(473 days)
No
The document describes a complex anesthesia delivery and ventilation system with various modes and electronic controls, but it does not mention any use of AI or ML for decision-making, control, or analysis. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device provides ventilatory support and delivers inhalation anesthetics, which are forms of medical treatment and intervention aimed at improving patient health or mitigating disease.
No
The device is an anesthesia system designed for delivering inhalation anesthetics and ventilatory support, and while it involves monitoring patient parameters, its primary function is therapeutic (administering anesthesia and providing ventilatory support) rather than solely diagnostic. Its purpose is to deliver treatment and maintain vital functions during surgery, not to diagnose a condition.
No
The device description clearly outlines numerous hardware components including gas mixers, vaporizers, ventilators, a touchscreen interface, and physical connections for gases and cylinders. While it contains software, it is an integral part of a larger hardware system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide monitored anesthesia care, general inhalation anesthesia, and ventilatory support to patients. This involves delivering gases and controlling breathing, which are direct patient interventions.
- Device Description: The description details a system for mixing and delivering gases, providing ventilation, and monitoring physiological parameters like airway pressure and exhaled volume. It also mentions integrated respiratory gas monitoring, but this is a component that measures gases within the patient's breathing circuit, not analyzing samples taken from the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is entirely focused on supporting and controlling the patient's respiratory and anesthetic state during a medical procedure.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Carestation 750/750c does not fit this definition.
N/A
Intended Use / Indications for Use
The Carestation750/750c anesthesia systems are intended to provide monitored anesthesia care, general inhalation anesthesia and/ or ventilatory support to a wide range of patients (neonatal, pediatric, and adult). The anesthesia systems are suitable for use in a patient environment, such as hospitals, surgical centers, or clinics. The systems are intended to be operated by a clinician qualified in the administration of general anesthesia.
Product codes (comma separated list FDA assigned to the subject device)
BSZ
Device Description
The GE Carestation 750/750c anesthesia machines (Carestation 750 series) are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonate, pediatric, and adult). The anesthesia systems are suitable for use in a patient environment such as hospitals, surgical centers, or clinics. They represent one of the systems in a long line of products based on the Datex-Ohmeda Aestiva (K000706), Aespire View (K122445), Aisys CS2 (K170872), Avance CS2 (K131945), Carestation 620/650/650c (Carestation 600 series) (K151570) Anesthesia Systems. The Carestation 750 series anesthesia systems are intended to be operated by a clinician qualified in the administration of general anesthesia.
The Carestation 750/750c anesthesia systems combine advanced anesthesia delivery, patient monitoring. and care information management. The contemporary, compact design allows for easy mobility and addresses many ergonomic considerations including an effective cable management solution, aesthetic covers, and an expandable work surface area. Optional integrated features include auxiliary common gas outlet, auxiliary 02 outlet, auxiliary 02+Air outlet, suction control, and respiratory gas monitoring. The system provides integration of ventilation and gas delivery on a 15-inch color graphical touchscreen interface. This system also features electronic gas mixing of oxygen and a balance gas of either N2O or Air. The Carestation 750 series represents one of the systems in a long line of products based on the Datex-Ohmeda Aestiva (K000706), AespireView (K122445), Aisys CS2 (K170872), Avance CS2 (K131945), and Carestation 600 Series (K151570) Anesthesia Systems.
This anesthesia system is designed for mixing and delivering inhalation anesthetics (Isoflurane, Sevoflurane, or Desflurane), Air, O2, and N2O. This anesthesia system has Recruitment maneuvers, a feature to perform automated lung recruitment maneuver in a single step or in multi steps.
This anesthesia system uses electronic flow valve ventilation technology offering Volume Control Ventilation with tidal volume compensation and electronic PEEP. This technology also features Pressure Control Ventilation, optional Pressure Support Ventilation with an Apnea Backup (PSVPro) that is used for spontaneously breathing patients, Synchronized Intermittent Mandatory Ventilation (SIMV) modes, Pressure Control Ventilation-Volume Guarantee (PCVG), Continuous Positive Airway Pressure + Pressure Support Ventilation (CPAP + PSV), and VCV Cardiac Bypass. In Volume Control Ventilation, a patient can be ventilated using a minimal tidal volume of 20 ml. In Pressure Control Ventilation, volumes as low as 5 ml can be measured. These advanced features allow for the ventilation of a broad patient range. The device includes the following basic components:
The Carestation 750 series anesthesia systems supply set flows of medical gases to the breathing system using an electronic gas mixer (O2 with Air or O2 with N2O). Gas flows are adjusted by the user on the touchscreen, the flows are displayed on the system graphical user interface assembly as numerical digits and as electronic representations of flow meters. The system provides an option for auxiliary mixed Oxygen + Air flow delivery where 02 with Air are blended and delivered to an auxiliary port used to support spontaneously breathing patients using a nasal cannula. An optional auxiliary O2 supply includes a separate O2 flow tube and needle valve flow control that delivers O2 flow to an auxiliary port used to support spontaneously breathing patients using a nasal cannula. The gas flow from the optional auxiliary O2 subsystem does not flow through the electronic gas mixer.
