BABYTHERM 8004 BABYTHERM 8010 by DRAGER, INC.

Babytherm 8004 / 8010 is an infant warmer system intended as a therapeutic device providing warmth for premature and full-term neonates and infants with a weight up to 16 lbs. It is intended for use in delivery rooms, operating theatres, maternity and obstetric units, neonatal wards, neonatal and paediatric intensive care units. Both Systems can be equipped with the optional phototherapy system for treatment of Hyperbilirubinemia.

Device Description

Babytherm 8004 / 8010 is a warmer system for infants that provides a combination of a heated mattress (Babytherm 8010, only), a radiant heater and an optional phototherapy system. The radiant heater is in a fixed position over the mattress and is equipped with an examination light. The phototherapy system can be installed by the manufacturer or by the biomedical engineer in the housing of the radiant heater. Babytherm 8004 provides warmth by a radiant heater in "manual mode" or with "skin temperature control". Babytherm 8010 provides warmth by a radiant heater in "manual mode" or with "skin temperature control". The Babytherm 8010 also has a heated gel mattress for conductive warmth.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the Dräger Babytherm 8004 / 8010 infant warmer system. The document claims substantial equivalence to several predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document presents a "Table of Comparison" which implicitly serves as the acceptance criteria by comparing the new device (Dräger Babytherm 8004 / 8010) against predicate devices (Babytherm 8000 WB, Radiant Heater RH 600, PT4000, and Microlite™). The "reported device performance" for the Dräger Babytherm 8004 / 8010 is listed within this table.

