(268 days)
No
The summary describes a microprocessor-based, electronically controlled, pneumatically driven ventilator with integrated monitoring and various ventilation modes. It mentions "clinical decision support" but does not provide any details suggesting the use of AI or ML algorithms for this support or any other function. The testing described is standard verification and validation, not performance studies typical for AI/ML devices.
Yes
The device is a ventilator designed to provide mechanical ventilation or support, which directly treats patients and provides therapy.
No
Explanation: The device is described as a mechanical ventilator designed to provide ventilation support and monitoring (FiO2, airway pressure, flow, volume). While it monitors physiological parameters, its primary function is therapeutic (ventilation), not diagnostic (identifying or characterizing a disease or condition). The text explicitly states, "The CARESCAPE R860 ventilator is not a pulmonary function calculation device."
No
The device is described as a microprocessor based, electronically controlled, pneumatically driven ventilator, which clearly indicates it includes significant hardware components beyond just software.
Based on the provided text, the CARESCAPE R860 ventilator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed to provide mechanical ventilation or support to patients. This is a direct interaction with the patient's respiratory system, not the examination of specimens derived from the human body.
- Device Description: The description focuses on the mechanical and electronic functions of the ventilator, including ventilation modes, monitoring of physiological parameters (FiO2, airway pressure, flow, volume), and optional respiratory gas monitoring. These are all related to supporting and monitoring the patient's breathing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. The device's function is to assist with breathing, not to diagnose or monitor disease through in vitro testing.
Therefore, the CARESCAPE R860 ventilator falls under the category of a medical device that directly interacts with the patient for therapeutic and monitoring purposes, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
CBK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonatal, pediatric, and adult patients weighing 0.25 kg and above. For O2 Therapy, all adult patients and pediatric patients greater than 10 kg in weight.
Intended User / Care Setting
Only be used under the orders of a clinician. Designed for facility use, including within-facility transport.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 modified CARESCAPE R860 has been shown to comply with the applicable standards referenced 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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) |
| ☑ | ☐ |
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3
Section 5: 510(k) Summary
CARESCAPE R860
4
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 | ||
| Predicate | |||
| Device | 510(k) Number | K142679 | |
| Trade Name | CARESCAPE R860 | ||
| Product Code | CBK | ||
| Reference | |||
| Device | 510(k) Number | K193228 | |
| Trade Name | Hamilton G5 | ||
| Product Code | CBK, DQA | ||
| Intended Use/ | |||
| Indications for 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. |
In accordance with 21 CFR 807.92 the following summary of information is provided:
5
| 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)
6
- 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.
7
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 |
| software | |||
| Product Code | CBK | CBK | Identical to CARESCAPE R860 with v10 |
| software | |||
| Manufacturer | Datex-Ohmeda, Inc. | Datex-Ohmeda, Inc. | Identical to CARESCAPE R860 with v10 |
| software | |||
| Indications for | |||
| 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. | 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. | Substantially Equivalent – The indications for
use are essentially unchanged from the
predicate device CARESCAPE R860 with v10
software. The only addition to the intended use
language is to specifically identify that for the
newly added O2 Therapy feature, it is intended
only for adults and pediatric patients greater
than 10 kg in weight. |
| | Not all features are available for all patient
types or product configurations. | 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 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 |
| Patient
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.
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
The specific patient population for O2 therapy was added for additional clarity. |
| Environment
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
met | • 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. |
8
9
| • ISO 80601-2-12:2011 + Technical
Corrigendum 1, Medical electrical
equipment, Part 2-12: Particular
requirements for basic safety and essential
performance of critical care ventilators
• IEC 62366:2008, Medical devices -
Application of usability engineering to
medical devices
• ISO 5356-1 Third edition 2004-05-15
Anaesthetic and respiratory equipment -
Conical connectors: Part 1: Cones and
sockets | essential performance - Collateral Standard:
General requirements, tests and guidance for
alarm systems in medical electrical
equipment and medical electrical systems
• ISO 80601-2-12 First edition 2011-04-15,
Medical electrical equipment - Part 2-12:
Particular requirements for the safety of
lung ventilators - Critical care ventilators
[Including: Technical Corrigendum 1
(2011)]
• IEC 62366-1 Edition 1.0 2015-02 Medical
devices - Part 1: Application of usability
engineering to medical devices [Including
CORRIGENDUM 1 (2016)]
• IEC 62304 Edition 1.1 2015-06
CONSOLIDATED VERSION Medical
device software - Software life cycle
processes
• ISO 18562-1 First edition 2017-03
Biocompatibility evaluation of breathing gas
pathways in healthcare applications - Part 1:
Evaluation and testing within a risk
management process
• ISO 18562-2 First edition 2017-03
Biocompatibility evaluation of breathing gas
pathways in healthcare applications - Part 2:
Tests for emissions of particulate matter
• ISO 18562-3 First edition 2017-03
Biocompatibility evaluation of breathing gas
pathways in healthcare applications - Part 3:
Tests for emissions of volatile organic
compounds
• ISO 5356-1 Third edition 2004-05-15
Anaesthetic and respiratory equipment - |
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
10
| | | Conical connectors: Part 1: Cones and
sockets
• AIM 7351731 Rev. 2.00 2017-02-23
Medical Electrical Equipment and System
Electromagnetic Immunity Test for
Exposure to Radio Frequency Identification
Readers - An AIM Standard | |
|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Energy
delivered | Air and Oxygen | Air and Oxygen | Identical to the predicate CARESCAPE R860
with v10 software |
| Ventilation
Modes | 1.Volume Control (A/C VC) | 1.Volume Control (A/C VC) | Identical to CARESCAPE R860 with v10
software.
