(295 days)
Ventilation
Each model of the ZOLL 731 Series of Ventilators is in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. ZOLL Ventilators are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an " label, ZOLL Ventilators are suitable for use in an MRI environment with appropriate precautions. ZOLL Ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers
Pulse Oximetry (SpO2)
The ZOLL Ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse SpO2 oximeter and accessories are indicated for use on adult and pediatric patients during both no motion conditions, and for patients who are well or poorly perfused, in hospital-type facilities, or in mobile environments.
The ZOLL 731 Series Ventilators family (acquired by ZOLL Medical Corporation through an asset acquisition of Impact Instrumentation, Inc. and reviewed and cleared under K111473) consists of AEV, EMV+ and Eagle II models which are small, durable, full-featured portable mechanical ventilators which provide ventilatory support for infants (> 5 kg), pediatric and adult patients. 731 Series ventilators are designed to operate in hospitals, prehospital, and field hospital settings. The ventilators can be operated from an AC or DC external power source, or from an integrated battery system, and support the following pressure and volume ventilation modes: Assist/Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV) with or without Pressure Support (PS), Continuous Positive Airway Pressure (CPAP) with or without PS, with and without Noninvasive Positive Pressure ventilation (NPPV)/ Positive Pressure Ventilation (PPV).
As part of the current submission we are proposing to revise the device software to accomplish the following:
- Introduce Bilevel Mode Functionality
- Expanded Leak Compensation Functionality
- Introduce Start Menu Functionality
- . Expanded Parameter Ranges
- . Introduce Plateau Pressure (Pplat) Functionality
- . Introduce Automatic Tubing Compensation Functionality
- Change Oxygen Supply Pressure Alarm Logic
- Introduce Inverse I:E Ratio Functionality ●
No hardware changes were made to the 731 Series Ventilators for the proposed software change.
The provided text describes a 510(k) premarket notification for the ZOLL 731 Series Ventilators, focusing on software changes that introduce new functionalities. The document primarily focuses on non-clinical evidence to establish substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a specific table of "acceptance criteria" with numerical targets and corresponding "reported device performance" values in the traditional sense of a clinical or analytical performance study. Instead, the acceptance criteria are implicitly tied to the successful completion of various engineering and software validation tests, and compliance with recognized standards.
The document states:
"Extensive performance testing in the software verification and system level validation ensured that the 731 Series Ventilators performs as well as the indicated predicate devices and met all of its functional requirements and performance specifications."
and
"The device was evaluated and found to be in compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, EN 794-3, IEC 60601-1-8 and ISO 80601-2-61."
Therefore, the reported device performance is that these tests were passed and compliance was achieved, demonstrating that the device meets its design, performance, and safety specifications and is substantially equivalent to predicate devices.
Example Interpretation of Acceptance Criteria and Performance (as implied by the document):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software functionality meets design requirements and specifications | "Extensive performance testing in the software verification and system level validation ensured that the 731 Series Ventilators... met all of its functional requirements and performance specifications." |
| Software performs as well as indicated predicate devices | "Extensive performance testing in the software verification and system level validation ensured that the 731 Series Ventilators performs as well as the indicated predicate devices..." |
| Compliance with relevant international safety standards | "The device was evaluated and found to be in compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, EN 794-3, IEC 60601-1-8 and ISO 80601-2-61." "Safety testing ensures that the device complies with applicable sections of recognized industry and safety standards." |
| Usability meets user requirements and intended use | "Usability testing was performed, where appropriate, to ensure that the proposed functionalities meet the user requirements and can be used as intended." |
| Software deemed "major" level of concern (FDA Guidance) | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submission for Software Contained Medical Devices'. The software for this device was considered as a 'major' level of concern, since a failure or latent flaw in the software could result in serious injury or death to the patient." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify a "test set" in the context of clinical data for performance evaluation. All testing mentioned is non-clinical (software verification/validation, safety testing, usability testing). Therefore, details like sample size for a test set (e.g., number of patients), country of origin, or whether it was retrospective/prospective are not applicable or 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 provided. Since no clinical "test set" requiring ground truth establishment by experts is described, this detail is not relevant to the presented evidence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided because no clinical "test set" or expert adjudication process is described in the document.
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 MRMC study was conducted or reported. The device is a ventilator with software updates, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a medical device (ventilator) with software as an integral component, not a standalone algorithm in the typical sense applied to AI/ML devices. The performance evaluation focuses on the integrated system (ventilator with new software). The software's performance was validated as part of the overall device performance through non-clinical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for the non-clinical testing described. For software verification and validation, the "ground truth" would be the pre-defined functional and performance specifications, and for safety, it would be compliance with published standards.
8. The sample size for the training set:
Not applicable. The document describes software updates to a medical device, not a machine learning or AI algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established:
Not applicable, as no training set for an AI/ML algorithm is described.
§ 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).