The HeRO Graft 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® 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 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.e. 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.

Device Description

The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis composed of three components: Arterial Graft Component, Venous Outflow Component and Accessory Component Kit. The Venous Outflow Component is made of radiopaque silicone and contains reinforcing braided filaments that impart kink and crush resistance. During surgery, the Venous Outflow Component is sized to fit the patient by cutting it to the proper length and sliding it over the barbs of the connector on the Arterial Graft Component. The Arterial Graft Component is a conventional ePTFE hemodialysis graft that has been attached to a titanium connector. An alternate to the Arterial Graft Component is The Adapter which allows the physician to choose and connect a 6mm ID vascular graft from the list of qualified grafts. The Accessory Component Kit (a convenience kit) contains instruments that assist in the implantation of the HeRO Graft.

AI/ML Overview

The provided text describes the HeRO® Graft, a vascular graft prosthesis, and its 510(k) clearance (K124039). The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (design verification testing). There is no information provided regarding a study conducted to prove the device meets specific acceptance criteria based on clinical outcomes or a comparison against a defined performance target. Instead, the submission states that "Additional clinical performance data was not required to support the modification of the device." and relies on "design verification testing" and comparison to a predicate device.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be answered directly from the provided text.

Here's an analysis based on the available information:

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

The document provides a table of "Test Parameter" and "Results" which essentially act as acceptance criteria and their successful fulfillment.

Test Parameter	Acceptance Criteria (Implied)	Reported Device Performance
Component Integrity - Proper assembly	None of the graft connections that used strain reliefs had the coil portion of the strain relief under the clamshells.	None of the graft connections that used strain reliefs had the coil portion of the strain relief under the clamshells.
Connector and strain relief Inspection (after attachment)	None of the graft connections showed any damage or delamination.	None of the graft connections showed any damage or delamination.
Connection Kink Radius	Meet the kink radius test specification.	All of the grafts met the kink radius test specification with the highest kink value and the greatest HTL value.
Connection Leakage	No leakage.	None of the connections tested leaked.
Connection Water Entry Pressure (WEP)	Successfully characterized for WEP.	All graft connections were successfully characterized for WEP.
Connector Attachment strength	Passing tensile strength.	All of the graft connections had passing tensile strength.
Strain Relief Bond Strength	Successfully characterized for bond strength.	All strain reliefs were successfully characterized for bond strength.
Corrosion Resistance	No signs of corrosion.	None of the devices showed any signs of corrosion on any of the components.
Nitinol Coil Strain Relief Af	Acceptable levels.	All nitinol strain reliefs had acceptable levels.
Nitinol Spring Af	Acceptable levels.	All nitinol springs had acceptable levels.
MR Compatibility	MR Conditional.	MR Conditional.
Component Integrity- Proper use of strain relief	The strain relief was used on all grafts requiring the strain relief.	The strain relief was used on all grafts requiring the strain relief.
Human Factors/ Usability engineering (Ease of connection)	Rated "PASS" by doctors.	All doctors rated the ease of making the connection "PASS".
Human Factors/ Usability engineering (Adequacy of labeling)	Rated "PASS" by doctors.	All doctors rated the adequacy of the labeling "PASS".

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

The document refers to "design verification testing." However, it does not specify the sample sizes used for each of the non-clinical tests. For example, it says "None of the connections tested leaked," but not how many connections were tested. It also does not mention data provenance (country of origin) as these are non-clinical, in-vitro tests, nor does it specify if any clinical data was retrospective or prospective (as "additional clinical performance data was not required").

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)

For the "Human Factors/ Usability engineering" tests, it states "All doctors rated..." However, the number of doctors (experts) is not specified, nor are their specific qualifications (e.g., years of experience, specialty). For the other non-clinical tests, the "ground truth" would be established by engineering standards and measurements, not medical experts.

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

There is no mention of an adjudication method for any of the tests. For the human factors portion, it simply states "All doctors rated," implying either unanimous agreement or that individual ratings were sufficient without a formal adjudication process.

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 MRMC comparative effectiveness study was done as this device is a vascular graft prosthesis, not an imaging AI diagnostic device. The application is for a physical medical device, not a software or AI-assisted diagnostic tool.

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

This question is not applicable as the device is a physical vascular graft, not an algorithm.

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

For the non-clinical performance data, the "ground truth" is based on engineering specifications, standardized test methods, and direct physical measurements of the device's components and connections. For the "Human Factors/Usability engineering" tests, the ground truth is based on subjective ratings by "doctors."

8. The sample size for the training set

This device is a physical product, not an algorithm that requires a training set. Therefore, this question is not applicable.

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

This question is not applicable as there is no training set for this type of device.

