(71 days)
The 840 Ventilator System with ET/Tracheostomy Tube Compensation, TC, Option is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from infant to adult and for a wide variety of clinical conditions.
The 840 Ventilator System is a "Continuous Ventilator", a Class II device, per 21 CFR Part 868.5895. This device is designated as Class I, Type B equipment, per IEC 601-1. The 840 Ventilator's gas delivery system consists of two proportional solenoid valves, PSOLs and an active expiratory valve. Previously cleared modes of ventilation include Assist Control, AC, Synchronized Intermittent Mandatory Ventilation, SIMV and Spontaneous, SPONT. The 840 Ventilator System supplies mandatory or spontaneous breaths with a preset level of positive end expiratory pressure, PEEP, trigger sensitivity and oxygen concentration. A mandatory breath can be either pressure or volume controlled, except in the optional BiLevel mode, when it is always pressure-controlled. A spontaneous breath type allows patient inspiratory flows of up to 200 L/min, with or without pressure support. This 840 Ventilator modification comprises the addition of a new ET/Tracheostomy Tube Compensation, "TC", feature. This feature is implemented on the 840 Ventilator through additional functionality in software and by using the existing User Interface panel. "TC" has been added as a Breath Type choice in the Touch Screen SPONT Type menu. The ventilator's pneumatic design and electrical circuitry remain functionally unchanged.
The provided text is a summary of a 510(k) submission for a medical device, the Puritan-Bennett 840 Ventilator System with ET/Tracheostomy Tube Compensation Option. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study in the way one might for a novel diagnostic AI.
The document does not contain information about acceptance criteria or a study designed to prove the device meets those criteria in the context of a new diagnostic algorithm. Instead, it focuses on demonstrating that the modified ventilator is substantially equivalent to existing predicate devices.
Therefore, many of the requested sections (Table of acceptance criteria, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, sample size for training set, how training ground truth was established) cannot be answered from the provided text. These are typically elements of studies designed to validate the performance of new diagnostic or predictive algorithms, which is not the primary purpose of this 510(k) submission.
The relevant information from the document pertains to the device's intended use and the regulatory pathway.
Here's a breakdown of what can be extracted based on the nature of the submission:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the provided document. The document describes the device modification and its intended use, emphasizing its substantial equivalence to predicate devices. It does not lay out specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity for a diagnostic claim) or report detailed numerical performance metrics for the modified feature. The assessment in a 510(k) is about safety and effectiveness in comparison to predicates, not usually a standalone performance trial against specific numerical targets.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not present in the provided document. The 510(k) does not describe a clinical study with a "test set" in the context of evaluating a new algorithm's performance. The review focuses on design controls, verification, and validation testing (software, etc.) to ensure the modification is safe and effective compared to predicates, but details of such testing, including sample sizes for clinical data, are not provided.
3. 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 present in the provided document, as no such "test set" and ground truth establishment are described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the provided document, as no such "test set" and adjudication process are 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:
This information is not present in the provided document. This type of study is relevant for AI-powered diagnostic aids, which is not the nature of this ventilator modification.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not present in the provided document. The device is a ventilator, not an AI-only algorithm. The "TC" feature is an integrated software function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not present in the provided document.
8. The sample size for the training set:
This information is not present in the provided document. The "TC" feature is described as an "additional functionality in software" using the existing user interface. It's not presented as a machine learning model requiring a discrete "training set" in the common sense of AI development.
9. How the ground truth for the training set was established:
This information is not present in the provided document.
Summary of what is known from the document:
- Device: Puritan-Bennett 840 Ventilator System with ET/Tracheostomy Tube Compensation (TC) Option.
- Modification: Addition of a new ET/Tracheostomy Tube Compensation, "TC", feature implemented via additional software functionality using the existing User Interface.
- Regulatory Pathway: 510(k) Pre-market Notification, asserting substantial equivalence to predicate devices (Puritan-Bennett 7200 Series Ventilator and Drager Evita 4 Ventilator).
- Basis for Equivalence: The intended use, materials, and design are similar to predicate devices. The technical characteristics of the modification do not introduce new questions of safety or effectiveness. Compensation for ET/Tracheostomy Tube resistance via positive pressure support is common clinical practice.
- Software Development: Followed FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 29, 1998) and internal company requirements for verification and validation testing.
- Intended Use: To provide continuous ventilation for infant, pediatric, and adult patients (tidal volume 25 - 2500 mL) requiring respiratory support in hospitals and hospital-type facilities. Not for transport between facilities or in the presence of flammable anesthetics. For use and servicing by trained and qualified clinicians/persons only, and by prescription.
§ 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).