The HeRO Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the KDOQI guidelines[1] as patients who:

· Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts).

• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography.

• Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography (e.g. fistula/graft salvage).

· Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.

• Have a compromised central venous system or central venous stenosis (CVS) as determined by a history of previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.

• Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.[2]

Device Description

The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis which provides arterial venous access with continuous outflow into the central venous system. The HeRO Graft is composed of the following components: (1) Venous Outflow Component (VOC), (2) Arterial Graft Component (AGC) or HeRO Adapter with Support Seal (used in conjunction with commercial vascular grafts), and (3) Accessory Component Kit (ACK). The VOC consists of a radiopaque silicone base tube, a nitinol braid (imparts kink and crush resistance), a distal radiopaque marker band, and an outer silicone elastomer encapsulation layer. During surgery, the VOC is cut to length for the patient anatomy and then advanced over the barbs of the AGC Connector or HeRO Adapter. The AGC is a conventional ePTFE vascular graft attached to a custom titanium alloy connector. As an alternative to the AGC, the titanium alloy HeRO Adapter with Support Seal allow the clinician to choose one of the commercially available 6mm ID vascular grafts qualified for use with the HeRO Graft. The ACK (a convenience kit) contains instruments that aid in the implantation of the HeRO Graft including, introducers, dilators, delivery stylet, hemostasis valve with stopcock, vascular clamp and hemostasis plug.

The HeRO Graft is a fully subcutaneous surgical implant single-use

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Merit HeRO Graft, a vascular graft prosthesis. The document details the device's indications for use, comparison to a predicate device, and the performance data submitted to demonstrate substantial equivalence.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document lists various performance tests and states that the device "met the acceptance criteria applicable to the safety and efficacy of the device" for these tests. However, it does not explicitly state the quantitative acceptance criteria for each test. Instead, it broadly indicates conformity to recognized standards and guidance documents.

Performance Test Category	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	Requirements of ISO 10993-1 and FDA guidance for implant devices with tissue/circulating blood contact for permanent duration.	Met biocompatibility requirements.
Material Properties	(Not explicitly stated for each, but inferred from standards like ISO 7198)	Dimensions, Leakage, Tensile - Attachment Strength, Corrosion Resistance, Clamp Resistance, Kink Assessment, Pressurized Inner Diameter, Stiffness, Body Crush Resistance, V-Bend Flex Fatigue, Burst Resistance, Tip Recovery, Marker Band Retention, Radiopacity, Sheath Delivery/Pushability, VOC Connection to Adapter/Connector met acceptance criteria.
MRI Compatibility	Requirements of ASTM F756, F2052, F2503, F2119, F2182, F2213.	Met MRI compatibility requirements.
Sterilization	Requirements of ISO 11135.	(Implicitly met through conformity to standard)
Pyrogenicity	Requirements of United States Pharmacopeia, National Formulary 30, General Chapter <151>, Pyrogen Test.	(Implicitly met through conformity to standard)

Study that proves the device meets the acceptance criteria:

The study that proves the device meets the acceptance criteria is a series of performance tests conducted based on established FDA guidance documents and recognized performance standards. These standards include:

FDA Guidance for Industry and FDA Staff: Guidance Document for Vascular Prostheses 510(k) Submissions, Nov 1, 2000
FDA guidance document: Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process"
FDA Guidance Document: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, Dec 11, 2014
ISO 10555-1, Sterile, Single-Use Intravascular Catheters, Part 1: General Requirements
ISO 7198, Cardiovascular implants and extracorporeal systems - Performance Vascular prostheses - Tubular vascular grafts and vascular Data patches.
ISO 11135, Sterilization of health care products -Ethylene oxide - Requirements for the development, validation and routing control of a sterilization process for medical devices
ISO 10993 series (Parts 1, 3, 4, 5, 6, 10, 11) for Biological Evaluation of Medical Devices
ASTM F756, Standard Practice for Assessment of Hemolytic Properties of Materials
ASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
ASTM F2182 Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants during Magnetic Resonance Imaging
ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
United States Pharmacopeia, National Formulary 30, General Chapter <151>, Pyrogen Test.

