(306 days)
Not Found
Not Found
No
The description details a mechanical nebulizer that uses compressed gas to aerosolize medication, with no mention of software, algorithms, or any technology that would suggest AI/ML.
Yes
The device is used to administer various aerosol treatments out of a drug, indicating it delivers therapy.
No
Explanation: The device is a nebulizer, designed to administer aerosolized medication to patients. Its purpose is therapeutic (drug delivery), not diagnostic (identifying or monitoring a medical condition).
No
The device description clearly outlines a physical medical device (nebulizer) that operates on a compressed gas source and includes various hardware components and accessories. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Headstar medical Small Volume Jet nebulizer is used to administer medication to a patient by creating a respiratory mist. It directly interacts with the patient's respiratory system to deliver a drug.
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any biological specimens. Its purpose is therapeutic, not diagnostic.
Therefore, the device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Headstar medical Small Volume Jet nebulizer creates respiratory mist out of the drug and is used to administer various aerosol treatments to adult and pediatric patients in homecare and hospital environments. It is not intended for transport use.
Based on practical measurement and comparison, Headstar Medical Small Volume Jet Nebulizer is intended for following populations:
HP-2557 Nebulizer with child face mask: 2~9 years old pediatric patients
HP-2558 Nebulizer with adult face mask: for adult patients
HP-2290 Nebulizer with mouth piece & O2 tubing: pediatric over 5 years and adult patients
HP-2291 Nebulizer with mouth/T piece & hose/O2 tubing: pediatric over 5 years and adult patients
The nebulizer operates on a compressed gas source which draws liquids from a refillable jar and aerosolizes it into respirable particles by impaction and baffling. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a It can be packaged with optional accessories; i.e .; oxygen tubing, small volume nebulizer. mouthpiece, T piece, hose and face mask. Nebulizer bottle, T piece and mouthpiece are single patient re-use devices; while other accessories are single use/disposable devices. Headstar Medical small volume jet nebulizer is packed non-sterile in a polyethylene bag.
Product codes
CAF
Device Description
The Headstar medical Small Volume Jet nebulizer creates respiratory mist out of the drug and is used to administer various aerosol treatments to adult and pediatric patients in homecare and hospital environments. It is not intended for transport use. The nebulizer operates on a compressed gas source which draws liquids from a refillable jar and aerosolizes it into respirable particles by impaction and baffling. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a small volume nebulizer. It can be packaged with optional accessories; i.e.; oxygen tubing, mouthpiece, T piece, hose and face mask. Nebulizer bottle, T piece and mouthpiece are single patient re-use devices; while other accessories are single use/disposable devices. Headstar Medical small volume jet nebulizer is packed non-sterile in a polyethylene bag.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Respiratory
Indicated Patient Age Range
HP-2557 Nebulizer with child face mask: 2~9 years old pediatric patients
HP-2558 Nebulizer with adult face mask: for adult patients
HP-2290 Nebulizer with mouth piece & O2 tubing: pediatric over 5 years and adult patients
HP-2291 Nebulizer with mouth/T piece & hose/O2 tubing: pediatric over 5 years and adult patients
Intended User / Care Setting
Homecare and hospital environments; healthcare professional
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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
April 17, 2013
Ms. Gloria Chen General Manager Headstar Medical Products Company, Limited 9F, Number 8, Sec 1 Chung-Shan Road, Hsin-Chang City, Taipei County China (Taiwan) 242
Re: K121770
Trade/Device Name: Headstar Medical Small Volume Jet Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: January 25, 2013 Received: March 11, 2013
Dear Ms. Chen:
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. Iisting 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.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
1
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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Ulmer -
for
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
Indications for Use Form
510(k) Number (if known): K121770 Device Name: _HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER Indications for Use:
The Headstar medical Small Volume Jet nebulizer creates respiratory mist out of the drug and is used to administer various aerosol treatments to adult and pediatric patients in homecare and hospital environments. It is not intended for transport use.
Based on practical measurement and comparison, Headstar Medical Small Volume Jet Nebulizer is intended for following populations:
HP-2557 Nebulizer with child face mask: 2~9 years old pediatric patients HP-2558 Nebulizer with adult face mask: for adult patients HP-2290 Nebulizer with mouth piece & O2 tubing: pediatric over 5 years and adult patients HP-2291 Nebulizer with mouth/T piece & hose/O2 tubing: pediatric over 5 years and adult patients
The nebulizer operates on a compressed gas source which draws liquids from a refillable jar and aerosolizes it into respirable particles by impaction and baffling. Its use is indicated whenever a healthcare professional administers or prescribes medical aerosol products to a patient using a It can be packaged with optional accessories; i.e .; oxygen tubing, small volume nebulizer. mouthpiece, T piece, hose and face mask. Nebulizer bottle, T piece and mouthpiece are single patient re-use devices; while other accessories are single use/disposable devices. Headstar Medical small volume jet nebulizer is packed non-sterile in a polyethylene bag.
Prescription Use × (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 In Vitro Diagnostic Devices (OIVD)
Albert
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
| 2013.04.16 11:28:41 -04'00' | (for LS) |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital |
510(k) Number: K121770
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Infection Control, Dental Devices
510(k)_K121770
Headstar Medical Products Co., Ltd. Product: Headstar Medical Small Volume Jet Nebulizer REV [ B ] Page 2/2