Feature / Acceptance Criteria	Dräger Babytherm 8004 / 8010 Reported Performance	Equivalent Predicate Device	Notes/Differences
Intended Use	Infant warmer system providing warmth for premature and full-term neonates and infants up to 16 lbs. Use in delivery rooms, neonatal wards, NICUs. Optional phototherapy for Hyperbilirubinemia.	Babytherm 8000 WB, Radiant Heater RH 600, PT4000, Microlite™	Combines functions of multiple predicate devices.
Physical Size
Height (mm)	1820 to 2385 with height adjustment	Babytherm 8000 WB (1220 to 1515)	New device is taller.
Length (mm)	1315	Babytherm 8000 WB (1070)	New device is longer.
Width (mm)	Like Babytherm 8000 WB (750)	Babytherm 8000 WB (750)	Same.
Weight	135 kg max	Babytherm 8000 WB (85 kg max)	New device is heavier.
Mattress Size (mm)	Like Babytherm 8000 WB (750 x 490)	Babytherm 8000 WB (750 x 490)	Same.
Bassinet Tilt	Like Babytherm 8000 WB (± 10° from horizontal)	Babytherm 8000 WB (± 10° from horizontal)	Same.
Case Material	Like Babytherm 8000 WB (PS-TSG)	Babytherm 8000 WB (PS-TSG)	Same.
Case Color	Like Babytherm 8000 WB (blue)	Babytherm 8000 WB (blue)	Same.
Power Input
Voltage	Like Babytherm 8000 WB (120 VAC, 60 Hz)	Babytherm 8000 WB (120 VAC, 60 Hz)	Same.
Total Power (W)	670 W (8004) / 790 W (8010) + 120 W (height adjust) + 440 W (Phototherapy)	Babytherm 8000 WB (135 W + 560 W height adjust), RH 600 (735 W), PT4000 (120 W), Microlite™ (300 W)	Higher total power due to combined functionality.
Fuses	2 x 15 A	Babytherm 8000 WB (2 x 1.6 A / 2 x 6.3 A), RH 600 (2 x 6.3 A), PT4000 (2 x 1.6 A), Microlite™ (2 x 4 A)	Higher fuse rating, likely due to increased power draw.
Leakage Current	< 0.5 mA	Babytherm 8000 WB (< 0.2 mA), RH 600 (< 0.1 mA), PT4000 (< 0.2 mA), Microlite™ (< 0.1 mA)	Higher leakage current, but still within acceptable safety limits (presumably IEC standards).
Heated Mattress (Babytherm 8010 only)
Type	Like Babytherm 8000 WB (4 mm Aluminium plate with heating foil)	Babytherm 8000 WB	Same.
Power	Like Babytherm 8000 WB (24 VAC / 120 W)	Babytherm 8000 WB	Same.
Setting Temp. Range	Like Babytherm 8000 WB (30.0°C - 38.0°C)	Babytherm 8000 WB	Same.
Measurement Range	Like Babytherm 8000 WB (5.0°C - 45.0°C)	Babytherm 8000 WB	Same.
Accuracy	Like Babytherm 8000 WB (± 0.5 °C)	Babytherm 8000 WB	Same.
Applied Part	Like Babytherm 8000 WB (BF)	Babytherm 8000 WB	Same.
Radiant Heater
Type	Like RH 600 (ceramic)	RH 600	Same type of ceramic heater, but different types and improved geometry.
Power	Like RH 600 (600 W)	RH 600	Same. Two ceramic heaters of 300W each.
Control	Like RH 600 (manual or servo)	RH 600	Same.
Distance heater - mattress	80 cm	RH 600 (70 cm default, possible 60cm to 80 cm)	Fixed distance specified for the new device.
Exam light	1 x 11 W, 1 x 19 W	RH 600 (1 x 35 W)	Different exam light configuration.
Manual setting	Level 0 to 10, 30 mW/cm² max. at 80 cm	RH 600 (Level 0 to 10, 23 mW/cm² max. at 70 cm)	Improved maximum irradiance due to better reflector geometry.
Setting Temp. Range	35°C - 37.5 °C	RH 600 (35°C - 37°C)	Improved performance (wider range).
Measurement Range	15°C to 42 °C	RH 600 (33°C - 38°C)	Extended measurement range.
Accuracy	Like RH 600 (± 0.3 °C)	RH 600	Same.
Applied Part	BF	RH 600 (B)	Improved safety requirement (BF vs B).
Power Fail	Actuates if there is a loss of supply voltage	Babytherm 8000 WB, RH 600	Same.
Phototherapy Option
Type	Integrated in radiant warmer housing, fixed distance to patient.	PT4000 (separate device), Microlite™ (separate device)	Integrated design, fixed distance (80 cm).
Light source	6 halogen bulbs	PT4000 (fluorescent bulbs), Microlite™ (3 halogen bulbs)	Different number and type of bulbs.
Power input	440 W	PT4000 (120 W), Microlite™ (300 W)	Higher power input.
Distance to mattress	80 cm	PT4000 (variable, 30 cm min), Microlite™ (variable)	Fixed distance.
On/Off switch	Yes	PT4000, Microlite™	Same.
Effective Irradiance	12 µW/cm²/nm at 80 cm distance (425..475 nm)	PT4000 (13 µW/cm²/nm at 40 cm, 400..500 nm), Microlite™ (17 µW/cm²/nm at 43 cm, 400..500 nm)	Different irradiance values and specified wavelength range due to fixed distance.
Bulb life	1000 hours	PT4000, Microlite™	Same.
Hour meter	Dual timing system for patient exposure time and bulb life.	PT4000, Microlite™	Same.
Control System
Type	Microprocessor based, digital	Babytherm 8000 WB, RH 600	Same.
Self-Calibrating	Yes	Babytherm 8000 WB, RH 600	Same.
Setpoint-Readout	Digital, 3 digit	Babytherm 8000 WB, RH 600	Same.
Power On	Green LED	Babytherm 8000 WB, RH 600 (Red LED)	Change in LED color to fulfill IEC 601 requirement.
Safety System
Overtemperature	For mattress: like Babytherm 8000 WB (40.0°C). For skin temp.: 39.0°C in skin mode or manual mode if sensor connected.	Babytherm 8000 WB (40.0°C)	Improved safety feature for radiant heater.
Overheat Protection	Yes	Babytherm 8000 WB, RH 600	Same.
Probe Fail	For mattress: like Babytherm 8000 WB. For radiant heater: like RH 600.	Babytherm 8000 WB, RH 600	Same.
Set point deviation	For mattress: like Babytherm 8000 WB (± 1°C). For skin temp.: like RH 600 but user-adjustable (0.3℃ to 1.0℃).	Babytherm 8000 WB (± 1°C), RH 600 (± 0.5°C)	User-adjustable deviation for skin temp.
Shut off temperature	Like Babytherm 8000 WB (42.0°C)	Babytherm 8000 WB	Same.
15 Minute Alarm	Actuates after 15 minutes in manual mode with level > 3, and heater output is reduced to level 2.	RH 600 (Actuates after 15 minutes in manual mode with level > 5)	Alarm condition modified based on IEC 601-2-21 requirements (trigger at >10 mW/cm²).
Visible Alarm	Yes	Babytherm 8000 WB, RH 600	Same.
Audible Alarm	Yes	Babytherm 8000 WB, RH 600	Same.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices. It does not describe a clinical study with a test set, sample size, or data provenance in the way a clinical trial report would. The "testing" referred to is against international standards, not a specific patient cohort for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. As this is not a study involving human interpretation or diagnostic accuracy, there is no "ground truth" established by experts in this context. The document relies on engineering specifications and adherence to international standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There is no test set or human adjudication 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 device is a medical apparatus (infant warmer), not a diagnostic or AI-powered system that would involve human readers or AI assistance.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. The "ground truth" in this context is the adherence to established international safety and performance standards (like IEC 601-2-21) and the functional specifications of predicate devices.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. There is no training set for this type of device.

