OXYLOG 3000

K062267 · Drager Medical B.V. · CBK · Oct 31, 2006 · Anesthesiology

Device Facts

• Record ID: K062267
• Device Name: OXYLOG 3000
• Applicant: Drager Medical B.V.
• Product Code: CBK · Anesthesiology
• Decision Date: Oct 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Oxylog 3000 is a time-cycled, volume-constant and pressure controlled emergency and transport ventilator for patients with a tidal volume from 50 mL upwards.

Device Story

Oxylog 3000 is a time-cycled, volume-constant, and pressure-controlled emergency and transport ventilator. It provides mechanical ventilation support for patients requiring tidal volumes of 50 mL or higher. Operated by trained healthcare professionals—including physicians, nurses, respiratory therapists, and paramedics—the device is designed for mobile use in emergency vehicles, aircraft, and hospital environments (e.g., recovery rooms, accident/emergency departments). It supports patient transport and secondary transfers. The device utilizes pressure-controlled ventilation and pressure support modes to assist patient breathing. By providing controlled respiratory support, it aids in the stabilization and management of patients during transport or emergency care, ensuring consistent ventilation parameters.

Clinical Evidence

Bench testing only. Safety and performance verification included hazard analysis, system-level qualification, and validation testing conducted per IEC60601-1, IEC60601-1-2, and other applicable standards for mechanical, electrical, and biocompatibility requirements.

Technological Characteristics

Time-cycled, volume-constant, and pressure-controlled ventilator. Features include Pressure Controlled Ventilation plus and Pressure Support modes. Designed for mobile use. Compliance with IEC60601-1 and IEC60601-1-2 standards for electrical and mechanical safety. Biocompatibility testing performed. Connectivity and specific software architecture details are not provided.

Indications for Use

Indicated for patients requiring mechanical ventilation with tidal volumes of 50 mL or greater. Intended for use by trained healthcare professionals (doctors, nurses, technicians, respiratory therapists, paramedics) in emergency medical care, primary care, and transport settings (vehicles, aircraft, hospital recovery rooms, and secondary transfers).

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)
• LTV 1000 (K040790)
• Savina (K003068)
• Crossvent-4 (K942938)
• iVent 201 (K042468)
• Primus US (K042607)

Submission Summary (Full Text)

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# 510(k) Summary

acc. to 807.92

OCT 3 1 2006

| Submitter's Name and Address: | Dräger Medical b.v.<br>Kanaaldijk 29<br>5683CR Best<br>The Netherlands |
|-------------------------------|------------------------------------------------------------------------------|
| Contact Person: | Mr. Hans Venings<br>Vice President Processes, Quality and Regulatory Affairs |
| | |
| Phone: | [phone] |
| Fax: | [phone] |
| Applicants US Contact Person: | Mr. Bryan Overton<br>Regulatory Affairs |
| | |
| Phone: | [phone] |
| Fax: | [phone] |
| Date submission was prepared: | 2006-07-31 |
| Device Name: | Ventilator |
| Common Name: | Ventilator, Continuous |
| Classification Name: | 21 CRF 868.5895 |
| Regulation Number: | II |
| Class: | |

Legally Marketed Device Identification: Oxylog 3000#### Device Description:

The Oxylog 3000 is a time-cycled, volume-constant and pressure controlled emergency and transport ventilator for patients with a tidal volume from 50 mL upwards. The device is intended for use by trained healthcare professionals, i.e. doctors, nurses, technicians, respiratory therapists, paramedics.

The device is intended for mobile use for emergency medical care or primary care of emergency patients:

- During transport in emergency rescue vehicles or aircrafts including helicopters .
. In accident and emergency departments, in the recovery room.

Mobile use for secondary transfers:

- During transfer by road or air '
- l When moving ventilated patients around in the hospital.

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Image /page/1/Picture/1 description: The image shows the logo for Dräger Medical. The logo is in black and features the word "Dräger" in a bold, stylized font with an umlaut over the "a". Below the logo is the text "A Dräger and Siemens Company" in a smaller font. The logo is simple and professional, and it is likely used on the company's products, website, and marketing materials.

#### Predicate Devices:

| 510(k) Number | Device Name |
|---------------|-------------|
| K984577 | Oxylog 2000 |
| K040790 | LTV 1000 |
| K003068 | Savina |
| K942938 | Crossvent-4 |
| K042468 | iVent 201 |
| K042607 | Primus US |

#### Substantial Equivalence:

The Oxylog 3000 is found similar to the Oxylog 2000 (K984577) and the transport features of the LTV 1000 (K040790).

The Oxylog 3000 incorporates a Pressure Controlled Ventilation plus mode and a Pressure Support mode identical to the Savina ventilator (K003068). Furthermore, the Oxylog 3000 uses the same operating principle as the Savina.

Specific features and setting ranges of the Oxylog 3000 are found similar to those features on the Crossvent-4 ventilator (K942938) and the iVent 201 ventilator (K042468).

The accessories of the Oxylog 3000 are similar to the accessories of the LTV 1000 (K040790) and the accessories of the Primus US (k042607).

#### Summary of Performance Testing:

Safety testing was conducted per IEC60601-1, IEC60601-1-2 and other applicable standards with respect to mechanical, electrical and biocompatibility.

The results of all verification and validation testing demonstrate that all system and design requirements for the Oxylog 3000 device have been met.

Qualification included hazard analysis, system level qualification and verification / validation tests.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The seal is presented in black and white.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dräger Medical B.V. C/O Mr. Bryan Overton Regulatory Affairs Dräger Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

### OCT 3 1 2006

Re: K062267

Trade/Device Name: Oxylog 3000 Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 31, 2006 Received: August 4, 2006

Dear Mr. Overton:

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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Page 2 - Mr. Overton

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.

Syette Y. Michael Davis

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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Image /page/4/Picture/0 description: The image shows the logo for Dräger Medical. The word "Dräger" is in bold, with two dots above the "a". The word "medical" is next to it in a thinner font. Below the logo, it says "A Dräger and Siemens Company".

## INDICATIONS FOR USE STATEMENT

Indications for Use

510(k) Number (if known):

Device Name: Oxylog 3000

Indications for Use:

is document / contents is forbidden without express authority. All rights reserved. Refer to protection notice ISO 16016. Drager Med

Oxylog 3000 is a time-cycled, volume-constant and pressure controlled emergency and transport ventilator for patients with a tidal volume from 50 mL upwards.

| Prescription Use | ✓ |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

| Over-The-Counter Use | |
|------------------------|--|
| (21 CFR 801 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


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| | ion of Anesthesiology, General Hospital, |
| | ...ion Control, Dental Devices |
| ) Number: | K062267 |

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