BABYAIR

K060497 · Promedic, Inc. · CAF · Jul 11, 2006 · Anesthesiology

Device Facts

• Record ID: K060497
• Device Name: BABYAIR
• Applicant: Promedic, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Jul 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The BabyAir™ is a pneumatic nebulizer, UDN, with a hood, which nebulizes specific drugs for inhalation by a patient. The patient population includes infants. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a nebulizer. This product is a single patient, multi- use, non-sterile prescriptive device. It is intended to be used in either a hospital or homecare environment.

Device Story

BabyAir™ is a pneumatic nebulizer system for infants; consists of a transparent hood covering shield on a plastic base and a nebulizer assembly. Device requires an external standard nebulizer compressor (operating flow rate 8-11 Lpm at no back pressure or 3 bar pressure at no flow). Nebulizer converts liquid medication into fine aerosol mist; hood directs aerosol toward infant. Used in hospital or homecare settings; operated by physicians, healthcare professionals, or caregivers. Provides aerosolized medication for inhalation; intended to improve drug delivery efficiency and safety for infants. Single-patient, multi-use, non-sterile prescriptive device.

Clinical Evidence

Bench testing only. Comparative particle size testing (MMAD and GSD) performed using a cascade impactor to demonstrate equivalence to the predicate device.

Technological Characteristics

Pneumatic nebulizer; includes transparent hood and nebulizer assembly. Operates via external compressor (8-11 Lpm flow or 3 bar pressure). Single-patient, multi-use, non-sterile. Materials include plastic base and hood shield.

Indications for Use

Indicated for infants requiring administration of medical aerosol products via nebulizer. No contraindications.

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

• Cardinal - Misty Max 10 - K023602

Submission Summary (Full Text)

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K060497

### Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 22-Feb-06

| Baby's Breath Ltd.<br>Ha'hadas St., Bldg. # 5<br>North Industrial Area<br>Or-Akiva, 30600 ISRAEL | Tel - 011-972-4-6262551<br>Fax - 011-972-4-6262552 | [JUL 11 2006] |
|--------------------------------------------------------------------------------------------------|----------------------------------------------------|---------------|
| Official Contact -- | Gilad Golan - Managing Director | |
| Proprietary or Trade Name -- | BabyAir™ | |
| Common/Usual Name -- | Nebulizer | |
| Classification Name -- | Nebulizer (direct patient interface) | |
| Device -- | BabyAir™ | |
| Predicate Devices -- | Cardinal - Misty Max 10 - K023602 | |

Device Description --

:

The BabyAir™ is comprised of:

- Transparent Hood Covering shield draped over a plastic base. ●
- . Nebulizer Assembly - The Nebulizer converts the liquid medication into a fine aerosol mist and directs the aerosol toward the infant efficiently and safely.
- Compressor Not included. Any standard nebulizer compressor which has an operating . flow rate range of 8 to 11 Lpm at no back pressure or has a pressure of 3 bar under a no flow conditions, may be used.

| Indications for Use -- | The BabyAir™ is a pneumatic nebulizer, UDN, with a hood,<br>which nebulizes specific drugs for inhalation by a patient. Its<br>use is indicated whenever a physician or healthcare professional<br>administers or prescribes medical aerosol products to a patient<br>using a nebulizer. This product is a single patient, multi- use,<br>non-sterile prescriptive device |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population -- | For use with infants |

Environment of Use --Hospital and homecare

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# Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 22-Feb-06

Contraindications --None

#### Comparative Particle Size testing --

Comparative Particle Size testing via a Cascade Impactor demonstrated that the MMAD and GSD are substantially equivalent for the BabyAir™ and the predicate.

#### Substantial Equivalence -

The BabyAir™ based upon a comparison to the predicate is viewed as substantially equivalent.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 1 2006

Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creek Court # 102 Bonita Springs, Florida 34134-2015

Rc: K060497 Trade/Device Name: BabyAir™ Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: July 1, 2006 Received: July 3, 2006

Dear Mr. Dryden:

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. Dryden

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 (OS) 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 vour 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,

Auu Syluom for

Chiu Lin. Ph.P 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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Indications for Use Statement

4

Page 4.1

Page 1 of 1

| 510(k) Number: | (To be assigned) |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | BabyAir™ |
| Indications for Use: | The BabyAir™ is a pneumatic nebulizer, UDN, with a hood, which nebulizes specific drugs for inhalation by a patient. The patient population includes infants. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a nebulizer. This product is a single patient, multi- use, non-sterile prescriptive device. It is intended to be used in either a hospital or homecare environment. |

Prescription Use XX
(Part 21 CFR 801 Subpart D)
or
Over-the-counter use
(21 CFR 807 Subpart C)

Part 21 CFR 601 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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on of Anesthesiology, General Hospital, con Control, Dental Devic

) Number:

BabyAir™