Summary

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K124039

510(k) Summary (per 21 CFR 807.87(h))

MAR 0 7 2013

Common/Usual Name:	Vascular Graft Prosthesis
Product Trade Name:	HeRO® Graft
Classification Name:	21 CFR 870.3450; Vascular graft prosthesis; ClassII; DSY, LJS, MSD, Cardiology
Predicate Device:	K071778, K091491 HeRO™ Vascular Access DeviceK120006, K121532 HeRO® Graft
Manufacturer:	Hemosphere, a CryoLife, Inc. Company1655 Roberts Blvd. NWKennesaw, GA 30144
Contact:	David M. FronkVP, RA/QA
Date Prepared:	November 20, 2012

Device Description:

Intended Use:

The HeRO Graft 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.

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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 readly identified using the KDOQI 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 (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. KDOQ1 . guidelines recommend a minimum Kt/V of 1.4.2

Substantial Equivalence Comparison:

The predicate device is the GRAFTcath, Inc. HeRO Vascular Access Device, K071778, K091491, K120006 and K121532. The company name has been changed from GRAFTcath, Inc. to Hemosphere, Inc. and the product name has been changed from HeRO Vascular Access Device to HeRO Graft.

Results of design verification testing demonstrate that the device system as modified is as safe as the predicate device. The risk assessment results, together with the results of design verification testing presented in this submission, confirm that the HeRO Graft, as modified, raises no new questions of safety or effectiveness compared to the predicate device. The HeRO Graft has been shown to be substantially equivalent to the legally marketed device for the purpose of 510(k) clearance.

' Vascular Access Work Group. National Kidney Foundation KDOQ! clinical practice guidelines for vascular access. Guideline 1: patient preparation for permanent hemodialysis access. Am J Kidney Dis 2006;48(1 Suppl1): S188-91. 2 Hemodialysis Adequacy 2006 Work Group. National Kidney Foundation KDOQ! clinical practice guidelines for hemodialysis adequacy, update 2006. Am J Kidney Dis 2006;48(Suppl 1):S2-S90.

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Summary of Non-Clinical Performance Data:

Test Parameter	Results
Component Integrity - Properassembly	None of the graft connections that used strain reliefs had the coilportion of the strain relief under the clamshells.
Connector and strain reliefInspection (after attachment)	None of the graft connections showed any damage ordelamination.
Connection Kink Radius	All of the grafts met the kink radius test specification with thehighest kink value and the greatest HTL value.
Connection Leakage	None of the connections tested leaked.
Connection Water Entry Pressure(WEP)	All graft connections were successfully characterized for WEP,
Connector Attachment strength	All of the graft connections had passing tensile strength.
Strain Relief Bond Strength	All strain reliefs were successfully characterized for bond strength.
Corrosion Resistance	None of the devices showed any signs of corrosion on any of thecomponents.
Nitinol Coil Strain Relief Af	All nitinol strain reliefs had acceptable levels.
Nitinol Spring Af	All nitinol springs had acceptable levels.
MR Compatibility	MR Conditional
Component Integrity- Proper use ofstrain relief	The strain relief was used on all grafts requiring the strain relief.

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Component Integrity- Properassembly	None of the graft connections that used strain reliefs had the coilportion of the strain relief under the clamshells.
Connector and strain reliefInspection (after attachment)	None of the graft connections showed any damage ordelamination.
Connection Kink Radius	PASS for kink radius.
Connection Leakage	None of the connections tested leaked.
Connection Water Entry	All graft connections were successfully characterized for WEP.
Connector Attachment strength	All of the graft connections had passing tensile strength.
Human Factors/ Usabilityengineering	All doctors rated the ease of making the connection "PASS".
Human Factors/ Usabilityengineering	All doctors rated the adequacy of the labeling "PASS".

Summary of Clinical Performance Data:

Additional clinical performance data was not required to support the modification of the device.

and the comments of the comments of the comments of

. . . . .

and the comments of the country

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 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 that resembles an abstract caduceus or a representation of human figures.

Public Health Service

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

March 7, 2013

Hemosphere, a CryoLife, Inc. Company c/o Mr. David Fronk Vice President of Regulatory Affairs 1655 Roberts Boulevard, NW Kennesaw, GA 30144

Re: K124039

Trade/Device Name: HeRO Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY, LJS, MSD Dated: December 27, 2012 Received: December 28, 2012

Dear Mr. Fronk:

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. Iisting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. David Fronk

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Bram D. Zujekerman

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 STATEMENT

Current 510(k) Number: K124039

Device Name:

HeRO® Graft

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 (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

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(1Suppl1): S188-91. 4 Hemodialysis Adequacy 2006 Work Group. National Kidney Foundation KDOQ! clinical practice guidelines for hemodialysis adequacy, update 2006. Am J Kidney Dis 2006;48(Suppl 1):S2-S90.

Prescription Use (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)

Image /page/6/Picture/18 description: The image shows the name "Bram D. Zuckerman" in a large, bold font at the top. Below the name, there is a timestamp-like string "2013.03.07 17:40:30 -05'00'". The timestamp appears to indicate a date of March 7, 2013, and a time of 17:40:30 with a time zone offset of -05'00'.

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.”