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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Babi.Plus Infant Nasal Cannula System:

The information provided describes a 510(k) premarket notification for a medical device (Babi.Plus Infant Nasal Cannula System), emphasizing its substantial equivalence to a predicate device. The core of the "study" proving acceptance criteria here is a bench testing and dimensional analysis comparison to a legally marketed predicate device, rather than a clinical trial with human subjects.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by demonstrating "substantially equivalent performance" to the predicate device. The performance characteristics compared are "Resistance to gas flow in the inspiratory circuit" and "Resistance to gas flow in the expiratory circuit."

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion (Implicit)	Predicate Device Performance (Reported)	Proposed Device Performance (Reported)
Resistance to gas flow in the inspiratory circuit:
Gas Flow (L/min) 1	0	<0.1
Gas Flow (L/min) 2	0.1	<0.1
Gas Flow (L/min) 3	0.2	0.1
Gas Flow (L/min) 4	0.3	0.2
Gas Flow (L/min) 5	0.4	0.2
Gas Flow (L/min) 6	0.5	0.3
Gas Flow (L/min) 7	0.7	0.5
Gas Flow (L/min) 8	0.9	0.6
Gas Flow (L/min) 9	1.1	0.8
Gas Flow (L/min) 10	1.3	0.9
Gas Flow (L/min) 11	1.6	1.1
Gas Flow (L/min) 12	1.9	1.3
Resistance to gas flow in the expiratory circuit:
Gas Flow (L/min) 1	0.0	<0.1
Gas Flow (L/min) 2	0.0	<0.1
Gas Flow (L/min) 3	0.0	<0.1
Gas Flow (L/min) 4	0.0	0.1
Gas Flow (L/min) 5	0.0	0.1
Gas Flow (L/min) 6	0.0	0.2
Gas Flow (L/min) 7	0.0	0.2
Gas Flow (L/min) 8	0.1	0.3
Gas Flow (L/min) 9	0.1	0.3
Gas Flow (L/min) 10	0.1	0.4
Gas Flow (L/min) 11	0.1	0.5
Gas Flow (L/min) 12	0.1	0.6

The acceptance criteria is met by demonstrating that the "Proposed Device" (Babi.Plus Nasal Cannula) has "substantially equivalent performance" to the "Predicate" device based on the measured resistance to gas flow values. Visually, the reported values for the proposed device are consistently close to, or slightly lower than, the predicate device's values, especially for the inspiratory circuit, indicating comparable or even slightly reduced resistance.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in terms of number of devices tested. The data presented is a series of measurements across different gas flow rates (1 to 12 L/min). It implies measurements were taken for at least one unit of each device type (Proposed and Predicate).
Data Provenance: The data is generated from bench testing conducted by A Plus Medical. There is no mention of country of origin of the data, nor is it clinical (retrospective or prospective) data. It's engineering performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the study is a bench test comparing physical performance characteristics (gas flow resistance) of medical devices, not an evaluation requiring expert interpretation of medical images or patient outcomes. The "ground truth" is derived from metrology/measurement techniques, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

None. This concept is not applicable to a bench testing study comparing physical specifications. Adjudication methods are typically used in clinical studies or studies involving human readers to resolve discrepancies in expert interpretation of qualitative data.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. An MRMC comparative effectiveness study was not done. This study is a bench comparison of physical device characteristics, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This study does not involve an algorithm or AI. It's a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this study is the measured physical properties (resistance to gas flow) of the predicate device. The proposed device's performance is then compared directly against these established measurements. This is based on objective measurements from a bench test setup, not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

Not applicable. This study does not involve a training set as it is a bench test comparison of physical devices, not a machine learning model.

9. How the ground truth for the training set was established:

Not applicable. As there is no training set, this question is irrelevant to the described study.

Summary

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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:

Indications for Use:

5411 Avenida Encinas, STE G Carlsbad, CA 92008-4411 2. +740-930-4025 Fax: +760-930-0040 ~ 13~

OCT - 7 2011

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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	<0.1	<0.1	0.1	0.2	0.2	0.3	0.5	0.6	0.8	0.9	1.1	1.3
Resistance to gas flow in the expiratory circuit.
Gas Flow	1	2	3	4	5	6	7	8	9	10	11	12
Predicate	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.1	0.1	0.1	0.1	0.1
Proposed Device	<0.1	<0.1	<0.1	0.1	0.1	0.2	0.2	0.3	0.3	0.4	0.5	0.6

Conclusion:

The revised Babi*Plus Nasal Cannula is substantially equivalent to the predicate of Application K093716 because:

Both are made from identical material.
. Both have substantially equivalent performance.
. Both have identical indications for use.
. Both are used in identical patient populations.
. Both are used in identical environments of use.

5411 Avenida Encinas, STE G Carlsbad, CA 92008-4411 28. +740-930-4025 Fax: +760-930-0040 ~ 14~

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized abstract design, resembling an eagle or bird in flight. The emblem is composed of three curved lines that converge at the bottom.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Thomas C. Loescher, R.R.T President A Plus Medical 5431 Avenida Encinas. Suite G Carlsbad, California 92008

OCT - 7 2011

Re: K110471

Trade/Device Name: Babi.Plus™ Infant Nasal Cannula System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatorv Class: II Product Code: BZD Dated: September 7, 2011 Received: September 8, 2011

Dear Mr. Loescher:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Loescher

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Anthony D. Watson, B.S., M.S., M.B.A. 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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Image /page/4/Picture/0 description: The image shows the logo for A Plus Medical. The logo consists of the letter "a" in a circle, followed by the words "A Plus Medical" in bold font. Below the company name is the text "Solutions for Respiratory Care" in a smaller font.

Indications for Use Statement

510(k) Number:

(To be assigned)

Device Name:

Babi.Plus"Infant Nasal Cannula System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

or Over-the-counter use

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultze

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: u110471

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).