(30 days)
Not Found
No
The device description and intended use focus on a physical vascular graft prosthesis and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "vascular graft prosthesis" intended for "maintaining long-term vascular access for chronic hemodialysis patients" and is indicated for "end stage renal disease patients on hemodialysis." These are medical interventions designed to treat a disease condition, fitting the definition of a therapeutic device.
No
The provided text describes the HeRO® Graft as a device intended for maintaining long-term vascular access in hemodialysis patients, a therapeutic and restorative function. It does not mention any capabilities for diagnosing medical conditions or diseases.
No
The device description clearly states it is a physical vascular graft prosthesis composed of three hardware components: an arterial graft component, a venous outflow component, and an accessory component kit.
Based on the provided text, the HeRO® Graft is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for maintaining long-term vascular access for hemodialysis patients. This is a therapeutic and access-related function, not a diagnostic one.
- Device Description: The description details a synthetic vascular graft prosthesis designed for implantation. This is a medical device used within the body, not a reagent, instrument, or system used to examine specimens derived from the human body for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. The HeRO® Graft's function is to provide a physical pathway for hemodialysis, which is a treatment, not a diagnostic process.
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 quidelines1 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
Product codes
DSY, LJS, MSD
Device Description
The HeRO® Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis composed of three components: HeRO® Arterial Graft Component, HeRO® Venous Outflow Component and HeRO® Accessory Component Kit. The HeRO® Venous Outflow Component is made of radiopaque silicone and contains reinforcing braided filaments that impart kink and crush resistance. During surgery, the 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 graft component. The HeRO® Arterial Graft Component is a conventional ePTFE hemodialysis graft that has been attached to a titanium connector. The HeRO® Accessory Component Kit (a convenience kit) contains tools that assist in the implantation of the HeRO® Graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Packaging verification and sterilization have been conducted and all testing demonstrated that the HeRO® Graft met its acceptance criteria. 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
FEB - 2 2012
510(k) Summary (per 21 CFR 807.87(h))
| 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 |
| Manufacturer: | Hemosphere, Inc. |
| 6545 City West Parkway | |
| Eden Prairie, MN 55344 | |
| Contact: | Laurie E. Lynch, Ph.D. |
| Director QA/RA/R&D |
December 30, 2011 Date Prepared:
Device Description:
The HeRO® Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis composed of three components: HeRO® Arterial Graft Component, HeRO® Venous Outflow Component and HeRO® Accessory Component Kit. The HeRO® Venous Outflow Component is made of radiopaque silicone and contains reinforcing braided filaments that impart kink and crush resistance. During surgery, the 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 graft component. The HeRO® Arterial Graft Component is a conventional ePTFE hemodialysis graft that has been attached to a titanium connector. The HeRO® Accessory Component Kit (a convenience kit) contains tools 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 readily identified using the KDOQI quidelines1 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 and K091491. The company name has been changed from GRAFTcath to Hemosphere, Inc.
Results of design verification and validation 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 and validation testing presented in this submission, confirm that the HeRO® Graff, 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:
Packaging verification and sterilization have been conducted and all testing demonstrated that the HeRO® Graft met its acceptance criteria. Additional clinical performance data was not required to support the modification of the device.
l 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.
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is centered horizontally in the image. The font is a simple serif font, and the text is black on a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
FEB - 2 2012
Hemosphere, Inc. c/o Laurie E. Lynch, Ph.D. 6545 City West Parkway Eden Prairie, MN 55344
Re: K120006
Trade/Device Name: HeRO® (Hemodialysis Reliable Qutflow) Graft (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 30, 2011 Received: January 3. 2012
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. 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.
3
Page 2 - Laurie E. Lynch, Ph.D.
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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 10.11 in the quiation 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/CDRH/CDRHOffices/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 Tou may 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 yours,
M. G. Killelea
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
120006 Current 510(k) Number: _
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 KDOQ! 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.
- t 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 KIV) via cathefers. KDOQI guidelines recommend a minimum Kt/V of 1.4.2
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.
2Hemodialysis 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)
M.A. Hillebrand
vascular Devices
510(k) Number K120006