(45 days)
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Not Found
No
The summary describes a simple mechanical manometer for measuring airway pressure and contains no mention of AI or ML.
No
The device is a manometer used to monitor airway pressure, not directly treat a condition. Its function is diagnostic/monitoring, providing visual indication rather than therapeutic intervention.
No
The device provides a visual indication of airway pressure, which is a measurement rather than a diagnosis. It assists in monitoring a physiological parameter during ventilation.
No
The device is described as a "Disposable Manometer," which is a physical device used to measure pressure. The description of its intended use and how it attaches to ventilation devices further confirms it is a hardware device, not software.
Based on the provided information, the PULMANEX® Disposable Manometer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed to measure and display airway pressure during ventilation. This is a measurement of a physiological parameter within the body (airway pressure), not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Mechanism: Manometers work by physically measuring pressure. They do not involve chemical, immunological, or molecular analysis of biological samples, which are characteristic of IVDs.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
Therefore, the PULMANEX® Disposable Manometer is a medical device used for monitoring a physiological parameter during a medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PULMANEX® Disposable Manometer is designed to provide visual indication of a pediatric/infant/neonate's airway pressure during ventilation. It may be attached to the manometer port on manual ventilation devices such as resuscitation bags or hyperinflation bags.
Product codes
CAP
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
airway
Indicated Patient Age Range
pediatric/infant/neonate
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 868.2600 Airway pressure monitor.
(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(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 features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
MAR 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Stephanie Wasielewski VP. Regulatory Affairs/Quality Assurance Viasys Medsystems 100 Chaddick Drive Wheeling, Illinois 60090
Re: K050309
Trade/Device Name: PULMANEX® Disposable Pressure Manometer Regulation Number: 21 CFR 868.2600 Regulation Name: Airway Pressure Monitor Regulatory Class: II Product Code: CAP Dated: February 7, 2005 Received: February 8, 205
Dear Ms. Wasielewski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Ms. Wasielewski
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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). please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Senite Michin Ems.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K050309
Device Name: PULMANEX® Disposable Pressure Manometer
Indications For Use: The PULMANEX® Disposable Manometer is designed to provide visual indication of a pediatric/infant/neonate's airway pressure during ventilation. It may be attached to the manometer port on manual ventilation devices such as resuscitation bags or hyperinflation bags.
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE! IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ques Suliom
tion of Anesthesiology, General Hospital, con Control, Dental Devices
Number K05030