GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM by DATEX-OHMEDA, INC.

The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva/5 MRI Anesthesia System performed to specifications when tested directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss.

Device Description

The Aestiva SmartVent MRI Anesthesia System is substantially equivalent to the following currently marketed device: 1. Datex-Ohmeda Aestiva SmartVent MRI Anesthesia System - Class II -21CFR868.5160. The Aestiva/5 MRI provides the functional feature set offered by the conventional Aestiva 3000 (K973896) to the clinician with the added ability to be used in the MR environment (as cleared in K993410). Among those standard Aestiva 3000 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent (Including those cleared in K023366) along with the Aestiva breathing circuit. The Aestiva/5 MRI is constructed of primarily non-ferrous materials to help prevent attraction to the cryogenic magnets in the MRI systems. The Aestiva/5 MRI performed to specifications when tested directly next to an MRI device of the field strength listed in the product labeling. Safety features and devices within the Aestiva/5 MRI decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.

AI/ML Overview

The GE Datex-Ohmeda Aestiva/5 MRI Anesthesia System is a gas machine for anesthesia or analgesia, designed to provide the functionalities of a conventional anesthesia system within an MRI environment.

Here's an analysis of its acceptance criteria and the study that supports it:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Based on Compliance to Standards and Stated Functionality)	Reported Device Performance
Functional Equivalence: Provide the functional feature set of the conventional Aestiva 3000 (K973896).	The Aestiva/5 MRI provides the functional feature set offered by the conventional Aestiva 3000, including the Datex-Ohmeda user interface, all ventilation parameters of the SmartVent (including K023366 cleared features), and the Aestiva breathing circuit.
MRI Compatibility: Ability to be used in the MR environment.	The Aestiva/5 MRI is constructed of primarily non-ferrous materials to help prevent attraction to cryogenic magnets. It performed to specifications when tested directly next to an MRI device of the field strength listed in the product labeling. Specifically, it performed to specifications when tested next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength not exceeding 300 gauss.
Safety Features: Decrease the risk of hypoxic mixtures, agent mixtures, and complete power or sudden gas supply failures.	Safety features and devices within the Aestiva/5 MRI decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. (Implied by compliance to safety standards).
Compliance with Voluntary Standards:	The Aestiva SmartVent MRI was designed to comply with the applicable portions of the following voluntary standards, and "rigorous testing" supported this compliance:
- EN 740 Anesthetic Work Stations	- Compliance to EN 740 is indicated.
- EN 60601-1, IEC 601-1: 1988 Medical Electrical Equipment	- Compliance to EN 60601-1, IEC 601-1: 1988 is indicated.
- EN 60601-1-2, IEC 601-1-2: 1998 Medical Electrical Equipment - Electromagnetic Compatibility	- Compliance to EN 60601-1-2, IEC 601-1-2: 1998 is indicated.
- ISO 5358 Anesthetic Gas Machines	- Compliance to ISO 5358 is indicated.
- ASTM F1208-94 Anesthesia Breathing Circuit Standard	- Compliance to ASTM F1208-94 is indicated.
Adherence to FDA Guidance: Incorporate testing and labeling requirements derived from "A Primer on Medical Device Interactions with Resonance Imaging Systems."	This document was used to help determine testing and labeling requirements, indicating adherence.

The "study" evidencing these criteria is described as "rigorous testing" that validated the device, in part, supporting its compliance with the mentioned standards. This testing focused on both functional equivalence to its predicate device (Aestiva 3000) and its specific performance in an MRI environment (non-ferrous nature and specified operation near 1.5T and 3.0T MRI devices within 300 gauss field strength).

Details of the Study:

This submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a de novo clinical trial to prove efficacy or safety from scratch. Therefore, the "study" described is primarily a series of engineering tests and compliance evaluations against recognized standards and predicate device performance.

