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. Pre-conditioned gas (heat, moisture, flow and oxygen concentration) is provided to the device's inspiratory circuit. The gas is channeled to the nasal cannula for inhalation. Expired gas is channeled away from the nasal cannula and eventually is vented to the surrounding environment. The device also includes a pressure monitor nasal prong (proximal airway) pressure.

AI/ML Overview

The provided text describes the Babi*Plus Nasal Cannula system and its substantial equivalence to a predicate device, focusing on technological characteristics and bench testing. However, it does not include information about acceptance criteria or specific studies detailing device performance in the way typically expected for AI/ML medical devices. The document is a 510(k) summary for a physical medical device (nasal cannula), not a software or AI product.

Therefore, many of the requested details, particularly those related to AI/ML development (e.g., sample size for test/training sets, ground truth methodology, expert adjudication, MRMC studies, standalone performance), are not applicable or present in this document.

Here's a breakdown of the available information in relation to your request:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state "acceptance criteria" in a quantitative, threshold-based manner as might be seen for an AI diagnostic. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The performance is reported in terms of bench testing for specific characteristics.

Acceptance Criteria (Implied by Substantial Equivalence Goal)	Reported Device Performance (Bench Testing)
Substantially equivalent dimensions and calculated dead space (Vps) within the nasal prong.	A dimension analysis of the Babi*Plus Nasal Cannula and the predicate was performed which demonstrated substantially equivalent dimensions as well as calculated dead space (Vps) within the nasal prong.
Substantially equivalent resistance to gas flow in the inspiratory circuit at 1-12 LPM.	Testing of resistance to gas flow in the inspiratory circuit of the Babi*Plus Nasal Cannula and predicate device at gas flows of 1 to 12 LPM showed substantial equivalency.
Substantially equivalent resistance to gas flow in the expiratory circuit at 1-12 LPM.	Testing of resistance to gas flow in the expiratory circuit of the Babi*Plus Nasal Cannula and predicate device at gas flows of 1 to 12 LPM showed substantial equivalency.
Accurate measurement of nasal prong (proximal airway) pressure at various pressures and gas flows.	Testing was performed to show the accuracy of measuring nasal prong (proximal airway) pressure at various pressures and gas flows. (The document states "Testing to show the accuracy," implying successful results for this criterion for substantial equivalence, but specific accuracy metrics are not provided).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not applicable as the described tests are bench tests on physical devices (nasal cannulas), not data-driven tests on a "test set" in the context of AI/ML or clinical data. There is no mention of human subjects, data provenance, or retrospective/prospective studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable. Ground truth, expert consensus, and expert qualifications are relevant for studies involving human interpretation or complex diagnostic tasks, typically with AI/ML. The evaluation here is based on physical measurements and engineering principles for a medical device.

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

This information is not applicable as there is no "test set" requiring adjudication by experts.

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:

This information is not applicable. This is a physical medical device (nasal cannula), not an AI-assisted diagnostic tool. Therefore, MRMC studies and human reader improvement with AI are irrelevant to this submission.

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

This information is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the bench tests would be the accurate physical measurements obtained using standard methods and calibrated equipment (e.g., flow meters, pressure transducers). It's based on scientific principles and engineering measurements rather than clinical expert consensus or pathology.

8. The sample size for the training set:

This information is not applicable as there is no "training set" in the context of an AI/ML device.

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

This information is not applicable as there is no "training set."

Summary

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Image /page/0/Picture/0 description: The image shows the logo for A Plus Medical. The logo features the letter A in a stylized font, with a small figure standing on top of it. Next to the letter A is the text "A Plus Medical" in a bold font. Below that is the text "Solutions for Respiratory Care" in a smaller font.

KOS37Li

5.0. 510(k) Summary

December 1, 2009 Date:

Owner:

A Plus Medical 5431 Avenida Encinas, STE G Carlsbad, CA 92008-4411 + 760-930-4025 Tel: + 760-930-0040 Fax:

Owner/Operator Number:

10023166

Official Contact:

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

Trade Names:

The Babi*Plus Nasal Cannula

Common/Usual Name:

Nasal Cannula, Infant Nasal Cannula

Classification Name:

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

Device:

The Babi*Plus Nasal Cannula

Predicate Devices:

Number:.	K871157
Product Name:	Infant Nasal CPAP Cannula
Manufacturer:	Hudson Oxygen Therapy Sales Company(Teleflex Medical)
Product Codes:	1683, 1685, 1686, 1687, 1688, 1689, 1690,1691, 1692, 1693, 1694, 1695

Device Description:

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

MAY 1~3 2010

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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 stylized font, with the words "A Plus Medical" written in bold letters. Below the company name is the text "Solutions for Respiratory Care" in a smaller font. The logo is black and white.

Indications for Use:

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 Babi*Plus Nasal Cannula and the predicate device provide flow-by gas the nasal pharynx via a cannula body and ● nasal prong.
Each device has an inspiratory side (circuit), nasal cannula body, nasal prong and an expiratory side (circuit). .
Each device allows pre-conditioned gas (heat, moisture, flow and oxygen concentration) to be delivered to the . inspiratory side (circuit) of the device.
Each device has an expiratory side (circuit) that allows expired gas to be channeled away from the nasal cannula, . eventually venting into the surrounding environment.
. A dimension analysis of the Babi*Plus Nasal Cannula and the predicate was performed which demonstrated substantially equivalent dimensions as well as calculated dead space (Vps) within the nasal prong.
. Bench Testing of the Babi*Plus Nasal Cannula and the predicate device to determine substantial equivalency in performance included:
- . Testing of resistance to gas flow in the inspiratory circuit of the Babi*Plus Nasal Cannula and predicate device at gas flows of 1 to 12 LPM.
- . Testing of resistance to gas flow in the expiratory circuit of the Babi*Plus Nasal Cannula and predicate device at gas flows of 1 to 12 LPM.
- . Testing to show the accuracy of measuring nasal prong (proximal airway) pressure at various pressures and gas flows.

Conclusion:

The Babi*Plus Nasal Cannula is substantially equivalent to the identified predicate. .
The Babi*Plus Nasal Cannula and the identified predicate have substantially equivalent performance. .
. The Babi*Plus Nasal Cannula and the identified predicate are made from substantially equivalent material, have substantially equivalent intended uses, are used in similar patient populations and are used in the same environment.

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

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

MAY 1 3 2010

Mr. Tom Loescher President A Plus Medical, Incorporated 5431 Avenida Encinas, Suite G Carlsbad, California 92008

Re: K093716

Trade/Device Name: Babi Plus Infant Nasal Cannula System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 15, 2010 Received: April 19, 2010

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. Tom 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 (QS) 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/ucm115809.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,

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 features the letter A in a circle with a small dot above it. To the right of the circle is the text "A Plus Medical" in a bold, sans-serif font. Below the text is the phrase "Solutions for Respiratory Care" in a smaller font.

Indications for Use Statement

510(k) Number:

(To be assigned)

Device Name: Indications for Use: Babi*Plus Nasal Cannula System

Prescription Use X (Part 21 CFR 801 Subpart D)

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. Schultheis

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

510(k) Number: K093716

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).