HSINER JET NEBULIZER, MODEL HS-31100

K052811 · Hsiner Co., Ltd. · CAF · Dec 21, 2005 · Anesthesiology

Device Facts

• Record ID: K052811
• Device Name: HSINER JET NEBULIZER, MODEL HS-31100
• Applicant: Hsiner Co., Ltd.
• Product Code: CAF · Anesthesiology
• Decision Date: Dec 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Hsiner Jet Nebulizer is used to administer various aerosol treatments 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

Hsiner Jet Nebulizer is a small volume nebulizer for aerosolizing liquid medications. Device connects to a compressed gas source; utilizes venturi principle to draw liquid from a refillable jar; aerosolizes liquid into respirable particles via impaction and baffling. Used in homecare and hospital settings by patients or healthcare professionals. Output is a mist of respiratory-sized aerosolized particles delivered to the patient. Enables administration of prescribed aerosol treatments; provides therapeutic benefit through targeted delivery of medication to the respiratory tract.

Clinical Evidence

Bench testing only. In vitro performance evaluated using Cascade Impactor method per FDA guidance. Metrics included Mass Median Aerodynamic Diameter (MMAD), Geometric Standard Deviation (GSD), respirable fraction (0.5-5 microns), total mass delivered, respirable mass, and treatment time. Results showed no significant difference compared to predicate devices.

Technological Characteristics

Small volume nebulizer; venturi-based aerosolization; compressed gas source; refillable jar; manual operation. No electronic components or software. Sterilization method not specified.

Indications for Use

Indicated for adult and pediatric patients requiring aerosolized medication delivery via a small volume nebulizer, as prescribed by a physician. Contraindicated for use without FDA-approved drugs or without physician direction.

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

• Allegiance Misty-Neb (K883964)
• Salter Labs Nebulizer (K884947)
• Hudson RCI Micro Mist (K930525)

Submission Summary (Full Text)

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K052811

DEC 2 1 2005

### 510(k) Summary 8.

In accordance with 21 CFR section 807.92 Hsiner is submitting the following 510(k) summary.

### Submitter Information 8.1.

Hsiner Company, LTD No. 13, Tyan Shin St., Taya Hsiang Taichung Hsien, Taiwan, ROC

[phone] Phone:

3003862188 Registration No .: Owner/Operator No .: 9053474

### Preparer of Submission and Contact for Information 8.2.

MDVentures Tom Shanks* - Principal 29201 Via Norte Temecula, CA 92591

[phone] Phone: FAX: [phone] tom(@mdventures E-mail:

* Submission contact for correspondence and additional information

#### Name of Device 8.3.

| Proprietary Name: | Jet Nebulizer |
|----------------------|--------------------------------------|
| Common Name: | Nebulizer |
| Classification Name: | Nebulizer (direct patient interface) |
| Product Code: | CAF |
| Regulation Number: | 868.5630 |
| Device Class | 2 |

### Substantially equivalent to: 8.4.

- 트 Allegiance Misty-Neb (K883964).
- Salter Labs Nebulizer (K884947) .
- Hudson RCI Micro Mist (K930525) .

#### 8.5. Description of the device

The Hsiner Jet Nebulizer is used to administer various aerosol treatments in both the homecare and This device is intended to only be use with FDA-approved drugs upon the hospital settings.

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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 nebuilizer sprays respirately sibe derosentes on a compressed gas source which draws liquids from a refillable Jar by the venturi principle and aerosolizes it into respirable particles by impaction and baffling.

### Intended Use of the Device 8.6.

The Hsiner Jet Nebulizer is used to administer various aerosol treatments 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.

### Comparison to Predicate Devices 8.7.

The Hsiner Jet Nebulizer is equivalent in design, materials and performance to the Predicate I he i suices All the predicate devices utilize the same principles of operation and have the same intended use

Performance testing was conducted invitro using a Cadcade Impactor method according to the "Reviewer Guidance for Nebulizers Metered Dose Inhalers, Spacers and Actuators (10-01-93)." The following characteristics were determined for each Nebulizer:

- Mass Mean Aerodynamic Diameter (MMAD) .
- Geometric Standard Deviation (GSD) .
- Respirable Fraction �
- Respirable Mass .
- Treatment Time ●
- Operating pressures .

The mean Mass Median Aerodynamic Diameter (MMAD), Geometric Standard Deviation (GSD), respirable fraction (% mass between 0.5 and 5 microns), total mass of medication delivered, respirable mass (mass of drug between 0.5 and 5 microns), and treatment time for the Hsiner Jet Nebulizer was not found to not be significantly different than the predicate device for any of the drugs tested.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### DEC 2 1 2005

Hsiner Company Limited Mr. Tom Shanks Principal Mdventures 29201 Via Norte Temecula, California 92591

Re: K052811

Trade/Device Name: Hsiner Jet Nebulizer Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: September 29, 2005 Received: October 4, 2005

Dear Mr. Shanks:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviews your ea your end the device is substantially equivalent (for the received to ruse 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 ntersule comments, or to devices that have been reclassified in accordance with the provisions of Amendinomono, or to active act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions 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 (1 Wr), it may of buyers in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish 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 mount that I Dr. Federal statutes and regulations administered by other Federal agencies. or the For of all , I vath 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 and libuing (s 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis reter 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), n Jose contact the Office of Compliance at [phone]. 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 maj overn 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,

Snette y. Mckien Oms

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

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# Indications for Use

### 510(k) Number (K052811):

Hsiner Jet Nebulizer Device Name:

### Indications for Use:

The Hsiner Jet Nebulizer is used to administer various aerosol treatments to adult and I he Hsiner Jet Nebulizer is ascu to administer val settings. This device is intended for pediatric patients in bon the nomecale and nospecific direction by a physician. Its use is
use only with FDA-approved drugs upon the specific direction by a precribes use only With FDA-approved drugs upon the are professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/4/Picture/11 description: The image shows a signature at the top and a number at the bottom. The signature appears to be cursive and difficult to read. The number at the bottom is "K052811".

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510(k) Submission for the Usiner Jet Nebulizer Revised 12-09-2005

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