The VentStar Resuscitaire CEU with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability. The valve is designed into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube.

The VentStar Resuscitaire CEU is a disposable breathing circuit for the transmission of breathing gases from a breathing gas source (Resuscitation Module) to the newborn patient in labor and delivery environments. It is suitable for newborn patients from birth to 1 month of age (maximum body weight of 10 kg (22 lb)). It is intended exclusively for use in combination with the Resuscitaire Radiant Warmer.

The VentStar Resuscitaire CEU is a prescription device.

Device Description

The VentStar Resuscitaire CEU with PEEP valve is indicated as accessory to add positive end expiratory pressure breathing capability. The valve is designed into the T-Piece of the breathing circuit with a standard fitting for face mask, laryngeal mask or endotracheal tube.

AI/ML Overview

The provided text describes the 510(k) summary for the Dräger VentStar Resuscitaire CEU, a medical device for neonates. It focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study proving the device meets specific acceptance criteria in the way a new, innovative AI/software device would. Therefore, many of the requested elements for an AI study are not applicable or cannot be extracted from this document.

However, I can extract information related to the device itself, the comparison to the predicate, and the type of testing performed.

Summary of Acceptance Criteria and Device Performance (Based on Substantial Equivalence):

The acceptance criteria for the VentStar Resuscitaire CEU are rooted in demonstrating substantial equivalence to a predicate device, the NeoPeep Neonatal Resuscitation Circuit. The "acceptance criteria" here are implicitly that the key performance parameters of the new device match or are functionally equivalent to the predicate.

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (VentStar-Resuscitaire CEU)
Connector size for breathing circuit	15 mm
Material composition (Latex-free, DEHP-free)	Latex Free, DEHP Free
Compatible Flow Rate range (lpm)	5 to 15 lpm
PEEP functionality	Adjustable and Dependent on Flow
Maintenance/Cleaning method	Disposable

Study Information (Based on provided document):

Sample size used for the test set and the data provenance: Not applicable. This document describes a medical device, not an AI/software device that would have a "test set" in the context of data. The testing was primarily non-clinical bench testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. As this is not an AI/software device, there is no "ground truth" derived from expert consensus on images or data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 is a physical medical device, not an AI or software component requiring MRMC studies.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device; there is no "algorithm only" performance to evaluate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of a "test set" for an AI device. The "ground truth" for this device's performance would be established by physical measurements and adherence to engineering standards (e.g., ISO, internal specifications) during the bench testing. The regulatory ground truth is its substantial equivalence to the legally marketed predicate.
The sample size for the training set: Not applicable. This is a physical medical device; it does not have a "training set" in the AI sense.
How the ground truth for the training set was established: Not applicable.

Additional Information from the Document regarding "Study":

Device Performance Assessment: The assessment of the VentStar Resuscitaire CEU involved non-clinical bench testing.
Standards Used for Bench Testing:
- ISO 5356 Anesthetic and Respiratory Equipment - Conical Connectors Part 1
- ISO 5367 Breathing tubes intended for use with anesthetic apparatus and ventilators
- System compatibility testing
Biocompatibility Testing: Performed per ISO 10993 - Biological Evaluation of Medical Devices Parts 1, 5 & 12.
Conclusion of the Study (Bench Testing): "In summary Dräger Medical AG & Co. KG has demonstrated that the proposed device is safe and effective and is substantially equivalent, based on intended use, design, operational and technological characteristics, and principles of operation, to the NeoPeep Neonatal Resuscitation Circuit."

In essence, the "study" demonstrating the device meets "acceptance criteria" for regulatory clearance (510(k)) was a series of non-clinical bench tests and biocompatibility tests designed to show that the VentStar Resuscitaire CEU performs equivalently to its predicate device and meets relevant safety standards for its classification.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Dräger medical, along with the text "A Dräger and Siemens Company". Above the logo is the text "KC92029". The logo is in bold, black font, and the text below is in a smaller, regular font.

