BESMED JET NEBULIZER BOTTLE SET

K091272 · Besmed Health Business Corp · CAF · Nov 10, 2009 · Anesthesiology

Device Facts

• Record ID: K091272
• Device Name: BESMED JET NEBULIZER BOTTLE SET
• Applicant: Besmed Health Business Corp
• Product Code: CAF · Anesthesiology
• Decision Date: Nov 10, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The BESMED Jet Nebulizer Bottle Set is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. 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

The BESMED Jet Nebulizer Bottle Set (PN-1128E) is a small volume nebulizer used to deliver aerosolized liquid medication to patients. It operates by compressing air to aerosolize liquid medication into particles smaller than 5 microns. The device is intended for use in both homecare and hospital settings under the direction of a physician or healthcare professional. It includes a medication cup with a 6 ml capacity and accessories including a mouthpiece, T-piece, corrugate tube, and air tube. The device is designed for simple operation and convenient transport. By converting liquid medication into a fine mist, the device allows for inhalation delivery, which can improve therapeutic outcomes for patients requiring respiratory aerosol treatments.

Clinical Evidence

Bench testing only. Includes nebulizer characterization study (per USFDA 21CFR part 58) and biocompatibility testing (cytotoxicity, skin irritation, and skin sensitization per ISO 10993-5 and ISO 10993-10).

Technological Characteristics

Small volume jet nebulizer; 6 ml medication cup capacity; particle size < 5 microns; dimensions 7.8 x 4.5 cm; non-oil lubrication single-cylinder piston pump for air pressure; accessories include mouthpiece, T-piece, corrugate tube, and air tube. Biocompatibility testing performed per ISO 10993 standards.

Indications for Use

Indicated for adult and pediatric patients requiring aerosolized medication delivery via small volume nebulizer in homecare or hospital settings.

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)

Submission Summary (Full Text)

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" ■ BESMED HE ALTH BUSINESS CORP. 【091272

NO. 5. LANE 116, WU-KONG 2nd RD., WU-KU INDUSTRIAL PARK, TAIWAN

TFL: [phone] FAX : + 886 2 2299 9076 = n www.bestied.com

## " 510k SUMMARY"

NOV 1 0 2009

### Submitter's Name: Besmed Health Business Corp.

No.5, Lane 116, Wu-Kong 2nd Road, Wu-Ku Industrial Park, Taipei Hsien, 24890, Taiwan

Date summary prepared:

April 10, 2009

Device Name:

#### Proprietary Name: BESMED Jet Nebulizer Bottle Set, Model PN-1128E

Common or Usual Name: Jet Nebulizer Classification Name: CAF, Class II 21 CFR 868.5630

Indications for Use:

The BESMED Jet Nebulizer Bottle Set is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. 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 Description:

The MAXHEALTH Air Nebulizer is intended to spray liquid medications in aerosol fonn into gases that re directly delivered to the patient.

Performance Testing:

1) Nebulizer Characterization Study: USFDA 21CFR part 58

- 2) Biocompatibility Test:
- Cytotoxicity study ISO 10993 · 5
- · Skin irritation study ISO 10993-10
- · Skin sensitization study ISO 10993.10

Legally marketed device for substantial equivalence comparison:

HSINER Jet Nebulizer, ( K052811 )

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# " & BESMED HEALTH BUSINESS CORP.

NO. 5. LANE 116. WU-KONG 2nd RD., WU-KU INDUSTRIAL PARK, TAIPEI. TAIWAN

TEL: [phone] FAX: + 886 2 2299 9076 www.besmed.com

| Comparison Areas | Predicate Device | New Device |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Manufacturer | Hsiner Co., Ltd. | Besmed Health Business Corp. |
| 510K number | K052811 | TBA |
| Device name | Jet Nebulizer | Jet Nebulizer Bottle Set |
| Model | HS-31100 | PN-1128 |
| <b>Similar:</b> | | |
| Intended for Use | The Jet Nebulizer is used to<br>administer various aerosol treatments<br>to adult and pediatric patients in both<br>the homecare and hospital settings.<br>This device is intended for use only<br>with FDA approved drugs upon the<br>specific direction by a physician.<br>Its use is indicated whenever a<br>physician or healthcare professional<br>administers or prescribes medical<br>aerosol products to a patient using a<br>Small Volume Nebulizer. | SAME |
| Principle | Aerosolizes liquid into aerosol<br>form by compressing air | SAME |
| Capacity of<br>medication cup | 6 ml | SAME |
| Particle size | < 5 micron | SAME |
| Accessories | Mouthpiece - 1 piece<br>T-piece - 1 piece<br>Corrugate tube - 1 piece<br>Air tube -- 1 piece | SAME |

### Comparison Table

(continued)

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#### 8 8 BESMED HEALTH BUSINESS CORP.

NO. 5. LANE 116, WU-KONG 2nd RD., WU-KU INDUSTRIAL PARK, TAIPEL TAIWAN

TEL: [phone] FAX: + 886 2 2299 9076 www.besmed.com

| Different: | | |
|------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimension | 7.9 x 4.1<br>(Tall x Diameter cm) | 7.8 x 4.5<br>(Tall x Diameter cm) |
| Features | Novel appearance, compact<br>structure, cabinet bulk, simple<br>operation, convenient carrying | 1. Provide non-oil<br>lubrication single-cylinder<br>piston pump for air pressure<br>2. Novel appearance,<br>compact structure, cabinet bulk<br>simple operation, convenient<br>carrying |

Differences between the Legally Marketed Predicate Devices:

- The BESMED Jet Nebulizer Bottle Set, PN-1128E is viewed as substantially equivalent to the predicate device: HSINER Jet Nebulizer, ( K052811 )
Except the different specifications, there are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Dr. Ke-Min-Jen Besmed Health Business 58 Fu-Chiun Street Hsin Chu City China (Taiwan) 300

NOV 1 0 2009

Re: K091272

Trade/Device Name: BESMED Jet Nebulizer Bottle Set, PN-1128E Regulation Number: 21CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: October 28, 2009 Received: October 28, 2009

Dear Dr. Jen:

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 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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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 device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting 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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## Indications for Use

## 510 (K) Number :

Device Name: BESMED Jet Nebulizer Bottle Set, PN-1128E

Indications for Use:

The BESMED Jet Nebulizer Bottle Set is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. 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 V

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

L. Schulthess

Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) K091272

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