Search Results

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.

O2 Therapy is intended to be used for all adult patients and pediatric patients greater than 10 kg in weight.

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 offering invasive and non-invasive ventilation support. 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. Icons represent configurable views of past (historical trends), present (patient status), and future patient needs (clinical decision support). The CARESCAPE R860 features patient monitoring, patient ventilation, and the capability of interfacing with central information management systems.

The CARESCAPE R860 ventilator is intended for healthcare facility use, including withinfacility transport.

The ventilator offers multiple 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)
• 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)

In addition, a breathing support mode, O2 Therapy, is being added as a new feature in this 510(k). The O2 Therapy mode is available for adult and pediatric patients weighing greater than 10kg.

Optional functionality includes integrated respiratory gas monitoring, capabilities to measure SpiroDynamics, and calculation of functional residual capacity of mechanically ventilated patients. The integrated respiratory gas monitoring is provided via the Datex-Ohmeda Gas Modules, which are physically integrated into the CARESCAPE R860, can receive electronic power from the CARESCAPE R860 and communicate measured values to the CARESCAPE R860 for display on the system display unit.

This document is a 510(k) Pre-market Notification for a medical device (CARESCAPE R860 ventilator). It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that a new AI/ML-based device meets specific performance criteria through a traditional clinical study with ground truth.

Therefore, many of the requested elements (e.g., acceptance criteria for AI performance, sample size for test sets, expert adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets) are not applicable in this context.

The document describes engineering verification and validation testing and compliance with recognized consensus standards to demonstrate that the modified device remains safe and effective and is substantially equivalent to its predicate.

Here's the information that is applicable and can be extracted from the provided text, along with explanations of why other points are not relevant:

1. A table of acceptance criteria and the reported device performance

The document doesn't present specific acceptance criteria in the format of a clinical performance study with AI metrics (like sensitivity, specificity, or AUC). Instead, it discusses the device's functional performance specifications and how they align with the predicate device and relevant standards. The "performance" is demonstrated through verification and validation that the modified device continues to meet its functional specifications and standards.

The closest to "acceptance criteria" are the specifications listed in the "Substantial Equivalence to the predicate CARESCAPE R860" and "Substantial Equivalence to the reference device, Hamilton G5" tables. The "reported device performance" is implied by the statement that the device meets these specifications and has undergone "Verification and validation was performed to demonstrate that the changes to the software continue to comply with applicable standards and guidances, and the product continues to meet the performance specifications."

Here's a partial summary derived from the tables:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as this is not a study involving a clinical test set from patient data for AI model evaluation. The "test set" here refers to engineering and software verification and validation activities. The document states:

• "Non-clinical testing was performed to establish substantial equivalence of the CARESCAPE R860."
• "Verification and validation testing has been performed according to predetermined acceptance criteria..."
• "Testing included: Software verification and validation, Waveform comparison analysis, System verification, Accuracy testing, Stress testing."
• "Where the changes to the ventilator affected compliance with applicable consensus standards, testing was performed to confirm continued compliance, or to demonstrate compliance with the recognized version of the standard."

The document does not detail specific sample sizes for these engineering tests (e.g., number of test cycles, duration of stress tests, number of waveforms analyzed). Data provenance (country of origin, retrospective/prospective) is also not applicable for this type of non-clinical testing.

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)

Not applicable. This submission focuses on hardware and software changes to a ventilator, not on a diagnostic AI device requiring expert-labeled ground truth from patient data. The "ground truth" for this device's performance is typically defined by engineering specifications, relevant industry standards, and established methods for measuring ventilator performance using test lungs and specialized equipment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for clinical studies where human experts disagree on interpretations of medical data used as ground truth for an AI assessment. This is an engineering verification and validation submission for a physical device.

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 not an AI-assisted diagnostic or clinical decision support device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device (a ventilator) is not a standalone algorithm in the sense of AI/ML. Its performance is inherent in its electromechanical and software operation, which is verified against engineering specifications, not evaluated as an "algorithm only" with data processing outputs.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is based on engineering specifications, established physical principles, and recognized consensus standards for medical device performance. For example, accuracy testing involves comparing device measurements (e.g., FiO2, flow, volume) against known, precise inputs from calibrated equipment. Waveform comparison analysis involves comparing generated waveforms against theoretical or expected waveforms.

8. The sample size for the training set

Not applicable. This device introduction does not describe the development or training of an AI/ML model from a "training set" of data. The software development follows traditional engineering processes, not AI model training.

9. How the ground truth for the training set was established

Not applicable. Per point 8, there is no AI/ML training set as described in the context of diagnostic or prognostic AI.

Ask a specific question about this device

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.

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.)

Ask a specific question about this device