(30 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's nebulizers are used to administer various aerosol treatments in both the homecare and hospital settings. They are intended to only be use with FDA-approved drugs upon the specific direction of a physician. These devices neither uses specific drug nor is it distributed with such drugs. These nebulizers generate respirable sized aerosols that are delivered directly to the patient for breathing. The nebulizer operates on a compressed gas source which draws liquids from a refillable Jar by the venturi principle and aerosolizes it into respirable particles by impaction ad baffling.
The provided text describes a 510(k) submission for a nebulizer bottle, but it fundamentally lacks any information about acceptance criteria or a study proving the device meets those criteria.
The document focuses on the administrative aspects of a 510(k) submission, including:
- Submitter Information: Hsiner Company, LTD.
- Device Name: Nebulizer Bottle
- Classification Information: Product Code CAF, Regulation Number 868.5630, Class 2.
- Substantial Equivalence: Listing two predicate devices (Hsiner Jet Nebulizer K052811 and Hsiner Bottle K070948).
- Device Description: General description of how nebulizers work and their intended use.
- Intended Use: Administering aerosol treatments to adult and pediatric patients with FDA-approved drugs.
- Comparison to Predicate Devices: Stating equivalence in design and performance to predicate devices.
- FDA Correspondence: The FDA's letter of substantial equivalence.
- Indications for Use Statement.
Therefore, I cannot populate the requested table or sections because the provided text does not contain any details regarding:
- Acceptance criteria: No specific performance metrics or thresholds are mentioned.
- Reported device performance: No data on the device's actual performance (e.g., aerosol particle size, delivery rate) is provided.
- Study design: No mention of a study conducted to demonstrate performance.
- Sample size: No information on test sets or training sets.
- Data provenance: No details about the origin of any data.
- Experts for ground truth: No mention of experts or their qualifications.
- Adjudication method: Not applicable as no ground truth is established.
- MRMC comparative effectiveness study: No such study is mentioned.
- Standalone performance: No standalone algorithm performance is discussed.
- Type of ground truth: Not applicable.
- Training set details: No training set is mentioned.
The 510(k) summary only states that the device is "equivalent in design and performance" to the predicate devices. This implies that the performance characteristics expected would be similar to those of the predicate devices, but it does not provide the actual data or the acceptance criteria used to prove this equivalence for the new device. A 510(k) notice typically refers to detailed testing reports, which are usually not included in the public 510(k) summary document itself.
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15. 510(k) Summary
In accordance with 21 CFR section 807.92 Hsiner is submitting the following 510(k) summary.
15.1. Submitter Information
Hsiner Company, LTD No.312, Jhongshan Rd., Shengang Township, Taichung County 429 Taiwan, ROC
AUG 2 2 2008
Phone: +86-4-25152480
Registration No .: 3003862188 Owner/Operator No .: 9053474
15.2. 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
15.3. Substantially equivalent to:
- 트 Hsiner Jet Nebulizer (K052811)
- 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로그램 프로 Hsiner Bottle (K070948)
Description of the device 15.4.
The Hsiner's nebulizers are used to administer various aerosol treatments in both the homecare and hospital settings. They are intended to only be use with FDA-approved drugs upon the specific direction of a physician. These devices neither uses specific drug nor is it distributed with such drugs.
These nebulizers generate respirable sized aerosols that are delivered directly to the patient for breathing. The nebulizer operates on a compressed gas source which draws liquids from a refillable Jar by the venturi principle and aerosolizes it into respirable particles by impaction ad baffling.
ાર્ રાંસે રાજ્યના સાંતર તાલુકામાં આવેલું એક ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી ખેતી કરવામાં આવેલું એક ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી ખેતી કરવામાં આવેલું એક ગામનાં લોકોનો મ Intended Use of the Device
The Hsiner's nebulizers are 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 tha patient using a Small Volume Nebulizer.
15.6. Comparison to Predicate Devices
The Hsiner Reusable Nebulizers are equivalent in design and performance to the Hsiner's Jet Nebulizer and Nebulizer Bottle.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing right, stacked on top of each other, representing the department's focus on people and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2008
Hsiner Company, Limited C/o Mr. Tom Shanks Principal MDventures 29201 Via Norte Temecula, California 92591
Re: K082009
Trade/Device Name: I-siner Nebulizer Bottle Regulation Number: 868. 5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: July 10, 2008 Reccived: July 15, 2008
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 Foderal 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 (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Chia S. Lin, Ph.D.
Chiu S. Lin. Ph. D Division 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 Reusable Nebulizer Special 510(k) Submission
Indications for Use
510(k) Number (K______________):
Device Name: Hsiner Nebulizer Bottle
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 X (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)
N.J. Patel
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082009
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§ 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).