BABYLOG 8000 PLUS

K974176 · Drager, Inc. · CBK · Jun 17, 1998 · Anesthesiology

Device Facts

• Record ID: K974176
• Device Name: BABYLOG 8000 PLUS
• Applicant: Drager, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Jun 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Babylog 8000 plus is a long term ventilator to be used in intensive care of premature and newborn babies and of infants up to 10 kg (22 lbs).

Device Story

Microprocessor-controlled intensive care ventilator for premature/newborn babies and infants up to 10 kg; operates on continuous-flow principle with time or volume control and pressure limitation. Inputs include air/O2 gas supply; device uses integrated air/O2 mixer. Outputs include mechanical ventilation support; monitoring of airway pressure, PEEP, tidal volume, minute volume, and lung mechanics (compliance, resistance). Used in clinical intensive care settings; operated by healthcare professionals. Optional analog/digital interface allows data transfer to patient monitors or computers. Device includes medicament nebulizer compatibility. Provides multiple ventilation modes (CMV, AIC, SIMV, PSV, CPAP, Volume Guarantee, VIVE). Safety features include continuous monitoring for failures and audible alarms for pressure, O2 concentration, minute volume, apnea, and technical errors. Benefits include precise respiratory support and monitoring for neonatal/infant patients.

Clinical Evidence

Bench testing only. Device performance compared against predicate devices (Babylog 8000 and Servo 300) regarding ventilation modes, monitoring parameters, and physical characteristics. No clinical trial data presented.

Technological Characteristics

Microprocessor-controlled intensive care ventilator; valve array (2x10 valves) for gas delivery; air/O2 mixer. Dimensions: 212x280x390 mm; weight: 14.5 kg. Connectivity: RS232 serial port and analog outputs. Power: 85-140 V, 47-63 Hz. Monitoring: peak/mean airway pressure, PEEP, tidal volume, minute volume, FiO2, compliance, resistance. Software-controlled ventilation modes.

Indications for Use

Indicated for intensive care ventilation of premature babies, newborns, and infants up to 10 kg (22 lbs).

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

• Babylog 8000 (K926292)
• Servo 300 (K902859)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the text "K974176" in a handwritten style on the top line. Below that is the word "Dräger" in a bold, sans-serif font. The word "Dräger" has two dots above the letter "a".

Datei: Sumstate.RTF Date: 10/08/1997 Author: Frank Clanzett

### 510(k) SUMMARY Summary of Safety and Effectiveness

### APPLICANTS NAME AND ADDRESS:

Dräger Inc. Critical Care Systems Ships Fleasent Valley Road 3136 QuARLY Road Ghantilly, VA 20154 Telford, PA 18969

APPLICANTS TELEPHONE NUMBER: (703)-817-0100

APPLICANTS FACSIMILE NUMBER: (703)-817-0101

APPLICANTS CONTACT PERSON: Harald Kneuer

Requlatory Affairs Manager

DATE THE SUMMARY WAS PREPARED: Oct. 8, 1997

DEVICE NAME: Trade Name: Classification Name:

Babylog 8000 plus Intensive Care Ventilator (per 21 CFR 868.5895)

LEGALLY MARKETED DEVICE TO WHICH DRAGER IS CLAIMING SUBSTANTIAL EQUIVALENCE:

Babylog 8000 - Manufactured by Dräger Medizintechnik GmbH. Lübeck. Germany and sold in the United States by Dräger Inc.

Servo 300 - Sold in the United States by Siemens

JUN 17 1998

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

Image /page/1/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font. The "a" in "Dräger" has two dots above it, which is called an umlaut. The text is black and the background is white. The font is a bit blocky.

### Brief description of the Babylog 8000 plus

The Babylog 8000 plus is an enhanced version of its predecessor Babylog 8000. It is a long-term, microprocessor-controlled, intensive care ventilator for premature and newborn babies, as well as for infants weighing up to about 10 kg.

The Babylog 8000 plus ventilates according to the continuous-flow principle with either time control or volume control, depending on the ventilation mode, and pressure limitation. Oxygen is metered out by the integrated air/O2 mixer.

