HeRO Graft

K172637 · Merit Medical Systems, Inc. · DSY · Nov 30, 2017 · Cardiovascular

Device Facts

• Record ID: K172637
• Device Name: HeRO Graft
• Applicant: Merit Medical Systems, Inc.
• Product Code: DSY · Cardiovascular
• Decision Date: Nov 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

HeRO Graft is a fully subcutaneous, single-use synthetic vascular graft prosthesis providing hemodialysis access with continuous outflow into the central venous system. Components include a Venous Outflow Component (VOC) (radiopaque silicone base tube, nitinol braid for kink/crush resistance, silicone elastomer encapsulation), an Arterial Graft Component (AGC) (ePTFE graft with titanium alloy connector), or a HeRO Adapter for use with qualified 6mm ID vascular grafts. Accessory kit includes introducers, dilators, and delivery tools. Implanted surgically by physicians; provides permanent (>30 days) vascular access for patients with exhausted access options. Device functions as a conduit for blood flow; output is the physical access site for dialysis. Benefits include maintaining dialysis clearance in patients with central venous stenosis or poor venous outflow.

Clinical Evidence

Bench testing only. Performance data included biocompatibility (ISO 10993), mechanical testing (tensile, leakage, kink, crush, fatigue, burst, radiopacity), and MRI compatibility (ASTM F2052, F2119, F2182, F2213).

Technological Characteristics

Materials: Radiopaque silicone, nitinol braid, ePTFE, titanium alloy. Design: Subcutaneous vascular graft prosthesis. Connectivity: None. Sterilization: Ethylene oxide (ISO 11135). Standards: ISO 10993 (biocompatibility), ISO 7198 (vascular prostheses), ISO 10555-1 (catheters), ASTM F756 (hemolysis), ASTM F2503/F2119/F2182/F2213 (MRI safety).

Indications for Use

Indicated for end-stage renal disease patients on hemodialysis who have exhausted all other access options, including those who are catheter-dependent, failing existing fistulas/grafts due to poor venous outflow, or have compromised central venous systems.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• HeRO Graft (K124039)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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]

[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)

| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------|-----------------------------------------------------------|
|------------------------------------------------------------|-----------------------------------------------------------|

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#### 510(k) Summary K172637

| General<br>Provisions | Submitter Name: | Merit Medical Systems, Inc. |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Address: | 1600 West Merit Parkway<br>South Jordan, UT 84095 |
| | Telephone Number: | [phone] |
| | Fax Number: | [phone] |
| | Contact Person:<br>Date Prepared:<br>Registration Number: | Susan Christensen<br>August 31, 2017<br>1721504 |
| Subject Device | Trade Name: | Merit HeRO® Graft |
| | Common/Usual Name: | Vascular Graft Prosthesis |
| | Classification Name: | Prosthesis, Vascular Graft, of 6mm and Greater<br>Diameter |
| | Regulatory Class:<br>Product Code:<br>21 CFR §:<br>Review Panel: | II<br>DSY, LJS, MSD<br>870.3450<br>Cardiovascular |
| | | |
| Predicate<br>Device | Trade Name: | HeRO Graft |
| | Classification Name: | Prosthesis, Vascular Graft, of 6mm and Greater<br>Diameter |
| | Premarket Notification: | K124039 |
| | Manufacturer: | Merit Medical Systems, Inc. |
| | | This predicate has not been subject to a design-related recall |
| Reference<br>Device | | No reference devices were used in this submission. |
| Device<br>Description | | The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graft<br>prosthesis which provides arterial venous access with continuous outflow<br>into the central venous system. The HeRO Graft is composed of the<br>following components: (1) Venous Outflow Component (VOC), (2)<br>Arterial Graft Component (AGC) or HeRO Adapter with Support Seal<br>(used in conjunction with commercial vascular grafts), and (3) Accessory<br>Component Kit (ACK). The VOC consists of a radiopaque silicone base<br>tube, a nitinol braid (imparts kink and crush resistance), a distal<br>radiopaque marker band, and an outer silicone elastomer encapsulation<br>layer. During surgery, the VOC is cut to length for the patient anatomy<br>and then advanced over the barbs of the AGC Connector or HeRO<br>Adapter. The AGC is a conventional ePTFE vascular graft attached to a<br>custom titanium alloy connector. As an alternative to the AGC, the<br>titanium alloy HeRO Adapter with Support Seal allow the clinician to<br>choose one of the commercially available 6mm ID vascular grafts<br>qualified for use with the HeRO Graft. The ACK (a convenience kit)<br>contains instruments that aid in the implantation of the HeRO Graft<br>including, introducers, dilators, delivery stylet, hemostasis valve with<br>stopcock, 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 patients<br>on hemodialysis who have exhausted all other access options.<br>These catheter-dependent patients are readily identified using the<br>KDOQI guidelines¹ as patients who: | |
| | • | Have become catheter-dependent or who are approaching<br>catheter-dependency (i.e., have exhausted all other access<br>options, such as arteriovenous fistulas and grafts). |
| | • | Are not candidates for upper extremity fistulas or grafts due to<br>poor venous outflow as determined by a history of previous<br>access failures or venography. |
| | • | Are failing fistulas or grafts due to poor venous outflow as<br>determined by access failure or venography (e.g. fistula/graft<br>salvage). |
| | • | Have poor remaining venous access sites for creation of a fistula<br>or graft as determined by ultrasound or venography. |
| | • | Have a compromised central venous system or central venous<br>stenosis (CVS) as determined by a history of previous access<br>failures, symptomatic CVS (i.e., via arm, neck, or face swelling)<br>or venography. |
| | • | Are receiving inadequate dialysis clearance (i.e., low Kt/V) via<br>catheters. KDOQI guidelines recommend a minimum Kt/V of<br>1.4.² |
| | ¹Vascular Access Work Group. National Kidney Foundation KDOQI clinical practice<br>guidelines for vascular access. Guideline 1: patient preparation for permanent<br>hemodialysis access. Am J Kidney Dis 2006;48(1Suppl1):S188-91.<br>²Hemodialysis Adequacy 2006 Work Group. National Kidney Foundation KDOQI<br>clinical practice guidelines for hemodialysis adequacy, update 2006. Am J Kidney<br>Dis 2006;48(Suppl 1):S2-S90. | |
| | There is no change in the Indications for Use Statement from the<br>predicate to the subject device. | |
| | The subject HeRO Graft device is similar in design and technological<br>characteristics to the predicate HeRO Graft Device. The purpose of<br>this 510(k) notification is to: modify the radiopaque marker band and<br>silicone material of the VOC; and qualify additional grafts for use with<br>the Adapter. | |
| | The comparison between the subject device and predicate devices is<br>based on the following characteristics: | |
| Comparison to<br>Predicate<br>Device | • | 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 Imp…