CARESCAPE R860

K210384 · Datex-Ohmeda, Inc. · CBK · Nov 4, 2021 · Anesthesiology

Device Facts

• Record ID: K210384
• Device Name: CARESCAPE R860
• Applicant: Datex-Ohmeda, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Nov 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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.

Device Story

CARESCAPE R860 is a microprocessor-based, pneumatically driven critical care ventilator for invasive and non-invasive ventilation. It accepts inputs for FiO2, airway pressure, flow, and volume; optional GE modules provide respiratory gas monitoring. The device features a touchscreen interface and Trim Knob for clinician control. It supports multiple ventilation modes (e.g., A/C VC, SIMV, CPAP/PS, APRV) and a new O2 Therapy mode for high-flow oxygen delivery. Used in healthcare facilities, including transport, it assists clinicians in managing patient respiratory needs by providing mechanical support and real-time monitoring. Output data is displayed on the unit to inform clinical decision-making and patient management. Benefits include flexible, adaptable respiratory support across a wide patient weight range.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including software verification/validation, waveform comparison, system verification, accuracy testing, and stress testing. Compliance with consensus standards (IEC 60601 series, ISO 80601-2-12, ISO 18562 series) confirmed.

Technological Characteristics

Microprocessor-based, pneumatically controlled ventilator. Components: display unit (resistive touchscreen, Trim Knob) and ventilator unit. Materials: breathing gas pathways evaluated per ISO 18562. Connectivity: integrated GE gas modules, central information management system interface. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, ISO 80601-2-12, ISO 80601-2-55, IEC 62366, IEC 62304, ISO 18562-1/2/3, ISO 5356-1.

Indications for Use

Indicated for mechanical ventilation or support for neonatal, pediatric, and adult patients weighing ≥0.25 kg. O2 Therapy indicated for adult and pediatric patients >10 kg. Not indicated for neonates for O2 Therapy.

Regulatory Classification

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.

Predicate Devices

• CARESCAPE R860 (K142679)

Reference Devices

• Hamilton G5 (K193228)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Datex-Ohmeda, Inc. Monica Morrison Regulatory Affairs 3030 Ohmeda Drive, PO Box 7550 Madison, Wisconsin 53707-7550

# Re: K210384

Trade/Device Name: Carescape R860 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: Class II Product Code: CBK Dated: October 5, 2021 Received: October 6, 2021

# Dear Monica Morrison:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801; medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Brandon Blakely, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory, and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K210384

Device Name

CARESCAPE R860

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| <span style="font-size: 16px;">☑</span> | ☐ |

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# Section 5: 510(k) Summary

CARESCAPE R860

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# 510(k) Summary

| Date: | November 3, 2021 | | |
|---------------------------------------|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitter: | Datex-Ohmeda, Inc. (GE Healthcare) | | |
| | 3030 Ohmeda Drive | | |
| | PO Box 7550 | | |
| | Madison, WI 53707-7550 USA | | |
| Primary Contact Person: | Monica Morrison | | |
| | Datex-Ohmeda, Inc. | | |
| | 3030 Ohmeda Drive | | |
| | PO Box 7550 | | |
| | Madison, WI 53707-7550 | | |
| | Telephone: [phone] | | |
| | Fax: [phone] | | |
| | Email: [e-mail] | | |
| Secondary Contact Person: | Kimberly Mangum | | |
| | Datex-Ohmeda, Inc. | | |
| | 3030 Ohmeda Drive | | |
| | Madison, WI 53707-7550 | | |
| | Telephone: [phone] | | |
| | Email: [e-mail] | | |
| Device Trade Name: | CARESCAPE R860 | | |
| Common/Usual Name: | Ventilator, Continuous | | |
| Classification Names: | Ventilator, continuous, facility use | | |
| | Product Code: | CBK | |
| Predicate<br>Device | 510(k) Number | K142679 | |
| | Trade Name | CARESCAPE R860 | |
| | Product Code | CBK | |
| Reference<br>Device | 510(k) Number | K193228 | |
| | Trade Name | Hamilton G5 | |
| | Product Code | CBK, DQA | |
| Intended Use/<br>Indications for Use: | | The CARESCAPE R860 ventilator is designed to provide<br>mechanical ventilation or support to neonatal, pediatric,<br>and adult patients weighing 0.25 kg and above. | |

