(88 days)
The Stöckert Coronary Perfusion Cannulae are intended to be used to cannulate the coronary ostium and to deliver cardioplegic solution during cardiopulmonary surgery for periods of up to six hours.
The Stöckert Coronary Perfusion Cannulae are comprised of either a flexible plastic (PVC) or a malleable stainless steel body, with a soft silicone tip and either a ¼" barbed tubing connector or a luer lock. They are offered in various tip outer diameters ranging from 3.0 to 5.0 mm (9 to 15 Fr). The P605, P607, P615, and P617 Series Stöckert Coronary Perfusion Cannulae are 26 cm long. The P606, P616, and P618 Series Stöckert Coronary Perfusion Cannulae are 14 cm long.
The provided text describes a 510(k) pre-market notification for the Stöckert Coronary Perfusion Cannulae. This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria via a comprehensive study with defined endpoints.
Therefore, many of the requested elements for a study proving acceptance criteria are unfortunately not applicable or not explicitly detailed in the provided document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific quantitative acceptance criteria with corresponding performance metrics for the Stöckert Coronary Perfusion Cannulae. Instead, it relies on demonstrating equivalence to a predicate device.
| Acceptance Criteria (Not explicitly stated as such, but inferred from equivalency claim) | Reported Device Performance (Inferred from equivalency claim) |
|---|---|
| Intended Use Equivalence: To be used to cannulate the coronary ostium and deliver cardioplegic solution during cardiopulmonary surgery for periods of up to six hours. | The Stöckert Coronary Perfusion Cannulae are intended for the same use as the predicate Medtronic DLP Coronary Ostial Perfusion Cannulae. |
| Design Feature Equivalence: Similar design characteristics. | Comprised of flexible plastic (PVC) or malleable stainless steel body, soft silicone tip, and either a ¼" barbed tubing connector or a luer lock. Offered in various tip outer diameters (3.0 to 5.0 mm / 9 to 15 Fr) and lengths (14 cm or 26 cm). These features are stated to be equivalent to the predicate. |
| Performance Characteristic Equivalence: Similar performance in handling and function. | "In-vitro performance and biocompatibility tests demonstrate substantial equivalency." (Specific test results are not provided). |
| Biocompatibility Equivalence: Safe for contact with the body. | "In-vitro performance and biocompatibility tests demonstrate substantial equivalency." (Specific test results are not provided). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "In-vitro performance and biocompatibility tests," but does not provide details on the number of samples tested or the methodology.
- Data Provenance: The tests were "in-vitro," meaning conducted in a lab setting rather than on human or animal subjects. The country of origin for the data is not explicitly stated, but the submitting company (Stöckert Instrumente GmbH) is based in Munich, Germany, so it is reasonable to infer the testing was likely conducted in Germany or by a contract lab on their behalf. The data is retrospective in the sense that the testing was completed before the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For a 510(k) submission based on substantial equivalence and "in-vitro" testing, ground truth is established through adherence to recognized testing standards and comparison to the predicate device's characteristics, not through expert consensus on a test set in the way one might for an AI image analysis device.
4. Adjudication Method for the Test Set
Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, this type of study was not done. MRMC studies are typically used to evaluate the diagnostic accuracy of AI algorithms and their impact on human reader performance, which is not relevant for this medical device (a coronary perfusion cannula).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth or basis for the claims of substantial equivalence are:
- Predicate Device Comparison: The Stöckert Coronary Perfusion Cannulae were compared to the Medtronic DLP Coronary Ostial Perfusion Cannulae in terms of intended use, design features, and performance characteristics.
- In-vitro Testing: Biocompatibility and performance tests were conducted in a laboratory setting. The outcomes of these tests, demonstrating equivalent performance, serve as the "ground truth" for the claim of substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI algorithm.
Summary regarding this specific submission:
This 510(k) notification for the Stöckert Coronary Perfusion Cannulae primarily relies on demonstrating substantial equivalence to an existing predicate device (Medtronic DLP Coronary Ostial Perfusion Cannulae). The "study" mentioned consists of "In-vitro performance and biocompatibility tests," which are generally standard engineering and biological safety tests for medical devices. The details of these tests, including specific methodologies, raw data, acceptance criteria for those tests, and sample sizes, are not provided in the summary document but would have been part of the full 510(k) submission reviewed by the FDA. The FDA determined that, based on these tests and the comparison to the predicate, the device was substantially equivalent and could be marketed.
§ 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).