(203 days)
The Vapamasta 6 Anaesthesia Vaporiser a temperature-compensated concentration-calibrated vaporiser. They are designed to introduce an accurately metered volume of vaporised anaesthetic agent into the fresh gas flow of a continuous-flow anaesthetic apparatus.
Their purpose of these devices is to vaporise an inhalable anaesthetic agent for which they have been calibrated and which is indicated on the labelling. They may be used for the induction and maintenance of a state of anaesthesia in humans during a medical procedure, usually involving a surgical operation. They may additionally be used for veterinary procedures.
The devices are calibrated for a specific anaesthetic agent and vaporisers for the following anaesthetic agents are available in the Vapamasta 6 range; Halothane, Enflurane, Isoflurane or Sevoflurane.
The Vapamasta 6 Anaesthesia Vaporiser a temperature-compensated concentration-calibrated vaporiser. They are designed to introduce an accurately metered volume of vaporised anaesthetic agent into the fresh gas flow of a continuous-flow anaesthetic apparatus.
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Vapamasta 6 Anaesthetic Vaporiser." This document indicates that the device has been found substantially equivalent to a legally marketed predicate device.
However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The letter focuses on regulatory approval based on substantial equivalence, and it outlines the indications for use of the Vapamasta 6 Anaesthetic Vaporiser. It does not include the detailed performance study results that would typically address your request.
Therefore, I cannot provide the requested information based on the given text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 1998
Mr. Henry Marshall Medical Industrial Equipment Falcon Road Sowton Industrial Estate Exeter, Devon, EX2 7NA UNITED KINGDOM
Re: K980489 Vapamasta 6 Regulatory Class: II (two) Product Code: 73 CAD Dated: May 26, 1998 Received: June 5, 1998
Dear Mr. Marshall:
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 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). 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 requlations 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 Failure to comply with the GMP regulation may result in assumptions. 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. Henry Marshall
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/dsma/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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510(k) Number (if known): K98 (1489
Device name: Vapamasta 6 Anaesthetic Vaporiser
Indications For Use:
The Vapamasta 6 Anaesthesia Vaporiser a temperature-compensated concentration-calibrated vaporiser. They are designed to introduce an accurately metered volume of vaporised anaesthetic agent into the fresh gas flow of a continuous-flow anaesthetic apparatus.
Their purpose of these devices is to vaporise an inhalable anaesthetic agent for which they have been calibrated and which is indicated on the labelling. They may be used for the induction and maintenance of a state of anaesthesia in humans during a medical procedure, usually involving a surgical operation. They may additionally be used for veterinary procedures.
The devices are calibrated for a specific anaesthetic agent and vaporisers for the following anaesthetic agents are available in the Vapamasta 6 range; Halothane, Enflurane, Isoflurane or Sevoflurane.
It is recommended by the manufacturer that the device is prepared for use by trained technicians, and that they are used by trained physicians for the purpose for which they are designed and manufactured as described above. It is recommended that suitable agent monitoring should be utilised at all times when these devices are in use. It is recommended that servicing and re-calibration shall be done at intervals prescribed by the manufacturer and performed by fully trained and authorised persons.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| 8-28-98 | |
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, | |
| and Neurological Devices | |
| 510(k) Number | K980489 |
| Prescription Use | |
| (Per 21 CFR 801.109) | OR |
| Over The Counter Use | |
| (Optional Format 1-2-96) |
§ 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).