(304 days)
Not Found
None
No
The summary describes a mechanical PEEP valve with no mention of software, algorithms, or any terms related to AI/ML.
No
The provided text describes a device that provides positive end-expiratory pressure, which is a supportive rather than a therapeutic function. It helps maintain pressure in the lungs but does not actively treat a disease or condition.
No
The device is described as a PEEP valve used to provide positive end-expiratory pressure, which is a therapeutic function, not a diagnostic one. It modifies the patient's physiological state rather than assessing it.
No
The device description clearly states it is a "PEEP Valve," which is a physical hardware component used with manual resuscitators and ventilators. It is not software.
Based on the provided information, the Mercury Medical PEEP Valve is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "attached to manual resuscitators and portable ventilators and is used to provide positive end expiratory pressure." This describes a device used in the treatment or support of a patient's respiratory function, not for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- No Mention of IVD Characteristics: The provided text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
In summary, the Mercury Medical PEEP Valve is a medical device used in respiratory support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Mercury Medical PEEP Valve is a single patient use device that is attached to manual resuscitators and portable ventilators and is used to provide positive end expiratory pressure. The device is adjustable from 0-20 cm H2O pressure.
Product codes
BYE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5965 Positive end expiratory pressure breathing attachment.
(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Public Health Service
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Mr. Brian L. Morrison Manager, Quality Assurance and Regulatory Affairs Mercury Enterprizes DBA Mercury Medical Corporate Headquarters 11300 49th Street North Clearwater, Florida 33762.
MAR - 5 2009
K081266 Re:
Trade/Device Name: PEEP Valve Regulation Number: 21 CFR 868.5965 Regulation Name: Positive End Expiratory Pressure Breathing Attachment Regulatory Class: II Product Code: BYE Dated: February 20, 2009 Received: March 3, 2009
Dear Mr. Morrison:
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 - Mr. Morrison
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sutte y. Michael md.
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
od and Drug Administration
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Indications for Use
510(k) Number (if known): # K081266
Device Name: PEEP Valve
Indications for Use:
The Mercury Medical PEEP Valve is a single patient use device that is attached to manual resuscitators and portable ventilators and is used to provide positiveend expiratory pressure. The device is adjustable from 0-20 cm H2O pressure.
Prescription Use V (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sworn
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082664