A variety of the device functions are monitored in operation to make sure that safety-relevant failures are detected and safety for the patient is maintained.

The analog and digital interface is optionally available for connecting the Babylog 8000 plus to a device like a patient monitor or computer so that measured values and settings can be transferred to such equipment.

The ventilator can also be combined with a medicament nebulizer.

### Indented Use of the Babylog 8000

The Babylog 8000 plus is a long term ventilator to be used in intensive care of premature and newborn babies and of infants up to 10 kg (22lbs).

The device provides the following ventilation modes:

CMV Continuous Mandatory Ventilation

AIC Assist Control Ventilation

SIMV Synchronized Intermittent Mandatory Ventilation

Pressure Support Ventilation (available option) PSV

CPAP Continuous Positive Airway Pressure

Ventilation mode extension:

VG Volume Guarantee (available option), Volume controlled ventilation

VIVE Variable Inspiratory, Variable Expiratory Flow

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

Image /page/2/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font. The "a" in the word has an umlaut, which is a diacritical mark consisting of two dots placed over the letter. The word is in black and the background is white.

11.1 2.1 3.1 3.1 3. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1. 1

### Basis for the S&E - Decision

ﺍﻟﻤﻮﺿﻮﻋﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴ

ﺔ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ....... .

1

| Characteristics | Servo 300 | Babylog 8000 | Babylog 8000 plus | |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------|
| 510(k) number | K902859 | K926292 | under review | |
| Manufacturer | Siemens | Dräger | Dräger | |
| Classification | Intensive Care<br>Ventilator | Intensive Care<br>Ventilator | Intensive Care<br>Ventilator | |
| Control Principle | pressure-controlled<br>or volume-<br>controlled, time-<br>cycled or flow-<br>cycled;<br>pressure-limited | time-controlled, time-<br>cycled, pressure-<br>limited | time-controlled or<br>volume-controlled;<br>time-cycled or flow-<br>cycled;<br>pressure-limited | |
| Software controlled | yes | yes | yes | |
| Ventilation<br>modes: | | | | |
| • CPAP | yes | yes | yes | |
| • CMV | yes | yes | yes | |
| • Assist Control | yes | yes | yes | |
| • SIMV | yes | yes | yes | |
| • PSV | yes | no | substantially equivalent<br>to Servo 300 | |
| • VSV | yes | no | substantially equivalent<br>to Servo 300 | |
| • PRVC | yes | no | substantially equivalent<br>to Servo 300 | |
| • Manual<br>inspiration | no | yes | like Babylog 8000 | |
| Method of triggering | Flow or pressure | Volume | like Babylog 8000 | |
| Ventilator<br>settings: | | | | |
| • Tin | 10 to 80% of breath<br>cycle time | 0.1 to 2 s | like Babylog 8000 | |
| • Tex | via rate and Tin% | 0.2 to 30 s | like Babylog 8000 | |
| • CMV rate | 5 to 150 bpm | 2 to 150 bpm<br>(indirectly set via Tin<br>and Tex) | like Babylog 8000 | |
| • SIMV rate | 0.5 to 40 bpm | 2 to 150 bpm<br>(indirectly set via Tin<br>and Tex) | like Babylog 8000 | |
| Characteristics | Servo 300 | Babylog 8000 | Babylog 8000 plus | |
| I:E ratio | via rate and Tin% | 1:300 to 3:1 (indirectly<br>set via Tin and Tex) | like Babylog 8000 | |
| O2<br>concentration | 21 to 100 Vol%±3<br>Vol% | 21 to 100 Vol%±3<br>Vol% | like Babylog 8000 | |
| Pinsp | 10 to 120 cmH2O | 10 to 80 cmH2O | 5 to 80 cmH2O | |
| PEEP | 0 to 50 cmH2O | 0 to 25 cmH2O | like Babylog 8000 | |
| Insp. Flow | no | 1 to 30 L/min<br>continuous flow | like Babylog 8000 | |
| Tidal Volume | adult: 2 to 4000 mL<br>pediatric: 0 to 400<br>mL<br>neonate: 0 to 40 mL | no | 2 to 100 mL (when VG<br>option is activated) | |
