(38 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 Terumo® Dual-Stage Venous Return Cannula is indicated for use for adult single tube blood drainage from the right atrium and inferior vena cava (IVC) and delivery of the blood to the extracorporeal circuit during cardiopulmonary bypass.
The X-coated Sarns™ Dual-Stage Venous Return Catheters are indicated for single tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery.
The Sarns ™ Malleable Venous Return Catheters are indicated for venous drainage during cardiopulmonary bypass surgery: the 24, 28, 30, 32, 34, 36 and 40 Fr. are for dual cannulation of the superior and inferior vena cava: the 40 Fr. is for single cannulation of the right atrium.
The X-coated Sarns™ Malleable Dual-Stage Venous Return Catheters are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery.
The X-coated Sarns™ High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
The X-coated Sarns™ Soft-Flow™ Extended Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
These devices are indicated for up to 6 hours of use.
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 and arterial 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 several X-coated cannulae. The submission focuses on demonstrating substantial equivalence to unmodified cannulae, not on new device performance claims requiring extensive clinical studies with specific acceptance criteria as might be seen for novel AI/ML devices.
Therefore, many of the requested categories (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable or not explicitly detailed in this type of submission for this particular device. The performance evaluations described are primarily engineering and biocompatibility tests to show that the addition of the X-coat does not negatively impact the existing performance or safety characteristics of the predicate devices.
However, I can extract the information that is present and indicate where the requested information is absent or not relevant to this type of submission.
Acceptance Criteria and Device Performance Study for K083301
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are implied by demonstrating that the X-coated devices maintain the same performance and safety profile as their uncoated predicate devices. The primary performance claim related to the X-coat itself is a reduction in platelet adhesion.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Cannulae Performance | The X-coat application does not affect the functional cannulae performance. (Implied: performance remains equivalent to unmodified cannulae). |
| Reduced Platelet Adhesion | The X-coat application reduces platelet adhesion. (This is the specific enhancement claimed for the X-coat). |
| Hemolysis Equivalence | Hemolysis was evaluated to demonstrate equivalence to the uncoated cannulae. (Implied: Hemolysis rates are equivalent or within acceptable limits compared to predicate). |
| Bond Strength Equivalence | Bond strength tests (leak, pull, flex testing) were conducted to demonstrate equivalence to the uncoated cannulae. (Implied: Bond strength remains equivalent to unmodified cannulae). |
| Accelerated Aging / Shelf Life Equivalence | Accelerated aging / Shelf life tests were conducted. Materials were found to be stable over the expiry of the product through material characterization studies (physio-chemical profiles of aged and non-aged devices). (Implied: Shelf life and material stability are equivalent to unmodified cannulae). |
| Sterility Assurance Level (SAL) | Sterilization conditions validated in accordance with AAMI guidelines to provide SAL of 10⁻⁶. (Meets industry standards for sterility). |
| Residue Limits (Ethylene Oxide, etc.) | Post-sterilization release determined in consideration of maximum residue limits in accordance with EN ISO 10993-7 and AAMI TIR-19. (Meets industry standards for biocompatibility-related residues). |
| Biocompatibility | Biocompatibility studies conducted using the same materials or combination of materials as predicate devices as recommended in FDA guidance (ISO 10993). Blood contacting materials found to be biocompatible for limited exposure (≤ 24 hours) with circulating blood. (Meets industry standards for biocompatibility for its intended use). |
| No New Issues of Safety and Effectiveness | "Any noted differences between the devices do not raise new issues of safety and effectiveness." (Overall conclusion of substantial equivalence based on all evaluations). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size:
- Not explicitly stated for the individual performance evaluations (hemolysis, bond strength, accelerated aging, biocompatibility). These are typically bench or lab tests, not clinical studies with "test sets" in the AI/ML sense.
- Data Provenance: Not specified. These are likely internal laboratory tests conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. This type of information (experts for ground truth) is not relevant for this device submission, which involves physical device performance (mechanical, chemical, biological) rather than interpretation of diagnostic data where expert consensus creates ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. As there's no diagnostic interpretation or subjective assessment by multiple readers, an adjudication method is not relevant.
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. MRMC studies are used for evaluating diagnostic devices, particularly those involving human interpretation, sometimes with AI assistance. This device is a surgical cannula, not a diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device does not involve an algorithm.
7. The Type of Ground Truth Used
- For functional performance (Hemolysis, Bond Strength, Accelerated Aging): Ground truth is established by standardized test methods and comparisons to the performance characteristics of the unmodified predicate devices.
- For reduced platelet adhesion: The "ground truth" for this claim would be based on specific in vitro or ex vivo blood compatibility tests designed to quantify platelet adhesion, compared to a control (e.g., the uncoated device). The specific methods and results are not detailed in this summary.
- For Sterility, Residue, Biocompatibility: Ground truth is established by adherence to recognized international standards (AAMI, ISO 10993, EN ISO 10993-7, AAMI TIR-19).
8. The Sample Size for the Training Set
- Not Applicable. This device does not use an AI model that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, there is no ground truth to establish for it.
§ 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).