GAS MODULE II, MODEL 0998-00-0143

K974903 · Datascope Corp. · CBS · Mar 13, 1998 · Anesthesiology

Device Facts

• Record ID: K974903
• Device Name: GAS MODULE II, MODEL 0998-00-0143
• Applicant: Datascope Corp.
• Product Code: CBS · Anesthesiology
• Decision Date: Mar 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1620
• Device Class: Class 2

Intended Use

The indications for use for the Gas Module II include monitoring of airway gases, during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.

Device Story

Gas Module II monitors airway gases during anesthesia or assisted respiration. Used in ORs and PACUs by clinicians. Device measures gas concentrations to assist in patient management during respiratory support. Provides real-time data to healthcare providers for clinical decision-making regarding anesthesia delivery and ventilation status. Benefits include continuous monitoring of patient respiratory gas levels.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Gas monitoring module for anesthesia and assisted respiration. Designed for integration into patient monitoring systems. Technical specifications not detailed in provided text.

Indications for Use

Indicated for monitoring airway gases in patients undergoing anesthesia or assisted respiration in clinical settings like ORs and PACUs.

Regulatory Classification

Identification

A halothane gas analyzer is a device intended to measure the concentration of halothane anesthetic in a gas mixture. The device may use techniques such as mass spectrometry or absorption of infrared or ultraviolet radiation.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 1998

Mr. Russell Olsen Datascope Corp. Patient Monitoring Division 580 Winters Avenue Paramus, NJ 07652

K974903 Re: Gas Module II Regulatory Class: II (two) Product Code: 73 CBS December 30, 1997 Dated: Received: December 31, 1997

Dear Mr. Olsen:

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 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 A substantially equivalent determination assumes compliance to 895. 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 Failure to comply with the GMP regulation may result in assumptions. 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. Russell Olsen

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/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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## Indications for Use Statement

The indications for use for the Gas Module II include monitoring of airway gases, during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.

Mr. Rusi

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

K974902 510(k) Number _

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Concurrence of CDRH, Office of Device Evaluation (ODE) --

Prescription Use
(Per 21 CFR 801.109)

ારી વિદ્વાર

Over-The-Counter Use

(Optional Format 1-2-96)