GE DATEX-OHMEDA AVANCE

K112722 · Datex-Ohmeda, Inc. · BSZ · Dec 16, 2011 · Anesthesiology

Device Facts

• Record ID: K112722
• Device Name: GE DATEX-OHMEDA AVANCE
• Applicant: Datex-Ohmeda, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Dec 16, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The GE Datex-Ohmeda Avance Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.

Device Story

Anesthesia system providing inhalation anesthesia and ventilatory support; inputs include medical gases (O2, air, N2O) and user-defined settings via keypad/rotary controller; microprocessor-controlled 7900 ventilator manages breathing patterns, PEEP, and gas delivery; system monitors inspired O2, airway pressure, and exhaled volume; optional integrated respiratory gas modules (M-Gas, E-Gas) provide additional monitoring; used in clinical settings (OR) by trained medical professionals; output displayed on system monitor; assists clinicians in maintaining patient ventilation and anesthesia depth; benefits include precise gas delivery, automated ventilation modes, and integrated monitoring to reduce risk of hypoxic mixtures or supply failures.

Clinical Evidence

No clinical data. Substantial equivalence supported by nonclinical design verification and validation testing, including software validation, risk analysis, and performance/safety testing.

Technological Characteristics

Microprocessor-controlled, pneumatically driven anesthesia system. Features electronic gas mixing, Selectatec vaporizer manifold, and 7900 ventilator. Connectivity via RS-232 serial port. Supports integrated respiratory gas modules and patient monitors. Software-controlled ventilation modes include VCV, PCV, SIMV/PSV, PSVPro, SIMV-PC, PCV-VG, and CPAP/PSV.

Indications for Use

Indicated for neonatal, pediatric, and adult patients requiring general inhalation anesthesia and ventilatory support via volume or pressure control ventilation.

Regulatory Classification

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. 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).

Predicate Devices

• GE Datex-Ohmeda Avance (K081844)
• GE Datex-Ohmeda Engstrom ventilator (K093886)

Reference Devices

• Datex-Ohmeda M-Gas Module (K001814)
• Datex-Ohmeda E-Gas Module (K051092)
• GE Carescape B850 (K092027)
• GE Carescape B650 (K102239)

Submission Summary (Full Text)

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DEC 1 6 2011

#### Premarket Notification 510(k) Summary As required by section 807.92 GE Datex-Ohmeda Avance

K112722

#### GENERAL COMPANY INFORMATION as required by 807.92(a)(1)

#### COMPANY NAME/ADDRESS/PHONE/FAX:

Datex-Ohmeda Inc. 3030 Ohmeda Drive PO Box 7550 Madison, WI 53707 USA Tel: [phone] Fax: [phone]

#### NAME OF CONTACT:

Mr. James P. Raskob Ms. Monica Morrison (alternate)

DATE:

December 16, 2011

#### DEVICE NAME as required by 807.92(a)(2)

TRADE NAME:

GE Datex-Ohmeda Avance Anesthesia System

#### COMMON NAME:

Gas Machine, Anesthesia

#### CLASSIFICATION NAME:

Anesthesiology, 73 BSZ, 21 CFR 868.5160 Gas Machine, Anesthesia

#### NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)

The GE Datex-Ohmeda Avance is substantially equivalent in safety and effectiveness to the legally marketed (predicate) GE Datex-Ohmeda Avance (K081844) and GE Datex-Ohmeda Engstrom ventilator (K093886).

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#### DEVICE DESCRIPTION as required by 807.92(a)(4)

The GE Datex-Ohmeda Avance is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). It represents one of the systems in a long line of products based on the Datex-Ohmeda Excel, Aestiva, and Aespire Anesthesia Systems. It is to be used only by trained and qualified medical professionals in the administration of general anesthesia.

The Datex-Ohmeda Avance Anesthesia System supplies set flows of medical gases to the breathing system using electronic gas mixing. Gas flows are selected by the user using the keypad and rotary controller on the main display unit and then displayed as electronic flow meters on the system display unit. The Avance is equipped with a pneumatic back-up O2 delivery system and traditional flow tube, as well. A large selection of frames options, gases, and vaporizers are available to give the user control of the system configuration. The Avance is also available in wall-mount and pendant models. It is available with two or three gases, up to two vaporizer positions and up to three cylinder connections. All models have O2. The Avance comes with up to two optional gases (air, N2O).