2. Sample size used for the test set and the data provenance:
- Test Set: Not explicitly stated as a "sample size" in the context of patients or data records. Instead, the testing likely involved a limited number of physical prototype devices.
- Data Provenance: The testing was conducted by the manufacturer (Datex-Ohmeda, Inc.) as part of the device development and validation process. This would be considered prospective engineering validation and verification testing. The geographical origin of the data is not specified beyond the manufacturer's location in Wisconsin, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (N/A): This type of device (Anesthesia System) and submission (510(k) of an MRI-compatible version of an existing device) does not typically involve expert consensus to establish a "ground truth" on a test set of medical data (e.g., images for diagnosis). Instead, performance is assessed against engineering specifications and voluntary standards. Experts would be involved in the design, testing protocols, and interpretation of results (e.g., engineers, medical device specialists, potentially anesthesiologists for functional review), but not in creating a diagnostic ground truth.
4. Adjudication method for the test set:
- N/A: As there's no "ground truth" to adjudicate in the typical sense of diagnostic accuracy, an adjudication method like 2+1 or 3+1 is not applicable. Performance would be determined by meeting predefined engineering criteria and passing standard-specific tests.
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:
- No: This is not an AI-enabled diagnostic device and therefore an MRMC study comparing human readers with and without AI assistance is not relevant or performed for this type of submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A: This is a physical medical device, not a software algorithm, so the concept of standalone performance (without human-in-the-loop) is not applicable in the typical sense of AI/software. Its functionality is inherently tied to human operation and interaction. The "standalone" performance here refers to the device itself operating according to specifications.
7. The type of ground truth used:
- Engineering Specifications and Voluntary Standards: The "ground truth" for this device's performance is its adherence to its own design specifications, the functional features of its predicate device, and the requirements outlined in the cited voluntary standards (EN 740, EN 60601-1, EN 60601-1-2, ISO 5358, ASTM F1208-94) and relevant FDA guidance. For MRI compatibility, the ground truth was "performed to specifications when tested directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss."
8. The sample size for the training set:
- N/A: This is not a machine learning model, so there is no concept of a "training set" of data for an algorithm. The development process would involve iterative design, prototyping, and testing.
9. How the ground truth for the training set was established:
- N/A: See point 8.

Summary

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K050055

December 28th, 2004

Subject: 510(k) Summary of Safety and Effectiveness Information for the GE Datex-Ohmeda Aestiva/5 MRI Anesthesia System Datex-Ohmeda Aestiva/5 MRI Anesthesia System Proprietary: Common: Gas Machine, Anesthesia Anesthesiology, 73CBK, 21CFR868.5160 Classification:

The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.

The Aestiva SmartVent MRI Anesthesia System is substantially equivalent to the following currently marketed device:

Datex-Ohmeda Aestiva SmartVent MRI Anesthesia System - Class II -21CFR868.5160

The Aestiva/5 MRI provides the functional feature set offered by the conventional Aestiva 3000 (K973896) to the clinician with the added ability to be used in the MR environment (as cleared in K993410). Among those standard Aestiva 3000 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent (Including those cleared in K023366) along with the Aestiva breathing circuit. The Aestiva/5 MRI is constructed of primarily non-ferrous materials to help prevent attraction to the cryogenic magnets in the MRI systems. The Aestiva/5 MRI performed to specifications when tested directly next to an MRI device of the field strength listed in the product labeling. Safety features and devices within the Aestiva/5 MRI decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.

The Aestiva SmartVent MRI was designed to comply with the applicable portions of the following voluntary standards:

1. EN 740 Anesthetic Work Stations
1. EN 60601-1, IEC 601-1: 1988 Medical Electrical Equipment
1. EN 60601-1-2, IEC 601-1-2: 1998 Medical Electrical Equipment -Electromagnetic Compatibility
1. ISO 5358 Anesthetic Gas Machines
1. ASTM F1208-94 Anesthesia Breathing Circuit Standard

In addition, the FDA Document, A Primer on Medical Device Interactions wi part of the Resonance Imaging Systems, was used to help determine testing and labeling requirements.

The Datex-Ohmeda Aestiva/5 MRI and the currently marketed devices are subst equivalent in design concepts, technologies and materials. The Datex-Ohmeda MRI has been walidated through rigorous testing that, in part, support the comp Aestivation 12 the above mentioned standards.

Datex-Ohmeda, Inc.

P.O. Box 7550

Madison, WI 53707-7550

www.datex-ohmeda.com

Now

GE family

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing protection and service. The image is in black and white.

Public Health Service

FEB - 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dan Kosednar Manager, Regulatory Planning and Submissions, CARE Datex-Ohmeda, Incorporated P.O Box 7550 Madison, Wisconsin 53707-7550

Re: K050055

Trade/Device Name: GE Datex-Ohmeda Aestiva/5 MRI Anesthesia System Regulation Number: 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: January 10, 2005 Received: January 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 Federal Register.

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Page 2 - Mr. Kosednar

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 (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.

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 (240) 276-0120. 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/industry/support/index.html.

Sincerely yours.

CluLs

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

KOSOOSS 510(k) Number (if known):

Device Name: GE Datex-Ohmeda Aestiva/5 MRI Anesthesia System

Indications For Use:

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 ____________________________________________________________________________________________________________________________________________________________________

Division Sign-Off

Division of Anesthaslology. General F Intection Control, Dental Devi 510(k) Number:

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).