(105 days)
The Sigma Delta 'T' vaporizer range is designed to attach to the back bar of an anaesthetic machine and deliver controlled concentrations of anaesthesia gasses into a fresh gas. The fresh gas is then delivered into a patient breathing system, from where the anaesthesia ventilator and breathing circuit will then deliver this fresh gas mixture to the patient. The Vaporizer is calibrated in Vol % of the fresh gas flow and is compensated for changes in both fresh gas flows and temperature changes within the specified range. The indicated use of the Sigma Delta 'T' has therefore not changed from that of the legally marketed device the Sigma Delta.
Anaesthetic Vaporizer
This document is a 510(k) premarket notification decision letter from the FDA for an "Anaesthetic Vaporizer." It does not contain any information about acceptance criteria or a study proving device performance in the context of AI/ML or medical imaging diagnostics. The device described is a traditional medical device (anesthetic vaporizer), not a software device that would typically have performance metrics like sensitivity, specificity, and a ground truth study.
Therefore, I cannot provide the requested information.
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Image /page/0/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest wings and a body. The overall design is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 9 2004
Mr. Alan Green Technical Director Penlon Limited Abingdon Science Park Barton Lane Abingdon United Kingdom OX14 3PH
Re: K041076
Trade/Device Name: Anaesthetic Vaporizer Regulation Number: 868.5880 Regulation Name: Anesthetic Vaporizer Regulatory Class: II Product Code: CAD Dated: July 12, 2004 Received: August 3, 2004
Dear Mr. Green:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becaler researce 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 interstate conninetee pror to may 20, 10, 10, 10, 10, 10, 20, 10, 2011, 10, 2019, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 1 Alliendinents, on to devices that nave of the that do not require approval of a premarket the Federal Pood, Drug, and Cosments , therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the ristration, 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 II your device is classified (500 above) in the major regulations affecting (FMA), it may oc subject to back addin the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Orderning your device in the Federal Register.
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Page 2 -Mr. Green
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvised that I Dr. 3 issualled or that your device complies with other requirements mean that i DA mas made a detect and regulations administered by other Federal agencies. of the Act of ally I edelar statues and registered to the limited to: registration You must comply with an the Pict 8 rog (21 CFR Part 801); good manufacturing practice allu listing (21 CF R Part 067), abolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in alle qt 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) Fins letter will anow yourse of substantial equivalence of your device to a premarket notified.com - The Pre 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), If you desire specific at 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 may obtain ourer generational 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,
Carl
Chiu Lin, Ph.D.
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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ATTACHMENT 10
Indications for Use
510(k) Number (if known):
Device Name:
Anaesthetic Vaporizer
Indications For Use:
The Sigma Delta 'T' vaporizer range is designed to attach to the back bar of an anaesthetic The Digma Bolla - 1- Taprolled concentrations of anaesthesia gasses into a fresh gas. The fresh gas is then delivered into a patient breathing system, from where the anaesthesia ventilator and breathing circuit will then deliver this fresh gas mixture to the patient.
The Vaporizer is calibrated in Vol % of the fresh gas flow and is compensated for changes in both fresh gas flows and temperature changes within the specified range.
The indicated use of the Sigma Delta 'T' has therefore not changed from that of the legally marketed device the Sigma Delta.
. AND/OR Prescription Usc (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clue O. Sulton
Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K041076
§ 868.5880 Anesthetic vaporizer.
(a)
Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.(b)
Classification. Class II (performance standards).