(29 days)
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
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.
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).
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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.
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"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.
§ 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.”