510(k) Summary

Summary of Safety and Effectiveness

Applicants Name and Address:

Dräger Medical AG & Co. KG Moislinger Allee 53-55 23542 Lübeck Germany

Establishment Registration Number: 9611500

Contact Person:

Ullrich Schröder Director Regulatory and Clinical Affairs

Tel. No .: + 49 (451) 882-3648 Fax No.: + 49 (451) 882-3018

Applicants US Contact Person

Ms. Joyce Kilroy VP Processes, Quality & Regulatory Affairs

Tel. No .: (215) 660-2626 Fax No .: (267) 885-9989

Date submission was prepared:

2009-11-11

Device Name:

VentStar Resuscitaire CEU Trade Name:

Common Name: Positive End Expiratory Pressure Breathing Attachment

Classification:

Class IIRegulation No.
Device	Product Code
Preferred Code:
868.5965	Positive End Expiratory Pressure Breathing Attachment BYE
For predicates:
868. 5965	Positive End Expiratory Pressure Breathing Attachment BYE

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Image /page/1/Picture/1 description: The image shows the logo for Dräger Medical. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name, in a smaller font, is the text "A Dräger and Siemens Company". A horizontal line is present below the text.

Legally Marketed Device to which Substantial Equivalence is claimed:

510(k) numberand a characterial charges and charges and the charges and the charges of the first to the	. Trade name	Company
K070416	NeoPeep	Neoforce Group. Inc.

Device Description:

Intended Use:

Substantial Equivalence:

The intended use and indications for use of VentStar Resuscitaire CEU are similar to the referenced predicate device, the NeoPeep Neonatal Resuscitation Circuit.

Both devices contain a PEEP valve and connect directly to standard endotracheal tubing.

	VentStar-Resuscitaire CEU	NeoPeep
Connector	15 mm	15mm
Material	Latex Free, DEHP Free	Latex Free, DEHP Free
Flow Rate	5 to 15 lpm	5 to 15 lpm
Peep	Adjustable and Dependanton Flow	Adjustable and Dependanton Flow
Maintenance/Cleaning	Disposable	Disposable

A comparison of the data shows the same values for the key performance parameters.

Neither the VentStar Resuscitaire CEU nor the predicate contain software or electrical components.

Biocompatibility testing was performed per ISO 10993 - Biological Evaluation of Medical Devices Parts 1, 5 & 12.

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Image /page/2/Picture/1 description: The image shows the logo for Drägermedical, a company formed by Dräger and Siemens. The logo is in bold, black font and is easily readable. The text "A Dräger and Siemens Company" is located below the main logo in a smaller font size. The overall design is simple and professional.

Performance assessment of the VentStar Resuscitaire CEU included non-clinical bench testing per ISO 5356 Anesthetic and Respiratory Equipment - Conical Connectors Part 1, ISO 5367 Breathing tubes intended for use with anesthetic apparatus and ventilators, and system compatibility testing.

In summary Dräger Medical AG & Co. KG has demonstrated that the proposed device is safe and effective and is substantially equivalent, based on intended use, design, operational and technological characteristics, and principles of operation, to the NeoPeep Neonatal Resuscitation Circuit

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird symbol, with its wings spread, facing towards the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

OCT 7 2010 Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Draeger Medical AG & Company KG C/O Ms. Joyce Kilroy Draeger Medical System, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K092029

Trade/Device Name: VentStar Resuscitaire CEU, Model MP00310 Regulation Number: 21 CFR 868.5965 Regulation Name: Positive and Expiratory Pressure Breathing Attachment Regulatory Class: II Product Code: BYE Dated: August 2, 2010 Received: August 3, 2010

Dear Ms. Kilroy:

This letter corrects our substantially equivalent letter of August 25, 2010.

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 (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 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. Kilroy

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Nh 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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Indications for Use

510(k) Number (if known): K092029

Device Name: VentStar Resuscitaire CEU

Indications for Use:

The VentStar Resuscitaire CEU is a prescription device.

Prescription Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infestion Control,

510(k) Numbe

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).