(29 days)
Not Found
Not Found
No
The summary describes a compressed air source for nebulizers and does not mention any AI or ML capabilities.
Yes
The device is designed to aerosolize physician-prescribed liquid medication, which is a therapeutic function.
No
Explanation: The device is described as providing a compressed air source to aerosolize physician-prescribed liquid medication, which indicates a therapeutic function for drug delivery, not a diagnostic one.
No
The device description explicitly states it is a "compressed air source" and is used "in combination with the packaged Salter Labs 8900 series nebulizer." This indicates a hardware component (the compressed air source) is the primary medical device, not software.
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 a compressed air source for aerosolizing liquid medication. This is a therapeutic function, delivering medication to a patient.
- Device Description: The description aligns with a medical device used for drug delivery (a nebulizer compressor).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed for testing biological samples outside the body to gain diagnostic or other health-related information. This device's function is to deliver medication into the body.
N/A
Intended Use / Indications for Use
The 9R-02X Series, MiniNeb & MiniPlus are designed to provide a compressed air source to aerosolize physician-prescribed liquid medication when used in combination with the packaged Salter Labs 8900 series nebulizer, except for Pentamidine Prescription Use.
Product codes
CAF
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
§ 868.5630 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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health, services, and people. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
FEB 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Alan Chang Quality Assurance Regulatory Affairs Director Apex Medical Corporation No.9, Minsheng Street Tucheng City, Taipei County 236, TAIWAN (R.O.C)
Re: K050104
Trade/Device Name: 9R-02X Series, MiniNeb & MiniPlus Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 5, 2005 Received: February 8, 2005
Dear Mr. Chang:
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 he 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. Chang
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 or any I 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) rrarrarket notification. The FDA finding of substantial equivalence of your device to a legally premated 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 Office of Compliance at (240) 276-_. 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/industry/support/index.html.
Sincerely yours,
Quitte H. Michie MD,
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
2
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: 9R-02X Series, MiniNeb & MiniPlus
Indications for Use:
The 9R-02X Series, MiniNeb & MiniPlus are designed to provide a compressed air
source to aerosolize physician-prescribed liquid medication when used in combination
with the packaged Salter Labs 8900 series nebulizer, except for Pentamidine
Prescription Use x ___________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use __ (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)
Cree Taylor
vision Sign-Off)
mision of Anesthesiology, General Hospital,
Infection Controi, Dental Devices
510(k) Number: K050104
Page 1 of 1