The HeRO vascular access device is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts.

The HeRO vascular access device 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 K/DOQI guidelines 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.
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 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. K/DOQI guidelines recommend a minimum Kt/V of 1.4.

Device Description

The HeRO device is a non-autogenous (i.e., synthetic) vascular access composed of four components: a catheter component, a pre-connected graft assembly, a crimp ring, and a sleeve. The catheter component is made of radiopaque silicone and contains reinforcing filaments that impart kink and crush resistance. The catheter is provided in two different lengths (referred to as left side and right side) to accommodate anatomical variations. During surgery, the catheter length is sized to fit the patient by peeling back the nylon filament and cutting the catheter. The pre-connected graft assembly is a conventional ePTFE hemodialysis graft that has been attached to a titanium connector. The titanium crimp ring is used during surgery to secure the catheter to the graft assembly. The silicone sleeve is placed during surgery to impart kink resistance of the catheter at the connector and to cover the metal crimp ring in silicone.

Additionally, a reusable stainless steel crimp tool is provided to compress the crimp ring for securing the catheter component to the graft assembly during surgery. The crimp tool is provided non-sterile and is steam sterilized before each use.

AI/ML Overview

The provided text describes the HeRO Vascular Access Device and its regulatory submission (K071778) to the FDA. It includes summaries of non-clinical (bench) and clinical performance data.

Here's the breakdown of the acceptance criteria and study information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text generally states that the device "met its acceptance criteria" for non-clinical tests and demonstrated comparable or better performance in clinical evaluation. However, specific numerical acceptance criteria for each test are not explicitly detailed in the given text. Instead, it offers a summary of the types of tests conducted and the overall outcome of meeting these criteria. For clinical performance, it compares the device's outcomes to established literature for catheters and grafts.

Test Category	Specific Test	Acceptance Criteria (General Statement)	Reported Device Performance
Non-Clinical	Catheter Burst Strength	Met acceptance criteria (Specific values not provided)	HeRO device met its acceptance criteria for all bench tests.
	Connection Leakage	Met acceptance criteria (Specific values not provided)	HeRO device met its acceptance criteria for all bench tests.
	Water Entry Pressure	Met acceptance criteria (Specific values not provided)	HeRO device met its acceptance criteria for all bench tests.
	Device Connection Strength	Met acceptance criteria (Specific values not provided)	HeRO device met its acceptance criteria for all bench tests.
	Crush Resistance (Catheter and Marker Band)	Met acceptance criteria (Specific values not provided)	HeRO device met its acceptance criteria for all bench tests.
	Catheter Stiffness	Met acceptance criteria (Specific values not provided)	HeRO device met its acceptance criteria for all bench tests.
	Catheter Tensile Strength and Elongation	Met acceptance criteria (Specific values not provided)	HeRO device met its acceptance criteria for all bench tests.
	Catheter Fatigue Testing (Flex, 180° & V-bend)	Met acceptance criteria (Specific values not provided)	HeRO device met its acceptance criteria for all bench tests.
	Kink Resistance	Met acceptance criteria (Specific values not provided)	HeRO device met its acceptance criteria for all bench tests.
Biocompatibility	ISO 10993 Biocompatibility Evaluations	Met acceptance criteria (Specific standards not provided)	ISO 10993 biocompatibility evaluations were conducted and met acceptance criteria.
Clinical	Rates and Types of Serious Adverse Events (SAEs)	Comparable to catheter and graft literature	Comparable to catheter and graft literature for the patient population studied; no new types of serious adverse events observed.
	Device-related Bacteremia Rates	Significantly lower than reported in catheter literature	Significantly lower than reported in catheter literature.
	Patency Rates	Not significantly different from graft literature; better than catheter literature	Not significantly different from graft literature reports and significantly better than catheter literature reports.
	Device Flow Rates	Not significantly different from graft literature; better than catheter literature	Not significantly different from graft literature reports and significantly better than catheter literature reports.
	Adequacy of Dialysis (e.g., Kt/V)	Not significantly different from graft literature; better than catheter literature (Recommended minimum Kt/V of 1.4)	Not significantly different from graft literature reports and significantly better than catheter literature reports. The device achieved adequacy of dialysis in line with or better than current methods.

