(169 days)
This is a 'T' containing a single check valve in each of two side ports causing inhaled gas to be delivered through proximal port and exhaled gas to be released through distal port. The reusable BE 117 Non-Rebreathing 'T' is designed for use with a spontaneously breathing patient where "back flow" must be avoided The 'T's are designed to prevent the flow of gas back toward the source and ensure unilateral breathing. The BE 117 'T' is intended to be used with a spirometer.
This is a 'T' containing a single check valve in each of two side ports causing inhaled gas to be delivered through proximal port and exhaled gas to be released through distal port.
This 510(k) summary does not contain sufficient information to answer the request. The document is primarily concerned with the FDA's clearance of the BE 117 Non-Rebreathing 'T' device based on substantial equivalence to a predicate device, rather than providing details of a study that proves the device meets specific acceptance criteria based on performance metrics.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study, or how human readers improve with AI assistance.
- Information on standalone (algorithm-only) performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
The document states the device's function: "This is a 'T' containing a single check valve in each of two side ports causing inhaled gas to be delivered through proximal port and exhaled gas to be released through distal port. The reusable BE 117 Non-Rebreathing 'T' is designed for use with a spontaneously breathing patient where "back flow" must be avoided. The 'T's are designed to prevent the flow of gas back toward the source and ensure unilateral breathing. The BE 117 'T' is intended to be used with a spirometer." This describes the intended function and design principles, but not performance metrics or studies proving acceptance criteria.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1998 FEB
Ms. Lori Zuravleff QA/RA Manager Instrumentation Industries, Inc. 2990 Industrial Boulevard Bethel Park, PA 15102
Re : K973066 BE 117 Non-rebreathing 'T' Requlatory Class: II (two) Product Code: СВР Dated: August 15, 1997 Received: August 18, 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, Druq, 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 reqistration, 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 Requlation (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 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 requlations.
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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.qov/cdrh/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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INDICATION FOR USE STATEMENT
- BE 117 Non-Rebreathing 'T' Device:
- This is a 'T' containing a single check valve in each of two side ports causing inhaled Summary: gas to be delivered through proximal port and exhaled gas to be released through distal port.
The reusable BE 117 Non-Rebreathing 'T' is designed for use with a spontaneously breathing patient where "back flow" must be avoided The 'T's are designed to prevent the flow of gas back toward the source and ensure unilateral breathing. The BE 117 'T' is intended to be used with a spirometer.
Lou Burlingoff
Signature
Lori Zuravleff Typed Name
. Rng
(Division Sign-Off) Division of Cardiovascular, Respiratory, January 27, 1998 Date
and Neurological Devices K973066 510(k) Number_
K973066 Premarket notification (510(k)) number
$\leftarrow$ Prescription Use
§ 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).