(142 days)
The device is intended for oral or nasal intubation and for airway management.
The tracheal tubes are made from medical grade PVC, with a connector and valve. The tracheal tubes may be cuffed or uncuffed and are for oral or nasal use.
The provided text is a 510(k) summary for an Endotracheal Tube, seeking clearance from the FDA. It does not describe specific acceptance criteria and a study proving the device meets those criteria in the way a medical device performance study typically would. Instead, it relies on substantial equivalence to predicate devices.
However, I can extract the information that is present and highlight what is missing based on your request.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by ISO Standard and Predicate Equivalence) | Reported Device Performance |
|---|---|
| Dimension (conformance with ISO 5361:1999(E)) | Conformed |
| Design (conformance with ISO 5361:1999(E)) | Conformed |
| Material (medical grade PVC, conformance with ISO 5361:1999(E)) | Conformed |
| Sterility (conformance with ISO 5361:1999(E)) | Conformed |
| Packaging (conformance with ISO 5361:1999(E)) | Conformed |
| General Purpose (oral or nasal intubation, airway management) | Met by Intended Use |
| Substantial Equivalence to specified predicate devices | Claimed |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a "test set" in the context of a formal performance study with a specific number of devices tested. The submission relies on conformance to an ISO standard and comparison to predicate devices, inferring that the design and manufacturing process meet these criteria. It doesn't detail a specific test sample size for an investigative study.
- Data Provenance: N/A for a specific test set. The submission itself is from China (Well Lead Medical Instruments Ltd, Guangzhou City, China). The basis for comparison is market-cleared predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This device clearance is based on substantial equivalence to predicate devices and conformance to an international standard (ISO 5361:1999(E)), not on a clinical or performance study requiring expert ground truth establishment for a test set. The FDA's review and clearance process involves their own experts, but not in the context of establishing ground truth for a specific device efficacy or diagnostic accuracy study.
4. Adjudication method for the test set
- N/A. No specific test set requiring adjudication in this context.
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
- N/A. This is a physical medical device (endotracheal tube), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- N/A. Not applicable for this type of device clearance. Instead of ground truth, the submission relies on:
8. The sample size for the training set
- N/A. Not applicable. There is no AI training set for this physical device.
9. How the ground truth for the training set was established
- N/A. Not applicable. There is no AI training set for this physical device.
Summary based on the provided text:
The clearance for the Well Lead Endotracheal Tube (K042683) was based on demonstrating substantial equivalence to predicate devices and conformance to the ISO 5361:1999(E) standard for dimensions, design, material, sterility, and packaging. This is typical for Class II physical medical devices where a new clinical performance study is not required if the device is sufficiently similar to existing devices on the market. The text does not describe a clinical study with specific acceptance criteria, test sets, or ground truth establishment as would be expected for a novel diagnostic or therapeutic device requiring de novo authorization or a PMA.
§ 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).