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

Sample Size for Test Set:
- 36 catheter-dependent subjects (catheter arm)
- 50 graft subjects (graft arm)
- Total: 86 patients
Data Provenance: The text does not explicitly state the country of origin. It indicates it was a clinical evaluation, implying a prospective collection of data from enrolled patients.

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

The text refers to a "clinical evaluation" and "clinical performance data," and comparisons to "catheter and graft literature." It does not mention the use of a panel of experts to establish a "ground truth" for the test set in the traditional sense of diagnostic accuracy studies (e.g., for image interpretation). Instead, the clinical outcomes (e.g., adverse events, bacteremia rates, patency, flow rates, dialysis adequacy) are likely direct measurements from patient follow-up, and their "truth" is established by the clinical observation and measurement process itself, then compared against established medical literature benchmarks.

4. Adjudication Method for the Test Set

The text does not describe an adjudication method for the clinical test set outcomes. Clinical outcomes would typically be recorded based on standard medical practice and potentially reviewed by an independent clinical events committee for a larger trial, but such details are not provided here. No mention of 2+1, 3+1, or similar adjudication for establishing ground truth is made, which is consistent with a clinical outcomes study rather than a diagnostic accuracy study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study described is a clinical evaluation of the device's safety and performance with human patients, not a study involving multiple human readers interpreting cases with and without AI assistance to measure an effect size of AI.

6. Standalone Performance Done

Yes, a standalone performance evaluation was done. The "Summary of Non-Clinical Performance Data" details in vitro performance testing and biocompatibility evaluations that were conducted on the HeRO device itself to ensure it met its engineering and safety specifications. This represents a standalone evaluation of the device's physical and functional properties. The "Summary of Clinical Performance Data" also describes the standalone clinical performance of the device in human patients, measuring outcomes directly related to the device's use.

7. Type of Ground Truth Used

For the non-clinical (bench) tests, the "ground truth" was based on engineering specifications and ISO standards for material properties and device performance. The device's ability to meet these predefined quantitative criteria served as the ground truth.

For the clinical study, the "ground truth" for evaluating safety and performance was based on observed clinical outcomes and physiological measurements from patients (e.g., actual rates of serious adverse events, measured bacteremia rates, observed patency, measured device flow rates, calculated Kt/V for dialysis adequacy). These outcomes were then compared against performance benchmarks established in published medical literature for similar vascular access methods (catheters and grafts).

8. Sample Size for the Training Set

The text does not mention a training set or how it was established. This device is a physical medical device, not an AI/ML algorithm that requires a training set of data. The "study" refers to a clinical trial/evaluation of its safety and performance in human patients, and a series of bench tests.

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

As no training set is mentioned or applicable for this type of physical medical device submission, this question is not relevant to the provided information.

Summary

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2 510(k) Summary

Date Prepared: January 25, 2008

JAN 30 2008

Submitter's Name / Contact Person

Manufacturer GRAFTcath, Inc. 6545 City West Parkway Eden Prairie, MN 55344

Contact Person

Laurie Lynch, PhD General Manager and Vice President of R&D, Operations, and RA/QA Office : (952) 224-2225 X 222 Fax : (952) 224-2226 Email : llynch@graftcath.com

General Information

Trade Name	HeRO vascular access device
Common / Usual Name	Hemodialysis vascular access device
Classification Name	870.3460 Vascular graft prosthesis, Class II876.5540 Catheter, hemodialysis, implant, Class III
Predicate Devices	K052964 Boston Scientific Exxcel Soft ePTFE graftK032900 Edwards Lifespan ePTFE graftBard Access Systems Hickman Chronic Dialysis Catheter

Device Description

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GRAFTcath, Inc.	Traditional 510(k) Premarket Notification
K071778	HeRO Vascular Access Device

Intended Use

The HeRO device is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts.

