NEB-90 LARGE VOLUME MEDICATION NEBULIZER

K080657 · Medi Nuclear Corp., Inc. · CAF · Jun 30, 2008 · Anesthesiology

Device Facts

• Record ID: K080657
• Device Name: NEB-90 LARGE VOLUME MEDICATION NEBULIZER
• Applicant: Medi Nuclear Corp., Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Jun 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Neb-90™ Large Volume Medication Nebulizer is indicated for the continuous aerosol administration of respiratory medication (inhalable solution) including, but not necessarily limited to, beta adrenergic bronchodilator (albuterol sulfate) and/or a wetting agent such as sodium chloride solution (saline) that is used for the treatment of respiratory and related diseases and conditions including, but not necessarily limited to asthma, COPD, bronchiolitis and cystic fibrosis. The Neb-90™ Large Volume Medication Nebulizer is for use in hospital Emergency Department, ICU or other similar settings for delivery of aerosolized medication to patients undergoing severe respiratory distress.

Device Story

Neb-90 is a single-patient, single-use large volume medication nebulizer. Device connects to external gas source via flexible tubing; gas stream contacts liquid medication, shattering it into small particles. Internal baffle further reduces particle size; larger particles settle via gravity/inertia, returning to liquid state for re-nebulization. Smaller particles are delivered to patient via inhalation. Used in hospital settings (ED, ICU) by clinicians to treat severe respiratory distress. Device provides continuous aerosolized medication delivery, aiding patient breathing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Single-patient, single-use pneumatic nebulizer. Operates via gas-powered aerosolization with internal baffle for particle size reduction. Non-sterile, non-electric, non-software driven. Materials and dimensions not specified.

Indications for Use

Indicated for patients with respiratory conditions including asthma, COPD, bronchiolitis, and cystic fibrosis requiring continuous aerosolized medication (e.g., albuterol sulfate, saline). For use in hospital settings (ED, ICU) for patients in severe respiratory distress.

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

• Medi/Nuclear Neb-3A Patient Nebulizer (K915075)
• Smiths Medical - DHD Health Flo-Mist
• B&B Medical Technologies Inc. Hope Nebulizer (K980407)

Submission Summary (Full Text)

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# 510(k) SUMMARY for

JUN 3 0 2008

# Neb-90™ Large Volume Medication Nebulizer

#### 1. SUBMITTER INFORMATION:

Medi/Nuclear Corporation, Inc. 4610 Littlejohn Street Baldwin Park, CA 91706-2267

| Establishment | |
|----------------------|---------------------------------------------------|
| Registration Number: | 2050098 |
| Primary contact: | Jerry Schoen |
| | Chief Operating Officer |
| | Medi/Nuclear & Healthline Medical |
| Telephone Number: | [phone] (corporate toll-free) |
| | [phone] (Los Angeles local) |
| Fax: | [phone] (corporate fax) |
| E-mail: | [e-mail] |
| Secondary contact: | Russell King |
| | Owner/Chairman, Medi/Nuclear & Healthline Medical |
| Telephone Number: | [phone] (corporate toll-free) |
| | [phone] (Los Angeles local) |
| Fax: | [phone] (corporate fax) |

Note: Medi/Nuclear Corporation, Inc. markets the products it manufacturers to the nuclear medicine industry under its own name. However, it also markets some of the same products to the respiratory therapy industry under the name of its affiliate company, Healthline Medical. Both companies share the same building, facilities, staff and management team at the above-listed address. The Neb-90 will be private-labeled for Healthline Medical upon receipt of clearance to market.

#### 2. DEVICE NAME:

| Classification Name: | Nebulizer (CAF), direct patient interface |
|----------------------|-------------------------------------------------------------------------------------------------|
| Regulation: | 21CFR868.5630 |
| Proprietary Name: | Healthline Neb-90™ Large Volume Medication Nebulizer (LVN), Hereinafter referred to as "Neb-90" |

#### 3. PREDICATE DEVICE:

Medi/Nuclear Neb-3A Patient Nebulizer (K915075) Smiths Medical - DHD Health Flo-Mist [B&B Medical Technologies Inc. Hope Nebulizer (K980407)

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## DESCRIPTION OF DEVICE:

The Nebulizer is a single patient/single use device which is filled with a fluid, typically respiratory medication and connected to a gas source via flexible tubing. The nebulizer works by Pavipng a cluid come into contact with the stream of gas. The gas shatters the liquid into small particles. These particles then impact a baffle that further reduces the size of the particles. The majority of the larger particles settle inside the nebulizer as a result of gravity and inertia, returning the mist to liquid to repeat the nebulization process. The smaller particles are then administered as the patient inhales. The treatment is completed when the majority of liquid has been nebulized.

## General Questions & Answers

Specific issues, as mentioned in "CDRH Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators; October 1, 1993" are addressed herewith:

| | Question | Yes | No |
|----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|----|
| 1 | Is the device life-supporting or life-sustaining? | | X |
| 2 | Is the device an implant (short-term or long-term)? | | X |
| 3 | Is the device sterile? | | X |
| 4 | Is the device for single use? | X | |
| 5 | Is the device prescription use? | X | |
| 6 | Is the device for home use or portable? | | X |
| 7 | Does the device contain a drug or biological product as a component? | | X |
| 8 | Is this device a kit? * | | X |
| 9 | Is the device software-driven? | | X |
| 10 | Is the device electrically operated? | | X |
| 11 | Are there applicable standards for this device to which conformance has been<br>demonstrated in addition to those already mentioned (e.g., IEC, ANSF, ASTM,<br>etc)? | | X |

*The Neb-90™ in of itself is not a kit; however it will be marketed as a component of a kit, ARK-1, LG-ARK-1, ARK-5, LG-ARK-5, AM-690A and AM-690P.

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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 and Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 2008

Mr. Michael McPeck Director, Aerosol Medicine Medi/Nuclear Corporation, Incorporated 4610 Littlejohn Street Baldwin Park, California 91706

Re: K080657

Trade/Device Name: Neb-90TM Large Volume Medication Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: June 19, 2008 Received: June 23, 2008

Dear Mr. McPeck:

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 - Mr. McPeck

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/industry/support/index.html.

Sincerely yours.

Clare

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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Medi/Nuclear Corporation, Inc. 4610 Littlejohn Street Baldwin Park, CA 91706-2267

# Indications for Use Statement

510(k) Number K080657

Neb-90™ Large Volume Medication Nebulizer Device Name:

Indications for Use:

The Neb-90™ Large Volume Medication Nebulizer is indicated for the continuous aerosol administration of respiratory medication (inhalable solution) including, but not necessarily limited to, beta adrenergic bronchodilator (albuterol sulfate) and/or a wetting agent such as sodium chloride solution (saline) that is used for the treatment of respiratory and related diseases and conditions including, but not necessarily limited to asthma, COPD, bronchiolitis and cystic fibrosis.

The Neb-90™ Large Volume Medication Nebulizer is for use in hospital Emergency Department, ICU or other similar settings for delivery of aerosolized medication to patients undergoing severe respiratory distress.

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

Prescription Use X Over-The-Counter Use

Prescription Use **__**

Min-Xh

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Amol, Dental Devices

-10(k) Number: K0840657

Page 2 of 39 Neb-90 Submission

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