The Carestation 750 series models include up to 3 breathing gases with O2 and Air as standard, and N20 as an optional breathing gas. The systems include two vaporizer positions compatible with, Isoflurane, Sevotlurane, and Desflurane vaporizers. The Carestation 750 is available with up to three back-up gas cylinder connections. The Carestation 750 series systems are also available in pendant (Carestation 750c) models.
The system uses touchscreen technology, hard keys, and a Comwheel to access system functions, menus, and settings on a 15'' color graphical user interface assembly (aka display). The graphical user interface assembly is mounted on an arm on the left side of the machine. It can be rotated via the arm toward, or away from, the system to adjust the horizontal position. The arm is available allowing the display to be tilted up or down to adjust the vertical viewing angle or be tilted left or right to adjust the horizontal position of the display. An optional arm can be raised/lowered and rotated 360 degrees. A split screen field can be set to show gas trends, Spirometry loops, a Paw gauge, airway compliance, and optional ecoFlow information. If none is selected, the waveforms expand to fill the split screen area.
The Carestation 750 series systems accept Tec 7, and Tec 820/850 series vaporizers on a 2-position Selectatec manifold. Safety features and devices within the systems are designed to decrease the risk of hypoxic mixtures, multiple anesthetic agent mixtures, complete power failure, or sudden gas supply The Carestation 750 series systems are available with optional integrated respiratory gas failures. monitoring which can be physically integrated into the system, receive electronic power from the Carestation 750/750c, and communicate measured values to the Carestation 750/750c for display on the system graphical user interface assembly. When supplied as an option, integrated respiratory gas monitoring is provided via the GE CARESCAPE series (EsCAiO or E-sCAiOV) respiratory airway modules (GE Healthcare Finland Oy, CE 0537) which is identical to the module used on Avance CS2.
The Anesthesia Ventilator used in the Carestation 750 series is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. This version of the GE 7900 ventilator is equipped with a built-in system for monitoring inspired oxygen (using an optional 02 cell or optional integrated gas module), patient airway pressure, and exhaled volume. Flow sensors in the breathing circuit are used to monitor and control patient ventilation.
This allows for the compensation of gas and tubing compression losses, fresh gas contribution, and small gas leakage from the breathing absorber, bellows, and pneumatic system connections. User settings and microprocessor calculations control breathing patterns. The user interface keeps ventilation settings in memory. The user may change settings with a simple ventilation parameter setting sequence. A bellows contains breathing gasses to be delivered to the patient and provides a barrier keeping patient gas separate from the ventilatory drive gas. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that occurs is outward from the patent breathing circuit.
This ventilator comes with a standard ventilation mode as well as optional ventilation modes.
Standard ventilation modes:
VCV (Time Cycled, Volume Controlled Ventilation)
PCV (Time Cycled, Pressure Control Ventilation)
Optional ventilation modes:
VCV-SIMV (Synchronized Intermittent Mandatory Ventilation Volume Control)
PCV-SIMV (Synchronized Intermittent Mandatory Ventilation Pressure Control)
PSVPro (Pressure supported ventilation with apnea backup)
PCV-VG (Pressure Controlled ventilation - Volume Guaranteed)
PCV-VG-SIMV (Synchronized Intermittent Mandatory Ventilation, Pressure Controlled ventilation - Volume Guaranteed)
CPAP+PSV (Continuous Positive Airway Pressure/Pressure Support)
The system can include an internal, factory installed, suction regulator and control visible from the front of the machine. It can mount different monitors using an arm or shelf mounts. The mounting is achieved through a combination of GE Healthcare adapters and other third-party mounts, including one that allows for the physical integration of the GE Monitor Series B650 (K102239). The Carestation 750 system also includes an optional cable management solution, which can help user to manage the various cables attached to the system.
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
Intended User / Care Setting
clinician qualified in the administration of general anesthesia / hospitals, surgical centers, or clinics.
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)
The Carestation 750/750c has been thoroughly tested through verifications and validation, including software validation for a major level of concern software. Verification of compliance with applicable voluntary standards has also been made to support safe use of the device in its intended environment. The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification) including but not limited to accuracy testing, environmental testing, tip testing and threshold testing
- Biocompatibility Testing including particulate matter (PM), Volatile Organic Compounds (VOC) and leachables in condensate (Classified as Limit exposure based on ISO18562-1:2017)
- Safety testing (Verification) including electrical safety and electromagnetic compatibility testing
- Simulated use testing (Validation)
Bench testing was performed to establish substantial equivalence of the Carestation 750/750c. Verification and validation testing was performed according to predetermined acceptance criteria, which concluded that the Carestation 750/750c is substantially equivalent to the predicate Carestation 620/650/650c.
