(34 days)
InterVascular InterGard Knitted Vascular Graft Sizer is an accessory to the InterGard Knitted Vascular Prosthesis and is designed to assist the physician in determining the size of the lumen of the host vessel in order to select the appropriate knitted vascular graft diameter.
The InterVascular Graft Sizer, an accessory to the InterGard Knitted Vascular Prosthesis, consists of a set of 5 disposable dual gauge sizers and 1 disposable single gauge sizer constructed of a biocompatible material. The size indicated on the instrument approximately corresponds to the size of the lumen of the host vessel. The labeled sizes of the instrument are 6, 7, 8, 10, 12, 14, 16, 18, 20, 22, and 24mm. The surgeon makes the ultimate decision on the size of the graft.
The provided text describes a 510(k) submission for the InterVascular InterGard Knitted Vascular Graft Sizer. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing comprehensive de novo clinical studies with acceptance criteria, human reader studies, or detailed ground truth establishment as would be common for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria and detailed study design is not applicable or explicitly stated in the provided documents.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Non-hemolytic, non-cytotoxic. Material meets USP XXIII Class VI-50 requirements, compatible with blood, and demonstrates no cytotoxic, mutagenic, or irritant potential. |
| Intended Use | Designed to assist the physician in determining the size of the lumen of the host vessel to select the appropriate knitted vascular graft diameter. (Performance is not quantified beyond this statement of intention) |
| Material/Function | Constructed of a biocompatible material; consists of a set of 5 disposable dual gauge sizers and 1 disposable single gauge sizer. The size indicated on the instrument approximately corresponds to the size of the lumen of the host vessel. |
| Substantial Equivalence | Demonstrated to be substantially equivalent in intended use, composition, and function to the predicate device (Meadox Graft Sizer, K854431). |
Study that proves the device meets the acceptance criteria:
The primary "study" described is the demonstration of biocompatibility and substantial equivalence to a predicate device.
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Biocompatibility Testing: Performed on the finished products and the material itself. This testing demonstrated the device is non-hemolytic and non-cytotoxic, and that the material meets the requirements of U.S. Pharmacopeia (USP) XXIII Class VI-50.
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Substantial Equivalence Argument: The manufacturer, InterVascular, asserted that their device is substantially equivalent to the Meadox Graft Sizer (K854431) based on intended use, composition, and function. The FDA's 510(k) clearance (K022242) signifies their agreement with this determination. This means the FDA found that the new device is as safe and effective as the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not detailed in the provided text. For a simple medical device like a sizer, a formal "test set" in the context of clinical performance or data-driven AI/ML validation is generally not required for 510(k) clearance. The focus is on material safety and functional similarity to the predicate. Biocompatibility testing typically involves laboratory tests on samples of the device materials.
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 information is not applicable/provided. The concept of "ground truth" established by experts for a test set is not relevant for this type of device and 510(k) submission. The device's function is a physical measurement aid, not an diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are not relevant for the type of testing described (biocompatibility and substantial equivalence for a physical sizing device).
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
This information is not applicable/provided. The InterVascular InterGard Knitted Vascular Graft Sizer is a physical medical device, not an AI/ML algorithm. Therefore, MRMC studies examining human reader improvement with AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is a physical sizer, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically discussed for diagnostic devices or AI algorithms is not directly applicable to this device.
- For biocompatibility, the "ground truth" would be established by standardized laboratory assays and their metrics (e.g., cell viability, hemolytic index) measured against established thresholds from standards like USP XXIII Class VI-50.
- For sizing accuracy, while not explicitly detailed as "ground truth" in the text, the device states "The size indicated on the instrument approximately corresponds to the size of the lumen of the host vessel." The ultimate "ground truth" for selecting the correct graft size is presented as the surgeon's clinical judgment.
8. The sample size for the training set
This information is not applicable/provided. The device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. As above, 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.”