| Minute Volume | 0.2 to 60 L/min | cannot be set; due to<br>the control principle<br>minute volume is result<br>of ventilator settings<br>and the characteristics<br>of the respiratory<br>system | like Babylog 8000 | |
| Trigger<br>sensitivity | 0 to -17 cmH2O, or<br>0.7 to 2 L/min<br>(adult);<br>0.3 to 1 L/min<br>(pediatric);<br>0.17 to 0.5 L/min<br>(neonate);<br>(effective in all<br>ventilation modes) | 1 to 10 (=0 to 3 mL) | like Babylog 8000 | |
| Trigger<br>response time | not specified | 40 to 60 ms at max<br>sensitivity | like Babylog 8000 | |
| Rise time | 0 to 10% of breath<br>cycle time | no | like Babylog 8000 | |
| Front panel controls | rotary dials and<br>push buttons | rotary dials and push<br>buttons;<br>screen menu | like Babylog 8000 | |
| Display technology | LED indicators;<br>LED array for<br>pressure bargraph | LCD or ELD graphics<br>screen;<br>LED indicators;<br>LED array for pressure<br>bargraph | like Babylog 8000 | |
| Audible alarm | yes | yes | yes | |
| Alarm sound level | adjustable | adjustable | like Babylog 8000 | |
| Pressure relief<br>valve | 120 cmH2O | 120 cmH2O | like Babylog 8000 | |
| Characteristics | Servo 300 | Babylog 8000 | Babylog 8000 plus | |
| <b>Alarms:</b> | | | | |
| Airway pressure high/low | yes | yes | yes | |
| O2 concentration low/high | yes | yes | yes | |
| Expired minute volume low/high | yes | yes | yes | |
| Apnea | yes | yes | yes | |
| Gas supply low/high | yes | yes | yes | |
| Breathing frequency low/high | no | no | yes (upper alarm limit only) | |
| Power failure | yes | yes | yes | |
| Battery supply voltage low/high | yes | NA | like Babylog 8000 | |
| O2 cell disconnect | yes | yes | yes | |
| flow sensor error | yes | yes | yes | |
| pressure transducer error | yes | yes | yes | |
| Ventilator inop (technical alarms) | yes | yes | yes | |
| <b>Monitoring Parameters</b> | | | | |
| peak airway pressure | yes | yes | yes | |
| mean airway pressure | yes | yes | yes | |
| PEEP | yes | yes | yes | |
| inspired tidal volume | yes | no | yes (not displayed) | |
| expired tidal volume | yes | yes | yes | |
| expired minute volume | yes | yes | yes | |
| spontaneous fraction of expired minute volume | no | yes | yes | |
| percent leakage | no | yes | yes | |
| | Characteristics | Servo 300 | Babylog 8000 | Babylog 8000 plus |
| • | breathing<br>frequency | yes | yes | yes |
| • | rate-volume-<br>ratio | no | no | yes |
| • | compliance | no | no | yes |
| • | resistance | no | no | yes |
| • | FiO2 | yes | yes | yes |
| • | supply<br>pressures | yes | yes | yes |
| Physical<br>Characteristics: | | | | |
| • | dimensions<br>WxDxH | 242x370x240 mm<br>(patient unit)<br>431x150x325 mm<br>(control unit) | 212x280x390 mm | like Babylog 8000 |
| • | weight | 24 kg | 14.5 kg | like Babylog 8000 |
| Gas Supply | | | | |
| • | Supply gas<br>pressure, O2<br>and air | 29 to 94 PSI | 45 to 90 PSI | like Babylog 8000 |
| • | Gas delivery<br>system | microprocessor-<br>controlled valves | microprocessor-<br>controlled valve array<br>(2x10 valves) | like Babylog 8000 |
| Power supply | | | | |
| • | Mains voltage<br>range | 100, 120, 220 and<br>240 V, 50-60 Hz | 85 to 140 V;<br>47 to 63 Hz | like Babylog 8000 |
| • | Power<br>consumption | 50 W | 140 W | like Babylog 8000 |
| • | internal battery | yes | no | like Babylog 8000 |
| • | Operating time<br>with internal<br>battery | 30 min | NA | like Babylog 8000 |
| Special functions | | | | |
| • | Communications<br>interface | serial port RS232 +<br>analog output;<br>Master/Slave<br>connection | serial port RS232 +<br>analog outputs<br>(optional) | like Babylog 8000 |
| • | Medicament<br>nebulizer | yes | yes | yes |

