(90 days)
The use of the Microcap capnograph monitor is indicated whenever a professionally trained health care providers determine that a patient requires the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate.
Not Found
This FDA letter from 1998 for the Microcap device (K981114) does not contain any information regarding acceptance criteria or a study proving the device meets such criteria.
The letter is a 510(k) clearance letter, which means the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device. This process focuses on comparing the new device's indications for use and technological characteristics to an existing device, rather than requiring the submission of new clinical or performance data against specific acceptance criteria.
Therefore, I cannot provide the requested information from the provided text. The document primarily confirms regulatory clearance, not detailed performance study results.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 25 1998
Mr. Sanford Brown Oridion Medical Ltd. 7 Hamarpe Street Har Hotzvim Industrial Park Jerusalem, 91450 ISRAEL
Re: K981114 Microcap Requlatory Class: II (two) 73 ССК Product Code: March 24, 1998 Dated: March 27, 1998 Received:
Dear Mr. Brown:
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 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 regulation may result in regulatory 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. Sanford Brown
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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INDICATIONS FOR USE 3.
March 24, 1998
| 510(k) Number (if known): | K981114 |
|---|---|
| --------------------------- | --------- |
Device Name: Microcap_
Indications For Use:
The use of the Microcap capnograph monitor is indicated whenever a professionally trained health care providers determine that a patient requires the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate.
(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) | Luk W. Mardor 6-19-98 |
|---|---|
| -------------------------- | ----------------------- |
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).