CS/3 COMPACT AIRWAY MODULE, M-COVX

• K Number: K982091
• Device Name: CS/3 COMPACT AIRWAY MODULE, M-COVX
• Manufacturer: DATEX-ENGSTROM, INC.
• Date Cleared: 1998-12-22 ( 190 days)
• Product Code: MHX
• Regulation Number: 870.1025
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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 Description

Not Found

AI/ML Overview

The provided text is a Fragment of a 510(k) summary letter from the FDA to Datex Engstrom, Inc. regarding their CS/3™ Compact Airway Module, M-COVX. This document primarily focuses on the FDA's decision of substantial equivalence and does not contain detailed information about acceptance criteria or specific study results to prove a device meets those criteria.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the text provided. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication methods.
5. Information about MRMC comparative effectiveness studies.
6. Results of standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is a regulatory approval letter, not a technical study report.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

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.

{1}------------------------------------------------

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

{2}------------------------------------------------

Page 1 of 1

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
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.(b)
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.