(55 days)
Mercury Medical PEEP Valve
Not Found
No
The description details a mechanical, spring-actuated valve with no mention of software, algorithms, or any technology typically associated with AI/ML.
No.
The device provides Positive End Expiratory Pressure (PEEP) or Continuous Positive Airway Pressure (CPAP), which are supportive therapies rather than treatments for a specific disease or condition. While beneficial for the patient, it does not cure or directly treat a disease.
No
The device is described as providing positive-end expiratory pressure or Continuous Positive Airway Pressure for therapeutic purposes, and there is no mention of it being used for diagnosis, disease detection, or medical condition assessment.
No
The device description clearly states it is an "adjustable valve" and describes physical components like a spring, clear construction, graduated markings, and connectors, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide positive-end expiratory pressure or Continuous Positive Airway Pressure to a patient. This is a therapeutic or supportive function related to breathing, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a mechanical valve that regulates pressure in a breathing circuit. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document 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 samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the Koo Americas valve PEEP is a medical device used in respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Koo Americas valve PEEP is intended as a single-patient use device to provide positive-end expiratory pressure or Continuous Positive Airway Pressure when used with masks and manual resuscitators. The device is adjustable from 0cm to 20cm H2O pressure.
Product codes
BYE
Device Description
The Koo Americas Valve PEEP is an adjustable valve, which is placed in a circuit and provides for positive end expiratory pressure for the patient. It is spring actuated and is a single patient use device. It is clear in construction allowing confirmation of functionality. Graduated markings allow for confirmation of settings. A convenience connector is provided to allow for conversion to 22mm. The connector is a male 30mm that connects to the female Peep Valve to provide 22mm.
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): 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.
Mercury Medical PEEP Valve
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).
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
JUN 6 - 2005
Substantial Equivalence 510(k) Summary
Koo Valve PEEP
To Whom It May Concern:
Date: 5/26/05
Submitter/ Contact Name and Address William Slevin Koo Americas, Inc 1050 Suite C Nine North Drive Alpharetta, GA 30004
Tel: (770) 360-0911
Trade Name: Koo Americas Valve PEEP
Breathing attachment - positive end expiratory pressure Classification Name:
Common/ Usual Name: PEEP Valve
Predicate Legally Marketed Device: Mercury Medical PEEP Valve
Intended Use
The Koo Americas valve PEEP is intended as a single-patient use device to provide positive-end expiratory pressure or Continuous Positive Airway Pressure when used with masks and manual resuscitators. The device is adjustable from 0cm to 20cm H2O pressure.
Description of the Device:
The Koo Americas Valve PEEP is an adjustable valve, which is placed in a circuit and provides for positive end expiratory pressure for the patient. It is spring actuated and is a single patient use device. It is clear in construction allowing confirmation of functionality. Graduated markings allow for confirmation of settings. A convenience connector is provided to allow for conversion to 22mm. The connector is a male 30mm that connects to the female Peep Valve to provide 22mm.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
JUN 6 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William Slevin Quality Contractor Koo Americas, Incorporated 1050-C Nine North Drive Alpharetta, Georgia 30004
Re: K050918
Trade/Device Name: Valve Peep Regulation Number: 21 CFR 868.5965 Regulation Name: Positive End Expiratory Pressure Breathing Attachment Regulatory Class: II Product Code: BYE Dated: April 4, 2005 Received: April 12, 2005
Dear Mr. Slevin:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to roweand 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 Interstate conmisees prior to tray are, as, as a reclassified in accordance with the provisions of Amendinents, or to act 1000 and Cosmetic Act (Act) that do not require approval of a premarket the roderal I out, Drag, and Comments , therefore, market the device, subject to the general approvin upprivation (the Act. The general controls provisions of the Act include controls providents or a 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 II your device is classified (see as a vitional controls. Existing major regulations affecting (1 Wrig, it may of casinos in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be fourther announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Slevin
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 1 27 mm and statutes and regulations administered by other Federal agencies. or the Act of all , I outh all the Act's requirements, including, but not limited to: registration 1 od intist contify was a 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 es read on );
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet rerrir 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 letter will anon you to one finding of substantial equivalence of your device to a promained fredicate 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), rr you dente speedfice 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 maj overn band 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 yours,
Sylute J. Michaudmd
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
3
Indications for Use
510(k) Number (if known): K 050918
Device Name: Valve Peep
Indications For Use: The Koo PEEP valve is intended as a single-patient use device to multations Por Society Pressure or Continuous Positive Airway Pressure provide pooltive one expirators. The device is adjustable from 0cm to 20cm H2O pressure.
1 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Amy Sheldon
(Division Sign-Qfff) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K050918
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