Superior Vena Cava (SVC) preferred
Catheter length 12.5 cm, 15 cm, 20 cm, and 24 cm ●
The tip configuration is an atraumatic tapered tip. The catheter is ● skived to create the venous and arterial lumen openings.
. 11F DLPolyurethane catheter with one set of four round side holes per dialysis lumen located toward the distal end of the shaft.

The following technological differences exist between the subject and

predicate devices:

The subject device is a smaller French size,
The tip configuration of the subject device is an atraumatic tapered purple tip, where-as the predicate is staggered with a black tip,
. Location of side holes are different between the subject and the predicate device,
The subject device has two more side holes than the predicate ● device,
. The lumen geometry of the subject device is an ellipse-shaped, where as the predicate's lumens are round shaped, and
Different bifurcation design.

The differences are not critical to the intended use of the device and do not raise any new questions regarding safety and/or effectiveness.

Technological Characteristics

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Verification tests were designed and performed in accordance with Design Controls as per 21 CFR §820.30. The following guidance documents and standards, in conjunction with in-house protocols were used to determine appropriate methods for evaluating the performance of the device:

o Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995;
Implanted Blood Access Devices for Hemodialysis, Guidance for ● Industry and Food and Drug Administration Staff, January 21, 2016:
. 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;
. ASTM F640:2012, Standard Test Methods for Determining Radiopacity for Medical Use;
ASTM F756:2013, Standard Practice for Assessment of Hemolytic Properties of Materials;
. ASTM F1841:1997 (R2013), Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps; and
ISO 10993-1 CORR1:2010, Biological Evaluation of Medical Devices; . Part 1 - Evaluation and Testing.

Safety & Performance Tests

The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device.

Risk management, including a failure modes and effects analysis (FMEA), of the subject device was conducted in accordance with ISO 14971:2012, Medical Devices - Risk Management for Medical Devices.

Performance Testing - Bench:

Priming Volumes .
Assembly Leak Resistance
Hemolvsis ●
Tip Tensile .
Recirculation
Dialysis Flow Testing and Collapse ●
Shaft to Bifurcation Tensile ●
Radiopacity .
Shaft Stiffness
Catheter Shaft Outer Dimensions ●
Extension Leg to Bifurcation Tensile ●
Assembly Burst Strength .
Axial Restraint

Summary of Substantial Equivalence

Based on the indications for use, technological characteristics, and safety and performance testing, the subject Zenysis™ Short-Term Dialysis 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 cited.

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.