(265 days)
Reinforced Tube: Rusch Reinforced Endotracheal Tubes are designed for nasal intubation and are indicated for airway management. The correct designation (oral, nasal or oral/nasal) is printed on the tube and unit package. Reinforced Endotracheal Tubes may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. The Reinforced Endotrached to be used on all patients requiring ventilation, pediatric and adult.
Safety Clear and Safety Clear Pediatric Tubes: Rusch Endotracheal Tubes, Cuffed and Uncuffed, with or without Murphy Eye are for oral or nasal intubation. They are indicated for airway management. The Rusch Endotracheal Tubes are intended to be used on all patients requiring ventilation, pediatric and adult.
An endotracheal tube is a device that is inserted into the trachea via the nose or the mouth to establish a patent airway to allow ventilation. The proposed Teleflex Medical Rusch Endotracheal Tubes are sterile, single use devices that are made non made with DEHP. The tracheal tubes contain a compatible cuff, inflation line, pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the Safety Clear tracheal tube, while the Reinforced tube contains an embedded stainless-steel spiral that allows for X-ray visualization. Each tracheal tube is supplied with an appropriately sized 15mm connector.
The provided document is a 510(k) Premarket Notification from Teleflex Incorporated to the FDA regarding their Rusch Endotracheal Tubes. It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Crucially, this document does NOT describe a study that involves AI or machine learning, human readers, or image-based diagnostics. The "device" in question is an endotracheal tube, a physical medical device, not a software or AI-driven diagnostic tool.
Therefore, many of the requested criteria related to AI/ML model performance, such as sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this submission.
The "acceptance criteria" and "device performance" in this context refer to the physical and biological characteristics of the endotracheal tube, verified through standard bench testing and biocompatibility assessments, rather than diagnostic accuracy or reader improvement.
Here's an attempt to fill in the relevant information based on the provided text, while clearly stating when information is Not Applicable (N/A) due to the nature of the device:
Acceptance Criteria and Device Performance Study for Rusch Endotracheal Tubes
This submission focuses on establishing substantial equivalence for physical medical devices (endotracheal tubes), not software or AI-driven diagnostic tools. Therefore, many standard AI/ML study components are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the successful completion of the described bench testing and biocompatibility assessments, demonstrating that the device performs as intended and is safe for its indicated use. The "reported device performance" is the successful fulfillment of these tests, confirming substantial equivalence to the predicate devices.
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance (as implied by acceptance) |
|------------------------------|----------------------------------------------------------------+|--------------------------------------------------------|
| Physical Performance | Visual inspection | Acceptable |
| | Dimensional testing | Within specifications |
| | Bonding strength (main tube to side arm, inflation tube, connector) | Acceptable |
| | Tube curvature | Acceptable |
| | Cuff restrained burst | Acceptable |
| | Bevel angle | Acceptable |
| | Cuff inflation | Acceptable |
| | Kink resistance | Acceptable |
| | Cuff herniation | Acceptable |
| | Cuff diameter | Acceptable |
| | Tube collapse | Acceptable |
| | Tracheal seal testing | Acceptable |
| Biocompatibility | Cytotoxicity (ISO 10993) | Pass |
| | Sensitization (ISO 10993) | Pass |
| | Irritation (ISO 10993) | Pass |
| | Acute Systemic Toxicity (ISO 10993) | Pass |
| | Material Mediated Pyrogenicity (ISO 10993) | Pass |
| | Implantation (ISO 10993) | Pass |
| | Subacute Systemic Toxicity (ISO 10993) | Pass |
| | Genotoxicity (ISO 10993) | Pass |
| | Chemical Characterization (Exhaustive & Simulated Use) | Pass (Toxicological Risk Assessment Related to Extractables and Leachables) |
| | Particulates and VOC | Pass (Toxicological Risks Related to Inhalation of VOCs and Particulates) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of tubes) used for each bench test or biocompatibility test. It indicates that "testing performed verifies that the performance of the subject device is substantially equivalent." For biocompatibility, it states "Materials have been tested per ISO 10993-1" and lists the tests performed, implying standard sample sizes as per the ISO standard.
- Data Provenance: The data provenance is from internal testing conducted by Teleflex Medical, Inc. (the manufacturer). The type of data is physical testing and chemical/biological analysis of device materials. It is implicitly "prospective" in the sense that the testing was performed on newly manufactured devices for the purpose of this submission. Country of origin not specified, but likely where Teleflex manufactures or tests its products, or where the testing labs are located.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable (N/A): For a physical device like an endotracheal tube, "ground truth" is established through standardized engineering specifications, material science, and regulatory standards (e.g., ISO standards). It does not involve expert readers reviewing output in the same way an AI diagnostic tool would. The experts involved would be engineers, material scientists, and toxicologists conducting the testing and interpreting the results against established physical and biological acceptance criteria.
4. Adjudication Method for the Test Set
- Not Applicable (N/A): As there is no human interpretation or subjective assessment of "ground truth" images or data points (as in an AI diagnostic study), there is no adjudication method in the context of multiple expert readers. Compliance is determined by objective measurements against predefined engineering and biological limits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No: This is a physical medical device; an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A): This submission is for a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
- Engineering Specifications and Standardized Test Results: The "ground truth" for this medical device is based on established engineering specifications for physical characteristics (e.g., dimensions, bond strength, kink resistance, cuff performance) and adherence to recognized international standards for biocompatibility (ISO 10993 series). The device's performance is measured against these objective criteria rather than expert consensus on a diagnostic outcome.
8. The Sample Size for the Training Set
- Not Applicable (N/A): This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable (N/A): As there is no training set, this question is not applicable.
§ 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).