(76 days)
The ENclose™ 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 anastomoses in ascending aortas free of atheromatous disease.
The modified ENclose™ Anastomosis Assist Device is a intraoperative device used to assist in the creation of one or more proximal anastomosis sites in the execution of coronary artery bypass grafting (CABG).
The provided text describes a 510(k) premarket notification for the ENclose™ Anastomosis Assist Device, seeking to expand its indications for use from single-vessel to one-to-three proximal anastomoses during coronary artery bypass grafting (CABG) procedures. The submission claims substantial equivalence to its previously cleared version (InCluder™ Vascular Clamp - K010694).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly tied to demonstrating "functional equivalence" and "substantial equivalence" to the predicate device for the expanded use. The performance is reported in a summary statement rather than specific quantitative metrics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device for single anastomosis | "The new anastomosis device is identical to the previous device. Equivalency can be seen with respect to place of manufacture, physical appearance, functional testing, material certification, surgical technique and indications for use." (Initial claim for the single anastomosis device in comparison to K010694) |
| Functional equivalence for 1-3 proximal anastomoses | "Clinical testing conducted in Canada and Europe demonstrate the functional equivalence of the added ENclose™ Anastomosis Assist Device." |
| Safety for 1-3 proximal anastomoses | "The collected clinical data demonstrate that one to three proximal anastomoses are no more difficult and are just as safe as the existing single anastomosis procedure performed using the previously cleared ENCLOSE™ Anastomosis Assist Device." |
| No increase in difficulty for 1-3 proximal anastomoses | "The collected clinical data demonstrate that one to three proximal anastomoses are no more difficult..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text does not provide a specific sample size for the clinical testing. It only states "Clinical testing conducted in Canada and Europe."
- Data Provenance: The data was collected from "Canada and Europe." It explicitly states "Clinical testing," implying prospective collection, though the precise study design (e.g., randomized controlled trial, observational) is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications for establishing ground truth within the clinical testing. It refers to "cardiac surgeons" as the intended users, but doesn't detail their role in defining study outcomes or ground truth.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device is a surgical clamp, not an imaging interpretation device where MRMC studies are typically performed. The comparison is between the new device's performance for 1-3 anastomoses and the predicate device's performance for single anastomosis, based on overall reported safety and difficulty.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The ENclose™ Anastomosis Assist Device is a surgical instrument, not an algorithm or AI system. Its performance is directly tied to its use by a human surgeon.
7. The Type of Ground Truth Used
The "ground truth" for the clinical testing appears to be based on observed clinical outcomes (safety, difficulty) during coronary artery bypass grafting procedures performed using the device for 1-3 anastomoses, compared to the previously established performance of the predicate device for single anastomosis. There is no mention of "expert consensus," "pathology," or other specific types of ground truth often seen in diagnostic device studies.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical surgical instrument, not a machine learning model that requires a training set. The development of the device would involve engineering and material testing, not data training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for a device of this nature.
§ 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).