(349 days)
The EMBOL-X Aortic Occlusion and Cardioplegia Cannula is intended for use during cardiopulmonary bypass (CPB) procedures to: (1) occlude the ascending aorta, (2) deliver cardioplegia solution, and (3) vent the aortic root.
The EMBOL-X Aortic Occlusion and Cardioplegia Cannula consists of a twolumen cannula with three lines and an elastomeric balloon mounted on a 14 French tip. The first cannula lumen is used to inflate the balloon. The inflated balloon occludes the ascending aorta, partitioning the aortic root from the remainder of the arterial circulation. The balloon is expandable to occlude a range of aortic diameters. A two-way stopcock maintains the inflation and deflation of the balloon. The second cannula lumen is attached to two separate lines. The first line is used to deliver antegrade cardioplegia solution, and the second line is used for venting the aortic root. A sliding flange, located at the base of the cannula hub, adjusts to accommodate for varying aortic diameters and assists in anchoring the device during use.
The provided text describes the EMBOL-X Aortic Occlusion and Cardioplegia Cannula, its intended use, and the studies conducted to demonstrate substantial equivalence to predicate devices, rather than a study against a pre-defined set of acceptance criteria with quantified performance metrics.
However, I can extract the information related to the device's performance demonstration and present it in a structured way to answer your request as closely as possible, interpreting "acceptance criteria" as the performance requirements that need to be met for clinical use and "reported device performance" as the outcomes of the performance studies.
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit numerical acceptance criteria were not provided in the document, I will infer them from the stated "performance requirements for the intended clinical use" and the results from the studies.
| Acceptance Criteria (Inferred from intended use) | Reported Device Performance |
|---|---|
| I. Functional Performance: The device must effectively occlude the ascending aorta. | "Animal testing results demonstrated that the device occludes the ascending aorta." "Proper balloon occlusion is confirmed, then balloon volume is maintained by re-turning the stopcock to the 'closed' position." "If excessive bleedback is observed, the balloon volume is increased 1 cc at a time up to, but not exceeding, the maximum recommended balloon volume until complete occlusion is achieved." |
| The device must effectively deliver cardioplegia solution. | "Animal testing results demonstrated that the device... delivers cardioplegia to arrest the heart." "After occlusion is achieved, cardioplegia solution delivery is initiated." |
| The device must effectively vent the aortic root. | "The second cannula lumen is attached to two separate lines... the second line is used for venting the aortic root." |
| The device must maintain balloon inflation/occlusion. | "A two-way stopcock maintains the inflation and deflation of the balloon." |
| The device must be able to adjust to varying aortic diameters. | "The balloon is expandable to occlude a range of aortic diameters." "A sliding flange, located at the base of the cannula hub, adjusts to accommodate for varying aortic diameters." |
| II. Biocompatibility: The materials used must be biocompatible. | "Biocompatibility testing demonstrated that the materials used to fabricate the EMBOL-X Device are biocompatible and meet the requirements of FDA's guidance document, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (1995)." |
| III. Safety: The device must not be thrombogenic. | "Animal testing results demonstrated that the device... is not thrombogenic." |
| The device must not result in depletion of cellular components. | "Animal testing results demonstrated that the device... does not result in depletion of cellular components." |
| The device must not damage the vessel wall. | "Animal testing results demonstrated that the device... does not damage the vessel wall." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a numerical sample size. The document mentions "Animal testing results," implying a cohort of animals but no specific number is given.
- Data Provenance: Prospective (animal testing). The country of origin is not specified, but the submission is to the US FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This information is not provided in the given text. The evaluations seem to be based on direct physiological observation and laboratory analysis within the animal study rather than expert interpretation of images or other subjective data.
4. Adjudication Method for the Test Set
- This information is not provided as the nature of the "test set" is an animal study with direct measurements and observations, not a study requiring adjudication of expert opinions.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The document describes performance, biocompatibility, and animal testing to demonstrate substantial equivalence, not a study comparing human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is a cardioplegia cannula, not an AI algorithm. Its performance is entirely mechanical/physiological in interaction with the human body.
7. Type of Ground Truth Used
- The "ground truth" for the animal study appears to be direct physiological observations and measurements during surgery, such as:
- Visual confirmation of aortic occlusion.
- Arrest of the heart due to cardioplegia delivery.
- Laboratory analysis for thrombogenicity and cellular component depletion.
- Histological examination for vessel wall damage.
8. Sample Size for the Training Set
- This question is not applicable as the device is a medical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as the device is a medical device, not an AI algorithm requiring a training set.
§ 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).