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510(k) Data Aggregation
(308 days)
Rusch tracheal tubes are indicated for airway management by oral or nasal intubation of the trachea.
The proposed Teleflex Medical Super Safety Silk and Nasal Safety Silk tracheal tubes are sterile, single use devices that are made from Polyvinyl chloride (PVC) resin that is formulated without DEHP ("Non-DEHP" =
This is a 510(k) premarket notification for a medical device (tracheal tube), not an AI/ML device. Therefore, the concepts of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" are interpreted in the context of medical device performance testing for substantial equivalence, rather than a clinical study evaluating AI performance.
For this device, the "acceptance criteria" are the defined physical and mechanical properties the tracheal tube must exhibit, and the "study" is the performance testing conducted to demonstrate that the new device (Rusch Safety Silk Tracheal Tube Series) meets these criteria and is substantially equivalent to existing predicate devices.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cuff Bonding Leak Evaluation | No leak around the welding area | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Tube Curvature Test | Must meet the product requirement of 140mm ± 20mm | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Tube Collapse | The steel ball (OD = 75% of the stated ID) must pass through the lumen freely. | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Cuff Resting Diameter | The cuff resting diameter shall be within ± 15% of specification for each individual size | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Cuff Herniation | No abnormality or defect on the cuff (any part of the inflated cuff reaches beyond the nearest edge of the bevel will be considered as defect). No abnormality on the configuration of the cuff during deflating the cuff over a period of not less than 10s (any abnormality will be considered as defect). | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Side Arm Bonding Strength | Must be able to sustain a minimum of 15N | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Connector Bonding Strength | Tube-Connector bonding must meet the minimum specification to 50N | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Tube Compression Evaluation | Must be within the range of current data | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Cuff Unrestrained Burst Evaluation | Must be within the range of current data | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Cuff Restrained Burst Evaluation | Must be within the range of current data | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Cuff Sealing Pressure Evaluation | Must be within the range of current data | Not explicitly stated in a quantifiable manner, but the document implies successful testing by stating "Performance test results demonstrate that the proposed device is substantially equivalent." |
| Biocompatibility | Materials have been tested per ISO 10993 | "All patient contacting materials are in compliance with ISO 10993-1. Testing included Cytotoxicity, sensitization, intracutaneous activity, implantation and genotoxicity testing." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size used for the test set: Not specified in the provided text.
- Data provenance: Not specified. This type of performance testing for medical devices is typically conducted in a laboratory setting by the manufacturer, not with human patient data in the sense of clinical trials for AI.
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)
This question is not applicable to this type of medical device submission. "Ground truth" in the context of expert consensus or clinical outcomes is relevant for AI/ML device evaluations. For a tracheal tube, performance testing involves objective measurements against defined physical and mechanical specifications, not expert interpretation of outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this involves objective physical testing, not subjective expert review requiring adjudication.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the performance testing, the "ground truth" is defined by the established engineering specifications, relevant ISO standards (like ISO 5361 for tracheal tubes), and internal product requirements. This is a functional truth derived from known physical properties and design objectives, not a clinical or expert "ground truth."
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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