The document states: "Conformity to these standards demonstrates that the proposed HeRO Graft meets the acceptance criteria established by the standards as they apply to device safety and efficacy."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document lists "Performance Data" and "Biocompatibility testing" as being provided. These are laboratory/benchtop test results, not clinical study data with human patients. Therefore, the concepts of "sample size for the test set," "country of origin of the data," and "retrospective or prospective" are not applicable in the context of this 510(k) submission for mechanical/material and biocompatibility testing. The data provenance is from laboratory tests conducted by the manufacturer, Merit Medical Systems, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The "ground truth" for these types of engineering and biocompatibility tests is based on the specifications defined by the recognized international and national standards (e.g., ISO, ASTM, USP) and FDA guidance documents. There is no mention of human experts establishing ground truth for these specific tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies for human reader interpretation of medical images or outcomes. This section of the document describes laboratory performance testing, not human reader studies.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing and biocompatibility. The device is a physical vascular graft, not an AI or imaging diagnostic tool that would involve human reader interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. The device is a physical vascular graft, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests and biocompatibility evaluation is derived from the quantitative specifications and methodologies outlined in the referenced national and international standards (ISO, ASTM) and FDA guidance documents. For instance, a tensile strength test would have a specified minimum allowed force, or a leakage test would have a maximum allowed leakage rate. Biocompatibility relies on adherence to the testing requirements and acceptable response limits defined in the ISO 10993 series.

8. The sample size for the training set

This question is not applicable. There is no mention of a "training set" as this is not an artificial intelligence or machine learning device. The 510(k) describes a physical medical device.

9. How the ground truth for the training set was established

This question is not applicable, as there is no "training set."

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 30, 2017

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

Re: K172637

Trade/Device Name: Merit HeRO Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY, LJS, MSD Dated: August 31, 2017 Received: September 1, 2017

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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);

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Page 2 - Susan Christensen

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nicole G. Ibrahim -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172637

Device Name Merit HeRO Graft

Indications for Use (Describe)

· Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts).

• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography.

• Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography (e.g. fistula/graft salvage).

· Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.

• Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.[2]

[1] Vascular Access Work Group. National Kidney Foundation KDOQI clinical practice guidelines for vascular access. Guideline 1: patient preparation for permanent hemodialysis access. Am J Kidney Dis 2006;48(1Suppl.):5188-91. [2] Hemodialysis Adequacy 2006 Work Group. National Kidney Foundation KDOQI clinical practice guidelines for hemodialysis adequacy, update 2006. Am J Kidney Dis 2006:48(Suppl 1):S2-S90.

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 K172637

GeneralProvisions	Submitter Name:	Merit Medical Systems, Inc.
	Address:	1600 West Merit ParkwaySouth Jordan, UT 84095
	Telephone Number:	(801) 208-4789
	Fax Number:	(801) 253-6919
	Contact Person:Date Prepared:Registration Number:	Susan ChristensenAugust 31, 20171721504
Subject Device	Trade Name:	Merit HeRO® Graft
	Common/Usual Name:	Vascular Graft Prosthesis
	Classification Name:	Prosthesis, Vascular Graft, of 6mm and GreaterDiameter
	Regulatory Class:Product Code:21 CFR §:Review Panel:	IIDSY, LJS, MSD870.3450Cardiovascular

PredicateDevice	Trade Name:	HeRO Graft
	Classification Name:	Prosthesis, Vascular Graft, of 6mm and GreaterDiameter
	Premarket Notification:	K124039
	Manufacturer:	Merit Medical Systems, Inc.
		This predicate has not been subject to a design-related recall
ReferenceDevice		No reference devices were used in this submission.
DeviceDescription		The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graftprosthesis which provides arterial venous access with continuous outflowinto the central venous system. The HeRO Graft is composed of thefollowing components: (1) Venous Outflow Component (VOC), (2)Arterial Graft Component (AGC) or HeRO Adapter with Support Seal(used in conjunction with commercial vascular grafts), and (3) AccessoryComponent Kit (ACK). The VOC consists of a radiopaque silicone basetube, a nitinol braid (imparts kink and crush resistance), a distalradiopaque marker band, and an outer silicone elastomer encapsulationlayer. During surgery, the VOC is cut to length for the patient anatomyand then advanced over the barbs of the AGC Connector or HeROAdapter. The AGC is a conventional ePTFE vascular graft attached to acustom titanium alloy connector. As an alternative to the AGC, thetitanium alloy HeRO Adapter with Support Seal allow the clinician tochoose one of the commercially available 6mm ID vascular graftsqualified for use with the HeRO Graft. The ACK (a convenience kit)contains instruments that aid in the implantation of the HeRO Graftincluding, introducers, dilators, delivery stylet, hemostasis valve withstopcock, vascular clamp and hemostasis plug.
		The HeRO Graft is a fully subcutaneous surgical implant single-use
Indications for Use	The HeRO® Graft is indicated for end stage renal disease patientson hemodialysis who have exhausted all other access options.These catheter-dependent patients are readily identified using theKDOQI guidelines¹ as patients who:
	•	Have become catheter-dependent or who are approachingcatheter-dependency (i.e., have exhausted all other accessoptions, such as arteriovenous fistulas and grafts).
	•	Are not candidates for upper extremity fistulas or grafts due topoor venous outflow as determined by a history of previousaccess failures or venography.
	•	Are failing fistulas or grafts due to poor venous outflow asdetermined by access failure or venography (e.g. fistula/graftsalvage).
	•	Have poor remaining venous access sites for creation of a fistulaor graft as determined by ultrasound or venography.
	•	Have a compromised central venous system or central venousstenosis (CVS) as determined by a history of previous accessfailures, symptomatic CVS (i.e., via arm, neck, or face swelling)or venography.
	•	Are receiving inadequate dialysis clearance (i.e., low Kt/V) viacatheters. KDOQI guidelines recommend a minimum Kt/V of1.4.²
	¹Vascular Access Work Group. National Kidney Foundation KDOQI clinical practiceguidelines for vascular access. Guideline 1: patient preparation for permanenthemodialysis access. Am J Kidney Dis 2006;48(1Suppl1):S188-91.²Hemodialysis Adequacy 2006 Work Group. National Kidney Foundation KDOQIclinical practice guidelines for hemodialysis adequacy, update 2006. Am J KidneyDis 2006;48(Suppl 1):S2-S90.
	There is no change in the Indications for Use Statement from thepredicate to the subject device.
	The subject HeRO Graft device is similar in design and technologicalcharacteristics to the predicate HeRO Graft Device. The purpose ofthis 510(k) notification is to: modify the radiopaque marker band andsilicone material of the VOC; and qualify additional grafts for use withthe Adapter.
	The comparison between the subject device and predicate devices isbased on the following characteristics:
Comparison toPredicateDevice	•	Clinical use
	•	Indications for use
	•	Basic Design
	•	Material types that meet ISO 10993
	•	Fundamental technology/principle of operation
	•	Labeling
	•	Packaging
	•	Sterilization methods
	•	Intended use

