BABYAIR

• K Number: K060497
• Device Name: BABYAIR
• Manufacturer: PROMEDIC, INC.
• Date Cleared: 2006-07-11 ( 137 days)
• Product Code: CAF
• Regulation Number: 868.5630
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: K023602

Intended 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 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.

1. 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.

2. 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.

3. Adjudication Method for the Test Set:

   • Not applicable. The data came from a technical measurement device (Cascade Impactor), not from human interpretation requiring adjudication.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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).