(14 days)
The Proximal Seal System is intended for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.
The Proximal Seal System is designed to create a hemostatic environment at the site of a proximal anastomosis during coronary artery bypass graft surgery, eliminating the need for a side-biter or cross clamp of the aorta and minimizing aortic manipulation. When used in conjunction with off-pump cardiac surgery the Proximal Seal System alleviates the need for any form of clamping. Additionally, the Proximal Seal System eliminates the need for clamping with the side-biter clamp during on-pump cardiac surgery.
This device, the Guidant Proximal Seal System, is a Class II medical device intended for use in Coronary Artery Bypass Graft (CABG) procedures. It is a vascular clamp designed to maintain hemostasis and facilitate proximal anastomosis without the need for an aortic clamp.
The provided information does not contain acceptance criteria in a quantitative or formal sense, typical of studies for AI/software devices. This is a traditional medical device (hardware) submission from 2002.
Instead, the submission states that the device was evaluated through bench testing and animal testing to demonstrate performance and substantial equivalence to predicate devices.
Here's an analysis of the provided text, outlining the available information and highlighting what is not applicable or not provided for this type of device submission based on your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided text in a quantitative manner (e.g., specific thresholds for success, pressure limits, or a specific range of values). | "All bench testing results met specified requirements." (without detailing what those requirements were). |
| Functionality confirmed. | |
| Biocompatibility confirmed. | |
| Sterilization confirmed. | |
| Packaging confirmed. |
Note: For a traditional hardware medical device like this in 2002, "acceptance criteria" were often implicit in design specifications and testing protocols (e.g., "device must not leak under X pressure," "material must be biocompatible per ISO XYZ"). The summary provided does not break down these specific pass/fail metrics.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided summary. The summary mentions "bench testing" and "animal testing," but no specific number of units tested or animals used is given.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given it's animal testing, it would be prospective within a controlled laboratory environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable / Not Provided: This device submission does not involve human expert interpretation for "ground truth" in the way an AI/software device submission would. The performance was likely assessed by engineers, lab technicians, and possibly veterinary professionals during animal studies.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided: Adjudication methods (like 2+1, 3+1) are typically used when subjective human interpretation is involved in establishing ground truth for performance evaluation (e.g., in diagnostic imaging studies). This traditional device's performance relies on objective measurements and observations in bench and animal testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No: An MRMC comparative effectiveness study is not mentioned and would not be applicable for this type of hardware device. MRMC studies are used to evaluate human reader performance, often with and without AI assistance, especially in medical imaging.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- No: This is a hardware medical device, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this submission.
7. The Type of Ground Truth Used
- Not Directly Applicable in the AI Sense: For this hardware device, "ground truth" would be established through:
- Objective Measurements: Bench testing would have involved quantifiable metrics like burst pressure, flow rates, material strength, leakage rates, etc., compared against predefined specifications.
- Biological Observation: Animal testing would have involved surgical observation of successful hemostasis, patency, tissue response, and lack of adverse events.
- Biocompatibility Testing: Compliance with established biocompatibility standards.
8. The Sample Size for the Training Set
- Not Applicable: This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set, this question is not relevant.
Summary of Device Features and Evaluation:
- Intended Use: To create a hemostatic environment at the site of a proximal anastomosis during CABG, eliminating the need for an aortic clamp.
- Predicate Devices: Baladi Inverter (K980128) and Novare Enclose anastomotic assist devices.
- Evaluation Approach: Bench testing (functionality, biocompatibility, sterilization, packaging) and animal testing.
- Conclusion: "All bench testing results met specified requirements." and the device was found to be "substantially equivalent to the predicate devices with regard to intended use, indications, device characteristics, method of use, labeling, and safety features."
§ 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).