(322 days)
Disposable tracheal tube is intended for oral or nasal intubation and for airway management.
The tracheal tubes are disposable and are supplied sterile. The tracheal tubes are available in a number of sizes/variants. All variants are primarily made from polyvinyl chloride. The tracheal tube without cuff is composed of a tubular body and a standard connector, and the cuffed tube is composed of tubular body, cuff, oneway valve, pilot balloon, inflating tube and standard connector. All variants have a Murphy eye. As the device functions in airway management/gas transport for anesthesia or resuscitation, it is required to be flexible and resistant to kinking. All variants have a radio-opaque line embedded into the tube which enables identification the device when the patient is X-rayed.
This document is a 510(k) Premarket Notification Submission for a Disposable Tracheal Tube. It outlines the device's indications for use, comparison to predicate devices, and performance data to support its substantial equivalence. The document is a regulatory submission filing and not a study report. Therefore, much of the requested information, such as sample sizes for test sets, data provenance, expert qualifications for ground truth, and details about clinical or comparative effectiveness studies, is either not applicable or not provided in the scope of this regulatory submission.
Here's a breakdown of the information that can be extracted and how it relates to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Testing Results) |
|---|---|
| Material Properties: | |
| Biocompatibility (ISO 10993-1, FDA Blue Book Memo #G95-1) | Met requirements for: |
| - Cytotoxicity | - Cytotoxicity (Passed) |
| - Sensitization | - Sensitization (Passed) |
| - Irritation | - Irritation (Passed) |
| Functional/Performance: | |
| Essential performance and safety requirements (ISO 5361:2012) | Met requirements of ISO 5361:2012 |
| Continuous wave resistance of the shaft (ISO 11990-1:2011) | Met requirements of ISO 11990-1:2011 |
| Kinking resistance (Shore hardness 88A) | Designed with Shore hardness 88A (Ensures effective intubation) |
| Radio-opacity (identification via X-ray) | Embedded radio-opaque line |
| Disposable and sterile | Supplied sterile |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only states that "testing results demonstrate that the proposed devices meet the requirements of the standards listed above" for performance and biocompatibility. This refers to laboratory testing, not a clinical test set with human subjects for performance evaluation.
- Data Provenance: The device manufacturer, Suzhou Weikang Medical Apparatus Co., Ltd., is located in China. The testing would have been conducted by or for this manufacturer, likely in China or by accredited labs. The document does not specify the country of origin of the raw test data but implicitly it originates from the manufacturer's testing efforts. The testing is for premarket notification, implying developmental/verification testing, not necessarily a "retrospective or prospective" study in the clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a medical device like a tracheal tube, "ground truth" is established by adherence to recognized international standards and bench testing protocols as specified (e.g., ISO 5361, ISO 11990-1, ISO 10993). There isn't a "ground truth" established by experts in the context of diagnostic accuracy, but rather by objective physical and biological tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic devices where human interpretation is involved and consensus is needed for a "ground truth" label. For physical device performance and biocompatibility testing, the results are objectively measured against predefined standard 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. This device is a disposable tracheal tube, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is entirely irrelevant to this product.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As stated above, this is not an AI algorithm but a physical medical device. No standalone algorithm performance was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Performance Standards and Biocompatibility Test Results: For this device, the "ground truth" is defined by the requirements outlined in international standards (ISO 5361:2012, ISO 11990-1:2011) for physical performance, and the results of specific biocompatibility tests (Cytotoxicity, Sensitization, Irritation) conducted according to ISO 10993-1. These are objective, measurable criteria, not subjective expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- Not Applicable. This 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:
- Not Applicable. As no training set is relevant for this device, no ground truth needed to be established for it.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).