(3 days)
The X-coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures.
The X-coated TenderFlow™ Pediatric Venous Return Cannula is indicated for use in dual cannulation of the superior and inferior vena cava and single cannulation of the right atrium during cardiopulmonary bypass surgery.
These devices are indicated for up to 6 hours of use.
The X-coated pediatric venous return cannulae discussed in this submission are used in open heart surgery. During open heart surgery blood is drained into a venous cannula just upstream of the heart, at the superior / inferior vena cava and right atrium. The cannula is connected to tubing that routes the blood to a heart / lung machine where the blood is pumped and oxygenated. The blood then continues through this perfusion circuit back to the outlet side of the heart (the patient's aorta), where the blood re-enters the patient's circulatory system via the ascending aorta through an arterial cannulae. Platelets adhesion is reduced while blood travels through this circulatory path on the surface covered with X-coat polymer.
The design of cannulae and catheters is such that they meet their stated intended use, and provide an acceptable level of performance and safety to the patients. Except for the X-coat application, the design and material of the X-coated cannulae will remain the same as the unmodified cannulae. The X-coat application does not affect the cannulae design.
Venous cannulae contained in this submission are structured as straight, or slightly curved, flexible tubes which are inserted into the heart to circulate blood. Depending on the location of cannulation, size, and clinicians' preference, there is a range of design variations. These features include, but are not limited, wire reinforcement, various stylets used to help guide the cannula, tip formation (conical vs. angled), number of drainage baskets (two stage), luers, and connectors.
The generic materials for these cannulae will remain the same.
The provided text describes a 510(k) summary for the X-coated TenderFlow™ Pediatric Venous Return Cannula, which is a modification of an existing device. The bulk of the submission focuses on demonstrating substantial equivalence to the predicate device, rather than presenting a performance study with acceptance criteria in the traditional sense for a new diagnostic or AI-driven device.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The submission does not present a table of acceptance criteria with specific quantitative thresholds or a direct comparison to reported performance for the modified device in a diagnostic context. Instead, it focuses on demonstrating equivalence to the predicate device for several engineering and biocompatibility characteristics. The "performance evaluations" are to show that the modified device performs the same as the unmodified device.
| Performance Evaluation Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Hemolysis | Remaining the same as unmodified cannulae | The performance of the X-coated Cannulae will remain the same as the unmodified cannulae. |
| Bond Strength (Leak testing) | Remaining the same as unmodified cannulae | The performance of the X-coated Cannulae will remain the same as the unmodified cannulae. |
| Bond Strength (Pull strength testing) | Remaining the same as unmodified cannulae | The performance of the X-coated Cannulae will remain the same as the unmodified cannulae. |
| Bond Strength (Flex testing) | Remaining the same as unmodified cannulae | The performance of the X-coated Cannulae will remain the same as the unmodified cannulae. |
| Accelerated aging / Shelf life test | Stability of materials over expiry | Material characterization studies demonstrated stability of materials over the expiry of the product. |
| Biocompatibility | Meeting ISO 10993 guidelines | Blood contacting materials were found to be biocompatible as per FDA General Program Memorandum #G95-1 (5/1/95) and ISO 10993. |
| Sterilization | SAL of 10-6 | Validated in accordance with AAMI guidelines to provide an SAL of 10-6. |
| Residue Limits | Adherence to EN ISO 10993-7 and AAMI TIR-19 | Post-sterilization release determined in consideration of maximum Ethylene Oxide, Ethylene Chlorohydrin and Ethylene Glycol residue limits. |
The primary claim for the X-coat application is that it reduces platelet adhesion. This is mentioned as its specific benefit, but no quantitative performance metric or acceptance criteria for this reduction are provided in the excerpt. It states: "The X-coat application reduces the platelet adhesion." without further detail on how this was evaluated or what constituted a "reduced" adhesion for regulatory acceptance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of diagnostic or AI performance evaluation. The performance evaluations conducted are primarily engineering and biocompatibility tests on device samples. Therefore, information regarding sample size for a "test set," data provenance, or retrospective/prospective nature is not applicable here.
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 information is not applicable to this submission, as it is not a diagnostic device involving expert interpretation or ground truth establishment in a clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable.
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
No MRMC comparative effectiveness study was done, as this is a medical device (cannula) and not an AI-driven diagnostic tool intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an algorithm or AI device, so standalone performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" here is based on established engineering standards for device performance (e.g., bond strength, hemolysis, sterilization), material science (biocompatibility, material stability), and regulatory guidelines for chemical residues. It's not a clinical "ground truth" derived from patient outcomes or pathology.
8. The sample size for the training set
This is not an AI/algorithm-based device, so the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established
Not applicable.
§ 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).