(90 days)
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[1] 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]
The HeRO Graft is a non-autogenous (i.e., synthetic) vascular graft prosthesis which provides arterial venous access with continuous outflow into the central venous system. The HeRO Graft is composed of the following components: (1) Venous Outflow Component (VOC), (2) Arterial Graft Component (AGC) or HeRO Adapter with Support Seal (used in conjunction with commercial vascular grafts), and (3) Accessory Component Kit (ACK). The VOC consists of a radiopaque silicone base tube, a nitinol braid (imparts kink and crush resistance), a distal radiopaque marker band, and an outer silicone elastomer encapsulation layer. During surgery, the VOC is cut to length for the patient anatomy and then advanced over the barbs of the AGC Connector or HeRO Adapter. The AGC is a conventional ePTFE vascular graft attached to a custom titanium alloy connector. As an alternative to the AGC, the titanium alloy HeRO Adapter with Support Seal allow the clinician to choose one of the commercially available 6mm ID vascular grafts qualified for use with the HeRO Graft. The ACK (a convenience kit) contains instruments that aid in the implantation of the HeRO Graft including, introducers, dilators, delivery stylet, hemostasis valve with stopcock, vascular clamp and hemostasis plug.
The HeRO Graft is a fully subcutaneous surgical implant single-use
The provided text describes a 510(k) premarket notification for the Merit HeRO Graft, a vascular graft prosthesis. The document details the device's indications for use, comparison to a predicate device, and the performance data submitted to demonstrate substantial equivalence.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists various performance tests and states that the device "met the acceptance criteria applicable to the safety and efficacy of the device" for these tests. However, it does not explicitly state the quantitative acceptance criteria for each test. Instead, it broadly indicates conformity to recognized standards and guidance documents.
| Performance Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Requirements of ISO 10993-1 and FDA guidance for implant devices with tissue/circulating blood contact for permanent duration. | Met biocompatibility requirements. |
| Material Properties | (Not explicitly stated for each, but inferred from standards like ISO 7198) | Dimensions, Leakage, Tensile - Attachment Strength, Corrosion Resistance, Clamp Resistance, Kink Assessment, Pressurized Inner Diameter, Stiffness, Body Crush Resistance, V-Bend Flex Fatigue, Burst Resistance, Tip Recovery, Marker Band Retention, Radiopacity, Sheath Delivery/Pushability, VOC Connection to Adapter/Connector met acceptance criteria. |
| MRI Compatibility | Requirements of ASTM F756, F2052, F2503, F2119, F2182, F2213. | Met MRI compatibility requirements. |
| Sterilization | Requirements of ISO 11135. | (Implicitly met through conformity to standard) |
| Pyrogenicity | Requirements of United States Pharmacopeia, National Formulary 30, General Chapter , Pyrogen Test. | (Implicitly met through conformity to standard) |
Study that proves the device meets the acceptance criteria:
The study that proves the device meets the acceptance criteria is a series of performance tests conducted based on established FDA guidance documents and recognized performance standards. These standards include:
- FDA Guidance for Industry and FDA Staff: Guidance Document for Vascular Prostheses 510(k) Submissions, Nov 1, 2000
- FDA guidance document: Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process"
- FDA Guidance Document: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, Dec 11, 2014
- ISO 10555-1, Sterile, Single-Use Intravascular Catheters, Part 1: General Requirements
- ISO 7198, Cardiovascular implants and extracorporeal systems - Performance Vascular prostheses - Tubular vascular grafts and vascular Data patches.
- ISO 11135, Sterilization of health care products -Ethylene oxide - Requirements for the development, validation and routing control of a sterilization process for medical devices
- ISO 10993 series (Parts 1, 3, 4, 5, 6, 10, 11) for Biological Evaluation of Medical Devices
- ASTM F756, Standard Practice for Assessment of Hemolytic Properties of Materials
- ASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
- ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
- ASTM F2182 Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants during Magnetic Resonance Imaging
- ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- United States Pharmacopeia, National Formulary 30, General Chapter ``, Pyrogen Test.
The document states: "Conformity to these standards demonstrates that the proposed HeRO Graft meets the acceptance criteria established by the standards as they apply to device safety and efficacy."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists "Performance Data" and "Biocompatibility testing" as being provided. These are laboratory/benchtop test results, not clinical study data with human patients. Therefore, the concepts of "sample size for the test set," "country of origin of the data," and "retrospective or prospective" are not applicable in the context of this 510(k) submission for mechanical/material and biocompatibility testing. The data provenance is from laboratory tests conducted by the manufacturer, Merit Medical Systems, Inc.
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)
This question is not applicable. The "ground truth" for these types of engineering and biocompatibility tests is based on the specifications defined by the recognized international and national standards (e.g., ISO, ASTM, USP) and FDA guidance documents. There is no mention of human experts establishing ground truth for these specific tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies for human reader interpretation of medical images or outcomes. This section of the document describes laboratory performance testing, not human reader studies.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing and biocompatibility. The device is a physical vascular graft, not an AI or imaging diagnostic tool that would involve human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The device is a physical vascular graft, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests and biocompatibility evaluation is derived from the quantitative specifications and methodologies outlined in the referenced national and international standards (ISO, ASTM) and FDA guidance documents. For instance, a tensile strength test would have a specified minimum allowed force, or a leakage test would have a maximum allowed leakage rate. Biocompatibility relies on adherence to the testing requirements and acceptable response limits defined in the ISO 10993 series.
8. The sample size for the training set
This question is not applicable. There is no mention of a "training set" as this is not an artificial intelligence or machine learning device. The 510(k) describes a physical medical device.
9. How the ground truth for the training set was established
This question is not applicable, as there is no "training set."
§ 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.”