(259 days)
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Not Found
No
The summary describes a simple mechanical valve for measuring auto-PEEP and explicitly states that AI, DNN, or ML are not mentioned.
No.
The device is used for measurement, not for treatment.
No
The device is described as a valve for measuring auto-PEEP, which is a measurement rather than a diagnostic interpretation.
No
The device description clearly states it is a "disposable KC 9-P one-way valve with removable cap," indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure auto-PEEP (Positive End-Expiratory Pressure) during ventilation. This is a physiological measurement taken directly from the patient's respiratory system, not a test performed on a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The description of a "one-way valve with removable cap" used with ventilator circuits aligns with a device used for respiratory support and monitoring, not for laboratory testing.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes in those samples
- Use in a laboratory setting
Therefore, the KC 9-P Auto-PEEP Measurement Device is a medical device used for respiratory monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The disposable KC 9-P one-way valve with removable cap allows a single breath measurement of auto-PEEP when used with certain ventilator circuits.
Product codes
73 СВР
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)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or waves, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 1999
Ms. Tricia Wood Instrumentation Industries, Inc. 2990 Industrial Boulevard Bethel Park, PA 15102
Re: K983631 Auto-PEEP Measurement Device Regulatory Class: II (two) Product Code: 73 СВР May 6, 1999 Dated: Received: May 7, 1999
Dear Ms. Wood:
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 Existing major regulations affecting your device additional controls. 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 assumptions. Failure to comply with the GMP regulation may result in requlatory 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.
1
Page 2 - Ms. Tricia Wood
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. 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
Indications for Use
Center for Devices and Radiological Health
Page 1 of 1
510(k) Number (if known): K983631
Device Name: KC 9-P Auto-PEEP Measurement Device
Indications for Use:
The disposable KC 9-P one-way valve with removable cap allows a single breath
measurement of auto-PEEP when used with certain ventilator circuits.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
Ur. Ruy
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Prescription USC
(Optional Format 3-10-98)
(Posted July 1, 1998)
Back to the Indications for Use Page