Clinical Testing: The Carestation 750/750c anesthesia machines incorporate modifications to the predicate Carestation 620/650/650c. These modifications did not require clinical testing. The changes made were completely evaluated by non-clinical design verification and validation tests to verify and validate the safety and functionality of the anesthesia machines.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the words "U.S. Food & Drug Administration" in a smaller font size.
March 28, 2023
Datex-Ohmeda, Inc. Kimberly Mangum Regulatory Affairs Director 3030 Ohmeda Drive, PO Box 7550 Madison, Wisconsin 53707-7550
Re: K213867
Trade/Device Name: Carestation 750/750c Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine For Anesthesia Or Analgesia Regulatory Class: Class II Product Code: BSZ Dated: February 17, 2023 Received: February 22, 2023
Dear Kimberly Mangum:
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/ofdocs/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,
James J. Lee -S
James J. Lee, Ph.D. Division 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Carestation 750/750c
Indications for Use (Describe)
The Carestation750/750c anesthesia systems are intended to provide monitored anesthesia care, general inhalation anesthesia and/ or ventilatory support to a wide range of patients (neonatal, pediatric, and adult). The anesthesia systems are suitable for use in a patient environment, such as hospitals, surgical centers, or clinics. The systems are intended to be operated by a clinician qualified in the administration of general anesthesia.
| 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
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Premarket Notification 510(k) Summary
As required by section 807.92 Carestation 750/750c GENERAL COMPANY INFORMATION as required by 807.92(a)(1) K213867
I. Submitter
Company Name/Address/Phone/Fax:
Mailing Address: Datex-Ohmeda, Inc. 3030 Ohmeda Drive PO Box 7550 Madison, WI 53707-7550 USA
Physical Address: Datex-Ohmeda, Inc. 3030 Ohmeda Drive Madison, WI 53718 USA Tel: 608-334-4281
Name of Contact:
Kimberly Mangum Regulatory Affairs Director - Anesthesia and Respiratory Care (ARC) Patient Care Solutions - GE HealthCare Kimberly.Mangum@ge.com Phone: 267-400-5180 www.gehealthcare.com
Date Prepared: March 24, 2023
II. DEVICE
Name of Device: Carestation 750/750c Common or Usual Name: Gas Machine, Anesthesia (21 CFR 868.5160) Regulatory Class: II Product Code: BSZ
III. PREDICATE DEVICE
Primary Predicate: Carestation 620/650/650c, K151570 Reference Device: Avance CS2, K131945
DEVICE DESCRIPTION IV.
The GE Carestation 750/750c anesthesia machines (Carestation 750 series) are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonate, pediatric, and adult). The
4
anesthesia systems are suitable for use in a patient environment such as hospitals, surgical centers, or clinics. They represent one of the systems in a long line of products based on the Datex-Ohmeda Aestiva (K000706), Aespire View (K122445), Aisys CS2 (K170872), Avance CS2 (K131945), Carestation 620/650/650c (Carestation 600 series) (K151570) Anesthesia Systems. The Carestation 750 series anesthesia systems are intended to be operated by a clinician qualified in the administration of general anesthesia.
The Carestation™ 750/750c anesthesia systems combine advanced anesthesia delivery, patient monitoring. and care information management. The contemporary, compact design allows for easy mobility and addresses many ergonomic considerations including an effective cable management solution, aesthetic covers, and an expandable work surface area. Optional integrated features include auxiliary common gas outlet, auxiliary 02 outlet, auxiliary 02+Air outlet, suction control, and respiratory gas monitoring. The system provides integration of ventilation and gas delivery on a 15-inch color graphical touchscreen interface. This system also features electronic gas mixing of oxygen and a balance gas of either N2O or Air. The Carestation 750 series represents one of the systems in a long line of products based on the Datex-Ohmeda Aestiva (K000706), AespireView (K122445), Aisys CS2 (K170872), Avance CS2 (K131945), and Carestation 600 Series (K151570) Anesthesia Systems.
This anesthesia system is designed for mixing and delivering inhalation anesthetics (Isoflurane, Sevoflurane, or Desflurane), Air, O2, and N2O. This anesthesia system has Recruitment maneuvers, a feature to perform automated lung recruitment maneuver in a single step or in multi steps.
