(69 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical properties of a vascular graft, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a non-autogenous vascular graft prosthesis used to maintain vascular access for hemodialysis, not a device that directly performs a therapeutic function.
No
Explanation: The HeRO Graft is a non-autogenous vascular graft prosthesis intended for maintaining long-term vascular access for chronic hemodialysis patients. It is an implantable medical device used for treatment, not for diagnosing a condition.
No
The device description clearly states that the HeRO Graft is a physical vascular graft prosthesis composed of three components: Arterial Graft Component, Venous Outflow Component, and Accessory Component Kit. These are physical, implantable components, not software.
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for maintaining long-term vascular access for hemodialysis patients. This is a surgical implant used in vivo (within the body) to facilitate a medical procedure (hemodialysis).
- Device Description: The description details a synthetic vascular graft prosthesis composed of physical components (graft, connector, accessory kit). It does not describe a device used to examine specimens derived from the human body in vitro (outside the body).
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The HeRO Graft is a medical device, specifically a vascular prosthesis, used for surgical implantation.
N/A
Intended Use / Indications for 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.
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 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.
Product codes
DSY, LJS, MSD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Venography, ultrasound
Anatomical Site
Central venous system, upper extremity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, hemodialysis patients
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Performance Data:
- Component Integrity - Proper assembly: 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.
- Connection Kink Radius: All of the grafts met the kink radius test specification with the highest kink value and the greatest HTL value. PASS for kink radius.
- 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 the components.
- 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 of strain relief: The strain relief was used on all grafts requiring the strain relief.
- Human Factors/ Usability engineering: All doctors rated the ease of making the connection "PASS". 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K071778, K091491, K120006, K121532
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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; Class |
| II; DSY, LJS, MSD, Cardiology | |
| Predicate Device: | K071778, K091491 HeRO™ Vascular Access Device |
| K120006, K121532 HeRO® Graft | |
| Manufacturer: | Hemosphere, a CryoLife, Inc. Company |
| 1655 Roberts Blvd. NW | |
| Kennesaw, GA 30144 | |
| Contact: | David M. Fronk |
| VP, RA/QA | |
| Date Prepared: | November 20, 2012 |
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.
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.
1
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.
2
Summary of Non-Clinical Performance Data:
.
·
| Test Parameter | Results |
|---|---|
| Component Integrity - Proper | |
| assembly | 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. | |
| Connection Kink Radius | All of the grafts met the kink radius test specification with the |
| highest 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 the |
| components. | |
| 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 of | |
| strain relief | The strain relief was used on all grafts requiring the strain relief. |
.
3
| Component Integrity- Proper
assembly | 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. |
| 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/ Usability
engineering | All doctors rated the ease of making the connection "PASS". |
| Human Factors/ Usability
engineering | 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
4
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
5
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
6
INDICATIONS FOR USE STATEMENT
Current 510(k) Number: K124039
Device Name:
HeRO® Graft
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 guidelines1 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
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'.