(14 days)
The GE Datex-Ohmeda Aespire 7900 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation modes. The Aespire 7900 is not suitable for use in a MRI environment.
The GE Datex-Ohmeda Aespire 7900 Anesthesia System supplies 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. The Aespire 7900 is available in trolley and pendant models. It is available with two or three gases, one or two vaporizer positions and up to three cylinder connections. All models have O2. The Aespire 7900 comes with up to two optional gases (air, N2O). The Aespire 7900 systems accept Tec 5, Tec 6, and Tec 7 vaporizers on a Selectatec manifold. Safety features and devices within the Aespire 7900 are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.
The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Aespire 7900 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 Mode, Pressure Control Mode, Pressure Support with Apnea Backup Ventilation (Optional) and Synchronized Mandatory Intermittent Ventilation(SIMV) (Optional) Mode. Ventilator parameters and measurements are displayed on the system display unit.
Here's an analysis of the provided text regarding the GE Datex-Ohmeda Aespire 7900 Anesthesia System, structured to answer your questions about acceptance criteria and supporting studies.
Based on the provided excerpt, the document is a 510(k) summary for the GE Datex-Ohmeda Aespire 7900 Anesthesia System, specifically focusing on its substantial equivalence to previously marketed devices. This type of submission relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving a new claim of effectiveness. Therefore, the information typically associated with detailed clinical studies proving performance against acceptance criteria in the way you've outlined for diagnostic or interventional devices (like those using AI) is not present in this document.
The document primarily focuses on:
- Identifying predicate devices.
- Describing the new device's intended use and functionality.
- Listing voluntary standards it was designed to comply with.
- Stating that "rigorous testing" was performed to support compliance with these standards.
As such, many of your specific questions regarding acceptance criteria, performance metrics, sample sizes, ground truth establishment, and MRMC studies are not applicable or cannot be answered from this document. The "study" here is primarily a design validation and verification process against established engineering and safety standards, not a clinical effectiveness trial in the traditional sense you might find for AI algorithms.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied/Stated) | Reported Device Performance (Implied/Stated) |
|---|---|---|
| Safety and Effectiveness | Substantial equivalence to predicate devices (GE Datex-Ohmeda S/5 Avance Anesthesia System, Datex-Ohmeda 7900 Ventilator Enhancements) | Device is determined substantially equivalent by the FDA (K050626). |
| Voluntary Standards Compliance | Compliance with applicable portions of listed standards: - UL 2601 (General requirements for Medical Electrical Equipment) - EN 740 (Anesthetic Work Stations) - EN/IEC 60601-1 (General requirements for Medical Electrical Equipment) - EN/IEC 60601-1-2 (Medical Electrical Equipment Electromagnetic Compatibility) - EN 475 (Electrically Generated Alarm Signals) - ASTM F1463-93 (Standard Specification for Alarm Signals) - ASTM F1208-94 (Anesthesia Breathing Circuit Standard) - ASTM F1101-90 (Standard Specification for Ventilators Intended for Use During Anesthesia) | "The GE Datex-Ohmeda Aespire 7900 Anesthesia System has been validated through rigorous testing that, in part, supports the compliance... to the standards listed above." |
| Functional Performance (e.g., Gas delivery, Ventilation modes, Safety features) | (Not explicitly detailed as quantifiable acceptance criteria in this document, but implied by compliance with standards and description of functions like "supplies set flows," "microprocessor based, electronically controlled," "built-in monitoring system," "safety features and devices... designed to decrease the risk of hypoxic mixtures"). | Device functions as described, providing general inhalation anesthesia and ventilatory support using various modes (Volume, Pressure Control, optional Pressure Support, optional SIMV). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This document does not describe a clinical study with a "test set" of patient data in the context of device performance against ground truth. The "testing" mentioned refers to engineering verification and validation against design specifications and regulatory standards.
- Data Provenance: Not applicable for a traditional clinical "test set." The document discusses previous 510(k) clearances and compliance with standards, which would involve internal testing, not external patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. The ground truth for this type of device (an anesthesia system) is established through engineering principles, regulatory standards, and medical consensus on safe and effective clinical practice.
- Qualifications of Experts: While not detailed, the development and testing would have involved a team of engineers, medical professionals (anesthesiologists), and regulatory specialists. However, they were not establishing discrete "ground truth" labels for a "test set" in the context of, for example, image interpretation or disease diagnosis.
4. Adjudication Method for the Test Set
- Not applicable, as there is no "test set" or adjudication process described for clinical output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
- Not applicable. MRMC comparative effectiveness studies are typically performed for diagnostic devices (e.g., imaging AI) where human readers' performance is compared with and without AI assistance. This document describes an anesthesia machine, which is a therapeutic and monitoring device, not a diagnostic one in that context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- Not applicable. The device is an anesthesia system, not an algorithm meant to operate independently in a diagnostic or interpretive capacity. It is a human-operated system with built-in electronic controls and monitoring.
