(169 days)
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No
The description focuses on a mechanical device with check valves and does not mention any computational or learning capabilities.
No
The device is described as a non-rebreathing 'T' intended for use with a spirometer to prevent backflow and ensure unilateral breathing in spontaneously breathing patients. Its primary function is to facilitate accurate spirometry by directing gas flow, not to diagnose, treat, prevent, cure, or mitigate disease. Therefore, it is not a therapeutic device.
No
The device is described as a non-rebreathing 'T' for use with a spirometer, designed to control gas flow (unilateral breathing). Its function is to prevent backflow during inhalation and exhalation, not to diagnose a medical condition.
No
The device description clearly describes a physical "T" shaped component with check valves, indicating it is a hardware device, not software only.
Based on the provided information, this device 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 description clearly states the device is a "Non-Rebreathing 'T'" designed for use with a spontaneously breathing patient to manage inhaled and exhaled gases. It's a component used in a respiratory system, likely for measuring lung function with a spirometer.
- No Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is purely mechanical, controlling the direction of gas flow.
Therefore, the device falls under the category of a medical device used in a clinical setting, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- 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.
Product codes
CBP
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
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Intended User / Care Setting
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines connecting them. The symbol is black and white.
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.
1
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
2
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
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