In accordance with 21 CFR 807.92 the following summary of information is provided:

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| The CARESCAPE R860 ventilator is a microprocessor<br>based, electronically controlled, pneumatically driven<br>ventilator that includes integrated monitoring of FiO2,<br>airway pressure, flow, and volume. Additional respiratory<br>gas monitoring capabilities are supported through the use<br>of optional GE patient monitoring modules. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Not all features are available for all patient types or<br>product configurations. |
| O2 Therapy is intended to be used for all adult patients<br>and pediatric patients greater than 10 kg in weight. |
| The CARESCAPE R860 ventilator is not a pulmonary<br>function calculation device. |
| The system is designed for facility use, including within-<br>facility transport, and should only be used under the orders<br>of a clinician. |

# Device Description:

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)

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- 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.

# Summary of the Technological Characteristics of the Device:

The CARESCAPE R860 is a microprocessor-based, pneumatically controlled, data driven ventilator which includes integrated FiO2, airway pressure, spirometry and volume monitoring. 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 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.

# Summary of changes in this 510(k):

This 510(k) proposes changes to the hardware and software of the CARESCAPE R860. However, there are no changes to the intended use or fundamental scientific technology of the ventilator. The fundamental function and operation of the CARESCAPE R860 is unchanged compared to the predicate CARESCAPE R860 with v10 software. This 510(k) introduces v11 software, which includes O2 Therapy, a non-invasive high flow oxygen therapy support mode, an upgrade to the display operating system, and additional userconfigurable options. Hardware changes include the addition of alternative components and accessories.

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# Determination of Substantial Equivalence:

The CARESCAPE R860 ventilator is substantially equivalent to the predicate CARESCAPE R860 (K142679) and the reference device, Hamilton G5 (K193228), as described in the following table:

| Substantial Equivalence to the predicate CARESCAPE R860 | | | |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specification | Predicate Device | Proposed | Discussion of Differences |
| | CARESCAPE R860 with v10 software | CARESCAPE R860 with v11 software | |
| | K142679 | (this 510(k)) | |
| Device Name | CARESCAPE R860 | CARESCAPE R860 | Identical to CARESCAPE R860 with v10<br>software |
| Product Code | CBK | CBK | Identical to CARESCAPE R860 with v10<br>software |
| Manufacturer | Datex-Ohmeda, Inc. | Datex-Ohmeda, Inc. | Identical to CARESCAPE R860 with v10<br>software |
| Indications for<br>Use | The CARESCAPE R860 ventilator is designed<br>to provide mechanical ventilation or support to<br>neonatal, pediatric, and adult patients weighing<br>0.25 kg and above.<br><br>The CARESCAPE R860 ventilator is a<br>microprocessor based, electronically<br>controlled, pneumatically driven ventilator that<br>includes integrated monitoring of FiO2, airway<br>pressure, flow, and volume. Additional<br>respiratory gas monitoring capabilities are<br>supported through the use of optional GE<br>patient monitoring modules. | The CARESCAPE R860 ventilator is designed<br>to provide mechanical ventilation or support to<br>neonatal, pediatric, and adult patients weighing<br>0.25 kg and above.<br><br>The CARESCAPE R860 ventilator is a<br>microprocessor based, electronically<br>controlled, pneumatically driven ventilator that<br>includes integrated monitoring of FiO2, airway<br>pressure, flow, and volume. Additional<br>respiratory gas monitoring capabilities are<br>supported through the use of optional GE<br>patient monitoring modules. | Substantially Equivalent – The indications for<br>use are essentially unchanged from the<br>predicate device CARESCAPE R860 with v10<br>software. The only addition to the intended use<br>language is to specifically identify that for the<br>newly added O2 Therapy feature, it is intended<br>only for adults and pediatric patients greater<br>than 10 kg in weight. |
| | Not all features are available for all patient<br>types or product configurations. | Not all features are available for all patient<br>types or product configurations. | |
| | The CARESCAPE R860 ventilator is not a pulmonary function calculation device.<br>The system is designed for facility use, including withinfacility transport, and should only be used under the orders of a clinician. | O2 Therapy is intended to be used for all adult patients and pediatric patients greater than 10 kg in weight.<br>The CARESCAPE R860 ventilator is not a pulmonary function calculation device.<br>The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician. | |
| Contraindications | None | None | Identical to CARESCAPE R860 with v10 software |
| Patient<br>Population | Adult, pediatric, infant and neonatal patients weighing 0.25 kg and above | Adult, pediatric infant and neonatal patients weighing 0.25 kg and above.<br><br>O2 Therapy is intended to be used for all adult patients and pediatric patients greater than 10 kg in weight. | Substantially Equivalent – the CARESCAPE R860 with v11 software patient population is substantially equivalent to the CARESCAPE R860 with v10 software patient population<br>The specific patient population for O2 therapy was added for additional clarity. |
| Environment<br>of Use | The system is designed for facility use, including within-facility transport. | The system is designed for facility use, including within-facility transport. | Identical to CARESCAPE R860 with v10 software |
| Key standards<br>met | • IEC 60601-1:2005 + A1 (2012) Medical Electrical Equipment – Part 1: General Requirements for Safety<br>• IEC 60601-1-2:2007 + 2010 Interpretation, Medical electrical equipment - Part 1-2: Collateral standard: Electromagnetic compatibility - Requirements and tests<br>• IEC 60601-1-6: 2010, Medical electrical equipment - Part 1-6: Collateral Standard: Usability<br>• IEC 60601-1-8: 2006, Medical Electrical Equipment - Part 1-8 - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical | • IEC 60601-1:2005 + A1 (2012) Medical Electrical Equipment - Part 1: General Requirements for Safety<br>• IEC 60601-1-2:2014 Interpretation, Medical electrical equipment - Part 1-2: Collateral standard: Electromagnetic compatibility - Requirements and tests<br>• IEC 60601-1-6 Edition 3.1 2013-10, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability<br>• IEC 60601-1-8 Edition 2.1 2012-11, Medical electrical equipment - Part 1-8: | Substantially Equivalent – the CARESCAPE R860 with v11 software complies with the latest versions of applicable FDA-recognized standards. Therefore, this product is substantially equivalent to the predicate CARESCAPE R860 with v10 software. |

