(14 days)
The ENclose™ II Anastomosis Assist Device is intended for use by cardiac surgeons in place of partial occluding clamps during coronary artery bypass grafting (CABG) procedures requiring one to three proximal anastomoses in ascending aortas free of atheromatous disease.
The modified ENclose™ II Anastomosis Assist Device is an intraoperative device used to assist in the creation of one to three proximal anastomosis sites in the execution of coronary artery bypass grafting (CABG) procedures. Materials for the new device are identical to the previous device with the exception of the colorant. The proposed changes are limited to manufacturing/processing changes, a change in the colorant used in the existing plastic of the device, a change in the shape of the expandable region of the lower jaw and the addition of a fiber reinforced polymer hex driver to assist with deployment of the device if desired.
This document is a 510(k) Premarket Notification for the ENclose™ II Anastomosis Assist Device, seeking clearance based on substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.
The document describes a medical device (a vascular clamp) and its physical characteristics, intended use, and comparison to predicate devices, but it does not detail any performance studies in the way one would for an AI/ML device. This submission focuses on demonstrating substantial equivalence to existing devices through feature comparison and material certification, not through clinical performance metrics against specific acceptance criteria.
Specifically, the document does not provide:
- A table of acceptance criteria and the reported device performance for an AI/ML model.
- Sample size used for the test set or data provenance for an AI/ML model.
- Number of experts and their qualifications for establishing ground truth for an AI/ML test set.
- Adjudication method for an AI/ML test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study information (human readers improving with AI vs. without AI).
- Standalone (algorithm-only) performance data for an AI/ML model.
- Type of ground truth used (e.g., pathology, outcomes data) for an AI/ML model.
- Sample size for the training set for an AI/ML model.
- How ground truth for the training set was established for an AI/ML model.
Because the ENclose™ II Anastomosis Assist Device is a physical surgical instrument and not an AI/ML diagnostic or therapeutic device, the information requested is not applicable to this submission. The "substantially equivalent" claims are based on physical design, materials, manufacturing, intended use, and functional testing, not data-driven performance metrics typical for AI/ML products.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).