(253 days)
The Aortic root cannulae are intended for use in adult and pediatric patients to cannulate the aortic root for cardioplegic solution delivery into the coronary arteries and for venting of the heart during cardiopulmonary bypass surgery for periods of up to six hours
The R501-R502 Aortic Root Cannula (hereinafter referred to as R501-R502 cannulae) are aortic root cannulae intended to be used to cannulate the aortic root, to vent and to deliver cardioplegic solution during heat bypass operations. The device is available in two styles: with a vent line ( R502) and without a vent line ( R501). Both models consist of a flexible Polyvinylchloride (PVC) tubing body, a PVC flanged tip and luer connector. The introducer is made of stainless steel with a PVC obturator. The vent line model have an additional feature constituted by a vent line provided as integral part of the device . This attribute makes it possible to vent and also introduce cardioplegic solutions using the same device. These cannulae are available in a range of sizes as per table below:
| Model | Tip size (internal diameter) | Product designation |
|---|---|---|
| R501 (aortic root | ||
| without vent line) | 1.5 mm | R501-15 |
| 2.0 mm | R501-20 | |
| 2.6 mm | R501-26 | |
| R502 (aortic root | ||
| with vent line) | 1.5 mm | R502-15 |
| 2.0 mm | R502-20 | |
| 2.6 mm | R502-26 | |
| The R501-R502 cannulae are a modified version of the currently marketed R501-R502 Aortic Root cannulae (K861310). |
This document is a 510(k) premarket notification for a medical device (aortic root cannula). It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this type of submission.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria for a newly developed device's performance, as its primary purpose is to show equivalence to an existing device. The performance is implied by its equivalence to the predicate device and the successful completion of non-clinical testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as acceptance criteria for performance metrics of a new device. The goal is "substantial equivalence" to a predicate. | "The R501-R502 Cannulae complies with all the applicable voluntary standards related to cardiopulmonary bypass arterial cannulae. The device passed all the testing in accordance with national and international standards." |
| "The non-clinical testing summarized in this submission supports the substantial equivalence of the subject device with the predicate device when used according to its intended use." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. No clinical test set was used to evaluate performance against acceptance criteria. The submission relies on non-clinical testing and equivalence to a predicate device.
- Data Provenance: Not applicable for a clinical test set. Non-clinical testing was conducted by SORIN GROUP ITALIA S.R.L. (Italy).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical test set requiring expert-established ground truth was performed for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set was performed.
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
Not applicable. This is a submission for a physical medical device (aortic root cannula), not an AI/software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical validation requiring ground truth was performed. The "ground truth" for the submission is the safety and efficacy track record of the predicate device.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).