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510(k) Data Aggregation
(57 days)
The Cardeon Cobra Catheter is indicated for use in open chest surgery on cardiopulmonary bypass up to 6 hours. It is used to provide separated perfusion of the arch and distal thoracic aorta with temperature differential, if desired.
The Cobra Catheter is an externally communicating device in limited contact with circulating blood.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cobra™ Catheter, structured according to your request:
Acceptance Criteria and Device Performance
The provided 510(k) summary focuses heavily on demonstrating substantial equivalence to predicate devices rather than clearly defined numerical acceptance criteria for the Cobra™ Catheter itself. The text implies that the acceptance criteria are met if the device demonstrates:
- Biological compatibility, non-toxicity, and safety for limited contact (up to 6 hours) with circulating blood.
- Structural integrity.
- Key device functionality.
- Ease of use.
- Adequate venous oxygen saturation delivery.
- Preservation of cerebral autoregulation (implied by differential temperatures).
However, no specific quantitative thresholds or numerical targets are provided for these criteria. The "reported device performance" is descriptive and comparative.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility, non-toxicity, safety for blood contact (up to 6 hours) | "Based on the test results, the Cobra Catheter is biologically compatible, non-toxic and safe for use in limited contact (up to 6 hours) with circulating blood." (Results from "standardized in vitro and in vivo tests" and "Good Laboratory Practice Regulation, 21 CFR Part 58" compliance). |
| Structural integrity | "In vitro and in vivo testing was designed to ensure device structural integrity..." (Implied positive outcome, no specific performance metric given). |
| Key device functionality | "In vitro and in vivo testing... [designed to ensure] key device functionality..." "Test results provided a high degree of confidence that the Cobra Catheter function as intended." (Implied positive outcome, no specific performance metric given). Compared directly to currently marketed devices for these aspects. |
| Ease of use | "In vitro and in vivo testing... [designed to ensure]... ease of use." (Implied positive outcome, no specific performance metric given). |
| Adequate venous oxygen saturation delivery | "Feasibility and randomized clinical studies demonstrated that adequate venous oxygen saturation was delivered..." (No specific saturation percentage or range provided, but reported as "adequate"). |
| Preservation of cerebral autoregulation | "... with differential temperatures indicating the preservation of cerebral autoregulation." (Implied through the presence and effectiveness of differential temperatures, but no specific physiological parameter or threshold for autoregulation is provided. This is a functional claim tied to the device's ability to provide differential perfusion for hypothermic arch perfusate). |
| Substantial Equivalence to Predicate Devices | "The Cobra Catheter is substantially equivalent to currently marketed devices... Substantial equivalence is also supported through comparison with several marketed devices with the same indications for use... Technological characteristics (design and materials) of the Cobra Catheter are substantially equivalent to arterial return devices currently marketed for CPB." "Thus, the Cobra Catheter is substantially equivalent to predicate arterial return devices with regard to intended use, technological characteristics and device performance." |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document mentions "clinical studies" including "Feasibility and randomized clinical studies" and "und case" (likely a typo for "one case" or "study case"). However, no specific numerical sample sizes are provided for these clinical studies.
- Data Provenance: The document does not explicitly state the country of origin. Given the applicant is Cardeon Corporation in Cupertino, CA, and the FDA is the reviewer, it's highly probable the studies were conducted in the United States. The studies were prospective as they were conducted to demonstrate the safety and effectiveness of a new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided in the document. The studies are described in terms of "clinical studies" and "standard surgical techniques," implying a clinical setting, but details on expert involvement for ground truth establishment are absent.
4. Adjudication Method:
- This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done as described. This device is a medical catheter, not an imaging or diagnostic AI device that typically involves human readers interpreting data. The comparison is between the new device's performance and predicate devices, or between the device and standard clinical practices/outcomes, rather than comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
- No, a standalone AI algorithm performance study was not done. The Cobra™ Catheter is a physical medical device, not an AI algorithm. Its performance is evaluated through in vitro, in vivo, and clinical studies of its physical function and clinical impact, not through an algorithm's output.
7. Type of Ground Truth Used:
- For the in vitro and in vivo tests, the ground truth was likely established through direct measurement against engineering specifications and biological response assessments (e.g., cell viability, clotting, inflammation).
- For the clinical studies, the ground truth was based on clinical outcomes and physiological measurements such as "adequate venous oxygen saturation" and "differential temperatures indicating the preservation of cerebral autoregulation." This constitutes outcomes data and physiological markers monitored during surgical procedures.
8. Sample Size for the Training Set:
- This information is not applicable/not provided because the Cobra™ Catheter is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable/not provided as there is no AI training set involved for this physical device.
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