(306 days)
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 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.
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.
{
"1. A table of acceptance criteria and the reported device performance": "The document provided is a 510(k) clearance letter for a medical device (Headstar Medical Small Volume Jet Nebulizer). It does not contain a table of acceptance criteria and reported device performance. This type of information would typically be found in the 510(k) submission itself or in a summary document, not in the FDA's clearance letter.",
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document does not detail any specific studies that would include sample sizes or data provenance for a test set. The clearance is based on substantial equivalence to a predicate device, implying that performance data was provided, but the specifics are not in this letter.",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "This information is not provided in the document. The clearance letter focuses on the regulatory decision and does not include details about ground truth establishment or expert qualifications for any testing that might have been conducted.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "The document does not describe any adjudication methods related to a test set. This type of information would be part of a detailed study report, not a clearance letter.",
"5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "No MRMC comparative effectiveness study is mentioned, nor is there any discussion of AI assistance or its effect size. The device is a nebulizer, which does not involve AI assistance for human readers.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "The concept of "standalone algorithm performance" is not applicable to a small volume jet nebulizer, which is a physical device used for drug delivery, not an algorithm. Therefore, no such study was conducted or mentioned.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "No information regarding ground truth is presented in this document. The FDA clearance letter for a nebulizer would not typically delve into such details which are more relevant to diagnostic devices or software.",
"8. The sample size for the training set": "There is no mention of a training set or its sample size. This information would be relevant for machine learning models, which is not applicable to the device described.",
"9. How the ground truth for the training set was established": "As there is no training set mentioned or implied for this medical device, there is no discussion of how its ground truth was established."
}
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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
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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
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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
§ 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).