The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for volume or pressure control ventilation. The devices are not suitable for use in a MRI environment.

Device Description

The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The systems are to be used only by trained and qualified medical professionals.

The Aespire 7900 and Aespire View supply set flows of medical gases to the breathing system. A large selection of frames, gases, and vaporizers are available to give the user control of the system configuration. They are available in trolley and pendant models, with two or three gases, two vaporizer positions and up to three cylinder connections. All models connect to oxygen and can additionally connect with up to two optional gases (air, N2O). The Aespire systems accept Tec 4, Tec 5, Tec 6, Tec 6+ and Tec 7 vaporizers on a Selectatec manifold. Safety features are designed to decrease the risk of hypoxic mixtures and complete power or sudden gas supply failures. The Aespire View family member provides optional electronic Total Fresh Gas Flow (TFS) monitoring. The Aespire View also features a color display, while the Aespire 7900 uses a monochromatic display.

The Datex-Ohmeda 7900 Anesthesia Ventilator is used in this family of Anesthesia Systems. 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 (VCV) Mode, Pressure Control (PCV) Mode (Optional), Synchronized Intermittent Mandatory Ventilation with Pressure Support Ventilation (SIMV/PSV) Mode, Pressure Support with Apnea Backup (PSVPro) Mode (Optional), Synchronized Intermittent Mandatory Ventilation with Pressure Control (SIMV-PC) Mode (Optional), and Pressure Control Ventilation - Volume Guaranteed (PCV-VG) mode (Optional on Aespire View variant only),

AI/ML Overview

This document is a 510(k) summary for the GE Datex-Ohmeda Aespire Anesthesia System, specifically introducing the Aespire View variant. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trials or acceptance criteria for a new device type. As such, much of the requested information regarding acceptance criteria, study details, and expert involvement is not present in the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria or reported device performance in the way typically associated with a new algorithm or diagnostic device. Instead, it states that the device was thoroughly tested through verification of specifications and validation. The performance is generally implied by the claim of substantial equivalence to predicate devices (K050626 and K090233), meaning it is expected to perform comparably.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a separate "test set" in the context of clinical performance evaluation. The "testing" mentioned refers to nonclinical verification and validation. Therefore, sample size and data provenance for a clinical test set are not applicable here.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not present as there was no clinical study described that involved establishing a ground truth by experts from a test set.

4. Adjudication Method:

This information is not present as there was no clinical study described that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document explicitly states: "The modifications to the family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator did not require clinical testing." Therefore, an MRMC comparative effectiveness study was not done.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This concept is not applicable to an anesthesia system. The Aespire Anesthesia System is a medical device operated by trained professionals, not a standalone algorithm. The document describes non-clinical testing for the device's functionality.

7. Type of Ground Truth Used:

The document does not describe any clinical ground truth (e.g., pathology, outcomes data) for performance evaluation, as no clinical testing was deemed necessary for the modifications. The "ground truth" for the device's functionality would be its adherence to engineering specifications and safety standards through nonclinical testing.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable here as this is a hardware/software medical device, not a machine learning algorithm being trained on data in the traditional sense. The software validation is mentioned, but "training set" doesn't fit the context.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the reasons stated above.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The document highlights that the GE Datex-Ohmeda Aespire View Anesthesia System underwent "thoroughly tested through verification of specifications and validation, including software validation." Additionally, biocompatibility testing was conducted for the total flow sensor module, and electrical safety and electromagnetic compatibility testing were completed.

The conclusion is that based on these nonclinical tests and the comparison to legally marketed predicate devices, there are "no new questions of safety and effectiveness for the introduction of the Aespire View". This indicates that the device met its internal design and safety specifications, and its performance was considered to be equivalent to existing, cleared devices. This represents a substantial equivalence claim under 510(k) regulations, rather than a de novo clinical study proving novel acceptance criteria.

Summary

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IC07
GE Healthcare

Datex-Ohmeda Inc. P.O. Box 7550 Madison, WI 53703 USA

JAN 1 2 2010

Premarket Notification 510(k) Summary

As required by section 807.92 GE Datex-Ohmeda Aespire Anesthesia System

GENERAL COMPANY INFORMATION as required by 807.92(a)(1) COMPANY NAME/ADDRESS/PHONE/FAX:

GE Healthcare Datex-Ohmeda, Inc. PO Box 7550 Madison, WI 53707 USA · Tel: 608-221-1551 Fax: 608-223-2476

NAME OF CONTACT:

Ms. Adrienne Lenz, RAC Ms. Karla Krause (alternate)

DATE:

September 16, 2009

DEVICE NAME as required by 807.92(a){2) TRADE NAME:

GE Datex-Ohmeda Aespire Anesthesia System

COMMON NAME:

Gas Machine, Anesthesia

CLASSIFICATION NAME:

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

General Electric Company
Datex-Ohmeda, Inc.

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

The original GE Datex-Ohmeda Aespire 7900 Anesthesia Systems received 510(k) clearance under the submittal number K050626.

Both the GE Datex-Ohmeda Aespire 7900 Anesthesia System and the GE Datex-Ohmeda Aisys (most recent clearance K090233) are used as predicates.

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

The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The systems are to be used only by trained and qualified medical professionals.

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

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

This submission introduces the Aespire View variant to the family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator. The Aespire 7900 variant remains available. The GE Datex-Ohmeda Aespire View Anesthesia System includes the following significant changes compared to the Aespire 7900:

Software version (6.X) which includes pressure control ventilation- volume guarantee . (PCV-VG) ventilation mode and Total Flow Sensing monitoring (optional)
. Total Flow Sensor Module (optional)
New display unit including a color display, high performance CPU and increased system ● memory

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

The GE Datex-Ohmeda Aespire View Anesthesia System has been thoroughly tested through verification of specifications and validation, including software validation. Biocompatibility testing was conducted for the total flow sensor module. Electrical safety and electromagnetic compatibility testing were also completed.

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

The modifications to the family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator did not require clinical testing.

CONCLUSION:

The summary above shows that, as compared to the predicate device, there are no new questions of safety and effectiveness for the introduction of the Aespire View to the family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the edge. Inside the circle is a stylized symbol that resembles three bird heads or wings layered on top of each other. The image is in black and white and appears to be a scan or photocopy due to its slightly grainy texture.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JAN 12 2010

JAN 1 2 2010

Ms. Adrienne Lenz Regulatory Affairs Director GE Healthcare Datex-Ohmeda, Incorporated P.O. Box 7550 3030 Ohmeda Drive Madison, Wisconsin 53707-7550

Re: K092864

Trade/Device Name: GE Datex-Ohmeda Aespire Anesthesia System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: December 18, 2009 Received: December 22, 2009

Dear Ms. Lenz:

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.

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 - Ms. Lenz

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/cdrh/mdr/ 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Wh 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): K.O G. Z86 Y 11 - 1 -

Device Name: GE Datex-Ohmeda Aespire Anesthesia System

Indications For Use:

The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for volume or, pressure control ventilation. The devices are not suitable for use in a MRI environment.

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)

L. Schultheis

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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

510(k) Number: K092864

Regulation Number and Section

§ 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).