The NeoPIP™ Resuscitation Circuit with PEEP is indicated as an accessory to add positive end expiratory pressure breathing capability to a T-Piece Resuscitator. The PEEP valve is incorporated into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube. The NeoPIP Resuscitation Circuit with PEEP is indicated for use in neonatal patients < 10Kg.

Device Description

The NeoPIP™ Resuscitation Circuit with PEEP control valve is a breathing circuit intended for use with manual resuscitation devices for emergency neonatal resuscitation.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance. The document describes a 510(k) summary for a medical device called "NeoPIP™ Resuscitation Circuit with PEEP," which is a physical breathing circuit for neonatal resuscitation.

The submission focuses on establishing substantial equivalence to a predicate device based on design, materials, and operational and technological characteristics, not on the performance of a software algorithm or AI model. Therefore, directly answering the questions related to AI/ML performance metrics, sample sizes for test/training sets, experts, and ground truth as outlined in the prompt is not possible from the provided text.

Here's a breakdown of why each requested point cannot be addressed:

Table of acceptance criteria and reported device performance: Not applicable. The document discusses "performance data" in the sense of demonstrating equivalence to a predicate device, not in the context of specific quantitative performance metrics for an AI/ML system.
Sample size for test set and data provenance: No test set is mentioned, as this is a hardware device.
Number of experts used to establish ground truth and qualifications: Not applicable. Ground truth for AI/ML is not relevant for this device.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as it's not an AI-assisted diagnostic tool.
Standalone (algorithm only) performance: Not applicable, as there is no algorithm described.
Type of ground truth used: Not applicable.
Sample size for training set: Not applicable.
How ground truth for the training set was established: Not applicable.

Instead, the document focuses on:

Intended Use: An accessory to add positive end expiratory pressure (PEEP) breathing capability to a T-Piece Resuscitator for neonatal patients < 10Kg.
Substantial Equivalence: Claimed based on similarity in intended use, design, operational and technological characteristics, and principles of operation to legally marketed predicate devices (K070416 NeoPEEP Neonatal Resuscitation Circuit with PEEP and Fisher & Paykel NEOPUFF Infant Resuscitator patient circuit with PEEP).
Performance Data (for equivalence): States that the technological characteristics (design and materials) are the same as the predicate device and that performance data demonstrate equivalence to the predicate device. This implies engineering or functional testing to ensure the device operates as expected and similarly to the predicate, not AI/ML performance evaluation.

Summary

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K103f33

510(k) Summary of Safety and Effectiveness

APR 2 0 2011

Applicant:

Neoforce Group, Inc. 35 Commerce Drive lvyland, Pa. 18974 Owner/Operator number: 9083179 Registration Number: 3005599562

Contact Person:

Neoforce Group, Inc. 35 Commerce Drive lvyland, Pa. 18974

Monica Ferrante Ph 215-672-6800 x203 Fax 215-672-1123

Device trade/proprietary name:

NeoPIP™ Resuscitation Circuit with PEEP

Device common/usual/classification name:

Attachment, Breathing, Positive End Expiratory Pressure

Classification:

Anesthesiology 21 CFR 868.5965 Attachment, Breathing, Positive End Expiratory Pressure, BYE, Class II

Performance Standards:

None applicable

Predicate Device:

K070416 NeoPEEP Neonatal Resuscitation Circuit with PEEP

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Device Description

The NeoPIP™ Resuscitation Circuit with PEEP control valve is a breathing circuit intended for use with manual resuscitation devices for emergency neonatal resuscitation.

Intended Use

Performance Data

The technological characteristics of the NeoPIP Resuscitation Circuit with PEEP are the same as the predicate device with regards to design and materials. Equivalence is also based on performance data which demonstrate that the subject NeoPIP device performs equivalently to the NeoPEEP Resuscitation Circuit with PEEP.

Substantial Equivalence

The NeoPIP™ Resuscitation Circuit with PEEP is believed to be substantially equivalent, based on intended use, design, operational and technological characteristics, and principles of operation, to the Fisher & Paykel NEOPUFF Infant Resuscitator patient circuit with PEEP and to the Marshall Products NeoPEEP NeoNatal Resuscitation Circuit with PEEP.

This summary was prepared on April 19, 2011.

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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 stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The logo is black and white.

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

Ms. Monica Ferrante Vice President Regulatory Neoforce Group, Incorporated 35 Commerce Drive Ivyland, Pennsylvania 18974

APR 2 0 2011

Re: K103833

Trade/Device Name: NeoPIP™ Resuscitation Circuit with PEEP Regulation Number: 21 CFR 868.5965 Regulation Name: Positive end expiratory Pressure Breathing Attachment Regulatory Class: II Product Code: BYE Dated: April 11, 2011 Received: April 11, 2011

Dear Ms. Ferrante:

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 commèrce prior to May 28, 1976, the enactinent 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- Ms. Ferrante

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.fdaggov/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

hr for

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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Updated Indications for Use Statement

1 Indication for Use Statement

510(k) Number:

Device Name: NeoPIP™ Resuscitation Circuit with PEEP

Indications for Use:

(Please do not write below this line continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Per 21 CFR 801.109)

Over-the-Counter Use

(Optional Format 1/2/96)

h l

Division Sign-Off) 'Ivision of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: K103833

Regulation Number and Section

§ 868.5965 Positive end expiratory pressure breathing attachment.

(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).