This anesthesia system uses electronic flow valve ventilation technology offering Volume Control Ventilation with tidal volume compensation and electronic PEEP. This technology also features Pressure Control Ventilation, optional Pressure Support Ventilation with an Apnea Backup (PSVPro™) that is used for spontaneously breathing patients, Synchronized Intermittent
Mandatory Ventilation (SIMV) modes, Pressure Control Ventilation-Volume Guarantee (PCVG), Continuous Positive Airway Pressure + Pressure Support Ventilation (CPAP + PSV), and VCV Cardiac Bypass. In Volume Control Ventilation, a patient can be ventilated using a minimal tidal volume of 20 ml. In Pressure Control Ventilation, volumes as low as 5 ml can be measured. These advanced features allow for the ventilation of a broad patient range. The device includes the following basic components:
The Carestation 750 series anesthesia systems supply set flows of medical gases to the breathing system using an electronic gas mixer (O2 with Air or O2 with N2O). Gas flows are adjusted by the user on the touchscreen, the flows are displayed on the system graphical user interface assembly as numerical digits and as electronic representations of flow meters. The system provides an option for auxiliary mixed Oxygen + Air flow delivery where 02 with Air are blended and delivered to an auxiliary port used to support spontaneously breathing patients using a nasal cannula. An optional auxiliary O2 supply includes a separate O2 flow tube and needle valve flow control that delivers O2 flow to an auxiliary port used to support spontaneously breathing patients using a nasal cannula. The gas flow from the optional auxiliary O2 subsystem does not flow through the electronic gas mixer.
The Carestation 750 series models include up to 3 breathing gases with O2 and Air as standard, and N20 as an optional breathing gas. The systems include two vaporizer positions compatible with, Isoflurane, Sevotlurane, and Desflurane vaporizers. The Carestation 750 is available with up to three back-up gas cylinder connections. The Carestation 750 series systems are also available in pendant (Carestation 750c) models.
The system uses touchscreen technology, hard keys, and a Comwheel to access system functions, menus, and settings on a 15'' color graphical user interface assembly (aka display). The graphical user interface
5
assembly is mounted on an arm on the left side of the machine. It can be rotated via the arm toward, or away from, the system to adjust the horizontal position. The arm is available allowing the display to be tilted up or down to adjust the vertical viewing angle or be tilted left or right to adjust the horizontal position of the display. An optional arm can be raised/lowered and rotated 360 degrees. A split screen field can be set to show gas trends, Spirometry loops, a Paw gauge, airway compliance, and optional ecoFlow information. If none is selected, the waveforms expand to fill the split screen area.
The Carestation 750 series systems accept Tec 7, and Tec 820/850 series vaporizers on a 2position Selectatec manifold. Safety features and devices within the systems are designed to decrease the risk of hypoxic mixtures, multiple anesthetic agent mixtures, complete power failure, or sudden gas supply The Carestation 750 series systems are available with optional integrated respiratory gas failures. monitoring which can be physically integrated into the system, receive electronic power from the Carestation 750/750c, and communicate measured values to the Carestation 750/750c for display on the system graphical user interface assembly. When supplied as an option, integrated respiratory gas monitoring is provided via the GE CARESCAPE series (EsCAiO or E-sCAiOV) respiratory airway modules (GE Healthcare Finland Oy, CE 0537) which is identical to the module used on Avance CS2.
The Anesthesia Ventilator used in the Carestation 750 series is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. This version of the GE 7900 ventilator is equipped with a built-in system for monitoring inspired oxygen (using an optional 02 cell or optional integrated gas module), patient airway pressure, and exhaled volume. Flow sensors in the breathing circuit are used to monitor and control patient ventilation.
This allows for the compensation of gas and tubing compression losses, fresh gas contribution, and small gas leakage from the breathing absorber, bellows, and pneumatic system connections. User settings and microprocessor calculations control breathing patterns. The user interface keeps ventilation settings in memory. The user may change settings with a simple ventilation parameter setting sequence. A bellows contains breathing gasses to be delivered to the patient and provides a barrier keeping patient gas separate from the ventilatory drive gas. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that occurs is outward from the patent breathing circuit.
This ventilator comes with a standard ventilation mode as well as optional ventilation modes.
Standard ventilation modes:
- VCV (Time Cycled, Volume Controlled Ventilation) .
- . PCV (Time Cycled, Pressure Control Ventilation)
Optional ventilation modes:
- VCV-SIMV (Synchronized Intermittent Mandatory Ventilation Volume Control)
- . PCV-SIMV (Synchronized Intermittent Mandatory Ventilation Pressure Control)
- PSVPro (Pressure supported ventilation with apnea backup)
- . PCV-VG (Pressure Controlled ventilation - Volume Guaranteed)
- . PCV-VG-SIMV (Synchronized Intermittent Mandatory Ventilation, Pressure Controlled ventilation - Volume Guaranteed)
- . CPAP+PSV (Continuous Positive Airway Pressure/Pressure Support)
The system can include an internal, factory installed, suction regulator and control visible from the front of the machine. It can mount different monitors using an arm or shelf mounts. The mounting is achieved through a combination of GE Healthcare adapters and other third-party mounts, including one that allows
6
for the physical integration of the GE Monitor Series B650 (K102239). The Carestation 750 system also includes an optional cable management solution, which can help user to manage the various cables attached to the system.
