(198 days)
Uni-directional valve to prevent back flow of gas in unintended, reverse direction
The reusable BE 130 series One-Way Valves are designed for use in a breathing circuit or ventilatory system where "back flow" must be avoided. They are designed to prevent the flow of gas back toward the source.
The reusable BE 130 series One-Way Valves are designed for use in a breathing circuit or ventilatory system where "back flow" must be avoided. They are designed to prevent the flow of gas back toward the source.
This document is a 510(k) clearance letter from the FDA for a medical device called the "BE 130 Series One-Way Valves." It does not contain information about acceptance criteria or a study proving device performance in the way requested.
Specifically, the document focuses on:
- The FDA's determination of substantial equivalence for the device.
- Regulatory class and product codes.
- General controls provisions of the Act.
- Contact information for compliance and assistance.
- Device indication for use and a brief summary of its function.
Therefore, I cannot provide the requested information from this document. This document is a regulatory approval notice, not a study report detailing performance metrics.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lori Zuravleff Instrumentation Industries, Inc. 2990 Industrial Boulevard Bethel Park, Pennsylvania 15102
SFP 1 8 1007
K970780 Re : BE 130 Series One-Way Valves Requlatory Class: II (two) Product Code: 73 CBP June 16, 1997 Dated: Received: June 23, 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, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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. requlatory action. In addition, FDA may publish further announcements this concerning your device in the Federal Register. Please note: 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 requlation (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/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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INDICATION FOR USE STATEMENT
BE 130 Series Reusable One-Way Valves Device:
Uni-directional valve to prevent back flow of gas in unintended, reverse direction Summary: toward source
The reusable BE 130 series One-Way Valves are designed for use in a breathing circuit or ventilatory system where "back flow" must be avoided. They are designed to prevent the flow of gas back toward the source.
Tai Buroulett
Signature
Lori Zuravleff Typed Name
February 28, 1997 Date
Premarket notification (510(k)) number
Premarket notification (510(k)) number
Ardl A. Ciddh
(Division Sian Off) Division of Cardiness and Neurological Devices 510(k) Number _
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).