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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dräger Babylog 8000 plus ventilator.

The document is a 510(k) Summary of Safety and Effectiveness for the Dräger Babylog 8000 plus. It focuses on demonstrating substantial equivalence to predicate devices (Babylog 8000 and Servo 300), rather than outlining specific, quantitative 'acceptance criteria' in the typical sense of a clinical trial or performance study with numerical thresholds and associated statistical proof.

Instead, the "acceptance criteria" here are implicitly defined by the characteristics of the predicate devices. The study's aim is to show the new device meets or exceeds the safety and effectiveness of these predicates.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, explicit numerical acceptance criteria are not presented in a traditional "pass/fail" format. The "acceptance criteria" are the functional specifications and performance characteristics of the legally marketed predicate devices (Babylog 8000 and Siemens Servo 300). The "reported device performance" is the claim of substantial equivalence for the Babylog 8000 plus to these characteristics.

Characteristic	Acceptance Criteria (Predicate)	Reported Device Performance (Babylog 8000 plus)
Ventilator Type	Intensive Care Ventilator (21 CFR 868.5895)	Intensive Care Ventilator (21 CFR 868.5895)
Intended Use	Long-term ventilation for premature/newborn babies and infants up to 10 kg.	Long-term ventilation for premature/newborn babies and infants up to 10 kg (22lbs).
Control Principle	Servo 300: pressure-controlled or volume-controlled, time-cycled or flow-cycled, pressure-limited. Babylog 8000: time-controlled, time-cycled, pressure-limited.	Time-controlled or volume-controlled; time-cycled or flow-cycled; pressure-limited. (Claimed substantially equivalent to Servo 300 where enhanced).
Software controlled	Yes (both predicates)	Yes
Ventilation modes:
CPAP	Yes (both predicates)	Yes
CMV	Yes (both predicates)	Yes
Assist Control	Yes (both predicates)	Yes (AIC Assist Control Ventilation - time-controlled, volume triggered, time-cycled, pressure-limited continuous flow ventilation, synchronized with each spontaneous patient breath)
SIMV	Yes (both predicates)	Yes (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)
PSV	Yes (Servo 300), No (Babylog 8000)	Substantially equivalent to Servo 300. (Pressure Support Ventilation - Time-controlled, volume triggered, flow cycled, pressure-limited ventilation synchronized with each spontaneous patient breath).
VG (Volume Guarantee)	No (both predicates)	Available option. Volume controlled ventilation. Ventilator controls inspiratory pressure to deliver preset tidal volume. May be combined with AIC, SIMV and PSV. (This is an enhancement, not a direct equivalence).
VIVE (Variable Insp. Exp. Flow)	No (both predicates)	Available option. Separate continuous flow during expiration in mandatory ventilation modes. (This is an enhancement, not a direct equivalence).
Method of Triggering	Flow or pressure (Servo 300); Volume (Babylog 8000)	Like Babylog 8000 (Volume triggering) where applicable, with flow triggering available for new modes (e.g., PSV).
O2 Concentration	21 to 100 Vol% ±3 Vol% (both predicates)	Like Babylog 8000 (21 to 100 Vol% ±3 Vol%)
Pinsp	10 to 120 cmH2O (Servo 300); 10 to 80 cmH2O (Babylog 8000)	5 to 80 cmH2O (This range partially overlaps with both predicates, with enhanced lower limit compared to Babylog 8000 and a more restricted upper limit than Servo 300, but still within a clinically appropriate range for intended population).
PEEP	0 to 50 cmH2O (Servo 300); 0 to 25 cmH2O (Babylog 8000)	Like Babylog 8000 (0 to 25 cmH2O)
Tidal Volume	Servo 300: adult: 2 to 4000 mL, pediatric: 0 to 400 mL, neonate: 0 to 40 mL. Babylog 8000: No (result of settings/system characteristics).	2 to 100 mL (when VG option is activated). This is an enhancement providing volume control, which was not directly available on the Babylog 8000 but was available on the predicate Servo 300 for neonates (0 to 40 mL, the Babylog 8000 plus range includes and extends this).
Alarm Functionality	Airway pressure, O2 concentration, Expired minute volume, Apnea, Gas supply, Power failure (common to both predicates).	Yes, for all common alarms. Breathing frequency low/high: Yes (upper alarm limit only) - improved over both predicates (which had none).
Monitoring Parameters	Peak airway pressure, Mean airway pressure, PEEP, Expired tidal volume, Expired minute volume, Breathing frequency, FiO2, Supply pressures (common to both predicates).	Yes, for all common monitoring parameters. New monitoring parameters: compliance, resistance, rate-volume-ratio (not on predicates). These are deemed "not essential for safety and effectiveness".
Physical Characteristics	Similar dimensions/weight, Gas supply pressure, Gas delivery system, Mains voltage range, Power consumption, Internal battery (where applicable to specific predicate).	Like Babylog 8000 for physical characteristics, gas supply, power supply (where comparable). Similar communication interface to predicates, medicament nebulizer capability.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a test set or a clinical study with patients or patient data. This 510(k) summary focuses on demonstrating substantial equivalence through comparison of technological characteristics with predicate devices and adherence to technical standards. It is a "bench study" style comparison, implicitly relying on the design, function, and testing against standards rather than patient-specific performance data.

