(182 days)
The ETView VivaSight-SL (TVT) is intended for intubation procedures. The ETView VivaSight-SL (TVT™) is indicated for use as a temporary artificial airway in adults requiring mechanical ventilation. It is intended for oral and nasal intubations.
The VivaSight-SL (TVT™) System is indicated for viewing during non-difficult and difficult intubation procedures, for verifying endotracheal tube and endobronchial blocker placement and repositioning, for viewing during suctioning and for general inspection of the airway. VivaSight-SL (TVT™) System is compatible for use with standard Laryngeal Mask Airway (LMA).
The ETView VivaSight-SL (TVT™) is a single use, cuffed device that functions as a standard endotracheal tube (ETT) and additionally has an embedded video imaging device embedded in a dedicated lumen. The system provides a video image of the patient's trachea, which is displayed on the monitor, for as long as the VivaSight-SL (TVTM) is inside the patient's trachea.
This document K152438, a 510(k) premarket notification for the ETView VivaSight-SL System (TVT™), describes the device's substantial equivalence to predicate devices rather than providing a standalone study with detailed acceptance criteria and performance metrics. Therefore, a complete table of acceptance criteria and reported device performance, and several other requested details cannot be extracted. However, based on the provided text, the following information can be inferred or explicitly stated:
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| LMA Compatibility | Insertion: Ability to insert the VivaSight-SL tube through the LMA tube. | Demonstrated. Performance test included inspections. |
| Operation: Ability to operate the VivaSight-SL tube and the LMA according to their specifications while the device is inserted through the LMA tube. | Demonstrated. Performance test included inspections. | |
| Resistance to Collapse: Resistance of the LMA to collapse with the VivaSight-SL tube inserted. | Demonstrated. Performance test included inspections. | |
| Safe Removal: Ability to safely remove the LMA while the VivaSight-SL tube remains in place. | Demonstrated. Performance test included inspections. | |
| Physical/Functional | Cuff Resting Diameter: (Specific limits for resting diameter not provided, but tested for predicate). | Tested for K121028 (predicate), which is identical for these parameters. Performance implicitly met/substantially equivalent to predicate. |
| Cuff Leak Resistance Integrity: (Specific limits for leak resistance not provided, but tested for predicate). | Tested for K121028 (predicate), which is identical for these parameters. Performance implicitly met/substantially equivalent to predicate. | |
| Resistance to Cuff Herniation: (Specific criteria not provided, but tested for predicate). | Tested for K121028 (predicate), which is identical for these parameters. Performance implicitly met/substantially equivalent to predicate. | |
| Cuff Symmetry: (Specific criteria not provided, but tested for predicate). | Tested for K121028 (predicate), which is identical for these parameters. Performance implicitly met/substantially equivalent to predicate. | |
| Air Flow Resistance: (Specific limits for airflow resistance not provided, but tested for predicate). | Tested for K121028 (predicate), which is identical for these parameters. Performance implicitly met/substantially equivalent to predicate. | |
| Biocompatibility | Compliance with ISO 10993-1. | Materials are identical to predicate (K121028) and were found to be biocompatible in accordance with ISO 10993-1. Tests were provided in K121028 submission. |
| Electrical Safety | Compliance with IEC 60601-1 (Medical Electrical Equipment, General Requirements for Safety). | Compliance for K121028 (predicate), which is identical for these parameters. Performance implicitly met/substantially equivalent to predicate. |
| EMC | Compliance with IEC 60601-1-2 (General Requirements for Safety, Collateral Standard: Electromagnetic Compatibility). | Compliance for K121028 (predicate), which is identical for these parameters. Performance implicitly met/substantially equivalent to predicate. |
| Endoscopic Safety | Compliance with IEC 60601-2-18 (Particular requirements for the safety of endoscopic equipment). | Compliance for K121028 (predicate), which is identical for these parameters. Performance implicitly met/substantially equivalent to predicate. |
| Sterilization | Compliance with ISO 11135 (Sterilization of health care products - Ethylene oxide). | Compliance for K121028 (predicate), which is identical for these parameters. Performance implicitly met/substantially equivalent to predicate. |
| Thermal Safety | (Specific criteria not provided, but tested for predicate). | Tested for K121028 (predicate), which is identical for these parameters. Performance implicitly met/substantially equivalent to predicate. |
| Camera EtO Durability | (Specific criteria not provided, but tested for predicate). | Tested for K121028 (predicate), which is identical for these parameters. Performance implicitly met/substantially equivalent to predicate. |
| Camera Imaging Performance | Ability to provide a video image of the patient's trachea. (Specific image quality metrics not provided, but tested for predicate). | Tested for K121028 (predicate), which is identical for these parameters. Performance implicitly met/substantially equivalent to predicate. The system "provides a video image of the patient's trachea, which is displayed on the monitor". |
Here's the additional information, based on the provided text:
2. Sample Size Used for the Test Set and Data Provenance:
- The document states, "Performance tests were conducted on ETView VivaSight-SL (TVT™)'s predicate (K121028) and provided in that submission. The two devices are identical; therefore the tests are applicable to both devices."
- For the specific performance test demonstrating LMA compatibility: The document only mentions "inspections" as part of the test. It does not explicitly state a numerical sample size (e.g., number of devices, number of trials, or number of patients/simulations).
- Data Provenance: The document does not specify the country of origin for the test data for either the predicate device (K121028) or the LMA compatibility test. It also does not explicitly state if the tests were retrospective or prospective, though device performance testing is typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This information is not provided in the document. The performance tests described (LMA compatibility, physical/functional, electrical, etc.) are primarily engineering and bench testing, not clinical studies requiring expert ground truth in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set:
- This information is not provided as the tests described are engineering/bench tests and not clinical studies involving human assessment that would require an adjudication method.
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:
- No, an MRMC comparative effectiveness study was not done. The device (ETView VivaSight-SL System) is an endotracheal tube with an embedded video imaging device, not an AI or diagnostic imaging interpretation system. Its function is to provide direct visualization during intubation and for airway inspection/verification, not to assist human readers in interpreting medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, this is not applicable. The device is a physical medical instrument (an endotracheal tube with a camera), not an algorithm. Its "performance" is inherently tied to its physical and functional characteristics and its use by a clinician ("human-in-the-loop").
7. The Type of Ground Truth Used:
- For the LMA compatibility test and other physical/functional tests, the "ground truth" was based on engineering specifications, direct observation/inspection during testing, and compliance with recognized standards (e.g., ISO, IEC). It was not based on expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic device.
8. The Sample Size for the Training Set:
- Not applicable/Not provided. This device is a hardware product and does not involve a "training set" in the context of machine learning or AI models. Its design and performance are based on engineering principles and testing against established standards.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As explained in point 8, there is no "training set" for this type of medical device. Its performance is demonstrated through testing against predefined engineering and biocompatibility standards.
§ 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).