(77 days)
in the accurate placement of central aid ﺍﻟﻤ catheters using the RAECG technique Venous
The Adapter is designed to aid in the accurate placement of central venous catheters using the RAECG technique.
The provided text describes a 510(k) submission (K973371) for the Certodyn® RAECG Universal Adapter. This submission focuses on establishing substantial equivalence to a predicate device (Arrow-Johans ECG Adaptor, K843263), rather than presenting a detailed study with specific acceptance criteria and performance metrics of the new device itself.
Therefore, many of the requested details about a study and its results, such as sample sizes, expert qualifications, and specific performance metrics, are not present in this document.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Testing as defined by Quality Control Test Procedure documents, conforming to product design specifications. | The device "must meet all required release specifications before distribution." This includes "physical testing, visual examination (in process and finished product)." The text states that "These tests are established testing procedures and parameters which conform to the product design specifications." |
| Material Suitability | "Composed of materials that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product." |
| Substantial Equivalence in materials, form, and intended use to the predicate device (Arrow-Johans ECG Adaptor, K843263). | "The Certodyn® RAECG Universal Adapter is equivalent in materials, form, and intended use to our the Arrow-Johans ECG Adaptor currently marketed under K843263 by Arrow International, Inc." |
| No New Issues of Safety or Effectiveness raised compared to the predicate device. | "There are no new issues of safety or effectiveness raised by the Certodyn® RAECG Universal Adapter." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the document. The submission focuses on substantial equivalence based on manufacturing controls and material suitability rather than a clinical or performance study with a test set of data.
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 present in the document. This type of information would typically be found in a study demonstrating clinical performance, which is not the primary focus of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the document.
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
There is no indication of an MRMC comparative effectiveness study being done. The device is a physical adapter, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical adapter and does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established safety and performance of the predicate device (Arrow-Johans ECG Adaptor), combined with internal Quality Control Test Procedure documents for physical and visual examination, and Tripartite Guidance for Plastics for material suitability.
8. The sample size for the training set
This information is not present in the document. As this is not an AI/algorithm-based device, a "training set" in that sense would not be applicable. The "training" for the device's design and manufacturing relies on established engineering principles and regulatory guidelines.
9. How the ground truth for the training set was established
The "ground truth" for the device's design and manufacturing (analogous to a training set for an algorithm) was established through:
- Conformance to the predicate device: The new device's design and materials were based on demonstrating equivalence to the Arrow-Johans ECG Adaptor, which was already legally marketed.
- Established Quality Control Test Procedures: Internal B. Braun Medical, Inc. documents define the testing procedures and parameters that conform to product design specifications.
- Tripartite Guidance for Plastics: This guidance was used to determine the suitability of materials.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).