(499 days)
The Model, MVD -70 POCKET NEB electronic vibrating mesh nebulizer is designed to nebulize liquid medications for inhalation by a patient. The POCKET NEB may be used in adults or children 2 years of age and older. The POCKET NEB is a portable unit for use in and out of the home environment.
The POCKET NEB is not intended as a life sustaining or life-supporting device.
The POCKET NEB is not intended for use with Pentamidine.
The Model, MVD -70 POCKET NEB electronic vibrating mesh nebulizer is designed to nebulize liquid medications for inhalation by a patient. The POCKET NEB is a portable unit.
This document is an FDA 510(k) clearance letter for a medical device called the "Pocket Neb" nebulizer. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria as would be found for a new diagnostic or AI-driven medical device.
The letter pertains to a Class II medical device (a nebulizer), falling under regulation 21 CFR 868.5630. For devices like this, the FDA process often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical performance studies with specific statistical acceptance criteria and ground truth validation that are typically seen for novel diagnostic algorithms (especially those involving AI).
Therefore, I cannot provide the requested information based on the provided text. The document is primarily an administrative letter confirming clearance, outlining regulatory requirements, and stating the device's indications for use.
No information regarding acceptance criteria or a study with performance metrics can be extracted from this document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2016
MicroVapor Devices, LLC Terrence O'Brien Official Correspondent 2682 West Fairbanks Ave. Winter Park, Florida 32789
Re: K142541
Trade/Device Name: Pocket Neb Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: January 5, 2016 Received: January 7, 2016
Dear Terrence O'Brien:
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 Federal Register.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name РОСКЕТ №В
Indications for Use (Describe)
The Model, MVD -70 POCKET NEB electronic vibrating mesh nebulizer is designed to nebulize liquid medications for inhalation by a patient. The POCKET NEB may be used in adults or children 2 years of age and older. The POCKET NEB is a portable unit for use in and out of the home environment.
The POCKET NEB is not intended as a life sustaining or life-supporting device.
The POCKET NEB is not intended for use with Pentamidine.
Labeling for this device in accordance with FDA regulations and will read:
"Federal Law Restricts This device to sale By Or On the Order of A Physician"
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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).