(135 days)
The TELEFLEX ISIS™ HVT™ Tracheal Tube, Cuffed with Subglottic Secretion Suction Port is indicated for airway management by oral intubation during mechanical ventilation and anesthesia including the capability to aid in the removal of subglottic secretions.
The ISIS Tube is a single-use, sterile tracheal tube made of polyvinyl chloride tube body, cuff inflation line and a compatible pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the tracheal tube. Each tracheal tube is supplied with an appropriately sized 15mm connector. ISIS Tube will be sold in Murphy eye style. Each tube has a dorsal lumen with an opening above the cuff and a male suction connector port attached to the tube which is close to the machine end of the tube. Access to the suction lumen is accomplished via a connection of the suction accessory pack (P/N 5-23000) directly to the male suction connector.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Teleflex ISIS HVT Tracheal Tube:
Summary of Acceptance Criteria and Device Performance:
The document primarily focuses on establishing substantial equivalence to predicate devices rather than defining explicit performance acceptance criteria with numerical targets. The "Summary of Testing" section indicates that the device meets relevant international standards and that its suction/aspiration capability is equivalent to predicate devices.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Conformance to ISO 5361 (Anesthetic and Respiratory Equipment) | Tube meets ISO 5361 standards. |
| Conformance to ISO 5356-1 (Conical Connectors) | Tube meets ISO 5356-1 standards. |
| Conformance to ISO 10993 (Biological Evaluation of Medical Devices) | Tube meets ISO 10993 standards. |
| Conformance to ISO 14971 (Risk Management) | Tube meets ISO 14971 standards. |
| Conformance to ISO 11135 (Sterilization) | Tube meets ISO 11135 standards. |
| Equivalent suction/aspiration capability to predicate devices | Bench testing determined suction/aspiration capability is equivalent to K822082, K965132, and K081086. |
Study Information:
Based on the provided text, the study conducted is primarily bench testing for equivalence and conformance to international standards.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify the sample size for the test set used during the bench testing or compliance checks.
- The data provenance is not specified beyond "Bench testing determined...". It's likely in-house testing conducted by Teleflex Medical, Inc.
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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 information is not provided as the study described is bench testing against standards and predicate devices, not studies involving human (e.g., clinical) interpretation or ground truth establishment by experts in that context.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided as the documentation describes bench testing for technical specifications and comparative performance, not a study requiring adjudication of human-derived data or expert consensus.
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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:
- No, an MRMC comparative effectiveness study was not done. This document describes a medical device (tracheal tube), not an AI-powered diagnostic system where human reader performance would be a relevant metric.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm performance evaluation was not done. This device is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the bench testing appears to be objective measurements and specifications defined by the referenced ISO standards and the measured performance of predicate devices. For example, the suction/aspiration capability was compared directly to that of other legally marketed devices.
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The sample size for the training set:
- This information is not applicable as the document describes the evaluation of a physical medical device, not an AI model that requires a training set.
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How the ground truth for the training set was established:
- This information is not applicable as the document describes the evaluation of a physical medical device, not an AI model.
In summary, the provided submission is an Abbreviated 510(k) for a medical device (tracheal tube). The "study" described is primarily bench testing and conformance to recognized standards, aiming to demonstrate substantial equivalence to existing predicate devices. It does not involve AI, human reader studies, or the methodologies typically associated with software-as-a-medical-device (SaMD) evaluations.
§ 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).