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| • ISO 80601-2-12:2011 + Technical<br>Corrigendum 1, Medical electrical<br>equipment, Part 2-12: Particular<br>requirements for basic safety and essential<br>performance of critical care ventilators<br>• IEC 62366:2008, Medical devices -<br>Application of usability engineering to<br>medical devices<br>• ISO 5356-1 Third edition 2004-05-15<br>Anaesthetic and respiratory equipment -<br>Conical connectors: Part 1: Cones and<br>sockets | essential performance - Collateral Standard:<br>General requirements, tests and guidance for<br>alarm systems in medical electrical<br>equipment and medical electrical systems<br>• ISO 80601-2-12 First edition 2011-04-15,<br>Medical electrical equipment - Part 2-12:<br>Particular requirements for the safety of<br>lung ventilators - Critical care ventilators<br>[Including: Technical Corrigendum 1<br>(2011)]<br>• IEC 62366-1 Edition 1.0 2015-02 Medical<br>devices - Part 1: Application of usability<br>engineering to medical devices [Including<br>CORRIGENDUM 1 (2016)]<br>• IEC 62304 Edition 1.1 2015-06<br>CONSOLIDATED VERSION Medical<br>device software - Software life cycle<br>processes<br>• ISO 18562-1 First edition 2017-03<br>Biocompatibility evaluation of breathing gas<br>pathways in healthcare applications - Part 1:<br>Evaluation and testing within a risk<br>management process<br>• ISO 18562-2 First edition 2017-03<br>Biocompatibility evaluation of breathing gas<br>pathways in healthcare applications - Part 2:<br>Tests for emissions of particulate matter<br>• ISO 18562-3 First edition 2017-03<br>Biocompatibility evaluation of breathing gas<br>pathways in healthcare applications - Part 3:<br>Tests for emissions of volatile organic<br>compounds<br>• ISO 5356-1 Third edition 2004-05-15<br>Anaesthetic and respiratory equipment - |
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| | | Conical connectors: Part 1: Cones and<br>sockets<br>• AIM 7351731 Rev. 2.00 2017-02-23<br>Medical Electrical Equipment and System<br>Electromagnetic Immunity Test for<br>Exposure to Radio Frequency Identification<br>Readers - An AIM Standard | |
|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Energy<br>delivered | Air and Oxygen | Air and Oxygen | Identical to the predicate CARESCAPE R860<br>with v10 software |
| Ventilation<br>Modes | 1.Volume Control (A/C VC) | 1.Volume Control (A/C VC) | Identical to CARESCAPE R860 with v10<br>software.<br>No new modes of ventilation are introduced to<br>the CARESCAPE R860 with the v11 software.<br>Note that a new breathing support mode, O2<br>Therapy is introduced. As this is not a<br>ventilation mode, it is discussed separately (see<br>below). |
| | 2.Pressure Control (A/C PC) | 2.Pressure Control (A/C PC) | |
| | 3.Pressure Regulated, Volume Control (A/C<br>PRVC) | 3.Pressure Regulated, Volume Control (A/C<br>PRVC) | |
| | 4.Synchronized Intermittent Mandatory<br>Ventilation, Volume Control (SIMV VC) | 4.Synchronized Intermittent Mandatory<br>Ventilation, Volume Control (SIMV VC) | |
| | 5.Synchronized Intermittent Mandatory<br>Ventilation, Pressure Control (SIMV PC) | 5.Synchronized Intermittent Mandatory<br>Ventilation, Pressure Control (SIMV PC) | |
