(50 days)
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No
The summary describes a standard nebulizer and makes no mention of AI, ML, or any related computational techniques.
Yes
The device is used to deliver aerosolized medications and diagnostic formulations for medical conditions, which inherently serves a therapeutic purpose.
No
The device is described as delivering "aerosolized medications and diagnostic formulations," but its primary function is medication delivery and secretion loosening, not disease diagnosis. While it can deliver "diagnostic formulations," it is not itself performing the diagnosis.
No
The description clearly states the device is a "nebulizer" and requires a "50 psig source gas," indicating it is a hardware device that delivers aerosolized medications. There is no mention of software as the primary or sole component.
Based on the provided information, the Res-Q Continuous Nebulizer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Res-Q Continuous Nebulizer Function: The description clearly states the device is used to "deliver aerosolized medications and diagnostic formulations" and provides "additional hydration." It's a device that administers substances into the body, not one that analyzes samples from the body.
- Intended Use: The intended use focuses on treating respiratory conditions by delivering medication, not on diagnosing conditions through sample analysis.
Therefore, the Res-Q Continuous Nebulizer falls under the category of a therapeutic or drug delivery device, not an IVD.
N/A
Intended Use / Indications for Use
The Res-Q Continuous Nebulizer is a device to used under the medical supervision in hospital, nursing homes, extended care facilities and outpatient clinics. The Res-Q Continuous Nebulizer is a high output nebulizer to be used to deliver aerosolized medications and diagnostic formulations. It provides additional hydration to help loosen secretions for patients whom extended therapy is required. Patient population: Asthma, pneumonia, COPD, or any other condition in which sympathomimetic ammines, parasympathetic ammines, or other appropriate medications would be nebulized. The Res-Q Continuous Nebulizer requires 50 psig source gas. HE air or oxygen may be added via Multi-gas inlet.
Product codes
CAF
Device Description
The Res-Q Continuous Nebulizer is a high output nebulizer designed to deliver aerosolized medications and diagnostic formulations. It provides additional hydration to help loosen secretions for patients requiring extended therapy. The device requires a 50 psig source gas, and HE air or oxygen can be added via a Multi-gas inlet.
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
Medical supervision in hospital, nursing homes, extended care facilities and outpatient clinics.
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
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§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(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 stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 7, 2012
Mr. Kenneth Miller President Pegasus Research Corporation 3303 Harbo Boulevard, Suite F3 Costa Mesa, California 92626
Re: K122857
Trade/Device Name: Res-Q Continuous Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: October 11, 2012 Received: October 17, 2012
Dear Mr. Miller:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
Page 2 - Mr. Miller
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kwame O.
Ulmer
Digitally signed by Kwame O. Ulmer
DN: c=US, o=U.S. Govemment, ou=HHS,
ou=FDA, ou People, cn Kwame O.
Ulmer,
0.9.2342.19200300.100.1.1-1300183618
Date: 2012.11.07 15:53:48-05'00
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
122857
510 (k) Number (if known) Pending
Device Name: RES-Q CONTINUOUS NEBULIZER
INDICATIONS FOR USE:
The Res-Q Continuous Nebulizer is a device to used under the medical supervision in hospital, nursing homes, extended care facilities and outpatient clinics. The Res-Q Continuous Nebulizer is a high output nebulizer to be used to deliver aerosolized medications and diagnostic formulations. It provides additional hydration to help loosen secretions for patients whom extended therapy is required. Patient population: Asthma, pneumonia, COPD, or any other condition in which sympathomimetic ammines, parasympathetic ammines, or other appropriate medications would be nebulized. The Res-Q Continuous Nebulizer requires 50 psig source gas. HE air or oxygen may be added via Multi-gas inlet.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schult
Division Sign-Off Division of cardiovascular, Respiratory, and Neurological Devices 85 K 510 (K) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter