(364 days)
No
The description mentions a "microprocessor based, electronically controlled" system with "microprocessor calculations" and "user setting and microprocessor calculations control breathing patterns." This indicates standard digital control and processing, not AI/ML. There is no mention of learning, adaptation, or complex pattern recognition beyond pre-programmed logic.
Yes
The device is a ventilator, designed to provide patient ventilation during surgical procedures, which directly addresses a physiological function.
No
The device is described as a ventilator that provides patient ventilation and monitoring of inspired oxygen, airway pressure, and exhaled volume, which are functions related to treatment and ongoing monitoring during surgical procedures, not diagnosis of a condition.
No
The device description explicitly states it is a "microprocessor based, electronically controlled, pneumatically driven ventilator" and includes physical components like sensors, a bellows, and an RS-232 port, indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Datex-Ohmeda 7900 Ventilator is a device that provides patient ventilation during surgical procedures. It controls and monitors breathing, measures inspired oxygen, and regulates pressure.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is to directly support the patient's breathing.
The device is a medical device used for patient support and monitoring, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestiva/5 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 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. 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 tot he 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. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation (optional).
Product codes
CBK
Device Description
This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestiva/5 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 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. 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 tot he 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. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation (optional).
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
Not Found
Intended User / Care Setting
This device is to be used only by trained and qualified medical professionals.
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
The 7900 Ventilator Enhancements to the Datex-Ohmeda Aestiva/5 Anesthesia System have been validated through rigorous testing that, in part, supports the compliance to the standards listed above.
Key Metrics
Not Found
Predicate Device(s)
Ohmeda 7900 Anesthesia Ventilator K960964, Ohmeda Excel 3000 Anesthesia Gas System K973896, Datex-Engstrom AS/3 Anesthesia Delivery Unit (ADU) K973985, Puritan Bennett 7200 ICU Ventilator K930017
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
OCT = 7 2003
June 17, 2003 Date: 510(k) Summary of Safety and Effectiveness Information for the 7900 Subject: Ventilator Enhancements to the Datex-Ohmeda Aestiva/5 Anesthesia System Datex-Ohmeda 7900 Anesthesia Ventilator Proprietary: Common: Ventilator, Continuous Classification: Anesthesiology, 73 CBK, 21 CFR 868.5895
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.
The 7900 Ventilator Enhancements to the Datex-Ohmeda Aestiva/5 Anesthesia System are substantially equivalent to the following currently marketed devices:
-
- Ohmeda 7900 Anesthesia Ventilator Class II 21CFR868.5895, which has been the subject of a cleared 510(k) with FDA log number K960964
- Ohmeda Excel 3000 Anesthesia Gas System Class II 21CFR868.5895, which has been 2. the subject of a cleared 510(k) with FDA log number K973896
-
- Datex-Engstrom AS/3 Anesthesia Delivery Unit (ADU) Class II 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K973985
-
- Puritan Bennett 7200 ICU Ventilator Class II 21CFR868.5895, which has been the subject of a cleared 510(k) with FDA log number K930017
This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestiva/5 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 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. 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 tot he 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. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation (optional). This device is to be used only by trained and qualified medical professionals.
Datex-Ohmeda, Inc. P.O. Box 7550 Madison, WI 53707-7550 www.datex-ohmeda.com
Telephone 608-221-1551 Toll Free 800-345-2700 Facsimile 608-222-9147
1
The 7900 Ventilator Enhancements to the Datex-Ohmeda Aestiva/5 Anesthesia System are 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: 1998 Medical Electrical Equipment Electromagnetic Compatibility
-
- ASTM F1101-90 Standard Specification for Ventilators Intended for Use During Anesthesia
-
- ISO 5358 Anesthetic Gas Machines
-
- ASTM F1209-94 Anesthesia Breathing Circuit Standard
-
- EN 475 Electrically Generated Alarm Signals
-
- ASTM F1463-93 Standard Specification for Alarm Signals
The 7900 Ventilator Enhancements to the Datex-Ohmeda Aestiva/5 Anesthesia System and the currently marketed devices are substantially equivalent in design concepts, technologies and materials. The 7900 Ventilator Enhancements to the Datex-Ohmeda Aestiva/5 Anesthesia System have been validated through rigorous testing that, in part, supports the compliance to the standards listed above.
William E. Exner Contact: Vice President, Regulatory and Quality Affairs
Datex-Ohmeda, Inc.
P.O. Box 7550
Madison, WI 53707-7550
www.datex-ohmeda.com
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is a stylized symbol resembling a bird or abstract human figures, composed of three curved lines or shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 7 2003
Mr. William E. Exner Vice President, Quality Regulatory Affairs Datex-Ohmeda, Incorporated P.O. Box 7550 Madison, Wisconsin 53707
Re: K023366
Trade/Device Name: 7900 Ventilator Enhancements for Datex-Ohmeda Aestiva/5 Anesthesia Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 7, 2003 Received: July 10, 2003
Dear Mr. Exner:
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 Federal Register.
3
Page 2 - Mr. Exner
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if 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) premarket notification. The FDA finding of substantial equivalence 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), please contact the Office of Compliance at (301) 594-4646. 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 Division 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/dsma/dsmamain.html
Sincerely yours,
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
4
510(k) Number (if known):
Device Name: 7900 Ventilator Enhancements for Datex-Ohmeda Aestiva/5 Anesthesia System
Indications For Use:
This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestiva/5 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 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. 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 tot he 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. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation (optional).
This device is to be used only by trained and qualified medical professionals.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Q. Iytock
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number: K023366
Prescription Use
(Per 21CFR801.109) ✓
OR
Over-The-Counter Use_ (Optional Format 1-2-96)