(72 days)
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.
Not Found
The provided text is a U.S. FDA 510(k) clearance letter for the "Datascope Corp. Patient Monitoring Division Gas Module II". This document confirms that the device has been found substantially equivalent to a predicate device and can be marketed.
However, a 510(k) clearance letter does not typically contain detailed information about the acceptance criteria or the specific study that proves the device meets those criteria, nor does it include the methodology details requested in your prompt. These details are usually found in the 510(k) submission itself (which is not this document) or in supporting documentation provided by the manufacturer.
The letter explicitly states: "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..." This statement is key – it indicates that the clearance is based on substantial equivalence, not necessarily on new studies proving acceptance criteria for novel performance claims.
Therefore, I cannot extract the requested information from the provided text. To answer your questions, one would need access to the full 510(k) submission for K974903, which would contain the performance summary and supporting studies.
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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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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00013
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)
§ 868.1620 Halothane gas analyzer.
(a)
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.(b)
Classification. Class II (performance standards).