(65 days)
The Pediatric Arterial Cannula is used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedure.
The Polystan pediatric arterial cannula is single-use, disposable, sterile and non-pyrogenic device. The cannula has a tapered wire reinforced PVC body with an open beveled distal tip. Three depth indicator marks are positioned at approximately 2 cm intervals from the distal tip. A stylet is incorporated to assist cannulation. The proximal cannula end terminates with either a " /16" or ¼" capped connector incorporating a female luer fitting. The cannulae range in size from 6 Fr. to12 Fr.
This K023251 submission is for a medical device (Pediatric Arterial Cannula), not an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria like sample sizes for test/training sets, ground truth establishment methods, expert qualifications, adjudication methods, and MRMC studies are not applicable.
However, I can provide information based on the device's summary of safety and effectiveness as a medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | In accordance with USP 23, USP 24, and ISO 10993 | Biocompatibility testing performed and demonstrated substantial equivalence to predicate device. |
| Performance | Equivalent to predicate device (Jostra Pediatric Arterial Cannula) | Performance testing (blood pressure drop vs. flow rate, blood cell damage, integrity) performed and demonstrated substantial equivalence to predicate device. |
| - Blood Pressure Drop vs. Flow Rate | Implicitly, comparable to predicate device performance | Testing performed; result supported substantial equivalence. |
| - Blood Cell Damage | Implicitly, comparable to predicate device performance | Testing performed; result supported substantial equivalence. |
| - Integrity Test | Implicitly, comparable to predicate device performance | Testing performed; result supported substantial equivalence. |
| Intended Use | To introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedure. | Device is designed and tested for this intended use, demonstrating equivalence to predicate device. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated in the provided summary. The summary mentions "testing," but details on the number of units tested for each performance criterion are not provided.
- Data Provenance: Not explicitly stated. Given that it's a submission from a Danish company (POLYSTAN A/S), the testing would likely have been conducted in their facilities or contracted labs, adhering to international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable to a medical device like a cannula. "Ground truth" in this context typically refers to an expert-validated diagnosis or finding, which is relevant for diagnostic AI algorithms. For a physical device, performance is measured against established scientific and engineering standards and specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for subjective interpretations of data, often in the context of diagnostic assessments. Device performance testing relies on objective measurements and comparison to predefined acceptance criteria.
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 for evaluating diagnostic accuracy, particularly for image-based diagnostics with human readers, and the impact of AI assistance on those readers. This device is a physical cannula, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This question pertains to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the AI/ML sense. For this device, the "ground truth" (or basis for evaluation) is established by:
- Adherence to recognized biocompatibility standards (USP 23, USP 24, ISO 10993).
- Comparative performance data against a legally marketed predicate device (Jostra Pediatric Arterial Cannula - K012617), implying that the predicate's established safety and performance serve as the benchmark.
8. The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
Not applicable. This device does not involve a "training set" in the context of AI/ML.
§ 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).