MYNEB NEBULIZER, MODEL RDD100

K053203 · Respironics New Jersey, Inc. · CAF · Dec 20, 2005 · Anesthesiology

Device Facts

• Record ID: K053203
• Device Name: MYNEB NEBULIZER, MODEL RDD100
• Applicant: Respironics New Jersey, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Dec 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

MyNeb is an AC or battery-pack powered nebulizer designed to convert liquid medication into aerosol for inhalation by the patient.

Device Story

MyNeb is a portable, battery or AC-powered nebulizer used for aerosolizing liquid medication for patient inhalation. The device utilizes a piezoelectric element driven by a microprocessor to generate ultrasonic energy. This energy is focused at the base of a medication chamber, creating a liquid fountain that travels through a guide tube. Cavitation at the tube exit converts the liquid into aerosol particles. An air draft, created by the fountain's forces, draws air through vents to carry the aerosol through a chimney and mouthpiece to the patient. Non-aerosolized liquid returns to the chamber for re-generation. The device is intended for home or clinical use, operated by the patient or a caregiver. It provides a portable method for medication delivery, potentially improving patient compliance and ease of treatment.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical, mechanical, environmental, and electromagnetic compatibility (EMC) testing in accordance with FDA guidance.

Technological Characteristics

Portable nebulizer (4.96" x 2.80" x 1.46", 4 oz). Components: piezoelectric element, microprocessor, lithium polymer battery pack. Power: 100-240 VAC, 50-60 Hz. Aerosolization via ultrasonic cavitation. Materials include PEEK film. Connectivity: None (standalone).

Indications for Use

Indicated for patients requiring inhalation of liquid medication converted into aerosol form via an AC or battery-powered nebulizer.

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

• MABISMist II (K990506)
• Pari Trek with LC+ (K960675)
• Pari Trek with LC+ (K935540)

Submission Summary (Full Text)

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# DEC 20 2005

#### EXHIBIT #1

#### 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.

The assigned 510(k) number is: K053203

#### 1. Submitter's Identification:

Respironics New Jersey, Inc. 41 Canfield Road Cedar Grove, NJ 07009

Contact: Lauren R. Ziegler, Senior Manager, Quality, Regulatory and Clinical Affairs Date Summary Prepared: October 3, 2005

#### 2. Name of the Device:

MyNeb Nebulizer, Model RDD100 Common Name or Classification Name (21 CFR Part 807.87) of Device: Nebulizer, 21 CFR Part 868.5630

#### 3. Predicate Device Information:

MABISMist II., K990506, Pari Trek with LC+, K960675 and K935540

#### 4. Device Description:

This AC (adaptor with DC converter) or battery-pack powered nebulizer is housed in a plastic case. Dimensions are 4.96"(II) x 2.80° (V) x 1.46"(I) x 1.46"(I) and weighs 4 ounces. It consists of a piezoelectric element driven by a microprocessor with dedicated software. The batteries are rechargeable via an AC power supply (100-240 VAC, 50-60 Hz). The external battery pack is made up of 2 lithium polymer cells.

The following is the method of acrosol generation:

Step 1: Ultrasonic energy is created and focused by a concave piezoelectric element, located within the generator, to a point at the base of the medication chamber that is located at the top of the generator.

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Step 2: The focused ultrasonic energy forms a liquid fountain that is driven up through the guide tube inside the nebulizer head. Upon exiting the tube, the energized liquid fountain generates cavitation of acrosol particles and the liquid medication is converted into an aerosol.

Step 3: The forces associated with the fountain generate an air draft whereby air is drawn into the nebulizer head via the air vents. The aerosolized medicine is carried by this air draft, through the nebulizer's chimney and out through the nebulizer's mouthpiece opening.

Step 4: Non aerosolized liquid medication returns back into the medication chamber for re-generation through the guide tube.

Image /page/1/Figure/3 description: This image shows a diagram of a nebulizer head. The diagram labels the different parts of the nebulizer head, including the cover, mouthpiece, chimney, air vent, medication chamber, energy formation point, body, generator, base, electronics board, on/off button, connector, piezoelectric element, PEEK film, guide tube, and aerosol formation. The nebulizer head is a device that is used to deliver medication to the lungs.

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Image /page/2/Picture/0 description: The image shows a black and white photograph of a complex mechanical or optical device. The device appears to be a combination of lenses, tubes, and supporting structures. The device is set against a dark background, which makes it difficult to discern the exact details of its construction.

MyNeb Aerosol Generation

### 5. Intended Use:

MyNeb is an AC or battery-pack powered nebulizer designed to convert liquid medication into acrosol for inhalation by the patient.

## 6. Comparison to Predicate Devices:

The subject (MyNeb) and predicate devices (MABISMist II, K990506; Pari Trek with 1.C+, K960675 and K935540) are indicated for the same intended use, are electrically powered, meet Environmental Safety and EMC requirements, and have similar compressor operating pressure and flow ranges. The MABISMist II. like the MyNeb, uilizes a piezoelectric element to achieve energy generation. Performance characteristics are basically the same, and all three units are fightweight.

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

When used as intended. MyNeb conforms or will conform to the electromagnetic compatibility, mechanical/environmental, and electrical testing recommendations, described in the Reviewer Guidance for Premarket Notification Submissions (November 1993). Testing information demonstrating safety and effectiveness of the My Neb nebulizer in the

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intended environment of use is or will be supported by testing that was corducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements.

### 8. Discussion of Clinical Tests Performed:

Not Applicable

#### 9. Conclusions:

We have demonstrated that the MyNeb Nebulizer, Model RDD100 is as safe and effective as predicate devices presently on the market, based on electrical, mechanical, environmental and EMC testing results outlined in the FDA DCRND November 1993 Draft *Reviewer Guidance for Premarket Notification Submissions". We also adhered to FDA's DCRND "Reviewer Guidance for Home Use Respiratory Devices``.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2005

Intertek Testing Services C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K053203

Trade/Device Name: MyNeb Nebulizer, Model RDD100 Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: December 14, 2005 Received: December 15, 2005

Dear Mr. Lehtonen:

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. Lehtonen

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,

Syfate y. Michie Orns.

Chia Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Exhibit B

Indications for Use

K053 203

510(k) Number (if known):

Device Name: MyNeb Nebulizer, Model RDD100

Indications for Use: MyNeb is an AC or battery-pack powered nebulizer designed to convert liquid medication into aerosol for inhalation by the patient.

Prescription Use X (Per 21 CFR 801 Subpart D)

Over -The-Counter Use ાર (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Amy Saliom

(Division Sinn-Off) Division of Asesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K053203