AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)

K973985 · Datex-Engstrom, Inc. · BSZ · Oct 30, 1998 · Anesthesiology

Device Facts

• Record ID: K973985
• Device Name: AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)
• Applicant: Datex-Engstrom, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Oct 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AS/3™ Anaesthesia Delivery Unit (AS/3™ ADU) is an Anesthesia Gas Machine for The A.J. > Anaesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia. The AS/3™ ADU is indicated for all persons that require inhalation anesthesia. The AS/3™ ADU shall be operated by qualified anesthesia personnel.

Device Story

AS/3™ Anesthesia Delivery Unit (ADU) functions as an anesthesia gas machine; provides anesthetic breathing gas and manual or mechanical ventilation to patients. Used in clinical settings (OR) by qualified anesthesia personnel. Device delivers gas mixtures and manages ventilation parameters to support patients undergoing anesthesia. Healthcare providers monitor output to adjust anesthetic delivery and ventilation settings, facilitating patient stability during surgical procedures.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device specifications and intended use.

Technological Characteristics

Anesthesia gas machine; provides manual and mechanical ventilation; gas delivery system. Designed for operation by qualified anesthesia personnel. Technical specifications and materials not detailed in provided documentation.

Indications for Use

Indicated for all persons requiring inhalation anesthesia, including manual or mechanical ventilation during anesthetic procedures. Contraindications not specified.

Regulatory Classification

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. 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).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 30 1998

Mr. Joel C. Kent Datex-Engstrom, Inc. Three Highwood Drive Tewksbury, MA 01876

Re: K973985 AS/3™ Anesthesia Delivery Unit (ADU) Requlatory Class: II (two) Product Code: 73 BSZ Dated: August 14, 1998 Received: August 17, 1998

Dear Mr. Kent:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Joel C. Kent

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Cal Maha Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ K973985

AS/3™ Anaesthesia Delivery Unit (AS/3TM ADU) Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The AS/3™ Anaesthesia Delivery Unit (AS/3™ ADU) is an Anesthesia Gas Machine for The A.J. > Anaesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia.

The AS/3™ ADU is indicated for all persons that require inhalation anesthesia.

The AS/3™ ADU shall be operated by qualified anesthesia personnel.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Mark Kramer

(Divisio Division of Cardio and Neurological Device 510(k) Number