(44 days)
A one-way valve that prevents the escape of inspiratory gases and rebreathing of expired gases while providing a means of egress for expired gases. Fits all 22 male T-pieces and allows the use of a PEEP valve as the gases exit the valve via a 22 mm port. ISO connections: When assembling any connections use a push and twist action to ensure a secure fit. All ports should remain capped when not is use. Recommended Change: every 24 hours or more frequently if visible deterioration is observed. Single patient use. Non-conductive. Non-sterile. Do not autoclave. CAUTIONS: Federal law restricts this device to sale by or on the order of a physician.
A one-way valve that prevents the escape of inspiratory gases and rebreathing of expired gases while providing a means of egress for expired gases. Fits all 22 male T-pieces and allows the use of a PEEP valve as the gases exit the valve via a 22 mm port.
The provided text is a 510(k) clearance letter from the FDA for an "Exhalation Valve - PN 1922". It does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance metrics.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. However, it does not describe any specific performance studies, their results, or the methodology used to establish such results.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed scientific study of the device's performance against predefined acceptance criteria.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 29 1999
Mr. Thomas R. Gunerman Intersurgical Incorporated 417 Electronics Parkway Liverpool, NY 13088-6098
Re: K984481 Exhalation Valve - PN 1922 Regulatory Class: II (two) Product Code: 73 CBP Dated: January 21, 1999 Received: January 26, 1999
Dear Mr. Gunerman:
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 leqally 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 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 regulations affecting your device can be found in the Code of Federal Requlations, 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 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 requlation 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 - Mr. Thomas R. Gunerman
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/dsma/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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Appendix G. Indication For Use
510(k) Number (if known):
Device Name: 1922 - Exhalation Valve
Indications For Use: A one-way valve that prevents the escape of inspiratory gases and rebreathing of expired gases while providing a means of egress for expired gases. Fits all 22 male T-pieces and allows the use of a PEEP valve as the gases exit the valve via a 22 mm port. ISO connections: When assembling any connections use a push and twist action to ensure a secure fit. All ports should remain capped when not is use. Recommended Change: every 24 hours or more frequently if visible deterioration is observed. Single patient use. Non-conductive. Non-sterile. Do not autoclave. CAUTIONS: Federal law restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark Kramer
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K984481
Prescription Use (Per 21 CFR 801.109)
를 두 곳 이 때 때 때 등 내 다 만 내 유의 바 가 와 바 아 아 에
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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).