No new modes of ventilation are introduced to
the CARESCAPE R860 with the v11 software.
Note that a new breathing support mode, O2
Therapy is introduced. As this is not a
ventilation mode, it is discussed separately (see
below). |
| | 2.Pressure Control (A/C PC) | 2.Pressure Control (A/C PC) | |
| | 3.Pressure Regulated, Volume Control (A/C
PRVC) | 3.Pressure Regulated, Volume Control (A/C
PRVC) | |
| | 4.Synchronized Intermittent Mandatory
Ventilation, Volume Control (SIMV VC) | 4.Synchronized Intermittent Mandatory
Ventilation, Volume Control (SIMV VC) | |
| | 5.Synchronized Intermittent Mandatory
Ventilation, Pressure Control (SIMV PC) | 5.Synchronized Intermittent Mandatory
Ventilation, Pressure Control (SIMV PC) | |
| | 6.Synchronized Intermittent Mandatory
Ventilation, Pressure Regulated Volume
Control (SIMV-PRVC) | 6.Synchronized Intermittent Mandatory
Ventilation, Pressure Regulated Volume
Control (SIMV-PRVC) | |
| | 7.BiLevel Airway Pressure Ventilation
(BiLevel) | 7.BiLevel Airway Pressure Ventilation
(BiLevel) | |
| | 8. BiLevel Airway Pressure Ventilation
Volume Guarantee (BiLevel VG) | 8. BiLevel Airway Pressure Ventilation
Volume Guarantee (BiLevel VG) | |
| | 9.Constant Positive Airway Pressure/Pressure
Support (CPAP/PS) | 9.Constant Positive Airway Pressure/Pressure
Support (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) (not
available in neonatal mode) | 11.Noninvasive ventilation (NIV) (not
available 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 Therapy
The O2 Therapy mode is available for adult and pediatric patients weighing greater than 10kg. | | |
| | n/a | | |
| Breathing
Support 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. |
| Hardware
Component
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. |
11
12
| 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 set | ||||||
| FiO2 and flow rate through an unsealed | ||||||
| heated patient interface. | O2 Therapy (High Flow Oxygen therapy) | |||||
| delivers heated and humidified gas at a set | ||||||
| FiO2 and flow rate through an unsealed | ||||||
| heated patient interface. | ||||||
| Circuits: intended to be delivered | ||||||
| through a single-limb or dual-limb | ||||||
| heated circuit | Substantially equivalent - High Flow Oxygen | |||||
| (O2) Therapy is being added to the | ||||||
| CARESCAPE R860. The High Flow Oxygen | ||||||
| therapy feature is substantially equivalent to | ||||||
| the predicate Hamilton G5 ventilator. The | ||||||
| technology for the delivery of High Flow | ||||||
| Oxygen therapy, which is delivery of a set | ||||||
| oxygen concentration (FiO2) at a fixed flow | ||||||
| rate, is not novel or new to the ventilator. The | ||||||
| intended patient for High Flow Oxygen | ||||||
| therapy on both products is a spontaneously | ||||||
| breathing patient. A heater/humidifier is | ||||||
| required for the delivery of High Flow | ||||||
| Oxygen from both ventilators to improve | ||||||
| patient comfort, due to the drying nature of | ||||||
| oxygen. The O2 Therapy mode is available | ||||||
| for adult and pediatric patients weighing | ||||||
| greater than 10kg. It is not indicated for | ||||||
| neonates. 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. The O2 Therapy feature on the | ||||||
| CARESCAPE R860 does not differ in its | ||||||
| technological characteristics, function, or | ||||||
| performance and therefore, it is substantially | ||||||
| equivalent. |
13
| 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 Flow | |||
| Oxygen | |||
| Therapy Flow | |||
| Rate | Adult/Ped: 1 to 60 liters/minute | 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 | |||
| Oxygen | |||
| Therapy FiO2 | |||
| (%) | Adult/Ped: 21% to 100% | Adult/Ped: 21% to 100% | Identical to the Hamilton G5 |
14
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 .
15
- 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.