V. INDICATIONS FOR USE
The Carestation750/750c anesthesia systems are intended to provide monitored anesthesia care, general inhalation anesthesia and/ or ventilatory support to a wide range of patients (neonatal, pediatric, and adult). The anesthesia systems are suitable for use in a patient environment, such as hospitals, surgical centers, or clinics. The systems are intended to be operated by a clinician qualified in the administration of general anesthesia.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Carestation 750 series is primarily based on the predicate device Carestation 600 series feature set (K151570) and contains identical or comparable hardware and software components. A comparison of the CS750 and predicate device technological characteristics is provided as Table 1 below.
7
| Specification | Proposed Device Carestation
750/750c | GE Datex-Ohmeda Predicate
Device
Carestation 620/650/650c | Reference Device Avance
CS2 (K131945) |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pneumatic System | Supplies set flows of medical gases to the breathing
system using electronic controlled gas mixing of 2
gasses (O2 with Air or O2 with N2O). | Supplies set flows of medical gases to
the breathing system using mechanical
controlled gas mixing of 2 gasses (O2
with Air or O2 with N2O) or 3 gases
(O2, Air, and N2O). | Supplies set flows of medical
gases to the breathing system
using electronic controlled
gas mixing of 2 gasses (O2
with Air or O2 with N2O). |
| Gas Supply | The gas mixing subsystem is a two gas mixer
providing a mixture of O2 and Air or O2 and N2O
(100% O2 or 100% Air (21% O2) can also be
selected). | The gas mixing subsystem is a three gas
mixer providing a mixture of O2 and
Air or O2 and N2O or O2, Air and N2O
(100% O2 or 100% Air (21% O2) can
also be selected). | The gas mixing subsystem is
a two gas mixer providing a
mixture of O2 and Air or O2
and
N2O (100% O2 or 100% Air
(21% O2) can also be
selected). |
| O2 Flow | A pressurized gas source (pipeline, or regulated
cylinder), supplies O2 directly to the gas mixing
subsystem. | A secondary pressure regulator in the
gas mixing subsystem regulates
constant O2 gas pressure and supplies it
to the O2 flow control valve. | A pressurized gas source
(pipeline, or regulated
cylinder), supplies O2 directly
to the gas mixing subsystem. |
| Air and N2O flow | Air gas flows from a pressurized gas source
(pipeline or regulated cylinder) to the Air/N2O
selector valve on the gas mixing subassembly. | Air gas flows from a pressurized gas
source (pipeline or regulated cylinder)
to the Air selector valve or a secondary
pressure regulator (optional) on the gas
mixing subassembly. | Air gas flows from a
pressurized gas source
(pipeline or regulated
cylinder) to the Air/N2O
selector valve on the gas
mixing subassembly. |
| Gas Mixer | Digital display and control of flows using an
electronic mass air flow sensor to provide
electronic mixing and proportioning of gases (O2
and Air or N2O). | Digital display of flows with traditional
needle valve flow control and flow head
mixing and proportioning of gases (Air,
O2, N2O). | Digital display and control of
flows using an electronic
mass air flow sensor to
provide electronic mixing and
proportioning of gases (O2
and Air or N2O). |
| Table 1: Carestation 750/750c Technological Characteristics Comparison | |
|---|---|
| ------------------------------------------------------------------------ | -- |
8
| Specification | Proposed Device Carestation
750/750c | GE Datex-Ohmeda Predicate
Device
Carestation 620/650/650c | Reference Device Avance
CS2 (K131945) |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Aux O2 option | An auxiliary O2 gas supply to provide O2 gas to
the patient through internal connections and
control with an auxiliary O2 flowmeter. | An auxiliary O2 gas supply to provide
O2 gas to the patient through internal
connections and control with an
auxiliary O2 flowmeter. | Not a comparison point |
| Aux O2+Air gas
delivery option | The Aux O2+Air gas delivery option provides an
auxiliary O2+Air gas mixture to the patient
through internal connections and control with the
O2 and Air fresh gas controls. | The Aux O2+Air gas delivery option
provides an auxiliary O2+Air gas
mixture to the patient through internal
connections and control with the O2 and
Air fresh gas controls. | Not a comparison point |
| ACGO | Use the optional Auxiliary Common Gas Outlet
(ACGO) switch to direct the fresh gas flow through
the ACGO port on the front of the system. | Use the optional Auxiliary Common
Gas Outlet (ACGO) switch to direct the
fresh gas flow through the ACGO port
on the front of the system. | Not a comparison point |
| O2 Flush | The O2 flush button supplies a high flow of O2 to
the breathing system. | The O2 flush button supplies a high
flow of O2 to the breathing system. | Not a comparison point |
| ALT 02 | The Alternate O2 control is not an auxiliary
source of O2. The Alternate O2 is intended to be
used when in certain failures, such as the
electronic gas mixer is not available or the display
screen has failed. | None | ALT O2 as the auxiliary
source of O2 for electronic
gas mixer |
| Vaporizers
Compatibility | Carestation 750 series provide a two position
vaporizer manifold to support up to 2 active
positions for Tec series GE vaporizers. | Carestation 620/650/650c provides a
two position vaporizer manifold to
support up to 2 active positions for Tec
series GE vaporizers. | Not a comparison point |
| Specification | Proposed Device Carestation
750/750c | GE Datex-Ohmeda Predicate
Device
Carestation 620/650/650c | Reference Device Avance
CS² (K131945) |
| Respiratory
Gas Monitors
Compatibility | Airway Gas Option is:
CARESCAPE series: E-sCAiO and E-
sCAiOV.