Therefore:

Sample size for the test set: Not applicable (no test set of patient data described).
Data provenance: Not applicable (no patient data described).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no test set with patient data is described, this section is not applicable. The assessment relies on engineering and regulatory experts to compare specifications and confirm adherence to standards. Dr. Klaus Freudenstein, Project Manager, is listed as having compared device performances, implying an engineering/technical background.

4. Adjudication Method for the Test Set

Not applicable, as no test set requiring ground truth adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device for ventilation, not an AI or imaging diagnostic device. No human reader studies are mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device, not an algorithm, and its performance is assessed against established device characteristics and standards.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is the established safety and effectiveness of the predicate devices as determined by their prior FDA clearance and general clinical use, along with conformity to recognized technical standards (e.g., for ventilators). The comparison table on pages 2-3 serves as the primary evidence.

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No AI model or training set is described.

Summary of the Study for Demonstrating Acceptance:

The "study" presented here is a comparison of the technological characteristics and intended use of the Dräger Babylog 8000 plus against two predicate devices: the Dräger Babylog 8000 (already marketed by the applicant) and the Siemens Servo 300.

The core of the study is a side-by-side tabular comparison (pages 2-3) of various features including:

Control Principle
Ventilation modes (CPAP, CMV, Assist Control, SIMV, PSV, VSV, PRVC, Manual inspiration, VG, VIVE)
Ventilator settings (Tin, Tex, CMV rate, SIMV rate, I:E ratio, O2 concentration, Pinsp, PEEP, Insp. Flow, Tidal Volume, Minute Volume, Trigger sensitivity, Trigger response time, Rise time)
Front panel controls and display technology
Alarm functionalities (Airway pressure, O2 concentration, Expired minute volume, Apnea, Gas supply, Power failure, Breathing frequency, Battery supply, O2 cell disconnect, flow/pressure sensor errors, Ventilator inop)
Monitoring Parameters (peak/mean airway pressure, PEEP, inspired/expired tidal volume, expired minute volume, spontaneous fraction of expired minute volume, percent leakage, breathing frequency, rate-volume-ratio, compliance, resistance, FiO2, supply pressures)
Physical Characteristics (dimensions, weight, gas supply, power supply, internal battery)
Special functions (communications interface, medicament nebulizer)

The study concludes that:

The Babylog 8000 plus is an "enhanced version" of the Babylog 8000.
New ventilation modes in the Babylog 8000 plus (not in Babylog 8000 software 3.0) are "substantially equivalent to ventilation modes of the Servo 300 ventilator of Siemens."
Additional monitoring features (compliance, resistance, rate volume ratio) are provided, but are "not essential for the safety and effectiveness" concerning the intended use.
The device "fulfills at least the same technical standards" as the predicate Dräger device and has been tested according to these standards.
Therefore, the device is "as safe and effective as the predicate devices."

This is a regulatory submission study, not a clinical trial or performance study requiring patient data within this document. The "proof" is based on technical specifications, established standards, and a direct comparison to legally marketed predicate devices, demonstrating that the design and function are equivalent or superior without raising new questions of safety or effectiveness.