{3}------------------------------------------------

## Dräger

and and the collection of the comments of the world

action maris as askais and the market for

・・・

:

.

{4}------------------------------------------------

### Dräger

・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

i

{5}------------------------------------------------

# Dräger

a ... .. .. .. .. .. .. ..

ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ

Device performances compaired by Dr. Klaus Freudenstein / project manager

{6}------------------------------------------------

And Control Controller Comments of Children

#### Explanations of the Comparison

The ventilation modes of the Babylog 8000 plus that are not included in Babylog 8000 with the software 3.0 are substantial equivalent to ventilation modes of the Servo 300 ventilator of Siemens.

The additional monitoring features for the lung mechanics measurement like compliance, resistance and rate volume ratio may assist the user and are not essential for the safety and effectiveness concerning the intended use of the Babylog 8000 plus.

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

Dräger's Babylog 8000 plus is substantial equivalent to either the Dräger Babylog 8000 or to the Siemens Servo 300 ventilator.

The Babylog 8000 plus functions are also covered by the predicate devices and the intended use of the Babylog 8000 plus is covered by the predicate devices, too.

The Babylog 8000 plus fulfills at least the same technical standards as the predicate device of Dräger and has been tested according to these standards.

Therefore the device is as safe and effective as the predicate devices.

Suuuuuu

Oct. 8, 1997

Frank Clanzett Quality Management. Regulatory Affairs Dräger Medizintechnik GmbH, Lübeck, Germany

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its wings, positioned to the right of a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference.

Public Health Service

JUN 17 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Harald Kneuer Dräger, Inc. Critical Care System 3136 Quarry Road Telford, PA 18969

K974176 Re: BABYLOG 8000 Plus Regulatory Class: II (two) Product Code: 73 CBK March 1, 1998 Dated: Received: March 19, 1998

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 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, Druq, and Cosmetic Act (Act). 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, qood 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 Regulations, 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 Regulation (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.

{8}------------------------------------------------

#### 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 regulation (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.qov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

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

Enclosure

{9}------------------------------------------------

The Babylog 8000 plus is a long term ventilator to be used in intensive care of premature and newborn babies and of infants up to 10 kg (22 lbs).

The device provides the following ventilation modes:

CMV Continuous Mandatory Ventilation Time-controlled, time-cycled, pressure-limited continuous flow ventilation.

- AIC Assist Control Ventilation Time-controlled, volume triggered, time-cycled, pressure-limited continuous flow ventilation that is synchronized with each spontaneous patient breath.
SIMV Synchronized Intermittent Mandatory Ventilation Time-controlled , volume triggered, flow cycled, pressure-limited continuous flow ventilation, synchronized with patient's spontaneous breathing at the set ventilation rate.

- Pressure Support Ventilation (available option) PSV Time-controlled , volume triggered, flow cycled, pressure-limited ventilation synchronized with each spontaneous patient breath.
- CAP Continuous Positive Airway Pressure

Spontaneous breathing with positive airway pressure

Ventilation mode extension:

- Volume Guarantee (available option), Volume controlled ventilation. VG The ventilator controls inspiratory pressure in order to deliver the preset tidal volume. May be combined with AJC, SIMV and PSV.
VIVE Variable Inspiratory. Variable Expiratory Flow Separate continuous flow during expiration in mandatory ventilation modes. ﺗﺮﺗ

Klaus Freudenstein

Dr. Klaus Freudenstein (project manager)

M. Puy

PESCRIPTION USE FOR