The CAiOV feature set of the
CARESCAPE series E-sCAiOVX and EsCAiOVE
Airway Modules | Airway Gas Option is :
CARESCAPE series: E-sCAiO and
E-sCAiOV.
The CAiOV feature set of the
CARESCAPE series E-sCAiOVX
and E-sCAiOVE Airway Modules
N-CAiO (without Spirometry
connector) | Airway Gas Option is:
CARESCAPE series:
EsCAiO and E-sCAiOV.
The CAiOV feature set of the
CARESCAPE series
EsCAiOVX and E-sCAiOVE
Airway Modules |
| Optional
Integrated
Suction
Regulation | The vacuum suction regulator uses an external
vacuum supply. The venturi suction regulator uses
the system air supply source. | The vacuum suction regulator uses an
external vacuum supply. The venturi
suction regulator uses the system air
supply source. | Not a comparison point |
| Optional Gas
Scavenging | Yes | Yes | Not a comparison point |
| Breathing System | The integrated circle breathing system can be used
for both manual (bag) and mechanical (automatic)
patient ventilation. The breathing system includes
bellows assembly, APL valve, bag-to-vent switch,
CO2 bypass assembly. | The integrated circle breathing system
can be used for both manual (bag) and
mechanical (automatic) patient
ventilation. The breathing system
includes bellows assembly, APL valve,
bag-to-vent switch, CO2 bypass
assembly. | Not a comparison point |
| Flow Sensors | Variable orifice flow sensor (autoclavable) with
pneumatic and electrical connections located in the
inspiratory outlet and expiratory inlet inside the
breathing system. The outer chamber of the sensor
is heated. | Variable orifice flow sensor
(autoclavable) with pneumatic and
electrical connections located in the
inspiratory outlet and expiratory inlet
inside the breathing system. The outer
chamber of the sensor is heated. | Not a comparison point |
| CO2 Absorber
Canister | CO2 absorber canister absorbs CO2 in the gas path
from bellows. | CO2 absorber canister absorbs CO2 in
the gas path from bellows. | Not a comparison point |
| Specification | Proposed Device Carestation
750/750c | GE Datex-Ohmeda Predicate
Device
Carestation 620/650/650c | Reference Device Avance
CS² (K131945) |
| Ventilator Engine | The ventilator engine is located in the middle pan
of the system, under the user work surface. A
precision flow servo system control gas flow to
the patient. | The ventilator engine is located in the
middle pan of the system, under the
user work surface. A precision flow
servo system control gas flow to the
patient. | Not a comparison point |
| System
Mountings | Carestation 750 is a trolley mounted configuration
while the Carestation 750c can be configured and
installed with a pendant mounted version. | Carestation 650 and Carestation 620 are
a trolley mounted configuration while
the Carestation 650c can be configured
and installed with either a pendant or
wall mounted version. | Not a comparison point |
| Cable
Management | Clip and cubby are to fix cables, rear cover could
shield hoses and cables. | Clips are to fix cables. | Not a comparison point |
| Electrical
Subsystem | The electrical system consists of two main
computing units: the Graphical user interface
assembly (previously known as the display unit)
and the Anesthesia Computer Board (ACB).
The other key electrical boards are Power
Management Board, Sensor Interface Board, and
Mixer Interface Board. | The electrical system consists of two
main computing units: the Graphical
user interface assembly (previously
known as the display unit) and the
Anesthesia Computer Board (ACB).
The other key electrical boards are
Power Management Board, Sensor
Interface Board, and Frame Interface
Board. | Mixer Interface Board to
support electronic mixer |
| Touch Screen | Projective Capacitive (P-Cap) touch screen detects
touch by measuring the capacitance at each
addressable electrode.
P-Cap touch screen software driver. | Surface acoustic wave (SAW) detects
touch by measuring SAW on the route
SAW P-Cap touch screen software
driver. | Not a comparison point |
| Specification | Proposed Device Carestation
750/750c | GE Datex-Ohmeda Predicate
Device
Carestation 620/650/650c | Reference Device Avance
CS2 (K131945) |
| Software
Subsystem | The software provides user interface, power
management, and controls the delivery of
therapy to patients. As the segregation strategy,
the Carestation 750 series software is comprised
of below top-level Software Items/Units.
