(235 days)
The Research Medical Dual Drainage Venous Return Cannulae is indicated for venous cannulation so that extracorporeal circulation of venous blood to a heart-lung machine may be achieved for a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations.
The Research Medical Duraflo Heparin Treated Dual Drainage Venous Return Cannulae is indicated for venous cannulation so that extracorporeal circulation of venous blood to a heart-lung machine may be achieved for a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.
The Research Medical Venous Return Cannulae are intended for cannula drainage superior and inferior vena cavae during extracorporeal circulation for a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in single cannula return of the right atrium.
The Research Medical Duraflo Heparin Treated Venous Return Cannulae are intended for cannula drainage superior and inferior vena cavae during extracorporeal circulation for a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in single cannula return of the right atrium. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.
The Research Medical FEM-FLEX Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician for a duration ≤ 6 hours. Femoral Cannulae in sizes 6 Fr. to 14 Fr. can be used in pediatric patient populations.
The Research Medical Duraflo Heparin Treated FEM-FLEX Femoral Access Cannulae are intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician for a duration ≤ 6 hours. Femoral Cannulae in sizes 6 Fr. to 14 Fr. can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.
The ERMI Pediatric Venous Return Cannulae are used to access the vena cavae or femoral vein during cardiopulmonary bypass.
This 510(k) submission describes the Edwards Lifesciences Research Medical Inc. Pediatric Venous Return Cannulae. It refers to a comparative analysis and functional/safety testing, but does not provide specific acceptance criteria or detailed study results in the provided text.
Here's a breakdown of the information that can be extracted and a clear indication of what is not present in the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided text. The document mentions "Functional/Safety Testing" was successfully undergone, but no specific performance metrics or their acceptance thresholds are listed. | The device "successfully undergone functional and biocompatibility testing." No specific numerical performance results are provided. |
Missing Information: The document does not explicitly state the acceptance criteria (e.g., minimum flow rates, pressure resistance, biocompatibility standards, etc.) or detailed numerical performance data for functional and safety testing.
2. Sample size 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 mentioned.
- Data Provenance: Not mentioned.
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)
This section is not applicable as the device is a medical cannulae, not an AI/diagnostic imaging device that requires expert-established ground truth for its performance evaluation (e.g., in terms of accuracy, sensitivity, specificity). The testing would involve engineering and biocompatibility evaluations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a medical device of this type. Adjudication methods are typically relevant for complex diagnostic interpretations or clinical endpoints where inter-rater variability might be a factor.
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 device is a physical medical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for a device like this would be established through engineering specifications, material standards, and validated testing methodologies to ensure it meets its intended functional and safety requirements.
8. The sample size for the training set
Not applicable. There is no training set involved for this type of medical device as it is not an AI/machine learning product.
9. How the ground truth for the training set was established
Not applicable. There is no training set involved.
Summary of what the document does provide regarding the study:
- Study Title/Description: "Functional/Safety Testing" and "Biocompatibility Testing."
- Conclusion of Testing: The ERMI Pediatric Venous Return Cannulae "have successfully undergone functional and biocompatibility testing."
- Comparative Analysis: The primary "study" in this context is a comparative analysis against predicate devices. The document states: "The only difference between the subject catheters and the predicate Research Medical catheters is the subject catheters are smaller in diameter and length. Aside from the smaller sizes, there is no difference between the ERMI Pediatric Venous Return Cannulae and the predicate devices." This implies that the performance of the new device is expected to be similar to the predicate devices due to their fundamental similarity, with the primary change being size.
- Substantial Equivalence: Based on the comparative analysis and the successful functional/biocompatibility testing, the conclusion is that the ERMI Pediatric Venous Return Cannulae are "substantially equivalent to the predicate devices."
In essence, the provided document focuses on demonstrating substantial equivalence to predicate devices through a comparative analysis and successful completion of standard functional and biocompatibility testing, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics typically found for novel diagnostic or therapeutic devices.
§ 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).