(91 days)
The Breathe Technologies Ventilator (BT-V2S), with Accessories, is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients, with or without a tracheostomy, that are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional environment. The device is intended for operation by trained personnel under the direction of a physician.
This application is being filed to allow a new breathing circuit for the Breathe Technologies Ventilator (BT-V2). The Ventilator is fundamentally unchanged. The only difference between the predicate and application submissions is that the application requests clearance to market the BT-NT nasal interface with the BT-V2S ventilator.
The BT-NT is a nasal mask style patient circuit which attaches to the patients nose. It connects to the BT-V2S ventilator.
The BT-NT is approximately 12cm wide and 2cm thick at its thickest point under the patient's nose. These dimensions do not include the 231 cm dual tubing that connects to the Ventilator. It is composed of various plastics.
The provided document is a 510(k) Summary for a medical device modification (BT-V2S Ventilator and accessories). It states that the device is substantially equivalent to a predicate device, meaning it does not claim to offer superior performance or new functionalities that require extensive studies to prove acceptance criteria. Instead, the focus is on demonstrating that the modification (a new nasal interface breathing circuit, BT-NT) does not introduce new safety or efficacy concerns and that the device remains compliant with existing standards.
Therefore, the document does not contain the information requested in points 1-9 regarding the acceptance criteria, sample sizes, ground truth establishment, or expert involvement for a study proving device performance against specific acceptance criteria in the way one would expect for a novel AI/Diagnostic device.
Here's a breakdown of what is available and why most of the requested information is absent:
Explanation of Missing Information:
This document describes a "Special 510(k): Device Modification" for a ventilator. The core claim is "substantial equivalence" to a predicate device (BT-V2). This means the manufacturer is asserting that the modified device is as safe and effective as the previously cleared device, not that it is a new device with novel performance claims requiring rigorous clinical trials or AI performance evaluations. The modification here is specifically a "new breathing circuit for the Breathe Technologies Ventilator (BT-V2S)."
Therefore, the study performed is primarily bench testing and biocompatibility to prove that the modification does not negatively impact the existing performance and safety of the ventilator. This is fundamentally different from a study to establish novel performance metrics for AI or diagnostic accuracy where many of your questions would be highly relevant.
Information from the Document (and limitations):
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Table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied): Compliance with
- ISO 10993 (Biocompatibility)
- FDA Draft Reviewer Guide for Ventilators (July 1995)
- ASTM F1100 90 (1997), Standard Specification for Ventilators Intended for Use in Critical Care
- IEC 60601 1 (1988), Amendment 1 (1991-11), Amendment 2 (1995): Medical electrical equipment - General Requirements for Safety
- IEC 60601 2- 12 (2001-10): Medical electrical equipment - Particular requirements for the safety of lung ventilators - Critical care ventilators.
- Reported Device Performance:
- Biocompatibility data demonstrates that the device is in compliance with ISO 10993.
- Bench testing, including a lung model, has demonstrated that the BT-V2S remains in compliance with the expectations of the medical community, the product labeling, and the listed Standards and Guidances.
- The document states: "The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy."
- Acceptance Criteria (Implied): Compliance with
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Sample size used for the test set and the data provenance: Not applicable. The "study" was bench testing (likely involving physical units of the ventilator and the new breathing circuit). There is no "test set" in the context of patient data, nor is there data provenance (e.g., country of origin, retrospective/prospective) for a bench test.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in this context, refers to the compliance with established engineering and medical device standards, which are evaluated by accredited labs and engineers, not typically by clinical experts establishing diagnostic "ground truth."
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Adjudication method for the test set: Not applicable. There is no "adjudication" in the sense of resolving disagreements among experts on a test set. Compliance is determined by objective measurements against specified standard thresholds.
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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: Not applicable. This device is a ventilator, not an AI-powered diagnostic tool, and no MRMC study was performed or needed for this type of modification.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
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The type of ground truth used: "Ground truth" was compliance with established engineering and medical device standards (ISO, ASTM, IEC) and the "expectations of the medical community" for ventilator performance, as verified through bench testing.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).