Summary of the Study and Device Performance:

The "study" described in the 510(k) summary is not a traditional clinical trial but rather an engineering and regulatory comparison. The Dräger Babytherm 8004 / 8010 device demonstrates its "acceptance criteria" and "performance" by:

Claiming Substantial Equivalence: The primary method is to show that the new device is substantially equivalent in intended use, technological characteristics, safety, and effectiveness to several legally marketed predicate devices.
Meeting International Standards: The document explicitly states that the Babytherm 8004 / 8010 "fulfill at least the same international standards as the predicate devices of Dräger and has been tested according to these standards" (e.g., IEC 601-2-21). This adherence to standards is the basis for demonstrating safety and effectiveness.
Detailed Comparison Table: The provided "Table of Comparison" outlines various technical specifications and features, highlighting similarities and differences with predicate devices. Where differences exist (e.g., increased height, improved irradiance, wider temperature range, enhanced safety features), the document often explains these as "improved performance" or modifications to meet current standards.

In essence, the "study" is a regulatory submission that leverages an engineering comparison and compliance with established medical device standards to argue for the device's safety and effectiveness. It does not involve patient data collection or clinical outcomes in the manner of a clinical trial.

Summary

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Image /page/0/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font, with two dots above the "a". Above the word "Dräger" is the number "1971/98" written in a cursive style. The text is black and the background is white. The image appears to be a logo or a label.

Datei: Summary.RTF Date:Jan.08, 1997 Author: Frank Clanzett

510(k) SUMMARY Summary of Safety and Effectiveness

- 3 1997

APPLICANTS NAME AND ADDRESS:

Drager Inc. Critical Care Systems 4101-100 Pleasant Valley Road Chantilly, VA 20151

APPLICANTS TELEPHONE NUMBER: (703)-817-0100

APPLICANTS FACSIMILE NUMBER: (703)-817-0101

APPLICANTS CONTACT PERSON: Harald Kneuer

Regulatory Affairs Manager

DATE THE SUMMARY WAS PREPARED:

January 08, 1997

DEVICE NAME:

Trade Name: Common Name: Classification Name: Babytherm 8004 / 8010 Babytherm 8004 / 8010 System. Thermal Regulating

LEGALLY MARKETED DEVICE TO WHICH DRAGER INC. IS CLAIMING SUBSTANTIAL EQUIVALENCE:

Babytherm 8000 WB - Manufactured by Dragerwerk AG, Lubeck, Germany and sold in the United States by Drager Inc.

RH 600 (Radiant Heater) - Manufactured by Dragerwerk AG, Lubeck, Germany and sold in the United States by Drager Inc.

PT 4000 (Phototherapy) - Manufactured by Dragerwerk AG, Lubeck, Germany and sold in the United States by Drager Inc.

