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.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 history or 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 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. The Accessory Component Kit (a convenience kit) contains instruments that assist in the implantation of the HeRO Graft.

AI/ML Overview

This 510(k) premarket notification for the HeRO® Graft vascular prosthesis does not describe a study to establish acceptance criteria or demonstrate device performance against such criteria in the way a diagnostic AI/ML device submission would.

Instead, this submission is for a physical medical device (a vascular graft) and relies on demonstrating substantial equivalence to a previously cleared predicate device.

Therefore, many of the requested elements for a typical AI/ML device study's acceptance criteria and performance study are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, accuracy, or a table of reported device performance against such criteria. For a physical device like a vascular graft, "performance" is typically assessed through aspects like graft patency, infection rates, blood flow, durability, and biocompatibility, often in clinical trials or through post-market surveillance. This 510(k) summary explicitly states:

"No changes were made to the previously cleared packaging verification and sterilization validation. Additional clinical performance data was not required to support the modification of the device."

This indicates that the focus of this particular submission was on demonstrating that the modified device (HeRO® Graft) is as safe and effective as the predicate device (HeRO™ Vascular Access Device) without requiring new clinical performance studies for this specific clearance.

2. Sample size used for the test set and the data provenance

Not applicable. There is no "test set" in the context of an AI/ML diagnostic study described here. The submission is for a physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no "test set" or "ground truth" establishment in the context of an AI/ML diagnostic study described here.

4. Adjudication method for the test set

Not applicable. No "test set" or adjudication method is described.

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

Not applicable. This is not an AI/ML diagnostic device, and no MRMC study is described. The device is a physical vascular graft.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. There is no ground truth described in the context of AI/ML performance. For a physical device, "ground truth" would relate to the actual clinical outcomes in patients, which is not detailed as a new study in this 510(k). The submission relies on the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set mentioned.

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

Not applicable. This is not an AI/ML device.

Summary based on the document:

The core of this 510(k) submission is to demonstrate substantial equivalence of the HeRO® Graft to its predicate device (K071778, K091491, K120006).

Acceptance Criteria for Substantial Equivalence: The primary "acceptance criteria" here relate to demonstrating that the modified device "raises no new questions of safety or effectiveness compared to the predicate device." This is achieved through:
- Design Verification Testing: "Results of design verification testing demonstrate that the device system as modified is as safe as the predicate device."
- Risk Assessment: "The risk assessment results... confirm that the HeRO Graft, as modified, raises no new questions of safety or effectiveness..."
- Lack of Required New Clinical Data: "Additional clinical performance data was not required to support the modification of the device." This implies that existing data for the predicate and the "minor modification" were deemed sufficient to maintain equivalence in safety and effectiveness.
"Study" Proving Acceptance: The "study" in this context is the design verification testing and risk assessment conducted by the manufacturer, which concluded that the changes (mainly branding and slight component-level modifications described in the Device Description) did not alter the fundamental safety or effectiveness profile of the device compared to the predicate. No new clinical trials or performance studies, as would be expected for a novel AI/ML device or a more significant device change, were conducted or required for this particular submission.

Summary

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K121532

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

JUN 2 2 2012

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 HeRO® Graft
Manufacturer:	Hemosphere, Inc.6545 City West ParkwayEden Prairie, MN 55344

Contact:

Laurie E. Lynch, Ph.D. Director QA/RA/R&D

Date Prepared:

May 11, 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 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.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 history or 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

Substantial Equivalence Comparison:

The predicate device is the GRAFTcath, Inc. HeRO Vascular Access Device, K071778, K091491 and K120006. 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.

Summary of Non-Clinical & Clinical Performance Data:

No changes were made to the previously cleared packaging verification and sterilization validation. Additional clinical performance data was not required to support the modification of the device.

1 Vascular Access Work Group. National Kidney Foundation KDOQI clinical practice quidelines 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 KDOQI clinical practice quidelines for hemodialysis adequacy, update 2006. Am J Kidney Dis 2006:48(Suppl 1):S2-S90.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three swooping lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.

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

Hemosphere, Inc. c/o Laurie E. Lynch, Ph.D. Director, QA/RA/R&D 6545 City West Parkway Eden Prairie, MN 55344

JUN 2 2 2012

Re: K121532

Trade/Device Name: HeRO® Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY Dated: May 23, 2012 Received: May 24, 2012

Dear Dr. Lynch:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(k) prematic is substantially equivalent (for the indications
referenced above and have determined the device is substanterled in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed president Device, mendments. for use stated in the enclosure) to regary market of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Medical Device American Food. D commerce prior to May 28, 1976, the elacultien and of the Federal Food. Drug, devices that have been reclassified in accordance was assessmoval application (PMA).
and Cosmetic Act (Act) that do not require approval assuresisions of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls provisions of the Act. The Act. The You may, therefore, market the device, subject of the general or annual registration, listing of
general controls provisions of the Act include requirements for annual regist general controls provisions of the Accurations against misbranding and devices, good manufacturing practice, rademig, and promonone related to contract liability.
adulteration. Please note: CDRH doesh or evaluate information related to adulteration. Please note: CDKFI does not evaluate international
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
and be If your device is classified (see and on into cince of (spinss affecting your device can be
may be subject to additional controls. Existing major regulations affecting your may be subject to additional controls. Exismig major regarators and man and more of the may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In additio found in the Code of Federal Regulations, This Beyone in the Federal Register.
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
ts of the Active that the start of the complies with other requirements of the Please be advised that FDA's issuance of a substance of the requirements of the Act
that FDA has made a determination that your device complies with of the Act that FDA has made a determination una your areas by other Federal agencies. You must
or any Federal statutes and regulations administered by other Federal on and listin or any Federal statutes and regulations and limited to: registration and listing (21
comply with all the Act's requirements, including, but not limited to registration of med comply with all the Act's requirements, micruding, out not minted on region
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Laurie E. Lynch, Ph.D.

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 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/Resourcesfor You/Industry/default.htm.

Sincerely youns.

Sincerely yours,

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: K121532

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 history or 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 KDOQ! clinical practice guidelines for vascular access. Guideline 1: patient preparation for permanent hemodialysis access. Am J Kidney Dis 2006;48(1Suppl1):S188-91. 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.

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)

(Divi
Division cardioprcular Devices
510(k) Number K121532

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.”