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 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)
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.

AI/ML Overview

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.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.

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)
☑	☐

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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: +1 (608) 515-3077
	Fax: +1 (608) 646-7464
	Email: monica.morrison@ge.com
Secondary Contact Person:	Kimberly Mangum
	Datex-Ohmeda, Inc.
	3030 Ohmeda Drive
	Madison, WI 53707-7550
	Telephone: +1 (267) 400-5180
	Email: kimberly.mangum@ge.com
Device Trade Name:	CARESCAPE R860
Common/Usual Name:	Ventilator, Continuous
Classification Names:	Ventilator, continuous, facility use
	Product Code:	CBK
PredicateDevice	510(k) Number	K142679
	Trade Name	CARESCAPE R860
	Product Code	CBK
ReferenceDevice	510(k) Number	K193228
	Trade Name	Hamilton G5
	Product Code	CBK, DQA
Intended Use/Indications for Use:		The CARESCAPE R860 ventilator is designed to providemechanical ventilation or support to neonatal, pediatric,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 microprocessorbased, electronically controlled, pneumatically drivenventilator that includes integrated monitoring of FiO2,airway pressure, flow, and volume. Additional respiratorygas monitoring capabilities are supported through the useof optional GE patient monitoring modules.
Not all features are available for all patient types orproduct configurations.
O2 Therapy is intended to be used for all adult patientsand pediatric patients greater than 10 kg in weight.
The CARESCAPE R860 ventilator is not a pulmonaryfunction calculation device.
The system is designed for facility use, including within-facility transport, and should only be used under the ordersof a clinician.

Device Description:

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.

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 v10software
Product Code	CBK	CBK	Identical to CARESCAPE R860 with v10software
Manufacturer	Datex-Ohmeda, Inc.	Datex-Ohmeda, Inc.	Identical to CARESCAPE R860 with v10software
Indications forUse	The CARESCAPE R860 ventilator is designedto provide mechanical ventilation or support toneonatal, pediatric, and adult patients weighing0.25 kg and above.The CARESCAPE R860 ventilator is amicroprocessor based, electronicallycontrolled, pneumatically driven ventilator thatincludes integrated monitoring of FiO2, airwaypressure, flow, and volume. Additionalrespiratory gas monitoring capabilities aresupported through the use of optional GEpatient monitoring modules.	The CARESCAPE R860 ventilator is designedto provide mechanical ventilation or support toneonatal, pediatric, and adult patients weighing0.25 kg and above.The CARESCAPE R860 ventilator is amicroprocessor based, electronicallycontrolled, pneumatically driven ventilator thatincludes integrated monitoring of FiO2, airwaypressure, flow, and volume. Additionalrespiratory gas monitoring capabilities aresupported through the use of optional GEpatient monitoring modules.	Substantially Equivalent – The indications foruse are essentially unchanged from thepredicate device CARESCAPE R860 with v10software. The only addition to the intended uselanguage is to specifically identify that for thenewly added O2 Therapy feature, it is intendedonly for adults and pediatric patients greaterthan 10 kg in weight.
	Not all features are available for all patienttypes or product configurations.	Not all features are available for all patienttypes or product configurations.
	The CARESCAPE R860 ventilator is not a pulmonary function calculation device.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.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.
Contraindications	None	None	Identical to CARESCAPE R860 with v10 software
PatientPopulation	Adult, pediatric, infant and neonatal patients weighing 0.25 kg and above	Adult, pediatric infant and neonatal patients weighing 0.25 kg and above.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 populationThe specific patient population for O2 therapy was added for additional clarity.
Environmentof 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 standardsmet	• IEC 60601-1:2005 + A1 (2012) Medical Electrical Equipment – Part 1: General Requirements for Safety• IEC 60601-1-2:2007 + 2010 Interpretation, Medical electrical equipment - Part 1-2: Collateral standard: Electromagnetic compatibility - Requirements and tests• IEC 60601-1-6: 2010, Medical electrical equipment - Part 1-6: Collateral Standard: Usability• 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• IEC 60601-1-2:2014 Interpretation, Medical electrical equipment - Part 1-2: Collateral standard: Electromagnetic compatibility - Requirements and tests• 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• 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 + TechnicalCorrigendum 1, Medical electricalequipment, Part 2-12: Particularrequirements for basic safety and essentialperformance of critical care ventilators• IEC 62366:2008, Medical devices -Application of usability engineering tomedical devices• ISO 5356-1 Third edition 2004-05-15Anaesthetic and respiratory equipment -Conical connectors: Part 1: Cones andsockets	essential performance - Collateral Standard:General requirements, tests and guidance foralarm systems in medical electricalequipment and medical electrical systems• ISO 80601-2-12 First edition 2011-04-15,Medical electrical equipment - Part 2-12:Particular requirements for the safety oflung ventilators - Critical care ventilators[Including: Technical Corrigendum 1(2011)]• IEC 62366-1 Edition 1.0 2015-02 Medicaldevices - Part 1: Application of usabilityengineering to medical devices [IncludingCORRIGENDUM 1 (2016)]• IEC 62304 Edition 1.1 2015-06CONSOLIDATED VERSION Medicaldevice software - Software life cycleprocesses• ISO 18562-1 First edition 2017-03Biocompatibility evaluation of breathing gaspathways in healthcare applications - Part 1:Evaluation and testing within a riskmanagement process• ISO 18562-2 First edition 2017-03Biocompatibility evaluation of breathing gaspathways in healthcare applications - Part 2:Tests for emissions of particulate matter• ISO 18562-3 First edition 2017-03Biocompatibility evaluation of breathing gaspathways in healthcare applications - Part 3:Tests for emissions of volatile organiccompounds• ISO 5356-1 Third edition 2004-05-15Anaesthetic and respiratory equipment -
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• ISO 80601-2-12:2011 + TechnicalCorrigendum 1, Medical electricalequipment, Part 2-12: Particularrequirements for basic safety and essentialperformance of critical care ventilators• IEC 62366:2008, Medical devices -Application of usability engineering tomedical devices• ISO 5356-1 Third edition 2004-05-15Anaesthetic and respiratory equipment -Conical connectors: Part 1: Cones andsockets

