DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS by DATEX-OHMEDA, INC.

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).

Device Description

AI/ML Overview

The Datex-Ohmeda 7900 Ventilator Enhancements to the Aestiva/5 Anesthesia System is a pneumatically driven, microprocessor-based, electronically controlled ventilator that provides patient ventilation during surgical procedures. The device includes a built-in monitoring system for inspired oxygen, airway pressure, and exhaled volume.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on regulatory substantial equivalence based on compliance with voluntary standards and comparisons to predicate devices, rather than explicit performance-based acceptance criteria with specific numerical targets. The "reported device performance" in this context refers to its successful validation against these standards and its similar functionality to predicate devices.

Acceptance Criterion (Implicit)	Reported Device Performance
Compliance with Voluntary Standards:
UL 2601 General requirements for Medical Electrical Equipment	Validated through rigorous testing to support compliance.
EN 740 Anesthetic Work Stations	Validated through rigorous testing to support compliance.
EN/IEC 60601-1: General requirements for Medical Electrical Equipment	Validated through rigorous testing to support compliance.
EN/IEC 60601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatibility	Validated through rigorous testing to support compliance.
ASTM F1101-90 Standard Specification for Ventilators Intended for Use During Anesthesia	Validated through rigorous testing to support compliance.
ISO 5358 Anesthetic Gas Machines	Validated through rigorous testing to support compliance.
ASTM F1209-94 Anesthesia Breathing Circuit Standard	Validated through rigorous testing to support compliance.
EN 475 Electrically Generated Alarm Signals	Validated through rigorous testing to support compliance.
ASTM F1463-93 Standard Specification for Alarm Signals	Validated through rigorous testing to support compliance.
Substantial Equivalence to Predicate Devices: Design concepts, technologies, and materials should be similar.	The device is stated to be substantially equivalent in design concepts, technologies, and materials to the Ohmeda 7900 Anesthesia Ventilator (K960964), Ohmeda Excel 3000 Anesthesia Gas System (K973896), Datex-Engstrom AS/3 Anesthesia Delivery Unit (ADU) (K973985), and Puritan Bennett 7200 ICU Ventilator (K930017). Similar functionality, including microprocessor-based control, pneumatic drive, monitoring of inspired oxygen, airway pressure, exhaled volume, compensation for losses, and various ventilatory modes, is described.
Safety and Effectiveness for Intended Use: Providing patient ventilation during surgical procedures.	Demonstrated through substantial equivalence to legally marketed predicate devices and compliance with relevant safety and performance standards. The device is intended for use by trained and qualified medical professionals.

2. Sample size used for the test set and the data provenance

The document does not detail specific "test sets" or "data provenance" in the context of clinical studies for performance metrics. The validation is described as "rigorous testing" to ensure compliance with voluntary standards. This suggests engineering and bench testing, rather than a clinical trial with a patient test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document describes compliance with engineering and electrical safety standards, as well as functional equivalence to predicate devices, not interpretation of clinical data by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of a clinical test set requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a ventilation device; its approval does not involve AI assistance or MRMC studies.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

Not applicable. This is a medical device, and its performance is assessed against established engineering and safety standards, and functional equivalence, not as an algorithm's standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is the successful demonstration of compliance with the detailed requirements outlined in the voluntary consensus standards (UL, EN/IEC, ASTM, ISO) and the functional specifications of the device itself, proving its substantial equivalence to the predicate devices. This involves engineering specifications, technical testing, and regulatory requirements rather than clinical ground truth from patient data.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary

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OCT = 7 2003

K023366

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:

1. 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
1. 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
1. Puritan Bennett 7200 ICU Ventilator Class II 21CFR868.5895, which has been the subject of a cleared 510(k) with FDA log number K930017

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

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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;

1. UL 2601 General requirements for Medical Electrical Equipment
1. EN 740 Anesthetic Work Stations
1. EN/IEC 60601-1: General requirements for Medical Electrical Equipment
1. EN/IEC 60601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatibility
1. ASTM F1101-90 Standard Specification for Ventilators Intended for Use During Anesthesia
1. ISO 5358 Anesthetic Gas Machines
1. ASTM F1209-94 Anesthesia Breathing Circuit Standard
1. EN 475 Electrically Generated Alarm Signals
1. 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

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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.

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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

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510(k) Number (if known):

Device Name: 7900 Ventilator Enhancements for Datex-Ohmeda Aestiva/5 Anesthesia System

Indications For Use:

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) ✓

Over-The-Counter Use_ (Optional Format 1-2-96)

Regulation Number and Section

§ 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).