Display Computer/Display Unit Power Supply Controller/Power
Subsystem Front Panel Controller Anesthesia Control Board/Anesthesia Computer Mixer Interface Board Subsystem Sensor Interface Board Subsystem Mixer | The software provides user
interface, power management, and
controls the delivery of therapy to
patients. As the segregation
strategy, the Carestation 600 series
software is comprised of below top-
level Software Items/Units. Display Computer/Display Unit Power Supply Controller/Power
Subsystem Front Panel Controller Anesthesia Control Board/Anesthesia Computer Frame Interface Board Subsystem Sensor Interface Board Subsystem | Not a comparison point |
| ecoFLOW | ecoFLOW option within the split screen that
shows a visual indicator reference for the total gas
flows, agent usage, cost and approximate
minimum O2 flow needed to maintain the
clinician's desired inspired O2 concentration.
Carestation 750 series flows are limited to only O2,
Air or N2O. | ecoFLOW option within the split screen
that shows a visual indicator reference
for the total gas flows, agent usage, cost
and approximate minimum O2 flow
needed to maintain the clinician's
desired inspired O2 concentration.
Carestation 620/650/650c allows all 3
gases to be present due to traditional
needle valve flow control. | ecoFLOW option within the
split screen that shows a
visual indicator reference for
the total gas flows, agent
usage, cost and approximate
minimum O2 flow needed to
maintain the clinician's
desired inspired O2
concentration.
Avance CS2 flows are limited
to only O2, Air or N2O. |
| User Interface | Color display with Com Wheel or touch activation.
Quick keys provide quick activation access via the
touch screen user interface. Seven quick keys
available for ventilation and three quick keys
available for gas. | Color display with Com Wheel or touch
activation. Quick keys provide quick
activation access via the touch screen
user interface. Seven quick keys
available for ventilation. | Not a comparison point |
| Specification | Proposed Device Carestation
750/750c | GE Datex-Ohmeda Predicate
Device
Carestation 620/650/650c | Reference Device Avance
CS2 (K131945) |
| Operating System | The graphical user interface operating system on
Carestation 750 series is WEC 2013 (
Windows). | The graphical user interface operating
system on Carestation 600 series is CE6
(Windows). | Not a comparison point |
| Display Arm | User Interface is mounted on an arm on the left
side of the machine. It can be rotated left or right
via the arm toward or away from the system to
adjust the horizontal position. Both standard arm
and premium arm can be tilted up or down to
adjust the vertical angle or be tilted left or right to
adjust the horizontal angle of the User Interface.
Premium arm can also be raised/lowered and
rotated 360 degrees. | User Interface is mounted on an arm on
the left side of the machine. It can be
rotated left or right via the arm toward
or away from the system to adjust the
horizontal position. For the Carestation
650 and 650c it can also be tilted up or
down to adjust the vertical angle or be
tilted left or right to adjust the
horizontal angle of the User Interface.
The Carestation 620 uses a basic arm
that allows the User Interface to move
left and right but does not tilt. | Not a comparison point |
| HDX GUI
Style | Added Modern Interface Style (HDX), user can
enable in Super User System Config menu. | Classic GUI Interface Style on
Carestation 600. | Not a comparison point |
| Super user and
service mode
passwords | User could change super user password and service
password. New Password Entry item will be
restricted to a 6-22 digit password.
User could set new password to protect the device
with only authorized personnel entering the Super
User mode and Service mode. | The different 5 digit passwords of Super
user and Service mode are fixed, user
could not change the passwords. | Not a comparison point |
| Specification | Proposed Device Carestation 750/750c | GE Datex-Ohmeda Predicate Device Carestation 620/650/650c | Reference Device Avance CS² (K131945) |
| Recruitment
Maneuver | Use the Single Step recruitment maneuver to
deliver a pressure breath for a set time. | Use the Vital Capacity procedure to
deliver a pressure breath for a set time. | Not a comparison point |
| | Use the Multi Step recruitment maneuver to deliver
pressure breaths through a series of ventilation
steps. | Use the Cycling procedure to deliver
pressure breaths through a series of
ventilation steps. | Not a comparison point |
| Direct access to
important functions | A button bar is at the right side of the user
graphical interface to allow direct user access to 10
important functions:
Audio Pause, Alarm Setup, Auto Limits,
System Setup, Next page, Trends, Recruitment
Maneuver, Pause Gas Flow, Timer function , End
case. | A button bar is at the right side of the
user graphical interface to allow direct
user access to 10 important functions:
Audio Pause, Alarm Setup, Auto
Limits, System Setup, Next page,
Trends, Spirometry, Procedures, Timer
function, End case. | Not a comparison point |
| Recourse & Recovery | When Display Computer (DC) software
error occurs a processor reset will initiate the DC
reboot. However, the Anesthesia Computer (AC)
will keep working by using the current parameters,
when the system reboot successfully it will go to
Therapy mode directly by using setting values
recovered by Anesthesia
Computer software. DISPLAY
COMPUTER RESTARTED alarm will be
displayed on screen. | None | Not a comparison point |
| Checkout
failure
troubleshooting
message panel | If checkout tests failed, it will display a