essential performance - Collateral Standard:General requirements, tests and guidance foralarm systems in medical electricalequipment and medical electrical systems• ISO 80601-2-12 First edition 2011-04-15,Medical electrical equipment - Part 2-12:Particular requirements for the safety oflung ventilators - Critical care ventilators[Including: Technical Corrigendum 1(2011)]• IEC 62366-1 Edition 1.0 2015-02 Medicaldevices - Part 1: Application of usabilityengineering to medical devices [IncludingCORRIGENDUM 1 (2016)]• IEC 62304 Edition 1.1 2015-06CONSOLIDATED VERSION Medicaldevice software - Software life cycleprocesses• ISO 18562-1 First edition 2017-03Biocompatibility evaluation of breathing gaspathways in healthcare applications - Part 1:Evaluation and testing within a riskmanagement process• ISO 18562-2 First edition 2017-03Biocompatibility evaluation of breathing gaspathways in healthcare applications - Part 2:Tests for emissions of particulate matter• ISO 18562-3 First edition 2017-03Biocompatibility evaluation of breathing gaspathways in healthcare applications - Part 3:Tests for emissions of volatile organiccompounds• ISO 5356-1 Third edition 2004-05-15Anaesthetic and respiratory equipment -

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		Conical connectors: Part 1: Cones andsockets• AIM 7351731 Rev. 2.00 2017-02-23Medical Electrical Equipment and SystemElectromagnetic Immunity Test forExposure to Radio Frequency IdentificationReaders - An AIM Standard
Energydelivered	Air and Oxygen	Air and Oxygen	Identical to the predicate CARESCAPE R860with v10 software
VentilationModes	1.Volume Control (A/C VC)	1.Volume Control (A/C VC)	Identical to CARESCAPE R860 with v10software.No new modes of ventilation are introduced tothe CARESCAPE R860 with the v11 software.Note that a new breathing support mode, O2Therapy is introduced. As this is not aventilation mode, it is discussed separately (seebelow).
	2.Pressure Control (A/C PC)	2.Pressure Control (A/C PC)
	3.Pressure Regulated, Volume Control (A/CPRVC)	3.Pressure Regulated, Volume Control (A/CPRVC)
	4.Synchronized Intermittent MandatoryVentilation, Volume Control (SIMV VC)	4.Synchronized Intermittent MandatoryVentilation, Volume Control (SIMV VC)
	5.Synchronized Intermittent MandatoryVentilation, Pressure Control (SIMV PC)	5.Synchronized Intermittent MandatoryVentilation, Pressure Control (SIMV PC)
	6.Synchronized Intermittent MandatoryVentilation, Pressure Regulated VolumeControl (SIMV-PRVC)	6.Synchronized Intermittent MandatoryVentilation, Pressure Regulated VolumeControl (SIMV-PRVC)
	7.BiLevel Airway Pressure Ventilation(BiLevel)	7.BiLevel Airway Pressure Ventilation(BiLevel)
	8. BiLevel Airway Pressure VentilationVolume Guarantee (BiLevel VG)	8. BiLevel Airway Pressure VentilationVolume Guarantee (BiLevel VG)
	9.Constant Positive Airway Pressure/PressureSupport (CPAP/PS)	9.Constant Positive Airway Pressure/PressureSupport (CPAP/PS)
	10.Apnea backup (available in SIMV VC,SIMV PC, SIMV PRVC, BiLevel VG,BiLevel, APRV, CPAP/PS, and VS)	10.Apnea backup (available in SIMV VC,SIMV PC, SIMV PRVC, BiLevel VG,BiLevel, APRV, CPAP/PS, and VS)
	11.Noninvasive ventilation (NIV) (notavailable in neonatal mode)	11.Noninvasive ventilation (NIV) (notavailable in neonatal mode)
	12.Infant Nasal CPAP (nCPAP)	12.Infant Nasal CPAP (nCPAP)
13. Volume Support (VS)14. Airway Pressure Release Ventilation (APRV)15. Spontaneous Breathing Trial (SBT)	13. Volume Support (VS)14. Airway Pressure Release Ventilation (APRV)15. Spontaneous Breathing Trial (SBT)	Substantially equivalent, refer to the table below for substantial equivalence comparison to the reference device, Hamilton G5.
	O2 TherapyThe O2 Therapy mode is available for adult and pediatric patients weighing greater than 10kg.
	n/a
BreathingSupport Mode
Software	Currently released software	Updated software which includes modifications to:- Add O2 Therapy (high flow oxygen therapy)- Minor user-configurable changes to ventilator options- Upgraded operating system of the display software including cybersecurity enhancements- 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.
HardwareComponentUpdates	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
	K193228	(this 510(k))