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FDA guidance documents and recognized performance standards have been established for Vascular Prostheses under Section 514 of the Food. Drug and Cosmetic Act. A battery of tests was performed based upon the risk analysis and the requirements of the following internationally recognized standards and guidance documents pertaining to the device performance, as well as biocompatibility. sterilization, and labeling standards and quidance. Conformity to these standards demonstrates that the proposed HeRO Graft meets the acceptance criteria established by the standards as they apply to device safety and efficacy. . FDA Guidance for Industry and FDA Staff: Guidance Document for Vascular Prostheses 510(k) Submissions, Nov 1, 2000 ● FDA guidance document: Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process" . FDA Guidance Document: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, Dec 11, 2014 . ISO 10555-1, Sterile, Single-Use Intravascular Catheters, Part 1: General Requirements . ISO 7198, Cardiovascular implants and extracorporeal systems -Performance Vascular prostheses - Tubular vascular grafts and vascular Data patches. . ISO 11135, Sterilization of health care products -Ethylene oxide - Requirements for the development, validation and routing control of a sterilization process for medical devices ISO 10993-1. Biological Evaluation of Medical Devices Part 1: ● Evaluation and Testing within a risk management process . ISO 10993-3, Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity ● ISO 10993-4. Biological evaluation of medical devices - Part 4: Selection of tests for interaction with blood ● ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity . ISO 10993-6, Biological evaluation of medical devices - Part 6: Tests for local effects after implantation . ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed type hypersensitivity ISO 10993-11, Biological evaluation of medical devices – Part . 11: Tests for systemic toxicity ASTM F756, Standard Practice for Assessment of Hemolytic ● Properties of Materials . ASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment . ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants

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	ASTM F2182 Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants during Magnetic Resonance Imaging ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment United States Pharmacopeia, National Formulary 30, General Chapter <151>, Pyrogen Test.
	The following performance data were provided in support of the substantial equivalence determination.
PerformanceData(Continued)	Biocompatibility testingThe biocompatibility evaluation for the HeRO Graft was conducted in accordance with the FDA guidance document: Use of International Standard ISO-10993-1, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process" and International Standard ISO 10993-1 “Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
	The HeRO Graft met the biocompatibility requirements for implant device with tissue and circulating blood contact for a permanent (> 30 days) duration.
	The results of the following performance tests demonstrated that the subject device met the acceptance criteria applicable to the safety and efficacy of the device.
	Performance Testing-Dimensions Leakage Tensile - Attachment Strength Corrosion Resistance Clamp Resistance Kink Assessment Pressurized Inner Diameter Stiffness
	Body Crush Resistance V-Bend Flex Fatigue Burst Resistance Tip Recovery
	Marker Band Retention Radiopacity Sheath Delivery/Pushability MRI Compatibility
	Graft Expander Compatibility

VOC Connection to Adapter/Connector .

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Summary of	Based on the indications for use, design, safety and performance testing
Substantial	the subject device raises no new questions of safety or effectiveness
Equivalence	compared to the predicate device and is substantially equivalent to thepredicate device, the HeRO Graft K124039.

Regulation Number and Section

§ 870.3450 Vascular graft prosthesis.

(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”