(343 days)
For the delivery of inhalation anesthesia gases in a medical setting.
Not Found
The provided text pertains to an FDA 510(k) clearance letter for the Mallard Model 3000 Anesthesia Machine. This document is a regulatory approval and does not contain information about a study proving the device meets acceptance criteria, an AI algorithm, or any of the detailed performance metrics requested in your prompt.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study design, expert qualifications, or ground truth establishment from this document. The document primarily focuses on the device's regulatory classification, its substantial equivalence to a predicate device, and the indications for use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EP - 3 2004
Mr. Robert M. Pearson President/CEO Mallard Medical, Incorporated 20268 Skypark Drive Redding, California 96002
Re: K033026
Trade/Device Name: Mallard Model 3000 Anesthesia Machine Regulation Number: 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: July 9, 2004 Received: July 12, 2004
Dear Mr. Pearson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Pearson
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K033026 510(k) Number:
Device Name:
Mallard Model 3000 Anesthesia Machine
Indications For Use:
For the delivery of inhalation anesthesia gases in a medical setting.
Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use No (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oum Suivom
(Division Sign-Off) (Division Sign-Om)
Division of Anesthesiology, General Hospital, Infection Control, Dental De 510(k) Number:
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).