Search Results

The BEVER™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea during mechanical ventilation and anesthesia.

BEVER Evaller Endotracheal Tube is indicated for airway management by oral/nasal intubation of the trachea and for evacuation or drainage of the contaminated mucous and subglottic secretion that accumulate above the cuff by continuous or intermittent suctioning.

BEVER™ Endotracheal Tube with cuff (Oral/Nasal) is available in sizes 3.0mm ~10.0 mm in 0.5 mm increments

BEVER™ Endotracheal Tube without cuff (Oral/Nasal) is available in sizes 2.0mm~9.0 mm in 0.5 mm increments

BEVER™ Endotracheal Tube with cuff (Oral preformed) is available in sizes 4.0mm~10.0mm in 0.5 mm increments

BEVER™ Endotracheal Tube without cuff (Oral preformed) is available in sizes 3.0mm ~9.0mm in 0.5 mm increments

BEVER™ Endotracheal Tube with cuff (Nasal preformed) is available in sizes 5.0mm ~10.0mm in 0.5 mm increments

BEVER™ Endotracheal Tube without cuff (Nasal preformed) is available in sizes 4.0 mm~9.0mm in 0.5 mm increments

BEVER Eva™ Endotracheal tube (Oral) is available in sizes 6.0mm~9.0mm in 0.5mm increments

The BEVER™ Endotracheal Tube made of polyvinyl chloride is sterile, single use device supplied with a standard 15 mm connector. The Endotracheal Tube is available in cuffed and uncuffed variants and is for oral or nasal use. The cuffed tube is composed of main tube, high volume/low pressure cuff, inflating system (including inflating tube, valve and pilot balloon) and 15mm connector. The uncuffed tube is composed of main tube and 15mm connector. The main tube incorporates a Magill curve, a beveled/hooded tip with Murphy eye and a tip-to-tip radiopaque line to assist in radiographic visualization.

The design of BEVER Evalls Endotracheal tube is based upon the cuffed Endotracheal Tube (Oral/Nasal) with the addition of a third (integral) lumen within the tube. The lumen terminates above the cuff via a 'notch' (evacuation port) which enables the entrance (via suction) of secretions which have pooled above the cuff into the third (suction) lumen. Approximately half way along the tube length the suction lumen is joined to a suction tube which is external to the main tube. The suction tube is joined to the suction lumen in a similar manner to that of the joint between the inflating tube and the inflating lumen. The distal end of the suction tube terminates in a capped Luer connector which can be connected to either suction tubing or a syringe. The Eva™ Endotracheal tube is available in cuffed and for oral use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BEVER™ Endotracheal Tube and BEVER Eva™ Endotracheal Tube. It's important to note that this document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to predicate devices rather than deeply detailed performance studies for an entirely novel device.

Acceptance Criteria and Study for BEVER™ Endotracheal Tube and BEVER Eva™ Endotracheal Tube

The manufacturer, Hangzhou Bever Medical Devices Co., Ltd., demonstrated device performance by confirming compliance with existing international standards, particularly ISO 5361:1999(E) for the physical characteristics of endotracheal tubes and various ISO 10993 standards for biological safety. No custom, performance-based acceptance criteria (e.g., minimum sensitivity/specificity for a diagnostic device) are explicitly stated beyond these standard compliances.

1. Table of Acceptance Criteria and Reported Device Performance

• Sensitization (compliance with AAMI/ANSI/ISO 10993-10:2002/Amd. 1:2006(E))
• Irritation (compliance with AAMI/ANSI/ISO 10993-10:2002/Amd. 1:2006(E))
• Genotoxicity (compliance with AAMI/ANSI/ISO 10993-3:2009)
• Implantation (compliance with AAMI/ANSI/ISO 10993-6:2007) | The subject device passed all listed biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Implantation) and is compliant with the respective AAMI/ANSI/ISO 10993 standards. |
  | Sterilization | - Ethylene Oxide sterilization process validation (compliance with AAMI/ANSI/ISO ISO11135-1:2007)
• Ethylene Oxide Sterilization Residuals (compliance with AAMI/ANSI/ISO 10993-7:2008) | The sterilization process has been validated to be compliant with AAMI/ANSI/ISO ISO11135-1:2007 and AAMI/ANSI/ISO 10993-7:2008. |
  | Shelf Life | - Device compliance with specification requirements after 183 days accelerated aging.
• Validation of 4-year shelf life through real-time stability study. | After 183 days of accelerated aging, BEVER™ Endotracheal Tubes and BEVER Eva™ Endotracheal Tubes remained compliant with device specification requirements. A 4-year shelf life has been validated through a real-time stability study. |

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical performance or a dataset of patient images. The testing described focuses on in-vitro (biocompatibility, sterilization, accelerated aging) and conformity to standards, not a clinical trial or performance evaluation on a patient cohort for diagnostic accuracy.

• Sample Size: Not applicable in the context of clinical test set. For biocompatibility, sterilization, and shelf-life, standard laboratory sample sizes would have been used as per the relevant ISO standards, but these are not explicitly detailed in the summary.
• Data Provenance: Not applicable for a "test set" from patients. The data provenance mentioned refers to laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no mention of a clinical test set requiring expert ground truth establishment for patient outcomes or diagnostic interpretations. The document describes laboratory testing and compliance with engineering and biological standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no clinical test set requiring expert 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 device is an endotracheal tube, not an AI-powered diagnostic tool, so an MRMC study is irrelevant to its approval.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is compliance with established international standards (ISO 5361, ISO 10993, ISO 11135) and internal device specifications for physical properties, sterility, biocompatibility, and shelf life. This is determined through objective laboratory testing.

8. The sample size for the training set

Not applicable. This device is not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI model.

Summary of Approach in the 510(k):

This 510(k) summary demonstrates substantial equivalence by showing that the new device shares the same intended use, technological characteristics, and materials as the predicate devices. The "device performance" section primarily focuses on showing compliance with recognized voluntary standards for safety and efficacy relevant to endotracheal tubes. This approach is typical for devices seeking 510(k) clearance, where the goal is to prove the new device is "as safe and effective" as a legally marketed predicate device, rather than to prove absolute safety and effectiveness through extensive novel clinical trials.

Ask a specific question about this device