OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082)

K082600 · Draeger Medical B.V. · CBK · Nov 26, 2008 · Anesthesiology

Device Facts

• Record ID: K082600
• Device Name: OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082)
• Applicant: Draeger Medical B.V.
• Product Code: CBK · Anesthesiology
• Decision Date: Nov 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oxylog 2000 plus is a time-cycled, volume controlled emergency and transport ventilator with pressure support for patients requiring mandatory or assisted ventilation with a tidal volume from 100 ml. upwards. The device is intended for use by and under the supervision of trained healthcare professionals. The device is intended for use in the following environments: Mobile use for emergency patients, in both outdoor and indoor environments; During transport in ambulances or aircraft, including helicopters; In accident and emergency departments; When moving ventilated patients around the hospital; In the recovery room.

Device Story

Time-cycled, volume-controlled emergency and transport ventilator; provides pressure support. Input: gas supply for ventilation. Operation: delivers mandatory or assisted ventilation to patients requiring tidal volumes ≥100 mL. Used in mobile emergency settings, ambulances, helicopters, accident/emergency departments, and recovery rooms. Operated by trained healthcare professionals. Output: mechanical ventilation support. Benefits: provides respiratory support during patient transport and emergency care.

Clinical Evidence

Bench testing only. Safety and performance verified per IEC60601-1, IEC60601-1-2, and other applicable standards covering mechanical, electrical, and biocompatibility requirements. No clinical data presented.

Technological Characteristics

Time-cycled, volume-controlled ventilator with pressure support. Features include mechanical and electrical components compliant with IEC60601-1 and IEC60601-1-2. Biocompatibility testing performed. Designed for portable use in emergency and transport environments.

Indications for Use

Indicated for patients requiring mandatory or assisted ventilation with tidal volumes from 100 mL upwards. Intended for use by trained healthcare professionals in emergency, transport, and hospital settings.

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)
• Oxylog 3000 (K062267)

Submission Summary (Full Text)

{0}------------------------------------------------

510(k) Notification Oxylog 2000 plus QM08 146

K082600 page 1 of 2

**Dräger**medical

A Dräger and Siemens Company

**NOV 26 2008**

# 510(k) Summary (Section 5)

acc. to 807.92

| Applicant'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]<br>Fax: [phone] |
| Applicants US Contact Person: | Ms. Joyce Kilroy<br>Vice President Processes, Quality and Regulatory |
| | Phone: [phone]<br>Fax: [phone] |
| Date submission was prepared: | 2008-09-02 |
| Device Name: | |
| Common Name: | Ventilator |
| Classification Name: | Ventilator, Continuous |
| Regulation Number: | 21 CRF 868.5895 |
| Class: | II |

#### Legally Marketed Device Identification: Oxylog 2000 plus

#### Device Description:

The Oxylog 2000 p/us is a time-cycled, volume controlled emergency and transport ventilator with pressure support for patients requiring mandatory or assisted ventilation with a tidal volume from 100 ml. upwards. The device is intended for use by and under the supervision of trained healthcare professionals. The device is intended for use in the following environments:

- Mobile use for emergency patients, in both outdoor and indoor environments;
- During transport in ambulances or aircraft, including helicopters;
- 트 In accident and emergency departments;
- 해 When moving ventilated patients around the hospital;
- 트 In the recovery room.

## Legally marketed devices to which substantial equivalence is claimed:

| 510(k) Number | Device Name |
|---------------|-------------|
| K984577 | Oxylog 2000 |
| K062267 | Oxylog 3000 |

| type | release status | effective date | number | organization | page/of |
|----------|----------------|----------------|---------------|----------------|---------|
| TEMPLATE | RELEASED | 30.09.2004 | DMS PQ2160 A4 | Dräger Medical | 1/2 |

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for Dräger medical, a Dräger and Siemens Company. The word "Dräger" is in bold, with two dots above the "a", while "medical" is in a thinner, non-bold font. Above the logo, there is some faded text that appears to say "page 2 of 2".

510(k) Notification Oxylog 2000 plus QM08_146

#### Substantial Equivalence:

The Oxylog 2000 plus is found substantially equivalent to the Oxylog 3000 (K062267). For those asepcts where the devices differ, the Oxylog 2000 plus is found substantially equivalent to the Oxylog 2000 (K984577).

#### 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 2000 plus device have been met.

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

| type | release status | effective date | number | organization | page/of |
|----------|----------------|----------------|---------------|----------------|---------|
| TEMPLATE | RELEASED | 30.09.2004 | DMS PQ2160 A4 | Dräger Medical | 2/2 |

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 2 6 2008

Dräger Medical, B.V. C/O Ms. Joyce Kilroy Vice President Processes, Quality and Regulatory Dräger Medical Systems, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K082600

Trade/Device Name: Oxylog 2000 Plus Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 2, 2008 Received: September 10, 2008

Dear Ms. Kilroy:

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 gencral 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 - 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); 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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-frec number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Suatte Y. Michie Omd.

Chiu Lin, Ph.D. Director Division of Ancsthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known):

Device Name: Oxylog 2000 plus

Indications For Use:

The Oxylog 2000 plus is a time-cycled, volume controlled emergency and transport ventilator with pressure support for patients requiring mandatory or assisted ventilation with a tidal volume from 100 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Koszta-Cola

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082600

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