Summary

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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

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Brief description of the Babylog 8000 plus

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 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

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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 ....... .

Characteristics	Servo 300	Babylog 8000	Babylog 8000 plus
510(k) number	K902859	K926292	under review
Manufacturer	Siemens	Dräger	Dräger
Classification	Intensive CareVentilator	Intensive CareVentilator	Intensive CareVentilator
Control Principle	pressure-controlledor volume-controlled, time-cycled or flow-cycled;pressure-limited	time-controlled, time-cycled, pressure-limited	time-controlled orvolume-controlled;time-cycled or flow-cycled;pressure-limited
Software controlled	yes	yes	yes
Ventilationmodes:
• CPAP	yes	yes	yes
• CMV	yes	yes	yes
• Assist Control	yes	yes	yes
• SIMV	yes	yes	yes
• PSV	yes	no	substantially equivalentto Servo 300
• VSV	yes	no	substantially equivalentto Servo 300
• PRVC	yes	no	substantially equivalentto Servo 300
• Manualinspiration	no	yes	like Babylog 8000
Method of triggering	Flow or pressure	Volume	like Babylog 8000
Ventilatorsettings:
• Tin	10 to 80% of breathcycle 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 Tinand Tex)	like Babylog 8000
• SIMV rate	0.5 to 40 bpm	2 to 150 bpm(indirectly set via Tinand Tex)	like Babylog 8000
Characteristics	Servo 300	Babylog 8000	Babylog 8000 plus
I:E ratio	via rate and Tin%	1:300 to 3:1 (indirectlyset via Tin and Tex)	like Babylog 8000
O2concentration	21 to 100 Vol%±3Vol%	21 to 100 Vol%±3Vol%	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/mincontinuous flow	like Babylog 8000
Tidal Volume	adult: 2 to 4000 mLpediatric: 0 to 400mLneonate: 0 to 40 mL	no	2 to 100 mL (when VGoption is activated)
Minute Volume	0.2 to 60 L/min	cannot be set; due tothe control principleminute volume is resultof ventilator settingsand the characteristicsof the respiratorysystem	like Babylog 8000
Triggersensitivity	0 to -17 cmH2O, or0.7 to 2 L/min(adult);0.3 to 1 L/min(pediatric);0.17 to 0.5 L/min(neonate);(effective in allventilation modes)	1 to 10 (=0 to 3 mL)	like Babylog 8000
Triggerresponse time	not specified	40 to 60 ms at maxsensitivity	like Babylog 8000
Rise time	0 to 10% of breathcycle time	no	like Babylog 8000
Front panel controls	rotary dials andpush buttons	rotary dials and pushbuttons;screen menu	like Babylog 8000
Display technology	LED indicators;LED array forpressure bargraph	LCD or ELD graphicsscreen;LED indicators;LED array for pressurebargraph	like Babylog 8000
Audible alarm	yes	yes	yes
Alarm sound level	adjustable	adjustable	like Babylog 8000
Pressure reliefvalve	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
•	breathingfrequency	yes	yes	yes
•	rate-volume-ratio	no	no	yes
•	compliance	no	no	yes
•	resistance	no	no	yes
•	FiO2	yes	yes	yes
•	supplypressures	yes	yes	yes
PhysicalCharacteristics:
•	dimensionsWxDxH	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 gaspressure, O2and air	29 to 94 PSI	45 to 90 PSI	like Babylog 8000
•	Gas deliverysystem	microprocessor-controlled valves	microprocessor-controlled valve array(2x10 valves)	like Babylog 8000
Power supply
•	Mains voltagerange	100, 120, 220 and240 V, 50-60 Hz	85 to 140 V;47 to 63 Hz	like Babylog 8000
•	Powerconsumption	50 W	140 W	like Babylog 8000
•	internal battery	yes	no	like Babylog 8000
•	Operating timewith internalbattery	30 min	NA	like Babylog 8000
Special functions
•	Communicationsinterface	serial port RS232 +analog output;Master/Slaveconnection	serial port RS232 +analog outputs(optional)	like Babylog 8000
•	Medicamentnebulizer	yes	yes	yes

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Dräger

and and the collection of the comments of the world

action maris as askais and the market for

・・・

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

Dräger

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

{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

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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 (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

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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

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).