7. The Type of Ground Truth Used
- The "ground truth" for this device's safety and effectiveness is largely based on engineering specifications, compliance with national and international voluntary standards (e.g., UL, EN, IEC, ASTM), and established medical practice for anesthesia delivery. For example, the ground truth for "accurate gas delivery" would be a certain percentage deviation from a set point, measured using calibrated equipment. The ground truth for "alarm functionality" would be its activation under specified fault conditions, as defined by safety standards.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires "training data" in the typical sense. Its functionality is based on established control systems, sensors, and mechanical components.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no "training set."
In summary: The provided document is a 510(k) summary for an anesthesia system, emphasizing its substantial equivalence to predicate devices and compliance with recognized standards. It does not contain the kind of detailed clinical study information relevant to diagnostic AI devices, and therefore, many of your questions related to performance metrics, sample sizes, and ground truth establishment in a clinical trial context are not addressed. The "study" referenced is primarily a design validation and verification process against engineering and safety benchmarks.
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MAR 2 5 2005
| K | 050626 |
|---|---|
| --- | -------- |
| Date: | March 9th, 2005 |
|---|---|
| Subject: | 510(k) Summary of Safety and Effectiveness Informationfor the GE Datex-Ohmeda Aespire 7900 Anesthesia System |
| Proprietary: | GE Datex-Ohmeda Aespire 7900 Anesthesia System |
| Common: | Gas Machine, Anesthesia |
| Classification: | Anesthesiology, 73 BSZ, 21 CFR 868.5160 |
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.
The GE Datex-Ohmeda Aespire 7900 Anesthesia System is substantially equivalent to the following currently marketed device:
GE Datex-Ohmeda S/5 Avance Anesthesia System - Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K0040743
Datex-Ohmeda 7900 Ventilator Enhancements Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K023366
The GE Datex-Ohmeda Aespire 7900 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. It represents the next system 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.
The GE Datex-Ohmeda Aespire 7900 Anesthesia System supplies 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. The Aespire 7900 is available in trolley and pendant models. It is available with two or three gases, one or two vaporizer positions and up to three cylinder connections. All models have O2. The Aespire 7900 comes with up to two optional gases (air, N2O). The Aespire 7900 systems accept Tec 5, Tec 6, and Tec 7 vaporizers on a Selectatec manifold. Safety features and devices within the Aespire 7900 are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.
The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Aespire 7900 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
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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 Mode, Pressure Control Mode, Pressure Support with Apnea Backup Ventilation (Optional) and Synchronized Mandatory Intermittent Ventilation(SIMV) (Optional) Mode. Ventilator parameters and measurements are displayed on the system display unit.
The GE Datex-Ohmeda Aespire 7900 Anesthesia System was designed to comply with the applicable portions of the following voluntary standards;
-
- UL 2601 General requirements for Medical Electrical Equipment
-
- EN 740 Anesthetic Work Stations
-
- EN/IEC 60601-1: General requirements for Medical Electrical Equipment
-
- EN/IEC 60601-1-2: 2001 Medical Electrical Equipment Electromagnetic Compatibility
-
- EN 475 Electrically Generated Alarm Signals
-
- ASTM F1463-93 Standard Specification for Alarm Signals
-
- ASTM F1208-94 Anesthesia Breathing Circuit Standard
-
- ASTM F1101-90 -- Standard Specification for Ventilators Intended for Use During Anesthesia
The GE Datex-Ohmeda Aespire 7900 Anesthesia System and the currently marketed device are substantially equivalent in design concepts, technologies and materials. The GE Datex-Ohmeda Aespire 7900 Anesthesia System has been validated through rigorous testing that, in part, supports the compliance of Aespire 7900 Anesthesia System to the standards listed above.
Contact: Dan Kosednar, RAC
Manager, Regulatory Planning and Submissions
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three stripes extending from its wing.
Public Health Service
MAR 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dan Kosednar Manager, Regulatory Planning and Submissions Datex-Ohmeda, Incorporated P.O. Box 7550 Madison, Wisconsin 53707
Re: K050626
Trade/Device Name: GE Datex-Ohmeda Aespire 7900 Anesthesia System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: March 8, 2005 Received: March 11, 2005
Dear Mr. Kosednar:
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 such 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 Eederal Register.
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Page 2 – Mr. Kosednar
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisou that 1 DTS isbaarse on that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal stars requirements, including, but not limited to: registration You must comply with an the Fee e requirements (21 CFR Part 801); good manufacturing practice and ilsing (21 CFR Part 007), laboling (21 -1 -1 -1 -1 -1 -1 -1 -1 -1 -1 -1 -1 -1 -1 -1 -1 -1 applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mainer of your device of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific author for your ce at (240) 276-0102. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sritte Michie O.D.
Chiu Lin, Ph.D. 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): KK050626 Device Name: GE Datex-Ohmeda Aespire 7900 Anesthesia System
Indications For Use:
The GE Datex-Ohmeda Aespire 7900 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation modes. The Aespire 7900 is 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)
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ology General Hospital,
Control. Dental Devices
§ 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).