HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER

K121770 · Headstar Medical Products Co., Ltd. · CAF · Apr 17, 2013 · Anesthesiology

Device Facts

• Record ID: K121770
• Device Name: HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER
• Applicant: Headstar Medical Products Co., Ltd.
• Product Code: CAF · Anesthesiology
• Decision Date: Apr 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Small volume jet nebulizer; utilizes external compressed gas source to aerosolize liquid medication via impaction and baffling; produces respirable mist for inhalation. Used in homecare and hospital environments; operated by healthcare professionals or patients. Device consists of nebulizer bottle, mouthpiece, T-piece, hose, and face mask accessories. Nebulizer bottle, T-piece, and mouthpiece are single-patient reusable; other accessories are single-use/disposable. Provides targeted respiratory drug delivery; facilitates treatment of respiratory conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Jet nebulizer; operates via compressed gas source; utilizes impaction and baffling for aerosolization. Materials include polyethylene (packaging). Non-sterile. Manual operation; no electronic components or software.

Indications for Use

Indicated for adult and pediatric patients (ages 2-9 for child mask; >5 years for mouthpiece/T-piece) requiring aerosolized medication delivery in home or hospital settings. Not for transport use.

Regulatory Classification

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.

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [phone] or [phone] 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
Page 1 of 1

Infection Control, Dental Devices

510(k)_K121770

Headstar Medical Products Co., Ltd. Product: Headstar Medical Small Volume Jet Nebulizer REV [ B ] Page 2/2