MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES

K041327 · Med2000 S.R.L. · CAF · Jul 20, 2004 · Anesthesiology

Device Facts

• Record ID: K041327
• Device Name: MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES
• Applicant: Med2000 S.R.L.
• Product Code: CAF · Anesthesiology
• Decision Date: Jul 20, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories, is a pneumatic nebulizer which, when driven by a compatible air compressor, nebulizes specific inhalable drugs for inhalation by a patient. It can be used with adult or pediatric patients. The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories, may be used with compatible compressors or an air gas source providing between 4 and 8 lpm.

Device Story

Pneumatic nebulizer; operates on Venturi principle; converts liquid medication into aerosol for patient inhalation. Input: liquid medication and compressed air/gas (4-8 lpm). Output: aerosolized drug. Components: injection-molded polypropylene nebulizer body, mouthpiece, connecting tube, pediatric mask, adult mask. Intended for single-patient use. Operated by patient or caregiver in clinical or home settings. Healthcare provider prescribes medication and device; patient inhales aerosol to treat respiratory conditions. Benefits: efficient delivery of inhaled medications.

Clinical Evidence

No clinical data. Bench testing only, specifically Nebulizer Particle Characterization Studies at 4 and 8 lpm ranges.

Technological Characteristics

Pneumatic nebulizer; Venturi principle; injection-molded polypropylene construction. Flow range: 4-8 lpm. Accessories: mouthpiece, connecting tube, adult/pediatric masks. Single-patient use. No electronic components or software.

Indications for Use

Indicated for adult and pediatric patients requiring nebulized inhalable drugs via a pneumatic nebulizer driven by a compatible air compressor or gas source (4-8 lpm).

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

• AndyFlow Nebulizer Model A1/C with accessories (K031908)

Submission Summary (Full Text)

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JUL 2 0 2004

Exhibit #1

# 510(K) SUMMARY

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is:_长64|327

### 1. Submitter's Identification:

Med2000 SpA Via dell'Artigianato, 23/25 25080 Padenghe Sul Garda, (BS) ITALY

Contact: Mr. Sandro Rossi, CEO

Date Summary Prepared: May 17, 2004

### 2. Name of the Device:

MED2000 SpA Nebulizer, AndyFlow Model A1/C with accessories

### 3. Predicate Device Information:

K#031908, AndyFlow Nebulizer Model A1/C with accessories, MED2000 SpA, ltalv

### 4. Device Description:

.

### Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories: .

The Nebulizer, Model A1/C (AndyFlow), is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing.

This device operates on the Venturi principle and is refillable. It is manufactured using polypropylene plastics, injection molded and is intended for single patient use.

The Nebulizer, Model A1/C (AndyFlow), has several attachments that are used with the nebulizer during the nebulization process. The attachments include a

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mouthpiece, a 2 meter connecting tube (which connects to the lower part of the nebulizer opposite the mouthpiece), a pediatric breathing mask and an adult breathing mask. These are standard accessories for nebulizer devices.

#### 5. Intended Use:

The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories, is a pneumatic nebulizer which, when driven by a compatible air compressor, nebulizes specific inhalable drugs for inhalation by a patient. It can be used with adult or pediatric patients.

The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories, may be used with compatible compressors or an air source providing between 4 and 8 lpm.

#### Comparison to Predicate Devices: 6.

The Med200 SpA Nebulizer, and Accessories, Model A1/C (AndyFlow), is substantially equivalent to the K#031908, AndyFlow Nebulizer Model A1/C with accessories, MED2000 SpA, Italy. The difference between the two devices is the labeling change made to the subject device: a flow range between 4 and 8 lpm has been added instead of one value and the pressure value has been deleted.

### 7.

## Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

In accordance with the risk analysis testing, the following performance testing was performed:

- Nebulizer Particle Characterization Studies at 4 and 8 lpm ranges .
Because the PCS testing revealed that no other parameters were affected, previously performed testing remained unchanged such as:

EPA PM 2.5 Testing ISO 10993 Biocompatibility Testing

### 8. Discussion of Clinical Tests Performed:

Not Applicable

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### 9. Conclusions:

The Med2000 SpA Nebulizer AndyFlow Model A1/C with Accessories has the same intended use and similar characteristics as the predicate. Moreover, bench testing intoniated in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Med2000 SpA Nebulizer, AndyFlow, Model A1/C with Accessories is substantially equivalent 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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 0 2004

MED2000 SpA C/O Ms. Susan Goldstein-Falk Official Correspondent MDI Consultants, Incorporated 55 Northern Boulevard Suite 200 Great Neck, New York 11021

Re: K041327

Trade/Device Name: Med2000 SpA Nebulizer Model A1/C (AndyFlow) with Accessories Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: July 2, 2004 Received: July 6, 2004

Dear Ms. Goldstein-Falk:

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 Federal Register.

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Page 2 -Ms. Goldstein-Falk

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 (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 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 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.

Shirin Liu, Ph.D.

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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### Exhibit B

Page 1

# 510(k) Number (if known): _ K0Y | 327

Device Name: The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories

### Indications For Use:

The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories, is a pneumatic nebulizer which, when driven by a compatible air compressor, nebulizes specific inhalable drugs for inhalation by a patient. It can be used with adult or pediatric patients.

The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories, may be used with compatible compressors or an air gas source providing between 4 and 8 lpm.

Prescription Use X (Per 21 CFR 801 Subpart D)

OR

Over-The Counter Use (21 CFT 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <img alt="Signature" src="signature.png"/> |
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| Division of Anesthesiology, General Hospital,<br>Infection Control, Dental Devices | |
| 510(k) Number: | K041327 |