Indications for Use

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.
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 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. K/DOQI . guidelines recommend a minimum Kt/V of 1.4.2

Substantial Equivalence Comparison

The HeRO device is substantially similar to legally marketed 510(k)-cleared devices in intended use, principles of use, composition, sizes, packaging, and sterility. The technological differences between HeRO and the predicate devices include use of a connector to combine the graft assembly and catheter component, use of imbedded nylon and nitinol reinforcements in the catheter component to impart kink and crush resistance, and a larger catheter ID and OD.

1 National Kidney Foundation. K/DOQI Clinical Practice Guidelines for Vascular Access, 2000. Am. J. Kidney Disease 37:S137-S181, 2001 (suppl 1).

Relates - Disease - PAD19 - Clinical Practice Guidelines for Hemodialysis Adequacy Guideline 4." Minimally Adequate Hemodialysis.

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GRAFTcath, Inc.	Traditional 510(k) Premarket Notification
K071778	HeRO Vascular Access Device

Results of design verification and validation testing demonstrate that the HeRO is as safe as the predicate devices and reliably maintains long-term vascular access for hemodialysis. The risk assessment results, together with the results of design verification and validation testing presented in this submission, confirm that the HeRO device raises no new questions of safety or effectiveness compared to the predicate devices. The HeRO device has, therefore, been shown to be substantially equivalent to legally marketed devices for the purpose of 510(k) clearance.

Summary of Non-Clinical Performance Data

In vitro performance testing and ISO 10993 biocompatibility evaluations were conducted on the HeRO device. Bench tests included catheter burst strength, connection leakage, water entry pressure, device connection strength, crush resistance (catheter and marker band), catheter stiffness, catheter tensile strength and elongation, catheter fatigue testing (flex fatigue, 180 degree and V-bend), and kink resistance. All testing demonstrated that the HeRO device met its acceptance criteria.

Summary of Clinical Performance Data

Safety and performance of the HeRO device was clinically evaluated. Thirty six (36) catheterdependent subjects (catheter arm) and 50 graft subjects (graft arm) were treated with the HeRO device for a total of 86 patients with a combined average follow-up of 10 months. The rates and types of serious adverse events reported were comparable to catheter and graft literature for the patient population studied and no new types of serious adverse events were observed. Devicerelated bacteremia rates were significantly lower than reported in catheter literature. Patency rates, device flow rates, and adequacy of dialysis were not significantly different from graft literature reports and significantly better than catheter literature reports. The study results demonstrate that the HeRO device is comparable to the predicate devices in materials and in bench and clinical performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, with three abstract shapes that could be interpreted as wings or flowing lines.

JAN 30 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GRAFTcath, Inc. C/O Dr. Laurie E. Lynch, Ph.D. General Manager and Vice President of R&D, Operations and RA/QA 6545 City West Parkway Eden Prairie, MN 55344

Re: K071778

HeRO (Hemodialysis Reliable Outflow) Vascular Access Device (formerly GRAFTcath Vascular Access System [GVAS] Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular graft prosthesis Regulatory Class: Class II Product Code: DSY, LJS, MSD Dated: December 11, 2007 Received: December 14, 2007

Dear Dr. Lynch:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 – Dr. Laurie E. Lynch

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); 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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dmna R. Varlinel

\ 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): K071778

Device Name: HeRO Vascular Access Device

Indications For Use: The HeRO vascular access device 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 K/DOQ! guidelines 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.
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 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, K/DQQ1 guidelines recommend a minimum Kt/V of 1.4.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

DUMNA R. VaLuneL

vision Sign-Off) Vision Sign-On-On-On-On-Vices

Page 1 of 1

Number K071778

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.”