VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310

K092029 · Draeger Medical AG & Co. KG · BYE · Aug 6, 2010 · Anesthesiology

Device Facts

• Record ID: K092029
• Device Name: VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310
• Applicant: Draeger Medical AG & Co. KG
• Product Code: BYE · Anesthesiology
• Decision Date: Aug 6, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5965
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

VentStar Resuscitaire CEU is a disposable breathing circuit accessory; transmits breathing gases from Resuscitation Module to newborn patients. Features integrated PEEP valve in T-Piece; connects to standard face masks, laryngeal masks, or endotracheal tubes. Used in labor and delivery settings; operated by clinicians. Device provides adjustable PEEP dependent on gas flow (5-15 lpm). Benefits include providing respiratory support to neonates. No software or electrical components.

Clinical Evidence

Bench testing only. Performed per ISO 5356 (conical connectors), ISO 5367 (breathing tubes), and ISO 10993 (biocompatibility). System compatibility testing also conducted.

Technological Characteristics

Disposable breathing circuit; latex-free and DEHP-free materials. Integrated PEEP valve in T-Piece with 15mm standard fitting. Flow rate 5-15 lpm. Mechanical operation; no software or electrical components. Tested per ISO 5356, ISO 5367, and ISO 10993.

Indications for Use

Indicated for newborn patients (birth to 1 month, max 10 kg) in labor and delivery environments requiring positive end expiratory pressure (PEEP) breathing support via face mask, laryngeal mask, or endotracheal tube; used exclusively with Resuscitaire Radiant Warmer.

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

• NeoPeep (K070416)

Submission Summary (Full Text)

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# 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 [phone] Fax No.: + 49 [phone]

### Applicants US Contact Person

Ms. Joyce Kilroy VP Processes, Quality & Regulatory Affairs

Tel. No .: [phone] Fax No .: [phone]

#### Date submission was prepared:

2009-11-11

#### Device Name:

VentStar Resuscitaire CEU Trade Name:

Common Name: Positive End Expiratory Pressure Breathing Attachment

#### Classification:

| Class II<br>Regulation 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) number<br>and 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:

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.

#### Intended Use:

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.

#### 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 Dependant<br>on Flow | Adjustable and Dependant<br>on 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 [phone] or [phone] 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 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.

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