O2 Therapy	HFO therapy (High Flow Oxygen therapy)delivers heated and humidified gas at a setFiO2 and flow rate through an unsealedheated patient interface.	O2 Therapy (High Flow Oxygen therapy)delivers heated and humidified gas at a setFiO2 and flow rate through an unsealedheated patient interface.Circuits: intended to be deliveredthrough a single-limb or dual-limbheated circuit	Substantially equivalent - High Flow Oxygen(O2) Therapy is being added to theCARESCAPE R860. The High Flow Oxygentherapy feature is substantially equivalent tothe predicate Hamilton G5 ventilator. Thetechnology for the delivery of High FlowOxygen therapy, which is delivery of a setoxygen concentration (FiO2) at a fixed flowrate, is not novel or new to the ventilator. Theintended patient for High Flow Oxygentherapy on both products is a spontaneouslybreathing patient. A heater/humidifier isrequired for the delivery of High FlowOxygen from both ventilators to improvepatient comfort, due to the drying nature ofoxygen. The O2 Therapy mode is availablefor adult and pediatric patients weighinggreater than 10kg. It is not indicated forneonates. Verification evidence demonstratesthat the performance and specifications of theO2 Therapy function on the CARESCAPER860 are equivalent to those on the HamiltonG5. The O2 Therapy feature on theCARESCAPE R860 does not differ in itstechnological characteristics, function, orperformance and therefore, it is substantiallyequivalent.

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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
	K193228	(this 510(k))
High FlowOxygenTherapy FlowRate	Adult/Ped: 1 to 60 liters/minute	Adult/Ped: 2 to 60 liters/minute	Equivalent to the Hamilton G5. The flowrange was narrowed slightly (lower end of theflow rate is 2LPM instead of 1 LPM in theHamilton G5). This does not affect the safetyor performance of this feature. Testing hasbeen completed as documented in the 510(k)to demonstrate the device meets thesespecifications.
High FlowOxygenTherapy FiO2(%)	Adult/Ped: 21% to 100%	Adult/Ped: 21% to 100%	Identical to the Hamilton G5

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The CARESCAPE R860 ventilator has been thoroughly tested through verification of specifications and validation, including software validation, to ensure safe use of the device in its intended use environment. Verification of compliance with applicable standards has also been completed. The following quality assurance measures were applied during the development of the CARESCAPE R860 system:

. Risk Analysis
. Requirements/Specification Reviews
. Design Reviews
Safety and Performance Testing (Verification) ●
. Standards compliance (verification)
. User Requirements Testing (Validation)

Summary of Non-Clinical Tests:

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, which concluded that the CARESCAPE R860 is substantially equivalent to the predicate devices. 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 ventilator complies with the following applicable standards:

IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + A1:2012 ●
IEC 60601-1-2: 2014 ●
IEC 60601-1-6: 2010 + AMD:2013 ●
IEC 60601-1-8: 2006 +A1:2012 ●
ISO 80601-2-12: 2011 ●
. ISO 80601-2-55: 2018
IEC 62366: 2015 ●
IEC 62304: 2006 ●
ISO 18562-1: 2018
ISO 18562-2: 2018 .

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ISO 18562-3: 2018 ●
ISO 5356-1 .

The modified CARESCAPE R860 has been shown to comply with the applicable standards referenced above, and the device meets the specifications and user requirements.

Summary of Clinical Tests:

The subject of this premarket submission, CARESCPE R860, incorporates modifications to the predicate device, the legally marketed CARESCAPE R860 ventilator. These modifications did not require clinical studies to support substantial equivalence.

Conclusion:

Datex-Ohmeda, Inc., doing business as GE Healthcare, considers the CARESCAPE R860 with the changes proposed in this 510(k) submission to be substantially equivalent to the predicate device, the CARESCAPE R860. The summary above demonstrates that there are no new questions of safety or effectiveness for the CARESCAPE R860.

Regulation Number and Section

§ 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).