troubleshooting message panel with problem
statement and step by step messages to instruct user
to remove the failure. | The preoperative checkout and
calibration are digitally shown and
guided according to the menu. | Not a comparison point |
| DatexOhmeda COM
changes | DatexOhmeda COM exists on
Carestation 700 (updates made) | DatexOhmeda COM exists on
Carestation 600. | Not a comparison point |
| Specification | Proposed Device Carestation
750/750c | GE Datex-Ohmeda Predicate
Device
Carestation 620/650/650c | Reference Device Avance
CS2 (K131945) |
| New Mixer and
Alternate O2
checkout test | Electronic Mixer and Alternate O2 checkout | None | Electronic Mixer and
Alternate O2 checkout |
| Gas Setup and
Preset menu,
Alt O2, Air Only and
related Alarms | Electronic mixer, alternate O2, and Air only mode | None | Electronic mixer, alternate
O2, and Air only mode |
| Remove latch alarm | The latched alarms could be removed because
alarm log history could be used instead. | Latched alarms exist as a feature in
Carestation 600 series. | Not a comparison point |
| Principles of
Operation:
Control and
Phase
Variables | Anesthesia machine settings are separated into five
categories:
Gas Flow (Electronic gas mixer) and Breathing Circuit Controls Main Ventilation Parameters Breath Timing Patient Ventilation Synchrony Safety | Anesthesia machine settings are
separated into five categories:
Gas Flow (Mechanical gas mixer) and Breathing Circuit Controls Main Ventilation Parameters Breath Timing Patient Ventilation Synchrony Safety | Gas Flow (Electronic gas
mixer) |
| Ventilation
Modes | VCV, PCV, VCV-SIMV,
PCV-SIMV, PSVPro,
PCV-VG, PCV-VG-SIMV,
CPAP-PSV | VCV, PCV, VCV-SIMV,
PCV-SIMV, PSVPro,
PCV-VG, PCV-VG-SIMV, CPAP-
PSV | Not a comparison point |
| Safety
Standards | Compliance with applicable FDA recognized
consensus standards | Compliance with applicable FDA
recognized consensus standards | Not a comparison point |
9
10
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Image /page/15/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of the GE monogram on the left and the words "GE HealthCare" on the right. The monogram and the words are both in purple.
VII. PERFORMANCE DATA
The Carestation 750/750c has been thoroughly tested through verifications and validation, including software validation for a major level of concern software. Verification of compliance with applicable voluntary standards has also been made to support safe use of the device in its intended environment. The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- . Requirements Reviews
- Design Reviews
- . Testing on unit level (Module verification)
- . Integration testing (System verification)
- . Performance testing (Verification) including but not limited to accuracy testing, environmental testing, tip testing and threshold testing
- . Biocompatibility Testing including particulate matter (PM), Volatile Organic Compounds (VOC) and leachables in condensate (Classified as Limit exposure based on ISO18562-1:2017)
- . Safety testing (Verification) including electrical safety and electromagnetic compatibility testing
- . Simulated use testing (Validation)
The product was designed and tested for compliance to FDA recognized consensus standards including the following:
| Standard | FDA
Recognition
Number |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and
A2:2010/(R)2012, , Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance (IEC 60601-1:2005, MOD) | 19-4 |
| IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests | 19-8 |
| 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 | 5-89 |
| IEC 60601-1-8 Edition 2.1 2012-11, Medical electrical equipment - Part 1-8:
General requirements for basic safety and essential performance - Collateral
Standard: General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems | 5-76 |
| ISO 80601-2-13:2011 and A1:2015 and A2:2018, Medical electrical equipment
- Part 2-13: Particular requirements for basic safety and essential performance
of an anesthetic workstation | 1-141 |
| IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of
usability engineering to medical devices [Including CORRIGENDUM 1 (2016)] | 5-114 |
16
| Standard | FDA
Recognition
Number |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes | 13-79 |
| 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 | 1-134 |
| ISO 18562-2 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter | 1-135 |
| 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 | 1-136 |
| ISO 18562-4 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate | 1-137 |
| 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 | 19-30 |
| ISO 17664:2017 Second edition 2017-10 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices | 14-515 |
Bench testing was performed to establish substantial equivalence of the Carestation 750/750c. Verification and validation testing was performed according to predetermined acceptance criteria, which concluded that the Carestation 750/750c is substantially equivalent to the predicate Carestation 620/650/650c.
Clinical Testing
The Carestation 750/750c anesthesia machines incorporate modifications to the predicate Carestation 620/650/650c. These modifications did not require clinical testing. The changes made were completely evaluated by non-clinical design verification and validation tests to verify and validate the safety and functionality of the anesthesia machines.
Conclusion
The subject device and the predicate device have the same intended use, and the technological differences do not raise different questions of safety and effectiveness.