(72 days)
The HeRO™ Vascular Access Device is intended for use in maintaining long-term hemodialysis access in patients who have exhausted peripheral vascular access sites suitable for fistulas or grafts.
The HeRO™ Vascular Access Device is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheterdependent patients are readily identified using the K/DOQI 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.
- 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. K/DOQI guidelines recommend a minimum Kt/V of 1.4.
The HeRO™ Vascular Access Device is a non-autogenous (i.e., synthetic) vascular access device composed of three components: HeRO™ Arterial Graft Component, HeRO™ Venous Outflow Component and HeRO™ Accessory Kit (a convenience kit). The HeRO™ Venous Outflow Component is made of radiopaque silicone reinforced with braided filaments that impart kink and crush resistance. During surgery, the barbs of the connector on the Outflow Component is sized to fit the patient by cutting it to the proper length and sliding it over the band in the patient. The HeRO™ Arterial Graft Component is a conventional ePTFE hemodialysis graft that has been attached to a titanium connector. The HeRO™ Vascular Access Component Kit (a convenience kit) contains tools that assist in the implantation of the HeRO™ Vascular Access Device.
The provided text is a 510(k) summary for the HeRO™ Vascular Access Device. It describes the device, its intended use, and indications for use, and states that it has been found substantially equivalent to a predicate device. However, it does not contain the detailed information necessary to complete the requested table and study description.
Specifically, the document states:
"Results of design verification and validation demonstrated that the HeRO™ Vascular Access Device met its acceptance criteria." and "Additional clinical performance data was not required to support the modification of the device."
This indicates that the submission relies on design verification and validation, likely non-clinical (bench testing, biocompatibility, sterilization, and packaging verification), rather than a clinical study with human subjects, to demonstrate the device meets acceptance criteria.
Therefore, many sections of your request cannot be fulfilled based on the provided text, as the detailed acceptance criteria and a study proving those criteria were met by clinical performance data are not present.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: Not explicitly stated in terms of specific metrics against acceptance criteria. The document only generally states, "demonstrated that the HeRO™ Vascular Access Device met its acceptance criteria."
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document with metrics) |
|---|---|
| e.g., Biocompatibility as per ISO 10993 | e.g., Passed all cytotoxicity, sensitization, and irritation tests. |
| e.g., Sterilization Assurance Level (SAL) of 10^-6 | e.g., Achieved SAL of 10^-6 following validation. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as no clinical test set/study is described to support the modification for this 510(k). The document specifically states, "Additional clinical performance data was not required to support the modification of the device."
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)
- Not applicable as no clinical test set/study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no clinical test set/study 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
- No MRMC study was done. This is a vascular access device, not an AI-assisted diagnostic tool. No AI is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device, not an algorithm, and no AI is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable as no clinical test set/study is described. The "ground truth" for design verification would be established through engineering specifications, material standards, and validated testing protocols.
8. The sample size for the training set
- Not applicable as no clinical study or AI algorithm is described. "Training set" is not relevant here in the context of device approval for this 510(k).
9. How the ground truth for the training set was established
- Not applicable as no clinical study or AI algorithm is described.
§ 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.”