(69 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.e. 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.
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.
The provided text describes the HeRO® Graft, a vascular graft prosthesis, and its 510(k) clearance (K124039). The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (design verification testing). There is no information provided regarding a study conducted to prove the device meets specific acceptance criteria based on clinical outcomes or a comparison against a defined performance target. Instead, the submission states that "Additional clinical performance data was not required to support the modification of the device." and relies on "design verification testing" and comparison to a predicate device.
Therefore, many of the requested elements for a study proving acceptance criteria cannot be answered directly from the provided text.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document provides a table of "Test Parameter" and "Results" which essentially act as acceptance criteria and their successful fulfillment.
| Test Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Component Integrity - Proper assembly | None of the graft connections that used strain reliefs had the coil portion of the strain relief under the clamshells. | 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. | None of the graft connections showed any damage or delamination. |
| Connection Kink Radius | Meet the kink radius test specification. | All of the grafts met the kink radius test specification with the highest kink value and the greatest HTL value. |
| Connection Leakage | No leakage. | None of the connections tested leaked. |
| Connection Water Entry Pressure (WEP) | Successfully characterized for WEP. | All graft connections were successfully characterized for WEP. |
| Connector Attachment strength | Passing tensile strength. | All of the graft connections had passing tensile strength. |
| Strain Relief Bond Strength | Successfully characterized for bond strength. | All strain reliefs were successfully characterized for bond strength. |
| Corrosion Resistance | No signs of corrosion. | None of the devices showed any signs of corrosion on any of the components. |
| Nitinol Coil Strain Relief Af | Acceptable levels. | All nitinol strain reliefs had acceptable levels. |
| Nitinol Spring Af | Acceptable levels. | All nitinol springs had acceptable levels. |
| MR Compatibility | MR Conditional. | MR Conditional. |
| Component Integrity- Proper use of strain relief | The strain relief was used on all grafts requiring the strain relief. | The strain relief was used on all grafts requiring the strain relief. |
| Human Factors/ Usability engineering (Ease of connection) | Rated "PASS" by doctors. | All doctors rated the ease of making the connection "PASS". |
| Human Factors/ Usability engineering (Adequacy of labeling) | Rated "PASS" by doctors. | All doctors rated the adequacy of the labeling "PASS". |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "design verification testing." However, it does not specify the sample sizes used for each of the non-clinical tests. For example, it says "None of the connections tested leaked," but not how many connections were tested. It also does not mention data provenance (country of origin) as these are non-clinical, in-vitro tests, nor does it specify if any clinical data was retrospective or prospective (as "additional clinical performance data was not required").
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)
For the "Human Factors/ Usability engineering" tests, it states "All doctors rated..." However, the number of doctors (experts) is not specified, nor are their specific qualifications (e.g., years of experience, specialty). For the other non-clinical tests, the "ground truth" would be established by engineering standards and measurements, not medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
There is no mention of an adjudication method for any of the tests. For the human factors portion, it simply states "All doctors rated," implying either unanimous agreement or that individual ratings were sufficient without a formal adjudication process.
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 MRMC comparative effectiveness study was done as this device is a vascular graft prosthesis, not an imaging AI diagnostic device. The application is for a physical medical device, not a software or AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical vascular graft, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance data, the "ground truth" is based on engineering specifications, standardized test methods, and direct physical measurements of the device's components and connections. For the "Human Factors/Usability engineering" tests, the ground truth is based on subjective ratings by "doctors."
8. The sample size for the training set
This device is a physical product, not an algorithm that requires a training set. Therefore, this question is not applicable.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this type of device.
§ 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.”