VIGORMIST COMPRESSOR NEBULIZER

K031413 · Vega Technologies, Inc. · BTI · Oct 7, 2003 · Anesthesiology

Device Facts

• Record ID: K031413
• Device Name: VIGORMIST COMPRESSOR NEBULIZER
• Applicant: Vega Technologies, Inc.
• Product Code: BTI · Anesthesiology
• Decision Date: Oct 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.6250
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The VigorMist Compressor is intended to be used with a compatible pneumatic nebulizer (specifically the WestMed VixOne) to convert certain inhalable drugs into an aerosol form for inhalation by a patient for the treatment of asthma, COPD, and other respiratory ailments. The device is intended for the home care market. It is intended for use with a single adult, pediatric, or infant patient.

Device Story

VigorMist Compressor is a portable air compressor (11 7/8" x 7 1/8" x 4 1/2"; 4.6 lbs) designed to provide pneumatic power to a handheld nebulizer (specifically WestMed VixOne). Device operates via internal compressor; includes thermal protection for automatic shut-off during overheating. External components include power switch, air filter, and AC cord. Used in home care settings by patients (adult, pediatric, or infant) to convert liquid medications into aerosol form for inhalation. Healthcare providers prescribe the device to manage respiratory conditions; patients operate the device to self-administer medication.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Portable air compressor; dimensions 11 7/8" x 7 1/8" x 4 1/2"; weight 4.6 lbs. Powered by AC electricity. Features internal compressor, thermal overload protection, and air filtration. Pneumatic output designed for compatibility with WestMed VixOne nebulizer. No software or electronic control algorithms.

Indications for Use

Indicated for adult, pediatric, or infant patients requiring aerosolized medication for treatment of asthma, COPD, or other respiratory ailments.

Regulatory Classification

Identification

A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

Predicate Devices

• OMRON Compressor Nebulizer (K914836)
• VEGA Ultrasonic Nebulizer (K002831)

Submission Summary (Full Text)

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OCT = 7 2003

K031413

# 510(k) Summary for the VigorMist COMPRESSOR NEBULIZER (per 21CFR807.92)

#### SUBMITTER 1.

Vega Technologies Inc. 11F-13, No.100 Chang Chun Road Taipei City Taiwan 104

Contact Person: Joseph Lu [phone] Telephone: Fax: [phone] E-mail: [e-mail] Date Prepared: January 03, 2003

#### 2. DEVICE NAME

| Proprietary Name: | VigorMist Compressor Nebulizer |
|-------------------------------------|--------------------------------------|
| | (Model: CN-01W) |
| | K031413 |
| Common/Usual Name: | Compressor Nebulizer |
| Classification Name: | Nebulizer (Direct patient interface) |
| Regulation Number: 21 CFR, 868.5630 | |

#### 3. PREDICATE DEVICE

- OMRON Compressor Nebulizer (K914836) .
- VEGA Ultrasonic Nebulizer (k002831) .

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#### DEVICE DESCRIPTION 4.

The VigorMist™ Compressor is a small air compressor designed to provide sufficient air pressure and flow to power a hand held nebulizer. It measures 11 7/8" x 7 1/8" x 4 1/2" and weights 4.6 lbs.

The device has a thermal protector that will automatically shut off the device when overheated. The operating components are located internally. The compressor, some minor wiring and exhaust/intake tubing are located inside .. External components include a switch, filter with housing, AC cord and cover or accessories compartment. The accessories coming with the compressor include a nebulizer, Air tube and mouthpiece.

#### INTENDED USE 5.

The VigorMist™ Compressor is intended to be used with a compatible pneumatic nebulizer (specifically the WestMed VixOne) to convert certain inhalable drugs into an aerosol form for inhalation by a patient for the treatment of asthma, COPD, and other respiratory ailments. The device is intended for the home care market. It is intended for use with a single adult, pediatric, or infant patient.

#### 6. PERFORMANCE TESTING

Testing provided in this premarket notification includes biocompatibility, standards conformity.. The VigorMist™ successfully completed testing and demonstrates that the product fulfills performance specifications.

Page A-2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2-2008

Vega Technologies, Incorporated C/O Mr. Tzu - Wei Li Responsible Third Party Official Center for Measurement Standards of Industrial Technology Research Institute Bldg 16, 321 Kuang Fu Road Sec. 2 Hsinchu TAIWAN 30042, R.O.C.

Re: K031413

Trade/Device Name: Vigormist Compressor Nebulizer (Model: CN-01W) Regulation Number: 21 CFR 868.6250 Regulation Name: Portable Air Compressor Regulatory Class: II Product Code: BTI, CAF Dated: September 18, 2003 Received: September 23, 2003

Dear Mr. Li:

This letter corrects our substantially equivalent letter of October 7, 2003.

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 (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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Page 2 - Mr. Li

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 electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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-fsee OC organization structure below for correct phone extension]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muhammad Yerdima

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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### 510(k) Number: K031413

## Device Name: VIGORMIST Compressor Nebulizer (model: CN-01W)

Indications For Use:

The VigorMist Compressor is intended to be used with a compatible pneumatic nebulizer (specifically the W estMed V ixOne) t o c onvert c ertain inhalable drugs into an aerosol form for inhalation by a patient for the treatment of asthma, COPD, and other respiratory ailments. The device is intended for the home care market. It is intended for use with a single adult, pediatric, or infant patient.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

e. Iatach

Control Der

510(k) Number. K031413

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)