K Number

Device Name

BABYLOG 8000 PLUS

Manufacturer

DRAGER, INC.

Date Cleared

1998-06-17

(223 days)

Product Code

CBK

Regulation Number

868.5895

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). 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

Device Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K926292, K902859

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on microprocessor control and standard ventilation modes, with no mention of AI or ML terms or functionalities.

Therapeutic

Yes
The device is a long-term ventilator used to provide breathing support for premature and newborn babies, which directly addresses a physiological need and provides medical treatment.

Diagnostic

Explanation: The device is described as a long-term ventilator used for providing respiratory support (ventilation modes) to premature and newborn babies, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description clearly indicates it is a hardware device (ventilator) with microprocessor control and integrated components like an air/O2 mixer, not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Babylog 8000 plus is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This is typically done outside of the body (in vitro).
Babylog 8000 plus Function: The Babylog 8000 plus is a ventilator. Its function is to assist or control breathing in patients by delivering air and oxygen directly into the lungs. This is a life-support device that interacts directly with the patient's respiratory system inside the body.
Intended Use: The intended use clearly states it's a "long term ventilator to be used in intensive care of premature and newborn babies and of infants". This describes a therapeutic intervention, not a diagnostic test performed on a specimen.
Device Description: The description details how it provides ventilation, mixes gases, and monitors functions related to breathing. There is no mention of analyzing biological samples.

Therefore, the Babylog 8000 plus falls under the category of a medical device used for patient treatment and support, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 (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.

Product codes (comma separated list FDA assigned to the subject device)

73 CBK

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

premature and newborn babies and of infants up to 10 kg (22lbs).

Intended User / Care Setting

intensive care

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K926292, K902859

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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

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 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

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.

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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 ....... .

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

Dräger

and and the collection of the comments of the world

action maris as askais and the market for

・・・

Dräger

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

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

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

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.

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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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