(142 days)
The Atlantis Hyperbaric Ventilator is indicated for use with pediatric and adult patients in respiratory failure or any other specific patient breathing requirements, as determined by the attending physician, when the patient is placed inside a hyperbaric chamber for prescribed therapy.
The Atlantis Hyperbaric Ventilator consists of two main components: (1) a Control Module; and (2) a Patient Breathing Circuit. The Control Module is exterior to the hyperbaric chamber, and allows the operator to control oxygen flow to the patient. The Control Module houses pressure regulators, timing valves for control of inspiratory time, expiratory time and inspiratory flow, and pressure gauges to monitor main regulator output pressure, hyperbaric chamber pressure, and timing valve control pressure. The Patient Breathing Circuit is located inside the hyperbaric chamber, and includes an exhalation valve, a pressure relief valve, and a pressure gauge. The Patient Breathing Circuit is supplied with oxygen from the Control Module, and returns interior chamber pressure values to the Control Module. Three high-pressure hoses connect these two components through the hyperbaric chamber bulkhead. The Patient Breathing Circuit is then attached to the patient's endotracheal tube for oxygen delivery. The Control Module and the Patient Breathing Circuit are components of the Atlantis Hyperbaric Ventilator, and are supplied with the device. Safety features include a patient airway pressure gauge, adjustable pressure relief valve, and a hand-operated oxygen flush valve.
This document is a 510(k) summary for the Atlantis Hyperbaric Ventilator. It is a premarket notification for a medical device seeking substantial equivalence to a predicate device. This type of document generally describes the device, its intended use, and argues for its equivalence to a device already on the market, rather than detailing a clinical study with acceptance criteria and performance data in the way one might expect for a novel device requiring extensive clinical trials.
Based on the provided text, there is no detailed clinical study described that specifically outlines acceptance criteria and then presents study results to prove the device meets those criteria. Instead, the document focuses on demonstrating substantial equivalence to a predicate device through a comparison of intended use, technological characteristics, and principles of operation.
Therefore, many of the requested elements for describing a study proving acceptance criteria cannot be extracted because such a study is not presented in this document.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: No specific numerical acceptance criteria are stated in this document. The "acceptance criteria" here is implicitly that the device is "as safe and effective" as the predicate and exhibits "no new issues of safety or effectiveness." This is a regulatory standard for substantial equivalence, not a performance metric.
- Reported Device Performance: No specific performance metrics (e.g., flow rate accuracy, pressure control precision, response time) are reported. The document states that the Atlantis Hyperbaric Ventilator is an "exact duplicate" of the predicate and has "exactly the same technological characteristics" and "exactly the same principles of operations."
2. Sample size used for the test set and the data provenance
- Not applicable. No "test set" in the context of a clinical performance study is described. The comparison is based on design and technical specifications against a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No "ground truth" or expert review of a test set is described.
4. Adjudication method for the test set
- Not applicable. No "test set" and thus no adjudication method is described.
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 a ventilator, not an imaging device requiring human reader interpretation or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a ventilator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for demonstrating substantial equivalence is the predicate device's established safety and effectiveness.
8. The sample size for the training set
- Not applicable. There is no mention of a "training set" for an algorithm or a clinical trial.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Relevant Information from the Document (Reinterpreted for Context):
This 510(k) submission seeks to establish substantial equivalence for the Atlantis Hyperbaric Ventilator (K092264) to the predicate device, the Level-S, Inc.'s Neptune Hyperbaric Ventilator (K082351).
The core of the "proof" that the Atlantis device meets "acceptance criteria" (which in this context means being substantially equivalent to the predicate) is the assertion that:
- "The Atlantis Hyperbaric Ventilator is as safe and effective and is an exact duplicate of the predicate, designed and built by the same person as the predicate Neptune Hyperbaric Ventilator, who is now Vice-President of the Company."
- "The Atlantis Hyperbaric Ventilator has the same intended uses, exactly the same technological characteristics, and exactly the same principles of operations as its predicate device."
- "Any minor technological differences between the Atlantis and its predicated device raise no new issues of safety or effectiveness."
Essentially, the "study" or justification here is a direct comparison of design and specifications to an already approved device, rather than an independent clinical performance study. The FDA's acceptance of the 510(k) implies that they agreed with this assessment of substantial equivalence based on the provided technical documentation and comparisons, rather than requiring a separate clinical trial to establish new performance benchmarks.
§ 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).