HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS

K082009 · Hsiner Co., Ltd. · CAF · Aug 22, 2008 · Anesthesiology

Device Facts

• Record ID: K082009
• Device Name: HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS
• Applicant: Hsiner Co., Ltd.
• Product Code: CAF · Anesthesiology
• Decision Date: Aug 22, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Nebulizer bottle for aerosol treatment delivery; used in homecare and hospital settings. Operates via compressed gas source; draws liquid from refillable jar using venturi principle; aerosolizes liquid into respirable particles via impaction and baffling. Operated by physicians, healthcare professionals, or patients under direction. Device delivers medication directly to patient airway; facilitates administration of prescribed aerosolized drugs. Benefits include effective delivery of respirable medication particles.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Reusable nebulizer bottle; venturi-based aerosolization; impaction and baffling mechanism; compressed gas source; refillable jar design; non-electronic; mechanical operation.

Indications for Use

Indicated for adult and pediatric patients requiring aerosolized medication delivery via small volume nebulizer in homecare or hospital settings. Contraindicated for use with non-FDA-approved drugs or without physician prescription.

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.

Predicate Devices

• Hsiner Jet Nebulizer (K052811)
• Hsiner Bottle (K070948)

Submission Summary (Full Text)

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K082004

## 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: [phone]

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 [phone]. 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 [phone] or [phone] 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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