(266 days)
The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume.
Additional respiratory gas monitoring capabilities are supported through the use of optional GE patient monitoring modules.
Not all features are available for all patient types or product configurations.
The CARESCAPE R860 ventilator is not a pulmonary function calculation device.
The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.
The CARESCAPE R860 is a flexible, adaptable, intuitive critical care ventilator. Touchscreen capability allows the user to quickly and easily access patient information and procedures. A wide selection of performance options gives the user full control of the system configuration. The CARESCAPE R860 features patient monitoring, patient ventilation, and the capability of interfacing with central information management systems.
The CARESCAPE R860 is designed to provide mechanical ventilation for adult, pediatric and neonatal patient types weighing 0.25 kg and above, and having degrees of pulmonary impairment varying from minor to severe.
The CARESCAPE R860 introduces a new user interface with touch screen capabilities. Icons represent configurable views of past (historical trends), present (patient status), and possible future patient needs through clinical decision support, including Spontaneous Breathing Trial to evaluate a patient's ability to breath spontaneously for a limited, specified duration of time.
This ventilator comes with standard ventilation modes as well as purchasable ventilation modes and clinical decision support features.
Standard ventilation modes:
- A/C VC (Assist Control Volume Control) .
- A/C PC (Assist Control Pressure Control) .
- A/C PRVC (Assist Control Pressure Regulated Volume Control)
- SIMV VC (Synchronized Intermittent Mandatory Ventilation Volume Control) ●
- SIMV PC (Synchronized Intermittent Mandatory Ventilation Pressure Control)
- CPAP/PS (Continuous Positive Airway Pressure/Pressure Support)
- SBT (Spontaneous Breathing Trial) .
Purchasable ventilation modes: - . nCPAP (nasal Continuous Positive Airway Pressure)
- . SIMV PRVC (Synchronized Intermittent Mandatory Ventilation Pressure Regulated Volume Control)
- . BiLevel
- . BiLevel VG (BiLevel airway pressure ventilation Volume Guaranteed)
- VS (Volume Support) ●
- NIV (Non-Invasive Ventilation) .
- . APRV (Airway Pressure Release Ventilation)
Additional features: - . FRC (Functional Residual Capacity)
- . SpiroDynamics
The CARESCAPE R860 is based on the Engström Carestation feature set and contains similar performance characteristics to the Engström family of ventilators.
The CARESCAPE R860 is a microprocessor-based, pneumatically controlled, data driven ventilator which includes integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb nebulizer control board. The ventilator consists of two main components: the display and the ventilator unit. The display allows the user to interface with the system through a resistive touch screen and Trim Knob with keys. The CARESCAPE R860 also includes an optional module bay which allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.
The user interface for control of nebulization is provided via the ventilator display unit. The standard nebulizer board is provided with the CARESCAPE R860. Users have the option to configure the system to use an external pneumatic nebulizer in place of the standard nebulizer.
Optional accessories common to the CARESCAPE R860 and the predicate Engström family of ventilators include a trolley/cart, integrated air compressor, support arm, humidifier and water trap mounting brackets. Additional optional accessories include airway modules, intratracheal pressure sensor, auxiliary electrical outlets, adjustable mounting rail, nebulizer and components, and module bay.
The optional medical air compressor is intended for use as an accessory to provide a dry, filtered, breathable compressed air supply. The compressor is installed in the base of the ventilator cart. The compressor is powered from AC mains only. A source of compressed oxygen is required to be connected to ventilator equipped with the optional compressor. The use of an integrated air compressor was first cleared on the predicate Engström Carestation and Engström Pro in K050597.
