(302 days)
The Blease 6200 anaesthesia ventilator is an advanced microprocessor (controller) specifically designed for controlled, pneumatically powered ventilation of adult and paediatric patients under general anaesthesia. It is designed for use with a circle type absorber and is ideally suited to both low-flow and high flow applications. It is assumed the ventilator may also be used with a Jackson-Rees/Ayres T-piece type paediatric circuit with no modification being necessary. The device is intended for use only by a suitably qualified physician.
The Blease 6200 anaesthesia ventilator is an advanced microprocessor (controller) specifically designed for controlled, pneumatically powered ventilation of adult and paediatric patients under general anaesthesia.
The provided text describes a 510(k) premarket notification for the Blease 6200 Anesthesia Ventilator II. However, it does not contain any information regarding:
- Acceptance criteria and reported device performance.
- The specifics of any study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Whether MRMC or standalone studies were conducted.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
The document is a letter from the FDA confirming the 510(k) clearance for the device and an "Intended Use Statement" for the Blease 6200 Anesthesia Ventilator. It does not delve into the technical details of the device's performance or the studies that led to its clearance beyond confirming its substantial equivalence to legally marketed predicate devices.
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Public Health Service
APR 15 :33
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard H. Cooke Blease Medical Equipment Limited c/o Mr. Francis X. Casey Invivo Research, Inc. 12601 Research Parkway Orlando, FL 32826
Re : K982132 Blease 6200 Anesthesia Ventilator II (two) Regulatory Class: Product Code: 73 CBK February 2, 1999 Dated: February 5, 1999 Received:
Dear Mr. Cooke:
We have reviewed your Section 510(k) notification of intent to market we have review food above and we have determined the device is the device referenced above and 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 Interstate commerce problem of 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 ine general concrols provisions quirements for annual registration, pisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special II your dovied in (Premarket Approval), it may be subject to such Controls) of Class III (Freakines offecting your device add cronar concessor Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. es 650. In Burrent 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 concerning your device 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. Richard H. Cooke
This letter will allow you to begin marketing your device as described This letter will afrow you co begin marksberg of substantial in your 310(K) premairket notification marketed predicate device equivalence of your device to a regarly manitor.
results in a classification for your device and thus, permits your device to proceed to the market.
If you dosire specific advice for your device on our labeling If you desire specific advice for your additionally 809.10 for in vitro regulation (2) crk rate are contact the Office of Compliance at diagnostic devices) predoc v. for questions on the promotion and (301) 394-4646. Addressary, 101 gassect the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, (301) 39-4053. "Also, premarket notification"(21 CFR 807.97). Misoranding by Leronon on your responsibilities under the Act may other general information of your manufacturers Assistance at its be obcailled from the Britison of 301) 443-6597, or at its internet corr rree number (000) { vse, corn/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
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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INTENDED USE STATEMENT
The Blease 6200 anaesthesia ventilator is an advanced microprocessor The Blease uzoo andoothoola Tonnilator (controller) specifically designed for controlled, pheumatiouny ewolf and paediatric patients under general anaesthesia.
It is designed for use with a circle type absorber and is ideally suited to both it is designed for assume the ventilator may also be used with low-now and high now applications a Jackson-Rees/Ayres T-piece type paediatric circuit with no modification being necessary.
The device is intended for use only by a suitably qualified physician.
A.L.A. Grahame.
insion Sinn-Off Division of Cardiovascular, Respiratory, and Neurological Dey 510(k) Number
pecumptions use
801.109
ठTZ
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).