(97 days)
Not Found
Not Found
No
The summary describes a simple mechanical pressure manometer and contains no mention of AI, ML, or related concepts.
No
Explanation: The device is described as providing "visual indication of the patient's airway pressure," which is a diagnostic or monitoring function, not a therapeutic one. It does not actively treat or mitigate a disease or condition.
No
The primary function described is to "provide visual indication of the patient's airway pressure," which is a measurement or monitoring function, not a diagnosis of a disease or condition. While the information provided by the device can be used in the diagnostic process, the device itself doesn't make a diagnosis.
No
The device is described as a "Disposable Pressure Manometer," which is a physical device used to measure pressure. The description of its use with venting bags, hyperinflation bags, CPAP masks, and CPAP circuits further indicates it is a hardware component. There is no mention of software in the provided text.
Based on the provided information, the Ambu Disposable Pressure Manometer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a visual indication of the patient's airway pressure. This is a measurement of a physiological parameter within the patient's body (in vivo), not an analysis of a sample taken from the patient's body (in vitro).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Ambu Disposable Pressure Manometer is a medical device used for monitoring a physiological parameter, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ambu Disposable Pressure Manometer will be used to provide visual indication of the Amou Disposable Prossure Managers and the may be attached to the manometer port on patient s an way pressure daming venting bags, hyperinflation bags, CPAP Mask or CPAP Circuits.
Product codes (comma separated list FDA assigned to the subject device)
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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
JUL 22 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Sanjay Parikh Technical & Regulatory Affairs Manager Ambu, Incorporated 611 North Hammonds Ferry Road Linthicum, Maryland 21090-1356
Re: K040991
Trade/Device Name: Ambu Disposable Pressure Manometer Regulation Number: 868.2600 Regulation Name: Airway Pressure Monitor Regulatory Class: II Product Code: CAP Dated: July 7, 2004 Received: July 8, 2004
Dear Mr. Parikh:
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 approvisions 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 Eederal Register.
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Page 2 - Mr. Parikh
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 mean that I Drimas made statutes and regulations administered by other Federal agencies. or the receively 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 and ifome (21 Cert 6 rth in the quality systems (QS) regulation (21 CFR Part 820); and if requirely as 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) I mis feter mification. The FDA finding of substantial equivalence of your device to a premaired fourted onedicate 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), n you deents the Office of Compliance at (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
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
Enclosure
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Page D-1
Indications for Use
510(k) Number (if known):
Device Name: Ambu Disposable Pressure Manometer
Indications For Use:
Ambu Disposable Pressure Manometer will be used to provide visual indication of the Amou Disposable Prossure Managers and the may be attached to the manoneter port on patient s an way pressure daming venting bags, hyperinflation bags, CPAP Mask or CPAP Circuits.
X Prescription Use _ (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K040991 Cluy Julion
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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