The Avance systems accept Tec 4, Tec 5, Tec 6, and Tec 7 vaporizers on a Selectatec manifold. Safety features and devices within the Avance are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Avance system is available with optional integrated respiratory gas monitoring. When supplied as an option, the integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-CAiO and M-CAiOV software revision 3.2 and above cleared via K001814) and E-Gas Module (E-CAiOVX software revision 4.5 and above cleared via K051092) which can be physically integrated into the Avance, receive electronic power from the Avance and communicate measured values to the Avance for display on the system display unit.

The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Avance Anesthesia System. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. The user interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilator modes for the device include Volume Control Ventilation (VCV), Pressure Control Ventilation (PCV) (optional), Synchronized Intermittent Mandatory Ventilation/Pressure, Support (SIMV/PSV) (optional), Pressure Support Ventilation (PSVPro) (optional), Synchronized Intermittent Mandatory Ventilation-Pressure Control (SIMV-PC) (optional), Pressure Control Ventilation-Volume Guaranteed (PCV-VG) (optional), Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV), and Volume Control Ventilation Mode for Cardiac Bypass Mode. Ventilator parameters and measurements are displayed on the system display unit.

Several frame configurations are available, including one that allows for the physical integration of the GE Monitors (most recently cleared Carescape B850 via K092027 and B650 cleared on K102239). This configuration also provides cable management solutions such that the necessary connections from the monitor display unit to the monitor are hidden within the Avance frame. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Avance.

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#### INTENDED USE as required by 807.92(a)(5)

The GE Datex-Ohmeda Avance Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.

#### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)

The GE Datex-Ohmeda Avance has been updated from the predicate version (K081844). There has been no change to fundamental scientific technology and indications for use have been clarified to indicate a wide range of patients includes neonatal, pediatric and adult patients.

The software for the Avance has been updated to introduce several new features. The changes to the software and display monitor include:

- Pediatric Improvements: 02 concentration resolution range improvement at low . flows, reduction of spurious alarms when patient is adequately ventilated, gas monitor ventilator Tidal Volume compensation, Breathing Tube Compliance On/Off option
- Highlight the border of the menu button for increased visibility .
- Checkout improvement: Remove "Leak < 250" question .
- . Temporary gas flow suspension capability
- Improved "unconfirmed" setting notification .
- Ventilator defaults for each individual vent mode .
- New ventilation mode: CPAP/PSV with backup breaths .
- Lung mechanics procedure options of Vital Capacity and Cvcling .
- Procedures, Trend and Spirometry buttons added to the existing display monitor . Quick Kevs

#### SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)

The GE Datex-Ohmeda Avance has been thoroughly tested through verification of specifications and validation, including software validation. 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 Analvsis .
- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module verification) .
- Integration testing (System verification) .
- Performance testing (Verification) .
- Safety testing (Verification) .
- Simulated use testing (Validation) .

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#### SUMMARY OF CLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(2)

The modifications made to the GE Datex-Ohmeda Avance did not require clinical testing. The functionality of the modified software features were completely evaluated by performing nonclinical tests of design verification and validation testing.

### CONCLUSION.

t

The summary above shows that there are no new questions of safety and effectiveness for the GE Datex-Ohmeda Avance as compared to the predicate devices. The performance data demonstrates the device is substantially equivalent to the predicates.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 1 6 2011

Mr. James P. Raskob Regulatory Affairs Leader Datex-Ohmeda. Incorporated 3030 Ohmeda Drive P.O. Box 7550 Madison, Wisconsin 53707.

Re: K112722

Trade/Device Name: GE Datex-Ohmeda Avance Anesthesia System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine For Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: September 13, 2011 Received: September 19, 2011

Dear Mr. Raskob:

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. 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.

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#### Page 2 - Mr. Raskob

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K112722

Device Name: GE Datex-Ohmeda Avance Anesthesia System

Indications For Use:

The GE Datex-Ohmeda Avance Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.

Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

L. Schultheis

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division Control, Dental Devices

re 1122722

510(k) Number: