DRAGER OXYLOG 2000

K984577 · Drager, Inc. · CBK · Jan 22, 1999 · Anesthesiology

Device Facts

• Record ID: K984577
• Device Name: DRAGER OXYLOG 2000
• Applicant: Drager, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Jan 22, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oxylog 2000 is a time cycled, volume constant transport and emergency ventilator for patients with tidal volumes starting at 100 mL. With applications in: - mobile emergency and primary care of emergency patients - patient transports in emergency rescue vehicles or by helicopter - patient transfers by road or air - inner hospital transport of ventilated patients - emergency room - secondary transports between hospitals

Device Story

Oxylog 2000 is a software-controlled, time-cycled, volume-constant transport and emergency ventilator. Device operates via external power or internal NiCd battery pack for transport. Clinician adjusts ventilation parameters (rate, tidal volume, I:E ratio, inspiratory pressure, PEEP) using 5 rotary knobs. Used in emergency rooms, rescue vehicles, helicopters, and during patient transfers. Provides mechanical ventilation to patients with tidal volumes ≥100 mL. Monitoring and alarm functions ensure patient safety during transport. Software version 3.n update maintains core functionality of predecessor.

Clinical Evidence

Bench testing only. Laboratory tests compared breathing modes, monitoring, and alarm functions of the updated device against the predecessor, demonstrating substantial equivalence.

Technological Characteristics

Time-cycled, volume-constant ventilator. Software-controlled. Powered by external supply or internal NiCd battery. Interface: 5 rotary knobs for parameter adjustment. Includes monitoring and alarm systems. Materials, energy source, and control mechanisms are identical to the predicate device.

Indications for Use

Indicated for patients requiring mechanical ventilation with tidal volumes starting at 100 mL, including emergency patients, patients undergoing transport (ambulance, helicopter, air/road transfer), and patients requiring intra-hospital or inter-hospital transfer.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• Oxylog 2000 (K984577)

Submission Summary (Full Text)

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Special 510(k) for the Oxylog 2000 SW 3.n

JAN 22 1999

file: 510kstate.RTF Date: Nov, 1998 Author: Frank Clanzett

# 510(k) SUMMARY Summary of Safety and Effectiveness

# APPLICANTS NAME AND ADDRESS: Drager Inc. Critical Care Systems 3136 Quarry Road

APPLICANTS TELEPHONE NUMBER: (215)-721-6917

APPLICANTS FACSIMILE NUMBER: (215)-721-6915

APPLICANTS CONTACT PERSON: Harald Kneuer

DATE THE SUMMARY WAS PREPARED: October 1998

### DEVICE NAME:

Telford . PA 18969

f

Oxylog 2000 Common Name: Classification Name: Ventilator, Continuous (per 21 CFR 868.5895)

LEGALLY MARKETED DEVICE TO WHICH DRÄGER IS CLAIMING SUBSTANTIAL EQUIVALENCE: Oxylog 2000 - Manufactured by Dräger Medizintechnik GmbH, Lübeck, Germany and sold in the United States by Dräger, Inc ..

# DESCRIPTION OF THE DEVICE:

The device is a software controlled and time cycled transport and emergency ventilator. It can be equipped with an external power supply for stationary operation in hospitals and is equipped with a NiCd Battery Pack for the during transport. The Oxylog 2000 has 5 rotary knobs for the adjustment of the ventilator rate, tidal volume, I:E ratio, inspiratory pressure limitation and peep.

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Special 510(k) for the Oxylog 2000 SW 3.n

Image /page/1/Picture/1 description: The image shows a handwritten string of characters. The string appears to be "K984577". The characters are written in a cursive style with varying stroke thicknesses. The number 7 has a dash through the middle.

### INTENDED USE OF THE OXYLOG 2000

The Oxylog 2000 is a time cycled, volume constant transport and emergency ventilator for patients with tidal volumes starting at 100 mL.

### SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE:

The Oxylog 2000 with the enhanced software version has exactly the same intended use like the predicate device.

- The sw-change was carried out in accordance with Dräger's internal design control procedure and no questions regarding safety and effectiveness arose during this procedure.
The technology to achieve the additional monitoring function and ventilation mode is the same as already used with the predecessor. The control mechanism, the energy type and the materials used are exactly the same. The ventilator functions of the Oxylog 2000 under review were compared to the function of its predecessor. It was shown in laboratory tests that the breathing modes and the possibilities of the breathing modes are substantial equivalent.

The monitoring and alarm functions of the device under review are also comparable with the alarm and monitoring functions of the Oxylog 2000 predecessor. There were no elementary deviation between the different possibilities of the monitoring and alarm functions. The Oxylog 2000 under review is equipped with the same alarm functions as the predicate device

The device fulfils the same standards as the predecessor.

Therefore the device under review is substantially equivalent to the predicate device concerning safety, efficiency and intended use.

Sllum

Frank Clanzett Regulatory Affairs Dräger Medizintechnik

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number

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Image /page/2/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 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, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 22 1999

Mr. Harald Kneuer Drager, Inc. 3136 Quarry Road Telford, PA 18969

Re: K984577 Drager Oxylog 2000 Requlatory Class: II (two) Product Code: 73 CBK Dated: January 7, 1999 Received: January 11, 1999

Dear Mr. Kneuer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Harald Kneuer

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Intended Use Statement for the Oxylog 2000 with the Software version 3.n

The Oxylog 2000 is a time cycled, volume constant transport and emergency ventilator for patients with tidal volumes starting at 100 mL.

### With applications in:

- · mobile emergency and primary care of emergency patients
- · patient transports in emergency rescue vehicles or by helicopter
- · patient transfers by road or air
- · inner hospital transport of ventilated patients
- emergency room .
- secondary transports between hospitals

J. e. Rlöt

Joachim Schroeter Project Manager

12/03/1998

Date

Kramer

(Division Sign-Off Division of Cardiovascular, Respiratory, and Neurological Device. 510(k) Number