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 with Insertion Lengths of 15 cm, 20 cm, 24 cm and Precurved Extension Legs with Insertion Lengths of 12.5 cm, 15 cm, 20 cm, 24 cm. The subject catheters will be packaged with legally marketed components used in the placement procedure.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Zenysis™ Short-Term Dialysis Catheter. It does not describe a study involving an AI/algorithmic device or human readers. Instead, it focuses on demonstrating substantial equivalence to a predicate device through technological characteristic comparisons and performance testing to ensure safety and effectiveness.

Therefore, most of the information requested in your prompt (acceptance criteria tables, sample sizes for test/training sets for AI, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, type of ground truth used for AI) is not applicable to this document.

However, I can extract the acceptance criteria and performance related to the device itself from the safety and performance testing section.

Here's the relevant information that can be extracted from the provided document:

Study Type: This is a medical device substantial equivalence submission (510(k)), not a study on an AI/algorithmic medical device. It involves bench testing of the physical catheter, not evaluation of a diagnostic algorithm's performance with human readers.

Acceptance Criteria and Device Performance for Zenysis™ Short-Term Dialysis Catheter

Acceptance Criteria / Performance Metric	Reported Device Performance
Priming Volumes	Device met predetermined acceptance criteria based on listed industry standards and in-house protocols.
Assembly Leak Resistance	Device met predetermined acceptance criteria based on listed industry standards and in-house protocols.
Hemolysis	Device met predetermined acceptance criteria based on listed industry standards (ASTM F756, ASTM F1841).
Tip Tensile Strength	Device met predetermined acceptance criteria based on listed industry standards and in-house protocols.
Recirculation	Device met predetermined acceptance criteria based on listed industry standards and in-house protocols.
Dialysis Flow Testing and Collapse	Device met predetermined acceptance criteria based on listed industry standards and in-house protocols.
Shaft to Bifurcation Tensile Strength	Device met predetermined acceptance criteria based on listed industry standards and in-house protocols.
Radiopacity	Device met predetermined acceptance criteria based on listed industry standard (ASTM F640).
Shaft Stiffness	Device met predetermined acceptance criteria based on listed industry standards and in-house protocols.
Catheter Shaft Outer Dimensions	Device met predetermined acceptance criteria based on listed industry standards and in-house protocols.
Extension Leg to Bifurcation Tensile Strength	Device met predetermined acceptance criteria based on listed industry standards and in-house protocols.
Assembly Burst Strength	Device met predetermined acceptance criteria based on listed industry standards and in-house protocols.
Axial Restraint	Device met predetermined acceptance criteria based on listed industry standards and in-house protocols.
Overall Safety & Performance	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.

Details from the document that are not applicable to the AI prompt but are included for context:

Sample size used for the test set and the data provenance: Not applicable to an AI device. The testing here refers to physical product testing (bench tests) on the Zenysis™ catheter. The document does not specify the number of catheters tested for each metric, but mentions "Verification tests were designed and performed in accordance with Design Controls as per 21 CFR §820.30."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI and expert consensus are not relevant here.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI device. For this physical medical device, "ground truth" would be established by physical measurements, material properties, and functional performance testing against established engineering and medical standards.
The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Relevant Guidance Documents and Standards Used for Testing:

Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995
Draft Guidance for Industry and Food and Drug Administration Staff: 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
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
ISO 10993-1 CORR1:2010. Biological Evaluation of Medical Devices: Part 1 - Evaluation and Testing
ISO 14971:2012, Medical Devices - Risk Management for Medical Devices (for Risk Management/FMEA)

Summary

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

January 5, 2016

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

Re: K153190

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: October 30, 2015 Received: November 3, 2015

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. 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.

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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 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 vours.

Joyce M. Whang -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K153190

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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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) 522-542530 October 2015
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 beused 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 confiquration types, as summarized in the tablebelow:
		Straight Extension	Precurved Extension
		Legs	Legs
	Insertion Length	15 cm	12.5 cm15 cm
		20 cm	20 cm
		24 cm	24 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.
o 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: . Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995; . Draft Guidance for Industry and Food and Drug Administration Staff: 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; 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 The subject device met all predetermined acceptance criteria derived from the Tests 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 ● . Hemolysis 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 . Based on the indications for use, technological characteristics, and safety and performance testing, the subject Zenysis™ Short-Term Dialysis Catheter Summary of meets the requirements that are considered sufficient for its intended use and Substantial demonstrates that the subject device is substantially equivalent to the Equivalence

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.