| | 6.Synchronized Intermittent Mandatory<br>Ventilation, Pressure Regulated Volume<br>Control (SIMV-PRVC) | 6.Synchronized Intermittent Mandatory<br>Ventilation, Pressure Regulated Volume<br>Control (SIMV-PRVC) | |
| | 7.BiLevel Airway Pressure Ventilation<br>(BiLevel) | 7.BiLevel Airway Pressure Ventilation<br>(BiLevel) | |
| | 8. BiLevel Airway Pressure Ventilation<br>Volume Guarantee (BiLevel VG) | 8. BiLevel Airway Pressure Ventilation<br>Volume Guarantee (BiLevel VG) | |
| | 9.Constant Positive Airway Pressure/Pressure<br>Support (CPAP/PS) | 9.Constant Positive Airway Pressure/Pressure<br>Support (CPAP/PS) | |
| | 10.Apnea backup (available in SIMV VC,<br>SIMV PC, SIMV PRVC, BiLevel VG,<br>BiLevel, APRV, CPAP/PS, and VS) | 10.Apnea backup (available in SIMV VC,<br>SIMV PC, SIMV PRVC, BiLevel VG,<br>BiLevel, APRV, CPAP/PS, and VS) | |
| | 11.Noninvasive ventilation (NIV) (not<br>available in neonatal mode) | 11.Noninvasive ventilation (NIV) (not<br>available in neonatal mode) | |
| | 12.Infant Nasal CPAP (nCPAP) | 12.Infant Nasal CPAP (nCPAP) | |
| 13. Volume Support (VS)<br>14. Airway Pressure Release Ventilation (APRV)<br>15. Spontaneous Breathing Trial (SBT) | 13. Volume Support (VS)<br>14. Airway Pressure Release Ventilation (APRV)<br>15. Spontaneous Breathing Trial (SBT) | Substantially equivalent, refer to the table below for substantial equivalence comparison to the reference device, Hamilton G5. | |
| | O2 Therapy<br><br>The O2 Therapy mode is available for adult and pediatric patients weighing greater than 10kg. | | |
| | n/a | | |
| Breathing<br>Support Mode | | | |
| Software | Currently released software | Updated software which includes modifications to:<br>- Add O2 Therapy (high flow oxygen therapy)<br>- Minor user-configurable changes to ventilator options<br>- Upgraded operating system of the display software including cybersecurity enhancements<br>- Improved Checkout routine | Substantially equivalent – the CARESCAPE R860 with v11 software incoprorates the new High Flow O2 Therapy feature, along with several minor changes to the device software and hardware. 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. The modifications do not affect the intended use, nor do they significantly affect the technological characteristics of the device. The features of the CARESCAPE R860 are substantially equivalent to the predicate. |
| Hardware<br>Component<br>Updates | As cleared under K142679 | Alternative versions of previously cleared components have been introduced and reviewed under this 510(k). The alternative versions continue to provide mechanical ventilation and ventilatory support to patients, and are substantially equilvanet to those on the existing CARESCAPE R860 as cleared under K142679. | 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. |

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| Substantial Equivalence to the reference device, Hamilton G5 | | | | | | |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Specification | Reference Device | Proposed | Discussion of Differences | | | |
| | Hamilton G5 | CARESCAPE R860 with v11 software |…