NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP

K070416 · Neoforce Group, Inc. · BYE · May 29, 2007 · Anesthesiology

Device Facts

• Record ID: K070416
• Device Name: NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP
• Applicant: Neoforce Group, Inc.
• Product Code: BYE · Anesthesiology
• Decision Date: May 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5965
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The NeoPEEP Neonatal Resuscitation Circuit with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator. This valve is designed into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube attachment. This is a prescription device.

Device Story

NeoPEEP is a neonatal resuscitation breathing circuit accessory; integrates PEEP control valve into T-Piece design. Connects to manual resuscitators; provides PEEP capability during emergency neonatal resuscitation. Features standard fittings for face mask, laryngeal mask, or endotracheal tube attachment. Used in clinical settings by healthcare providers. Device enables controlled airway pressure delivery; assists in neonatal ventilation; supports clinical decision-making during resuscitation efforts.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Breathing circuit T-piece with integrated PEEP control valve. Standardized fittings for patient interfaces (mask/tube). Mechanical operation; no electronic components or software.

Indications for Use

Indicated for use as an accessory to manual resuscitators to provide positive end expiratory pressure (PEEP) during neonatal resuscitation. Compatible with face masks, laryngeal masks, or endotracheal tubes. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• NEOPUFF Infant Resuscitator (K892885)
• 0-20 cm H2O PEEP Valve (K981415)

Submission Summary (Full Text)

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#### 510(k) Summary of Safety and Effectiveness Section I

Applicant:

Marshall Products Ltd 13 Ferry Court, Ferry Lane Bath, United Kingdom BA2 4JW Owner/Operator number: 9095220 Registration No: In process

MAY 2 9 2007

Contact Person:

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

Mary Staniewicz Ph 215-672-6800 Fax [phone]

Device trade/proprietary name:

NeoPeep Neonatal 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:

.

K892885 NEOPUFF Infant Resuscitator K981415 0-20 cm H2O PEEP Valve

Device Description

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

#### Intended Use

The NeoPEEP Neonatal Resuscitation Circuit with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator. This valve is designed into the breathing circuit T-Piece with a standard fitting for face mask or endotracheal tube attachment.

## Substantial Equivalence

The Marshall Products NeoPeep Neonatal 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.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Monica Ferrante Vice President Regulatory NeoForce Group, Incorporated 35 Commerce Drive Ivyland, PA 18974

MAY 2 9 2007

Re: K070416

Trade/Device Name: NeoPEEP Neonatal 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: May 16, 2007 Received: May 21, 2007

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 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 III (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 Federal Register.

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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); 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sylette Y. Michel O. M.D.

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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#### Attachment B

#### Indication for Use Statement

# 510(k) Number: K 070 4/ 6

Device Name: NeoPEEP Neonatal Resuscitation Circuit with PEEP

Indications for Use:

The NeoPEEP Neonatal Resuscitation Circuit with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator. This valve is designed into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube attachment.

This is a prescription device.

### (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) OR

Over-the-Counter Use

Qld

(Optional Format 1/2/96)

an angn-Off) Claim of Anesthesiology, General Hospital, action Control, Dental Devices

2.3(K) Number: Kd70y1l

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