(181 days)
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No
The summary describes a mechanical exhalation valve with no mention of software, algorithms, or any technology related to AI or ML.
No
The device, an exhalation valve for ventilators, helps manage gas flow during ventilation but does not directly treat a medical condition or restore health. Its function is supportive, not therapeutic.
No
The device description states its function is to prevent gas escape and re-breathing during ventilation, which is a therapeutic/supportive function, not a diagnostic one.
No
The device description clearly states it is a "reusable exhalation valve," which is a physical hardware component used with ventilators.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manage the flow of gases during ventilation, preventing gas escape and re-breathing. This is a mechanical function related to respiratory support.
- Device Description: The description focuses on the physical mechanism of the valve (inflatable balloon) to control gas flow.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, disease, or condition.
- Using reagents or other substances to perform a test.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is a component used with a ventilator to manage gas flow during respiration, which is a life support function, not a diagnostic test.
N/A
Intended Use / Indications for Use
Prevent escape of inspiratory gases and re-breathing of expired gases while providing a means of egress for expired gases
Product codes
73 CBP
Device Description
The reusable exhalation valves are designed for use with ventilators. The exhalation valve prevents the reasured gases from escaping through the passage that will be made available to expired gases via the inflatable balloon. Also, the re-breathing of the expired gases are prevented by the balloon action.
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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three human profiles or stylized bird wings, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 24 1998
Ms. Lori Zuravleff Instrumentation Industries, Inc. 2990 Industrial Boulevard Bethel Park, PA 15102
Re: K980725 Exhalation Valve Models BE 30-115-B, NS 30-115-U, NS 30-115-5, and PS 54-A Regulatory Class: II (two) Product Code: 73 CBP Dated: June 16, 1998 Received: June 22, 1998
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 legally marketed predicate 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 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 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 (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/dsma/dsmamain.html".
Sincerely vours,
Thomas J. Callahon
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
Exhalation Valves Device:
Prevent escape of inspiratory gases and re-breathing of expired gases while providing a Summary: means of egress for expired gases
The reusable exhalation valves are designed for use with ventilators. The exhalation valve prevents the reasured gases from escaping through the passage that will be made available to expired gases via the inflatable balloon. Also, the re-breathing of the expired gases are prevented by the balloon action.
Mare Krappe
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K980725
Lori Burauleft
Signature
Lori Zuravleff Typed Name
Prescription Use:
(Per 21 CFR 801.109)
February 20, 1998
Date
Premarket notification (510(k)) number