Optional functionality includes integrated respiratory gas monitoring, capabilities to measure SpiroDynamics via a GE supplied intratracheal pressure sensor in patients using sized 6.5 tracheal tubes and larger, and calculation of functional residual capacity of mechanically ventilated patients using Nitrogen Wash In/Wash Out method. The integrated respiratory gas monitoring is provided via the Datex-Ohmeda Gas Modules, E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV, E-CAiOVX (K051092), E-MiniC module (K052582), or E-sCO, E-sCOV, E-sCAiO, E-sCAiOV (K123195) which are physically integrated into the CARESCAPE R860, receive electronic power from the CARESCAPE R860 and communicate measured values to the CARESCAPE R860 for display on the system display unit.
This document, a 510(k) Pre-market Notification, describes the CARESCAPE R860 ventilator and asserts its substantial equivalence to a predicate device, the Engström Carestation.
Based on the provided text, the CARESCAPE R860 device is a ventilator, not an AI/ML powered device designed to meet specific performance criteria based on an AI model's output. Therefore, many of the requested criteria regarding AI model evaluation (like sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or type of ground truth) are not applicable (N/A) in this context.
The document primarily focuses on demonstrating the device's adherence to regulatory standards and its functional equivalence to a previously cleared device through non-clinical testing.
Here's the information extracted and filled out based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a ventilator and not an AI/ML diagnostic or predictive device, the "acceptance criteria" are related to compliance with medical device standards and functional equivalence to a predicate, rather than specific performance metrics like sensitivity or specificity for an AI model.
| Acceptance Criteria Category | Reported Device Performance/Compliance |
|---|---|
| Safety and Essential Performance | Compliant with ANSI/AAMI ES60601-1:2005 (R 2012), Medical electrical equipment, Part 1: General requirements for basic safety and essential performance, and relevant collateral standards (IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, ISO 80601-2-12, IEC 62366, ISO 5356-1, IEC 62304). |
| Functional Equivalence | Demonstrated to have similar performance characteristics to the predicate Engström Carestation family of ventilators. Thoroughly tested through verification of specifications and validation. |
| Software Validation | Software validation completed. |
| Risk Management | Risk Analysis performed. |
| Requirements/Specifications | Requirements/Specification Reviews completed. |
| Design Development | Design Reviews completed. |
| Testing Levels | Testing performed on unit level, integration testing, performance testing (verification), safety testing (verification), simulated use/user requirements testing (validation). |
| Clinical Performance | No clinical testing required as modifications did not warrant it; modifications evaluated by non-clinical tests to verify and validate substantial equivalence. |
| Intended Use | Functions as a mechanical ventilator for neonatal, pediatric, and adult patients weighing 0.25 kg and above, with integrated monitoring of FiO2, airway pressure, flow, and volume. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: N/A (No specific "test set" in the context of AI/ML evaluation is mentioned. The testing involved functional verification and validation of a medical device against engineering specifications and regulatory standards.)
- Data Provenance: N/A (The testing performed is non-clinical, involving the device itself rather than patient data.)
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)
- Number of Experts: N/A
- Qualifications of Experts: N/A
- Explanation: Ground truth in this context refers to the correct functioning of the ventilator according to engineering specifications and regulatory standards. This is typically established through engineering and quality assurance processes, not by expert medical review of output data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: N/A
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
- MRMC Study Done: No.
- Effect Size: N/A
- Explanation: This is not an AI-assisted diagnostic device, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: N/A
- Explanation: This device is a ventilator, performing mechanical functions. While it has software, it's not an AI algorithm in the sense of making diagnostic or treatment recommendations that would have a standalone performance evaluated against a ground truth. Its "performance" is its ability to deliver ventilation parameters accurately and safely.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Engineering specifications, regulatory standards (e.g., ISO 80601-2-12 for medical ventilators), and performance characteristics of the predicate device (Engström Carestation). The "ground truth" is the established correct mechanical and software operation within specified tolerances.
8. The sample size for the training set
- Sample Size for Training Set: N/A (No AI model training involved.)
9. How the ground truth for the training set was established
- How Ground Truth Established: N/A (No AI model training involved.)
§ 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).