NEVONI CLASSIC, MODEL 6600-PO

K082878 · Nsr Comercio E Representacoes Ltda · CAF · Dec 30, 2008 · Anesthesiology

Device Facts

• Record ID: K082878
• Device Name: NEVONI CLASSIC, MODEL 6600-PO
• Applicant: Nsr Comercio E Representacoes Ltda
• Product Code: CAF · Anesthesiology
• Decision Date: Dec 30, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Nevoni Classic 6600-PO nebulizer is an ac powered portable compressor. This portable device uses a pneumatic piston that compresses air, forcing it to flow into the nebulizer cup. The force of the air flowing into the nebulizer cup disperses the medicine into fine mist particles for the inhalation treatment based on a physician's prescription. This device is intended for single patient home therapy.

Device Story

Nevoni Classic 6600-PO is a portable, AC-powered respiratory device for home therapy. Device uses a small wired AC-electric motor to drive an oil-free pneumatic piston; piston oscillates a sealed diaphragm to compress air into a chamber. Air intake is filtered via a felt filter. Compressed air travels through flexible tubing into a nebulizer cup, where pressurized contact with liquid medicine creates a fine aerosolized mist. Mist is delivered to the patient via an anatomical mask made of non-toxic material. Device is operated by the patient in a home setting. Output is a breathable aerosolized mist for inhalation. Healthcare providers prescribe the medication and treatment regimen; the device facilitates delivery of the prescribed therapy, potentially improving patient respiratory outcomes.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Piston-type compressor; AC-powered (110V 50/60Hz); oil-free motor; felt air intake filter; plastic case; includes air tubing and adult/child masks. Non-toxic mask material. Portable form factor. No software or electronic algorithm.

Indications for Use

Indicated for single patient home therapy requiring inhalation treatment of medication via aerosolized mist, as prescribed by a physician.

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

• Invacare Model IRC 1001 Aerosol Compressor (K992643)
• Sunrise Medical Devilbiss Model 3655 (K020932)
• Salter Labs Aire Compressor (K992285)
• DeVilbiss Model 800 (K993492)

Submission Summary (Full Text)

{0}------------------------------------------------

# DEC 3 0 2008

# 510(k) SUMMARY

- Submitter's Name: NSR Comercio e Representacoes Ltda Av. Gupe, Bloco C Galpao 16 Jardim Belval Barueri, SP 06422-120 Brazil
- Edvino Carbone Owner Name: Phone#: [phone] Fax#: [phone]
- Polly E. Scherman Contact Name: NSR Trading LLC. 11 Perry Drive, Unit G Foxboro, MA 02035 Phone#: [phone] Fax#: [phone]
- Date Prepared: May 13, 2008
- Regulation Number: 21 CFR 868.5630 Product Classification: Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF
- Nevoni Model Number: Nevoni Classic 6600-PO
- Purpose for Submission: New device that has never been marketed in the US. The Nevoni Classic 6600-PO is packaged so that it is ready for consumer use.

{1}------------------------------------------------

NSR, INDUSTRIA, COMERCIO E REPRESENTACOES LTDA

Equivalent Marketed Predicate Devices:

| Legally Marketed Predicate Device<br>Registration # | 510(k) |
|-----------------------------------------------------|---------|
| Invacare Model IRC 1001 Aerosol Compressor | K992643 |
| Sunrise Medical Devilbiss Model 3655 | K020932 |
| Salter Labs Aire Compressor | K992285 |

### Intended Use

The Nevoni Classic 6600-PO nebulizer is an ac powered portable compressor. This portable device uses a pneumatic piston that compresses air, forcing it to flow into the nebulizer cup. The force of the air flowing into the nebulizer cup disperses the medicine into fine mist particles for the inhalation treatment based on a physician's prescription. This device is intended for single patient home therapy.

