ENDOFLEX TRACHEAL TUBE

• K Number: K031794
• Device Name: ENDOFLEX TRACHEAL TUBE
• Manufacturer: MERLYN ASSOCIATES INC.
• Date Cleared: 2004-03-12 ( 276 days)
• Product Code: BTR
• Regulation Number: 868.5730
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: K871204

Intended Use

The EndoFlex Tracheal Tube is intended for airway management by oral/nasal intubation.

Device Description

The EndoFlex Tracheal Tube is sterile, single use device for airway management during anesthesia and mechanical ventilation. The tube is made in fifteen sizes; 3.0mm through 10.0mm in 0.5 mm increments. The EndoFlex Tracheal tube is identical to the predicate devices in terms of material composition, biocompatibility, and sterilization. The EndoFlex Tracheal tube has a beveled tip, high volume/low pressure cuff, inflation system, and 15mm connector equivalent to the predicate devices. The EndoFlex Tracheal tube differs from the predicate device in the following ways: The EndoFlex Tracheal tube has an articulating tip that can be flexed to facilitate intubation. The flexing tip eliminates the need for intubation stylets.

AI/ML Overview

The provided document describes the predicate device and the new device being submitted for 510(k) clearance, the EndoFlex Tracheal Tube. It explicitly states that no clinical performance data has been collected for the EndoFlex Tracheal Tube.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such study was performed or documented in the provided text.

Here is the information that can be extracted from the document based on your request, highlighting the lack of clinical study data:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria for Non-Clinical Performance: Conformance to ASTM 1242-96 performance standard.
     • Materials
     • Cuffs
     • Inflation system
     • Radius of curvature
     • Marking materials
     • Packaging
     • Tube collapse
     • Cuff materials
     • Radiopaque markers
     • Leak test
   • Reported Device Performance: The EndoFlex Tracheal Tube conforms to all of the performance standard criteria for materials, cuffs, inflation system, radius of curvature, marking materials, and packaging. The tube passes all performance tests for tube collapse, cuff materials, and packaging, radiopaque markers, and leak test.
   • Clinical Performance Data: To date, no clinical data has been collected.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable as no clinical study was performed.

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):

   • Not applicable as no clinical study was performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable as no clinical study was performed.

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 as this is a medical device (tracheal tube), not an AI diagnostic/imaging device, and no clinical study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable as this is a medical device (tracheal tube), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable as no clinical study was performed. For non-clinical testing, the ground truth was presumably defined by the ASTM 1242-96 standard.

8. The sample size for the training set:

   • Not applicable as no clinical study was performed and this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

   • Not applicable as no clinical study was performed and this is not an AI/machine learning device.

Summary of Clinical Data: The document explicitly states: "To date, no clinical data has been collected." The substantial equivalence assessment is based on non-clinical testing results against a predicate device.

Regulation Number and Section

§ 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).