(21 days)
The Hsiner Nebulizer Bottle is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.
The Hsiner Nebulizer Bottle is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended to only be use with FDA-approved drugs upon the specific direction of a physician. This device is not used specific drug nor is it distributed with such drugs. The nebulizer sprays respiratory size aerosolized liquids into gasses that are delivered directly to the patient for breathing. The nebulizer operates on a compressed gas source which draws liguids from a refillable Jar by the venturi principle and aerosolizes it into respirable particles by impaction and baffling.
The provided document is a 510(k) summary for the Hsiner Nebulizer Bottle. It does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (Hsiner Jet Nebulizer K052811) rather than presenting a performance study with acceptance criteria.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them, as that information is not present in the provided text.
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Hsiner Company Modified Jet Nebulizer 510(k) Submission
<070948
6. 510(k) Summary
In accordance with 21 CFR section 807.92 Hsiner is submitting the following 510(k) summary.
APR 2 5 2007
6.1. Submitter Information
Hsiner Company, LTD No.312, Jhongshan Rd., Shengang Township, Taichung County 429 Taiwan, ROC
Phone: +86-4-25152480
Registration No .: 3003862188 Owner/Operator No .: 9053474
6.2. Name of Device
| Proprietary Name: | Nebulizer Bottle |
|---|---|
| Common Name: | Nebulizer |
| Classification Name: | Nebulizer (direct patient interface) |
| Product Code: | CAF |
Regulation Number: 868.5630 Device Class 2
6.3. Substantially equivalent to:
- 0 Hsiner Jet Nebulizer (K052811)
6.4. Description of the device
The Hsiner Nebulizer Bottle is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended to only be use with FDA-approved drugs upon the specific direction of a physician. This device is not used specific drug nor is it distributed with such drugs.
The nebulizer sprays respiratory size aerosolized liquids into gasses that are delivered directly to the patient for breathing. The nebulizer operates on a compressed gas source which draws liguids from a refillable Jar by the venturi principle and aerosolizes it into respirable particles by impaction and baffling.
6.5. Intended Use of the Device
The Hsiner Nebulizer Bottle is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. This device is intended for use only with FDAapproved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.
6.6. Comparison to Predicate Devices
The Hsiner Nebulizer Bottle is equivalent in design, materials and performance to the Hsiner Jet Nebulizer and utilizes the same principles of operation and has the same intended use.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is the HHS logo, which consists of a stylized caduceus symbol. The caduceus is a staff with two snakes coiled around it, and it is a symbol of medicine and health care. The seal is a symbol of the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hsiner Company C/O Mr. Tom Shanks Principal MDVentures 29201 Via Norte Temecula, California 92591
APR 2 5 2007
Re: K070948
Trade/Device Name: Hsiner Nebulizer Bottle Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: April 1, 2007 Received: April 4, 2007
Dear Mr. Shanks:
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 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.
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Page 2 - Mr. Shanks
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); good manufacturing practice requirements as set forth in 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susa Rusone
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
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Hsiner Company Modified Jet Nebulizer 510(k) Submission
Indications for Use
510(k) Number (K^070948):
Hsiner Nebulizer Bottle Device Name:
Indications for Use:
The Hsiner Nebulizer Bottle is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chl Udo
rion of Anactheriology, General Hospital Jon Control, Central Devices
'(k) Number
Page 1 of 1
Page 10
§ 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).