#### Device Description:

The Nevoni Classic nebulizer is a portable AC-powered respiratory device used for home therapy. It uses a compressor to process medicine into a breathable aerosolized mist which is collected into a facial mask and inhaled by the patient.

The device's nebulization process is achieved through a small wired AC-electric motor that forces an oil-free piston into motion. This motion oscillates a sealed diaphragm and compresses air into a small chamber. Air intake is supplied to the compressor using a felt filter. The compressed air flow is conducted through a thin flexible tube into a nebulizer cup in which a fine particle mist is created by the medicine's highly pressurized contact. The nebulizer cup is attached to an anatomical mask made of soft, non-toxic material. The medicine's mist accumulates within this mask where it is ready for inhalation by the patient.

The Nevoni Classic nebulizer package includes a compressor, air tubing, air filters and adult and child size masks.

{2}------------------------------------------------

## Substantial Equivalence:

The Nevoni Classic compressor is substantially equivalent to:

- Invacare Model IRC 1001 Aerosol Compressor . FDA 510k Registration# K992643
- . DeVilbiss Model 800 FDA 510k Registration# K993492
- . Salter Labs Salter Aire Compressor FDA 510k Registration# K992285

### Comparative Product Table:

| Product<br>Properties | Nevoni Classic<br>Model 6600-PO<br>Compressor | Salter Aire<br>Compressor | DeVilbiss<br>Model 3655<br>Compressor | Invacare Model IRC<br>1001 Aerosol<br>Compressor |
|----------------------------------|-----------------------------------------------|------------------------------|---------------------------------------|--------------------------------------------------|
| Compressor type | Piston | Piston | Piston | Piston |
| Voltage | 110V 50/60Hz<br>0.5 Amps | 110V 60Hz<br>2.5 amps | 110V 60Hz<br>amps | 115V 60 Hz<br>1.6 amps |
| Free flow rate | 15 lpm | 11 lpm | 8 lpm | 8.5 lpm |
| Operating flow rate | 8 lpm | 6.5 lpm | 5.5 lpm | 4.8 lpm |
| Over-heating switch | No | Yes | Yes | Yes |
| Portable | Yes | Yes | Yes | Yes |
| Case material | Plastic | Plastic | Plastic | Plastic |
| Warranty | 1 year | 1 year | 5 year | 5 year |
| Maximum operating<br>temperature | 158 °F | 128.5 °F | 104 °F | 158 °F |
| Intended<br>environment use | Home therapy | Home therapy<br>and hospital | Home therapy | Home therapy |

#### Substantial Equivalence Statement:

The Nevoni Classic compressor nebulizer is equivalent to FDA registered predicate marketed devices. These devices are similar in that they deliver medicine in the form of aerosol within acceptable parameters. The Nevoni Classic nebulizer delivers similar durability and performance as existing legally marketed predicate devices.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEC 30 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NSR, Comercio, Industria e Representacoes, Ltda C/O Ms. Polly Scherman Business Manager NSR Trading LLC 11 Perry Drive, Unit G Foxboro, Massachusetts 02035

Re: K082878

Trade/Device Name: Nevoni Classic 6600-PO Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: September 23, 2008 Received: October 1, 2008

Dear Ms. Scherman:

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.

{4}------------------------------------------------

Page 2 - Ms. Scherman

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 «ouivalence 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.

Chisholm, 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

{5}------------------------------------------------

# Indications for Use

510(k) Number K082878

Device Name: Nevoni Classic 6600-PO

Indications for Use:

The Nevoni Classic 6600-PO nebulizer is an ac powered portable compressor. This portable device uses a pneumatic piston that compresses uir, forcing it to flow into the nebulizer cup. The force of the air flowing into the nebulizer cup disperses the medicine into fine mist particles for the inhalation treatment based on a physician's prescription. This device is intended for single patient home therapy.

Prescription Use X AND/OR

. .. . . . . . . . .

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

(Posted November 13, 2003)

Qre

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

510(k) Number: K-082878