(229 days)
The Sarns Aortic Arch Cannulae with Duraflo Treatment, Flexible Arterial Cannulae with Duraflo Treatment, High Flow Aortic Arch Cannulae with Duraflo Treatment, Soft Arc Cannula with Duraflo Treatment, D4 Cannulae with Duraflo Treatment, and the Soft Flow Cannulae with Duraflo Treatment are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
The Sarns Flexible Aortic Arch Cannula with Duraflo Treatment is indicated for use in perfusion of the descending thoracic aorta during cardiopulmonary bypass surgery.
The only difference between the Sams Arterial Cannulae and the Sarns Arterial Cannulae with Duraflo® Treatment is the addition of the Duraflo® Treatment. As a result of this process, a layer of heparin is deposited on the inside and outside of the cannula tip, tube, and connector. Like their predicate devices, the Sarns Arterial Cannulae with Duraflo® Treatment are sterile, single-use medical devices. They are available in sizes ranging from 3.8 mm to 8.0 mm outer diameter tip sizes, with tips being straight or angled, soft or rigid, metal or plastic. Several styles of the Sarns Arterial Cannulae are available in both wire-reinforced and non-wire-reinforced tube styles. Other features include an optional suture flange on some models as well as an optional Luer port for the venting of air.
The provided document is a 510(k) summary for Sarns Arterial Cannulae with Duraflo® Treatment. This document focuses on demonstrating substantial equivalence to predicate devices based on nonclinical performance testing, rather than presenting acceptance criteria and a study demonstrating device performance against those criteria in a typical clinical trial context.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not applicable or cannot be extracted from this type of regulatory submission. The submission explicitly states "Clinical testing was not performed on these devices."
However, I can extract information related to the nonclinical performance testing and the conclusion drawn.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with quantitative targets and reported performance values. Instead, it states that the performance characteristics were "exhaustively tested and compared with the performance characteristics of the currently marketed Sarns Arterial Cannulae." The acceptance criterion, implicitly, is that the Duraflo® treated cannulae should perform comparably to, and not worse than, the predicate devices in all relevant performance characteristics.
| Performance Characteristic | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Overall Performance | Comparable to currently marketed Sarns Arterial Cannulae | "The Sarns Arterial Cannulae with Duraflo® Treatment perform as intended according to their performance specifications. The Sarns Arterial Cannulae with Duraflo® Treatment are substantially equivalent to their predicate devices." "All new and existing performance characteristics of the Sarns Arterial Cannulae with Duraflo® Treatment have been validated." |
| Dimensions | No dimensional changes from predicate devices | "There will be no dimensional changes to the cannulae due to the addition of the Duraflo® Treatment." |
| Sterility | Sterile, single-use, as with predicate devices | "Like their predicate devices, the Sarns Arterial Cannulae with Duraflo® Treatment are sterile, single-use medical devices." |
| Coating Application | Heparin layer deposited on inside and outside of cannula | "As a result of this process, a layer of heparin is deposited on the inside and outside of the cannula tip, tube, and connector." |
| Biocompatibility | Not explicitly stated, but implied by substantial equivalence. | Given the addition of heparin, biocompatibility would have been a key test, although not detailed here. The conclusion of substantial equivalence implies these tests were satisfactory. |
| Flow Characteristics | Comparable to predicate devices | Implied by "performance characteristics... were exhaustively tested and compared" and the conclusion of performing "as intended." |
2. Sample size used for the test set and the data provenance
- Sample Size: The document mentions "selected models were chosen as being representative of the technological attributes of all models of Sarns Arterial Cannulae." However, it does not specify the exact number, type, or quantity of devices used in this "exhaustively tested" set.
- Data Provenance: The data is from nonclinical performance testing conducted by the manufacturer, 3M Health Care. There is no information on country of origin of the data as these are laboratory tests. It is by nature prospective as it evaluates the finished device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is Not Applicable (N/A). Ground truth established by experts is typically relevant for clinical studies, especially those involving image interpretation or diagnostic accuracy. This submission is for a medical device (cannulae) and relies on nonclinical (laboratory) performance testing rather than expert-derived ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is Not Applicable (N/A) for nonclinical performance testing. Adjudication methods are used to resolve disagreements among human readers/experts in clinical studies.
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
This is Not Applicable (N/A). This document is not about an AI device or a diagnostic device involving human readers. It's about a physical medical device (cannulae) for cardiopulmonary bypass.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This is Not Applicable (N/A). This device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on engineering and performance specifications for medical devices and the established performance of the predicate devices. The goal was to prove that the Duraflo® treated cannulae meet their own specifications and perform equivalently to the existing, legally marketed predicate devices.
8. The sample size for the training set
This is Not Applicable (N/A). There is no "training set" as this is not an algorithm or AI being developed through machine learning.
9. How the ground truth for the training set was established
This is Not Applicable (N/A). As there is no training set, this question is not relevant.
§ 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).