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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BabyAir™ device, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the BabyAir™ as substantially equivalent to a predicate device. The primary acceptance criterion and the reported performance relate to Comparative Particle Size testing.

Acceptance Criteria / Performance Metric	Predicate Device Performance Standard	Reported BabyAir™ Performance
Comparative Particle Size	MMAD and GSD of predicate	Substantially equivalent

Note: The document does not specify quantitative acceptance limits for MMAD (Mass Median Aerodynamic Diameter) and GSD (Geometric Standard Deviation) that the predicate device met. Instead, it states that the BabyAir™ demonstrated "substantially equivalent" performance to the predicate device in these parameters. This implies the BabyAir™'s MMAD and GSD were within an acceptable range relative to the predicate.

Study Details

Based on the provided text, the study conducted for the BabyAir™ device was a comparative equivalency study focused on particle size.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document mentions "Comparative Particle Size testing via a Cascade Impactor" but does not give the number of tests performed or the amount of medication used.
- Data Provenance: Not explicitly stated. Likely refers to testing conducted in a laboratory setting by the manufacturer or a contracted lab. There's no mention of country of origin for this specific test data, nor whether it was retrospective or prospective in the context of clinical data.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable as the study involved objective technical measurements of particle size, not subjective expert assessment as relevant for medical imaging or diagnostic devices. "Ground truth" in this context refers to the measured physical characteristics of the aerosol.
Adjudication Method for the Test Set:
- Not applicable. The data came from a technical measurement device (Cascade Impactor), not from human interpretation requiring adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study is typically used for diagnostic devices where human readers interpret images or data, and the AI's impact on reader performance is evaluated. The BabyAir™ is a medical device for drug delivery (nebulizer), not a diagnostic tool requiring image interpretation.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, in effect, a standalone performance was done. The "Comparative Particle Size testing" is a direct measurement of the device's physical output (aerosol particle characteristics) without human intervention in its operation or interpretation of its direct output for efficacy. The "algorithm" here is the device itself in its function of nebulizing medication.
Type of Ground Truth Used:
- Objective physical measurements/technical specifications. The ground truth for particle size testing is the scientifically accepted method of measuring aerosol characteristics, specifically MMAD and GSD using a Cascade Impactor. These are empirical measurements.
Sample Size for the Training Set:
- Not applicable. This device does not use an "algorithm" in the sense of machine learning that requires a training set. The device's design and manufacturing process are essentially its "training" to produce the desired particle size.
How the Ground Truth for the Training Set Was Established:
- Not applicable. As noted above, there's no machine learning training set for this device. The "ground truth" for the device's design would be established through engineering principles, regulatory requirements, and the performance characteristics of predicate devices, which guide the manufacturing process to achieve the desired output.

Summary

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K060497

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 22-Feb-06

Baby's Breath Ltd.Ha'hadas St., Bldg. # 5North Industrial AreaOr-Akiva, 30600 ISRAEL	Tel - 011-972-4-6262551Fax - 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,which nebulizes specific drugs for inhalation by a patient. Itsuse is indicated whenever a physician or healthcare professionaladministers or prescribes medical aerosol products to a patientusing a nebulizer. This product is a single patient, multi- use,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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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

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.

510(k) Number:

(To be assigned)

Device Name:

BabyAir™

Indications for Use:

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)

A-59-784	A B H A L P . C . C . C . C . L . L . L . L . L . L . L . L . L . L . L
	1

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

) Number:

BabyAir™

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
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.(b)
Classification. Class II (performance standards).