Search Results
Found 1 results
510(k) Data Aggregation
(203 days)
Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye
The oral/nasal cuffless non-DEHP pediatric endotracheal tube with Murphy eye is indication of the trachea for airway management.
The subject device is an oral/hasal cuffless pediatric endotracheal tube with Murphy eye. The tube incorporates a Maqill curve, radiopaque line, and ISO 15mm connector. It is manufactured from materials without latex or DEHP.
This document describes the Mallinckrodt™ Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye, and its substantial equivalence to a predicate device. The information provided focuses on the device's design and non-clinical testing.
Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving it:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the subject device met all acceptance criteria for verification testing per ISO 5361:2012. However, it does not provide a detailed table outlining specific acceptance criteria values and the device's reported performance against each criterion from the ISO 5361:2012 standard. It only broadly states that the criteria were met.
For example, a typical table would look like:
| Acceptance Criteria (from ISO 5361:2012) | Required Performance | Reported Device Performance |
|---|---|---|
| (Specific physical dimension, e.g., connector size) | (e.g., 15mm +/- tolerance) | (e.g., 15.02mm) |
| (Specific mechanical property, e.g., tensile strength) | (e.g., > X MPa) | (e.g., Y MPa) |
| (Specific sterility requirement) | (e.g., Sterility Assurance Level of 10^-6) | (e.g., Passed SAL testing) |
| ... and so on for all relevant clauses of ISO 5361:2012 |
The document mentions several qualities the device shares with the predicate, which can be inferred as design or performance requirements, but not explicit acceptance criteria with numerical values:
- Cuffless
- Standard 15mm connector
- Magill curve
- Murphy eye
- Similar size range (2.0 - 7.0mm for subject device, 2.0 - 9.0mm for predicate)
- Similar material composition (Medical grade PVC with a non-DEHP plasticizer for subject, Medical grade PVC for predicate)
Biocompatibility Testing: The device met all biocompatibility requirements for its intended use, according to ISO 10993-1:2009.
DEHP Content: Solvent extraction testing confirmed DEHP is less than 0.1% w/w.
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to "verification testing per ISO 5361:2012" and "biocompatibility testing per ISO 10993-1:2009." However, it does not specify the sample size used for these tests.
The data provenance is not explicitly stated in terms of country of origin, but it is a regulatory submission to the US FDA, implying testing was conducted to meet US regulatory standards, likely by the manufacturer (Covidien). The studies are inherent to the product development and regulatory submission process, thus they would be prospective in nature for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided. The testing refers to adherence to international standards (ISO 5361:2012 for performance, ISO 10993-1:2009 for biocompatibility), which typically involve standardized laboratory measurements and analyses, not expert consensus on qualitative data in the way a medical image interpretation study might.
4. Adjudication Method for the Test Set:
This concept of adjudication (e.g., 2+1, 3+1) is not applicable to the type of engineering and biocompatibility testing described in the document. These tests rely on objective measurements and established protocols rather than subjective interpretations requiring multiple expert adjudicators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "N/A - Clinical evidence was not necessary to show substantial equivalence." This type of study would involve human readers (e.g., clinicians) evaluating cases, often with and without AI assistance, which is not relevant to a tracheal tube.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:
No. This device is a physical medical device (tracheal tube), not a software algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used:
The "ground truth" here is adherence to specified technical standards.
- For performance, the ground truth is defined by the requirements of ISO 5361:2012 (Anesthesiology and respiratory equipment - Tracheal tubes and connectors).
- For biocompatibility, the ground truth is defined by the requirements of ISO 10993-1:2009 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).
- For DEHP content, the ground truth is the chemical composition confirmed by solvent extraction testing, verifying it's less than 0.1% w/w.
These are engineering standards and chemical analyses, not pathology, outcomes data, or expert consensus in the typical sense of clinical trials.
8. The Sample Size for the Training Set:
This information is not applicable. The device is an endotracheal tube, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
Ask a specific question about this device
Page 1 of 1