RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY

• K Number: K961837
• Device Name: RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY
• Manufacturer: RUSCH INTL.
• Date Cleared: 1996-08-16 ( 95 days)
• Product Code: BTR
• Regulation Number: 868.5730
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: K780004

Intended Use

The device is intended for oral or nasal intubation. It is intended for airway management.

Device Description

The Rusch Oral/Nasal Tracheal Tube, Cuffed, Magill/Murphy consists of a clear implant tested PVC tracheal tube with radiopaque stripe. The cuff is inflated via a pilot balloon using any lock-tip or luer taper syringe. The main tube is graduated with multiple centimeter markings to allow easy determination of intubated length. A black positioning ring is present on the tube to aid in visualization of the tube. An optional Murphy eye provides an alternative opening. The eye is the difference between the Murphy and the Magill Tube. The device is for Nasal/Oral use.

AI/ML Overview

This document is a 510(k) summary for a medical device (Rüsch Oral/Nasal Tracheal Tube, Cuffed- Magill/Murphy) and does not contain information about studies proving the device meets acceptance criteria in the context of AI/machine learning performance.

The document describes a physical medical device, not a software algorithm. Therefore, the questions about acceptance criteria for AI models, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment are not applicable.

Here's a breakdown of why the requested information cannot be provided from the given text:

1. Table of acceptance criteria and reported device performance: This document focuses on demonstrating substantial equivalence to a predicate device based on manufacturing standards and biocompatibility, not performance metrics like accuracy, sensitivity, or specificity for a diagnostic AI.
2. Sample size for test set and data provenance: Not applicable. There's no "test set" in the context of AI evaluation for this device.
3. Number of experts and qualifications: Not applicable. There's no ground truth established by experts for AI evaluation.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is for evaluating changes in human performance with AI assistance, which isn't relevant here.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable. The "ground truth" for this device would relate to its physical properties meeting engineering specifications and biocompatibility, not clinical outcomes or human expert labels for an AI.
8. Training set sample size: Not applicable.
9. How ground truth for training set was established: Not applicable.

What the document does state regarding "testing" is:

• Bench/Laboratory Testing: "Based on test data, the device conforms to ASTM 1242-89." and "The device is biocompatible per the requirements of ISO 10993."
• Acceptance Criteria Implied: The acceptance criteria are conformity to ASTM 1242-89 (a standard for tracheal tubes) and biocompatibility per ISO 10993.
• Study Proving Acceptance: The "test data" mentioned for conformity to ASTM 1242-89 and biocompatibility per ISO 10993 are the studies proving the device meets these implied acceptance criteria. However, no specifics about these studies (e.g., sample sizes, methodology beyond "bench/laboratory testing") are provided in this summary.

In summary, this document is for a traditional medical device's 510(k) clearance, not an AI/software as a medical device (SaMD), and therefore doesn't provide the type of information requested about AI model performance validation.

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).