(268 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.
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:
| Specification Category | Acceptance Criterion (from Predicate/Reference) | Reported Device Performance (Implied) |
|---|---|---|
| Device Name | CARESCAPE R860 (v10 software) | Identical (CARESCAPE R860 with v11 software) |
| Product Code | CBK | Identical (CBK) |
| Manufacturer | Datex-Ohmeda, Inc. | Identical (Datex-Ohmeda, Inc.) |
| Indications for Use | Mechanical ventilation/support for neonatal, pediatric, and adult patients ≥ 0.25 kg. Integrated monitoring of FiO2, airway pressure, flow, volume. | Substantially Equivalent: Essentially unchanged, with an added specific indication for O2 Therapy (adult and pediatric >10kg). "The modifications do not affect the intended use, nor do they significantly affect the technological characteristics of the device." |
| Contraindications | None | Identical (None) |
| Patient Population | Adult, pediatric, infant, neonatal patients ≥ 0.25 kg. | Substantially Equivalent: Added clarity for O2 Therapy (adults and pediatric >10kg). |
| Environment of Use | Facility use, within-facility transport. | Identical. |
| Key Standards Met | IEC 60601-1:2005 + A1 (2012), IEC 60601-1-2:2007, IEC 60601-1-6:2010, IEC 60601-1-8:2006, ISO 80601-2-12:2011, IEC 62366:2008, ISO 5356-1:2004. | Substantially Equivalent: Complies with latest versions of applicable FDA-recognized standards, including IEC 60601-1-2:2014, IEC 60601-1-6 Ed 3.1 2013-10, IEC 60601-1-8 Ed 2.1 2012-11, IEC 62366-1 Ed 1.0 2015-02, IEC 62304 Ed 1.1 2015-06, ISO 18562-1, -2, -3 (2017), AIM 7351731 Rev. 2.00. "The modified CARESCAPE R860 has been shown to comply with the applicable standards referenced above, and the device meets the specifications and user requirements." |
| Energy Delivered | Air and Oxygen | Identical. |
| Ventilation Modes | 15 listed modes (A/C VC, A/C PC, etc.) | Identical to predicate. No new modes of ventilation. |
| Breathing Support Mode | n/a (for predicate) | O2 Therapy (high flow oxygen therapy) for adult and pediatric patients >10kg. |
| O2 Therapy (Hamilton G5 ref) | Delivers heated and humidified gas with set FiO2 and flow via unsealed heated patient interface. | Substantially Equivalent: Same function/delivery method. "Verification evidence demonstrates that the performance and specifications of the O2 Therapy function on the CARESCAPE R860 are equivalent to those on the Hamilton G5." |
| High Flow O2 Therapy Flow Rate | Adult/Ped: 1 to 60 liters/minute (Hamilton G5) | Adult/Ped: 2 to 60 liters/minute. "Equivalent to the Hamilton G5. The flow range was narrowed slightly (lower end of the flow rate is 2LPM instead of 1 LPM in the Hamilton G5). This does not affect the safety or performance of this feature. Testing has been completed as documented in the 510(k) to demonstrate the device meets these specifications." |
| High Flow O2 Therapy FiO2 (%) | Adult/Ped: 21% to 100% (Hamilton G5) | Identical. |
| Software | Currently released software (v10) | Updated software (v11) adds O2 Therapy, minor user-configurable changes, upgraded display OS (cybersecurity enhancements), improved checkout routine. "Substantially equivalent – ... 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." |
| Hardware Component Updates | As cleared under K142679 | Alternative versions of previously cleared components introduced. "Substantially equivalent – Alternate versions of certain components have been introduced. There is no impact on the safety or effectiveness of the component or the CARESCAPE R860 ventilator as a result of the alternative designs. There is no change to the clinical use of the device." |
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.
§ 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).