(302 days)
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Not Found
No
The summary mentions a "microprocessor (controller)" but does not include any terms or descriptions indicative of AI or ML technology.
Yes
The device is intended for controlled, pneumatically powered ventilation of patients under general anesthesia, which is a medical treatment.
No
The device is described as an anaesthesia ventilator, designed for controlled ventilation of patients, not for diagnosing medical conditions. Its function is therapeutic/supportive, not diagnostic.
No
The device description explicitly states it is a "pneumatically powered ventilator," indicating it is a hardware device with a microprocessor controller, not a software-only device.
Based on the provided information, the Blease 6200 anaesthesia ventilator is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Blease 6200 is a ventilator designed to assist with breathing during general anaesthesia. It directly interacts with the patient's respiratory system, not with samples taken from the body.
- Intended Use: The intended use clearly describes providing controlled ventilation to patients, which is an in-vivo (within the living body) procedure.
Therefore, the Blease 6200 falls under the category of a medical device used for patient support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Blease 6200 anaesthesia ventilator is an advanced microprocessor controlled, pneumatically powered ventilator specifically designed for controlled, positive pressure 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; 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.
Product codes
73 CBK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult and paediatric patients
Intended User / Care Setting
suitably qualified physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.
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.
1
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
2
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
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