The Infant Flow Plus System consisting of a Driver and Generator plus NCPAP Prongs and Masks, is intended for the provision of Bi-Level CPAP (SiPAP) to produce a sigh. The system is for use in Hospitals, Hospital-type facilities and intra-Hospital transport environments and is indicated for the treatment of Newborn and Infant patients.

Device Description

The Infant Flow Plus System is a factory-installed modification to the Infant Flow Plus System. It uses the existing manually operated air / oxygen mixer and CPAP flow control. An ancillary manual flow control with electronic control solenoid valve allows timed delivery of augmented flow and pressure. The modification is housed in a robust enclosure that is designed to "piggy back" on to the existing Infant Flow Driver Unit.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Infant Flow Plus System. This is a medical device and the performance data presented is related to its compliance with safety and electrical standards, not the clinical performance of an AI/ML algorithm.

Therefore, many of the requested categories in the prompt (e.g., acceptance criteria for an AI algorithm, sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth for AI, etc.) are not applicable to this document. This document outlines the regulatory approval for a physical medical device.

However, I can extract the information relevant to the device's performance based on the standards it complies with.

Here's a summary of the available information:

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

Acceptance Criteria (Standard Compliance)	Reported Device Performance
IEC60601-1: Medical Electrical Equipment. Part 1; General requirements for safety, Second Edition, 1998; Amendment 1, 1991-11; Amendment 2, 1995-03	Compliant
IEC60601-1-2: Second Edition, 2001, Medical Electrical Equipment, Part 1; General Requirements for Safety; Electromagnetic Compatibility - Requirements for Tests.	Compliant
IEC60601-1-4: 1996. Medical Electrical Equipment Part 1: General requirements for safety: 4. Collateral Standard: Programmable electrical medical systems.	Compliant
UL 2601-1: Medical Electrical Equipment: General Requirements for Safety	Compliant

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

Not applicable. This document describes compliance with device safety and functional standards, not a clinical study involving a test set of patient data.

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

Not applicable. Ground truth in the context of AI/ML is not relevant here. The "ground truth" for these standards would be the specifications and requirements defined by the standards themselves, validated through engineering tests.

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

Not applicable. No adjudication method for a test set of patient data is mentioned as it's not a clinical study. Compliance with standards is typically verified through documented testing and review processes by qualified engineers and regulatory bodies.

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:

Not applicable. This device is an Infant Flow Plus System, a bi-level CPAP system, not an AI diagnostic tool. No MRMC study or AI assistance is mentioned.

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

Not applicable. This refers to an AI/ML algorithm's performance. The Infant Flow Plus System is a physical medical device.

7. The type of ground truth used:

Not applicable in the AI/ML sense. For the device itself, the "ground truth" for its performance is its adherence to the technical specifications and safety requirements outlined in the cited IEC and UL standards.

8. The sample size for the training set:

Not applicable. There is no AI/ML training set mentioned in this document.

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

Not applicable. There is no AI/ML training set mentioned in this document.

Summary

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510(k) Notification Infant Flow Plus System June 2003

510(k) SUMMARY

031745

Date Summary Prepared

May 1st, 2002

COMPANY NAME AND ADDRESS

SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, CA 92887 USA

CONTACT PERSON

Earl W. Draper Director QS/RA Telephone (714) 283-2228 (714) 283-8426 Fax:

DEVICE TRADE NAME

Infant Flow Plus ™

COMMON NAME

Bi-level Nasal CPAP

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510(k) Notification Infant Flow Plus System June 2003

PREDICATE DEVICES

Star Sync 1. Device Name: Classification: Class II Manufacturer: Infrasonics, Inc. 3911 Sorrento Valley Blvd. San Diego CA 92121-1402 K840865 & K884521 510(k) #:
1. Device Name: Infant Flow System Classification: Class II Manufacturer: EME (Electro Medical Equipment) Ltd 60 Gladstone Place Brighton Sussex, BN2 3QD United Kingdom 510(k) #: K011516
1. Device Name: Model IV-100B Infant Ventilator Classification: Class II Manufacturer: Sechrist 510(k)# K833982
1. Device Name: Infant Flow System Classification: Class II Manufacturer Manufactured for SensorMedics by EME (Electro Medical Equipment) Ltd 60 Gladstone Place Brighton Sussex, BN2 3QD United Kingdom 510(k)# K991972

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When compared to the predicate devices, the Infant Flow Plus System does not incorporate any significant change in intended use, method of operation, material or design that could affect the safety or effectiveness of the subject device.

DEVICE DESCRIPTION

INTENDED USE

The Infant Flow Plus System consisting of a Driver and Generator plus NCPAP Prongs and Masks, is intended for the provision of a Bi-Level CPAP (SiPAP) to produce a sigh. The system is for use in hospitals, hospital-type facilities and intra-hospital transport environments and is indicated for the treatment of newborn and infant patients.

PERFORMANCE DATA

The Infant Flow Plus System has been verified to be compliant with the requirements of the following standards:

IEC60601-1, Medical Electrical Equipment. Part 1; General requirements . for safety, Second Edition, 1998; Amendment 1, 1991-11; Amendment 2, 1995-03
IEC60601-1-2, Second Edition, 2001, Medical Electrical Equipment, Part 1; . General Requirements for Safety; Electromagnetic Compatibility -Requirements for Tests.
IEC60601-1-4: 1996. Medical Electrical Equipment Part 1: General . requirements for safety: 4. Collateral Standard: Programmable electrical medical systems.
UL 2601-1: Medical Electrical Equipment: General Requirements for . Safety,

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol resembling three abstract human figures or shapes, arranged in a row.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FFB 1 3 2004

SensorMedics, Incorporated c/o Mr. Tom Gutierrez P.E. VIASYS Healthcare GmbH 1100 Bird Center Drive Palm Springs, California 92262

Re: K031745

Trade/Device Name: Infant Flow Plus Infant CPAP System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 11, 2003 Received: December 16, 2003

Dear Mr. Gutierrez:

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 111 (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 Fedcral Register.

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.

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Page 2 - Mr. Tom Gutierrez P.E.

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 (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. 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 your 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 (301) 594-4646. 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/dsma/dsmamain.html.

Sincerely yours.

Susan Runn

Chiu Lin, Ph.D. 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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510(k) Notification Infant Flow Plus System June 2003

INDICATIONS FOR USE STATEMENT

Applicant:

SensorMedics Corporation

510(k) Number:

K021745

Infant Flow Plus System Device Name:

The Infant Flow Plus System consisting of a Driver and Indications for Use: Generator plus NCPAP Prongs and Masks, is intended for the provision of Bi-Level CPAP (SiPAP) to produce a sigh. The system is for use in Hospitals, Hospital-type facilities and intra-Hospital transport environments and is indicated for the treatment of Newborn and Infant patients.

Yes (Per 21 CFR 801.109) Prescription Use:

Please Do Not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)

Prescription Use

OTC Use

Kthun

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number K031745

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).