(88 days)
On/Off control of oxygen flow when using a resuscitator bag. For use with hyperinflation bag (not included) weighing ~3 ounces - 4 pounds (90 - 1814 grams). The use of these sizes of bags typically range from neonatal, pediatric to adult care. The valves are intended to be used with a flowmeter (not included) which controls the flow of oxygen to the valve. On/off oxygen action is controlled by lifting/replacing bag on arm of valve. Immediate oxygen flow is provided when bag is lifted from arm (preventing personnel from having to turn oxygen on). Oxygen flow is stopped when bag is replaced.
Instant Flow Valves
The provided text is a 510(k) clearance letter from the FDA for "Instant Flow Valves" and an "Indication for Use Statement". It does not contain any information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance), or training set information for a medical device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is solely a regulatory clearance for marketing based on substantial equivalence to a predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
100 - 100 -
Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are drawn with thick, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 1997
Ms. Lori Zuravleff Instrumentation Industries, Inc. 2990 Industrial Boulevard ..... Bethel Park, Pennsylvania 15102
ರ್ವಿರ K970599
- Re: ್ Instant Flow Valves Requlatory Class: II (two) Product Code: 73 BTM Dated: March 14, 1997 Received: March 17, 1997
Dear Ms. Zuravleff:
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 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, qood 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 regulations 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in 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 - Ms. Lori Zuravleff
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 (301k 594-4646. 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. C allahan, 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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INDICATION FOR USE STATEMENT
BE 3000 Series Instant Flow Valves Device:
Summary: On/Off control of oxygen flow when using a resuscitator bag.
For use with hyperinflation bag (not included) weighing ~3 ounces - 4 pounds (90 - 1814 grams). The use of these sizes of bags typically range from neonatal, pediatric to adult care. The valves are intended to be used with a flowmeter (not included) which controls the flow of oxygen to the valve.
On/off oxygen action is controlled by lifting/replacing bag on arm of valve. Immediate oxygen flow is provided when bag is lifted from arm (preventing personnel from having to turn oxygen on). Oxygen flow is stopped when bag is replaced.
Teri Runnells
Signature
Lori Zuravleff Typed Name
March 14, 1997 Date
Premarket notification (510(k)) number
Rha
and Neurological O 510(k) Number
prescription use
aver the - countin use
Page 4-1
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).