CS/3 COMPACT AIRWAY MODULE, M-COVX

K982091 · Datex-Engstrom, Inc. · MHX · Dec 22, 1998 · Cardiovascular

Device Facts

• Record ID: K982091
• Device Name: CS/3 COMPACT AIRWAY MODULE, M-COVX
• Applicant: Datex-Engstrom, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Dec 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

For monitoring hospital patient's respiration (CO2, O2, N2O and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption VO2, Carbon (an way production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). The system is intended for use by qualified medical personnel only.

Device Story

CS/3 Compact Airway Module (M-COVX) monitors respiratory and gas exchange parameters in hospital settings. Inputs include airway gas concentrations (CO2, O2, N2O) and ventilation data (pressure, volume, flow). Device processes these inputs to calculate VO2, VCO2, RQ, and EE. Operated by qualified medical personnel; output displayed for clinical assessment of patient respiratory status and metabolic needs. Facilitates clinical decision-making regarding ventilation and nutritional support.

Technological Characteristics

Compact airway module for gas and ventilation monitoring. Measures CO2, O2, N2O, airway pressure, volume, and flow. Performs metabolic calculations (VO2, VCO2, RQ, EE).

Indications for Use

Indicated for monitoring hospital patients requiring assessment of respiration (CO2, O2, N2O, respiration rate), ventilation (airway pressure, volume, flow), and gas exchange status (VO2, VCO2, RQ, EE). Intended for use by qualified medical personnel.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 22 1998

Mr. Joel C. Kent Datex Engstrom, Inc. 3 Highwood Drive Tewksbury, MA 01876

Re: K982091 CS/3™ Compact Airway Module, M-COVX Requlatory Class: III (three) Product Code: MHX Dated: September 27, 1998 Received: September 29, 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 requlation (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 regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 requlation (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 requlation 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. Callahan, Ph.D. 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):

CS/3™ Compact Airway Module, M-COVX Device Name:

Indications For Use:

For monitoring hospital patient's respiration (CO2, O2, N2O and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption VO2, Carbon (an way production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). The system is intended for use by qualified medical personnel only.

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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

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number