(181 days)
Prevent escape of inspiratory gases and re-breathing of expired gases while providing a 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.
The provided text is a 510(k) premarket notification letter from the FDA, dated August 24, 1998, regarding Exhalation Valve Models BE 30-115-B, NS 30-115-U, NS 30-115-S, and PS 54-A.
Unfortunately, this document does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
The letter is a regulatory approval, stating that the device is "substantially equivalent" to legally marketed predicate devices. This type of notification focuses on comparing a new device to an existing one that has already been approved, rather than presenting new performance study results against specific criteria.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance
- Sample size and data provenance for the test set
- Number and qualifications of experts for ground truth
- Adjudication method for the test set
- MRMC comparative effectiveness study results
- Standalone performance study
- Type of ground truth used
- Sample size for the training set
- Method for establishing ground truth for the training set
The document primarily states the device's classification, applicable regulations, and the FDA's decision regarding its marketability based on substantial equivalence. It does not delve into the detailed performance data or study methodologies that would typically be associated with demonstrating acceptance criteria.
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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
§ 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).