(322 days)
The 840 Series Ventilator is intended to provide continuous ventilation to patients requiring respiratory support. The 840 Ventilator System with Expanded NeoMode Option is intended for patients with an Ideal Body Weight (IBW) as low as 0.3 kg.
The 840 Series Ventilator with Expanded NeoMode Option is intended for use in hospital-type facilities. It may be used during hospital and hospital-type facility transport provided that electrical power and compressed gas are supplied.
The PB 840 Ventilator consists of a Breath Delivery Unit (BDU, a Graphical User Interface (GUI) and a number of optional accessories, including a Compressor, a Back-Up Power Source (BPS), and three cart options. Depending on the patient ideal body weight (IBW), the appropriate patient circuit is attached to the PB 840 Ventilator System and patient. When the system is operational and connected to the appropriate utilities, the ventilator system delivers sensitive, precise breaths to critically ill patients
The Puritan Bennett (PB) 840 Ventilator System is a dual-microprocessor-based, touch screen controlled, critical care ventilator intended to provide continuous ventilation for neonate to adult patients (with expanded NeoMode Option) or infant to adult patients (with no Option) who require either invasive ventilation or non-invasive ventilation.
The PB 840 Ventilator System includes software that is intended for patients with Ideal Body Weight (IBW) as low as 0.3 kg and provides the user with tidal volume to 2 mL. The ventilator determines values for operational variables and allowable settings based on breathing types and IBW. The software controls prevent inadvertent mismatching of patient size and breathing circuit type.
This document describes the Puritan Bennett™ 840 Series Ventilator System, a continuous ventilator. The submission is a 510(k) premarket notification for a modified version of an already cleared device, the Puritan Bennett™ 840 Ventilator System with Expanded NeoMode Option (K092847).
Based on the provided text, the device in question is a continuous ventilator, which falls under the regulation 21 CFR 868.5895. The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove effectiveness against a specific set of clinical acceptance criteria in a standalone study. The modifications are software enhancements (communication, reduction of idle flow for neonates, update to alarm defaults for CPAP, removal of redundant code, update apnea interval) and hardware enhancements (new BD and GUI PCBAs due to obsolescence, new Pole Cart and new Compressor Cart, optional four-hour 803 Backup Power Source (BPS), new O2 Sensor Manufacturer, Fuse Upgrade on the 9.4" GUI Backlight Inverter PCBA).
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the typical sense of a clinical study with performance metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" can be inferred from the regulatory requirements for demonstrating substantial equivalence for a medical device modification. The performance data focuses on demonstrating that the modified device continues to meet safety and performance specifications after changes.
| Acceptance Criteria (Inferred from regulatory requirements for device modification) | Reported Device Performance |
|---|---|
| Software Functionality and Safety | Software verification and validation testing were conducted, and documentation was provided according to FDA guidance. The software was considered "major" level of concern. The testing confirms the device meets its design, performance, and safety specifications. (Specific performance metrics are not detailed in this summary.) |
| Electrical Safety and Electromagnetic Compatibility (EMC) | Electrical safety and EMC testing were conducted. The system complies with IEC 60601-1:1988 + A1:1991 + A2:1995 for electrical safety and IEC 60601-1-2:2014 for EMC. The device also complies with all known national differences. (Specific outcomes of these compliance tests are not detailed.) |
| Usability of new hardware components | Usability testing was performed to ensure the new Pole Cart and Compressor Cart meet user requirements and can be used as intended. (Specific outcomes of usability testing are not detailed.) |
| Continued adherence to design and performance specifications against predicate device | All other PB840 Series Ventilator System requirements and specifications remain the same. The performance data demonstrates that the subject device can be considered substantially equivalent to the predicate device that is currently marketed for the same intended use. (This implies that all existing performance specs are met). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not mention "test sets" in the context of clinical data. The studies mentioned are primarily engineering-based (software V&V, electrical safety, EMC, usability). Therefore, concepts like sample size for a test set, country of origin, or retrospective/prospective data provenance are not applicable in this context. The "test set" would primarily refer to the device itself undergoing various non-clinical engineering tests.
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 is not applicable. The evaluations described are engineering verification and validation activities, not clinical studies requiring expert ground truth establishment for diagnostic or prognostic purposes. The "ground truth" for these tests would be the established engineering standards, specifications, and regulatory guidelines.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. As stated, the document describes non-clinical engineering tests, not studies that involve human interpretation requiring 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
No MRMC study was done, and the device is a ventilator, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A "standalone" performance study in the context of an algorithm or AI is not applicable here. The device is a ventilator, and its performance is evaluated through engineering tests, not as a standalone algorithm. The software verification and validation are "standalone" in the sense that they test the software's performance against its requirements, but not in the context of an AI algorithm's standalone clinical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests mentioned would be based on:
- Software Verification and Validation: Software design specifications, functional requirements, and established coding standards.
- Electrical Safety and EMC: International standards (IEC 60601-1, IEC 60601-1-2) and national differences.
- Usability Testing: User requirements, design specifications for the carts, and observed user performance against intended use scenarios.
8. The sample size for the training set
This is not applicable. The Puritan Bennett™ 840 Series Ventilator System is a traditional medical device, not an AI/Machine Learning system that requires a "training set" in the computational sense.
9. How the ground truth for the training set was established
This is not applicable, as there is no "training set."
§ 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).