(217 days)
The ByPass CorLink™ Anastomotic Device is intended to create vascular anastomoses between blood vessels. Specifically, the device is indicated for creation of a sutureless proximal anastomosis between a venous graft conduit and the aorta for coronary artery bypass grafting (CABG) procedures.
The ByPass CorLinkTM Automated Anastomotic Device (CorLinkTMAAD) intended use is to create the proximal graft-aorta anastomosis during a CABG procedure.
The CorLinkTM AAD, delivered with an introducer kit, is a single use system. The implant is made of self-expanding nitinol and composed of two main elements: the self-expandable center area and the flexible pins at both ends.
The center is made of connected elliptic arches, which upon implant expansion exert a radial force on the everted vein end and the aortic wall. The flexible pins from both ends of the device fold and "bite" the aortic wall in a way that connects and compresses the grafted vessel against the aorta. This procedure stabilizes the implant at the desired location and creates a sealing surface around the anastomosis.
This document describes a 510(k) premarket notification for the ByPass CorLink™ Automated Anastomotic Device (AAD). The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and detailed study results for the device itself. Therefore, many of the requested details about acceptance criteria, specific performance metrics, and study design are not explicitly available in the provided text.
Based on the available information, here's what can be extracted and what remains unknown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated/Implied) | Reported Device Performance as per Submission |
|---|---|
| Biocompatibility | All materials commonly used in medical applications or proven biocompatible through testing. |
| Safety & Effectiveness | Demonstrated through bench and animal testing. |
| Substantial Equivalence to Predicate Devices (USSC One-Shot Sutureless System, USSC Auto Suture Vascular Anastomosis Clip, Deknatel Gwathmey Vascular Stapling Kit) | Performance demonstrated as substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document states "Bench and animal testing" but does not provide numbers for either.
- Data Provenance: Not specified. The submission is from ByPass Ltd. in Herzelia, Israel, but the location of the animal testing and bench testing is not mentioned. The document does not specify if the data is retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: No, this is not an AI-assisted device and therefore an MRMC study is not applicable. The device is a physical medical implant/instrument for surgical procedures.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm. Bench testing and animal testing were performed, which can be considered "standalone" in the sense of evaluating the device's physical performance independently, but not in the context of an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the "bench and animal testing" to demonstrate safety and effectiveness, the ground truth would likely involve:
- Bench Testing: Engineering measurements, force testing, leak testing, material properties analysis, etc.
- Animal Testing: Surgical outcomes, histopathology of anastomotic sites, patency rates, observation of adverse events, etc.
- The document does not detail specific metrics or the "ground truth" definition for the equivalence to predicate devices, beyond demonstrating comparable safety and effectiveness.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device. The concept of a "training set" as understood in AI is not relevant here.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable (see point 8).
Summary of what is known and unknown:
- Known: The device is the ByPass CorLink™ Automated Anastomotic Device (AAD) for creating sutureless proximal anastomoses in CABG procedures. It's an implantable clip. Bench and animal testing were conducted to demonstrate biocompatibility, safety, effectiveness, and substantial equivalence to three predicate devices (USSC One-Shot Sutureless System, USSC Auto Suture Vascular Anastomosis Clip, and Deknatel Gwathmey Vascular Stapling Kit).
- Unknown: Specific numerical acceptance criteria, detailed results from bench and animal testing (e.g., number of animals, specific outcomes measured, statistical results), sample sizes for testing, exact methodologies for establishing safety/effectiveness beyond the general statement, and any information regarding expert involvement in ground truth determination.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.