BABI PLUS INFANT NASAL CANNULA SYSTEM

• K Number: K110471
• Device Name: BABI PLUS INFANT NASAL CANNULA SYSTEM
• Manufacturer: A PLUS MEDICAL
• Date Cleared: 2011-10-07 ( 231 days)
• Product Code: BZD C10
• Regulation Number: 868.5905

Intended Use

Single patient use device intended for use with neonates, infants and children under 10 Kg requiring a nasal prong interface during intermittent or continuous gas flow therapy in the hospital critical care unit.

Device Description

Single patient use nasal cannula offered in 8 different sizes which have been specifically designed for patents ≤ 10 Kg. The device includes a short length of 10 mm corrugated tubing allowing connection to a variety of devices. The device also provides a means to monitor delivered pressure at the nasal prong.

Predicate Devices

K093716

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a physical nasal cannula and its components, with no mention of AI/ML terms or functionalities.

Therapeutic

Yes
The device is a nasal cannula used for gas flow therapy in critically ill neonates, infants, and children, which is a therapeutic intervention.

Diagnostic

No

The device is described as a nasal cannula for gas flow therapy and provides a means to monitor delivered pressure. This indicates a therapeutic and monitoring function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "single patient use nasal cannula" which is a physical hardware component. It also mentions "corrugated tubing" and a "means to monitor delivered pressure," all indicative of a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is for "gas flow therapy" using a "nasal prong interface." This describes a device used to deliver gas to a patient, which is a therapeutic intervention, not a diagnostic test performed on a sample taken from the body.
• Device Description: The description details a "nasal cannula" with tubing for connection to other devices and a means to monitor pressure. This aligns with a device used for respiratory support or gas delivery, not for analyzing biological samples.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to deliver gas to the patient, which is a direct therapeutic action.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Single patient use device intended for use with neonates, infants and children under 10 Kg requiring a nasal prong interface during intermittent or continuous gas flow therapy in the hospital critical care unit.

Product codes

BZD

Device Description

Single patient use nasal cannula offered in 8 different sizes which have been specifically designed for patents ≤ 10 Kg. The device includes a short length of 10 mm corrugated tubing allowing connection to a variety of devices. The device also provides a means to monitor delivered pressure at the nasal prong.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

neonates, infants and children under 10 Kg

Intended User / Care Setting

hospital critical care unit

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Bench testing and dimensional analysis confirmed that the Babi*Plus Nasal Cannula and predicate device have similar performance characteristics. Testing was performed and the below identified differences were demonstrated:
. Resistance to gas flow in the inspiratory circuit.
. Resistance to gas flow in the expiratory circuit.

Summary of Performance Studies

Bench testing and dimensional analysis confirmed that the Babi*Plus Nasal Cannula and predicate device have similar performance characteristics. Testing was performed and the below identified differences were demonstrated:
. Resistance to gas flow in the inspiratory circuit.
. Resistance to gas flow in the expiratory circuit.

Key Metrics

Not Found

Predicate Device(s)

K093716

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo for A Plus Medical. The logo features a stylized letter "a" enclosed in a circle on the left. To the right of the "a" is the text "A Plus Medical" in a bold, sans-serif font. Below "A Plus Medical" is the tagline "Solutions for Respiratory Care" in a smaller font.

K110471

510(k) Summary 5.0.

February 18, 2010 Date:

Owner:

A Plus Medical 5431 Avenida Encinas, STE G Carlsbad, CA 92008-4411 Tel: + 760-930-4025

• 760-930-0040 Fax:

Owner/Operator Number: 10023166

Official Contact:

Thomas C. Loescher + 760-930-4025 Tel: Fax: + 760-930-0040

Trade Names: Babs.Plus" Infant Nasal Cannula System

Common/Usual Name:

Nasal Cannula, Infant Nasal Cannula

Classification Name:

Ventilator, non-continuous (respirator) Device Name: Product Code: BZD Regulation: 868.5905 II Device Class:

Device: The Babi*Plus Nasal Cannula

Predicate Devices:

K093716 Number: Product Name: Babs.Plus" Infant Nasal Cannula System A Plus Medical Manufacturer: Product Codes: C100 & C102

Device Description:

Single patient use nasal cannula offered in 8 different sizes which have been specifically designed for patents ≤ 10 Kg. The device includes a short length of 10 mm corrugated tubing allowing connection to a variety of devices. The device also provides a means to monitor delivered pressure at the nasal prong.

Indications for Use:

Single patient use device intended for use with neonates, infants and children under 10 Kg requiring a nasal prong interface during intermittent or continuous gas flow therapy in the hospital critical care unit.

5411 Avenida Encinas, STE G Carlsbad, CA 92008-4411 2. [phone] Fax: [phone] ~ 13~

OCT - 7 2011

1

Image /page/1/Picture/0 description: The image shows the logo for A Plus Medical. The logo features the letter "a" in a circle, followed by the words "A Plus Medical" in bold, sans-serif font. Below the company name is the tagline "Solutions for Respiratory Care" in a smaller font. The logo is simple and professional, and it conveys the company's focus on medical solutions for respiratory care.

Contraindications:

Patients not requiring a nasal prong interface during intermittent or continuous gas flow therapy. Patients > 10 Kg.

Patient Population:

Patient population of neonate (premature infant), infant and child

Environment of Use:

Hospital Critical Care Unit

Comparative of Technological Characteristics:

The BablPlus Nasal Cannula is substantially equivalent in indications for use, environment of use, patient population, material and function to the identified predicate. Bench testing and dimensional analysis confirmed that the BabiPlus Nasal Cannula and predicate device have similar performance characteristics. Testing was performed and the below identified differences were demonstrated:

. Resistance to gas flow in the inspiratory circuit.

	1	2	3	4	5	6	7	8	9	10	11	12
Gas Flow
Predicate	0	0.1	0.2	0.3	0.4	0.5	0.7	0.9	1.1	1.3	1.6	1.9
Proposed Device