Microlite™ (Phototherapy) - Manufactured by Air Shields, USA

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Table of Comparison

	Dräger	Dräger Radiant	Dräger	AirShields	Dräger
	Babytherm 8000 WB	Heater RH 600	PT4000	Microlite™	Babytherm 8004 / 8010
510(k) Number	K 94 5467	K 95 3489	K 95 4611	K 91 2908
Intended Use	Heated bassinet intendedas a therapeutic deviceproviding warmth forpremature and full-termneonates and infants witha weight up to 16 lbs.	Radiant warmersystem tocompensate forheat lost byinfants duringmedicalexaminations ortherapy.	PT 4000 is usedto decreaseblood bilirubinlevels viaphototherapy inpremature andfull term infantswho are treatedin incubators oron radiantwarmer beds.	Phototherapy fortreatment of Hyperbilirubinemia	Babytherm 8004 / 8010 is an infant warmersystem intended as a therapeutic deviceproviding warmth for premature and full-termneonates and infants with a weight up to 16 lbs.It is intended for use in delivery rooms, neonatalwards, neonatal and paediatric intensive careunits.Both Systems can be equipped with the optionalphototherapy system for treatment ofHyperbilirubinemia.
Physical Size (mm)
Height (mm)	1220 to 1515 with heightadjustment	-----	-----	-----	1820 to 2385 with heightadjustment
Length (mm)	1070	-----	-----	-----	1315
Width (mm)	750	-----	-----	-----	like Babytherm 8000 WB
Weight	85 kg max	-----	-----	-----	135 kg max
Mattress Size (mm)	750 x 490	-----	-----	-----	like Babytherm 8000 WB
Bassinet Tilt	$\pm$ 10° from horizontal	-----	-----	-----	like Babytherm 8000 WB
Case Material	PS-TSG	-----	-----	-----	like Babytherm 8000 WB
Case Color	blue	-----	-----	-----	like Babytherm 8000 WB
Power Input
Voltage	120 VAC, 60 Hz	110 / 127 VAC,60 Hz	110 / 127V	110 / 120 VAC	like Babytherm 8000 WB
Total	135 W+ 560 W for heightadjustment	735 W	120 W	300 W	670 W for Babytherm 8004790 W for Babytherm 8010+120 W for variable height adjust+ 440 W for Phototherapy
Fuses	2 x 1.6 A / 2 x 6,3 A	2 x 6.3 A	2 x 1.6 A	2 x 4 A	2 x 15 A
Leakage Current	< 0.2 mA	< 0.1 mA	< 0.2 mA	< 0.1 mA	< 0.5 mA
	DrägerBabytherm 8000 WB	Dräger RadiantHeater RH 600	DrägerPT4000	AirShieldsMicrolite™	DrägerBabytherm 8004 / 8010
Design	Heated MattressControl and heater unitand the mattress aretogether in one housingwhich is mounted on atrolley with optionalheight adjustment andfour casters	Radiant WarmerControl andheater unit aretogether in onehousing which ismounted onmobile stand oron a wall.	PhototherapyThe Photo-therapy is aseparate devicewith anexamination lightincluded.	PhototherapyThe Photo-therapy is aseparate device	The Babytherm 8004 / 8010 is developed tocombine the two products Dräger Babytherm8000 WB and Dräger Radiant warmer RH600.Components of the Heated Mattress (Babytherm8010 only) are the same as for Babytherm 8000WB.The ThermoMonitoring is included in theBabytherm 8004 and 8010.1The Radiant Warmer of the Babytherm8004/8010 is a further development of theRH 600.The Heater unit, the examination lightand the optional Phototherapy unit are togetherin one housing which is located in a distance of80 cm over the matress, mounted on twocolumns at the head end of the bed.The Control Unit is located below the end of theradiant warmer between the two columns at thehead end of the bed.
Energy used	Electric:A 120 W, 24 VAC heaterheats up an aluminiumplate and the patient isheated up by conductivewarm through the Gelmattress. The lowerheater voltage of 24 VACinsures maximum safetyfor the patient.	Electric:Four 150 W, 120VAC ceramicheater are usedto provideradiative heat indirection of thebed.	Electric:Flourescentbulbs for thephototherapy	Electric:Halogenbulbs for thephototherapy	Electric.For the heated mattress the same as Babytherm8000 WB.For the radiant warmer two ceramic heater of300 W are used to provide radiative heat in thedirection to the bed.2For the phototherapy halogen bulbs are used
Heated Mattress		------	------	------
Type	4 mm Aluminium platewith heating foil	------	------	------	like Babytherm 8000 WB
Power	24 VAC / 120 W	------	------	------	like Babytherm 8000 WB
	DrägerBabytherm 8000 WB	Dräger RadiantHeater RH 600	DrägerPT4000	AirShieldsMicrolite™	DrägerBabytherm 8004 / 8010

Heated Mattress(Continue)
Setting Temp. Range	$30.0°C - 38.0°C$	------	------	------	like Babytherm 8000 WB
Measurement Range	$5.0°C - 45.0°C$	------	------	------	like Babytherm 8000 WB
Accuracy	$± 0.5 °C$	------	------	------	like Babytherm 8000 WB
Applied Part	BF	------	------	------	like Babytherm 8000 WB

Radiant Heater
Type	------	ceramic	------	------	like RH 600
Power	------	600 W	------	------	like RH 600
Control	------	manual or servo	------	------	like RH 600
Distance heater -mattress	------	70 cm default,possible 60cm to80 cm	------	------	80 cm
Exam light	------	1 x 35 W	------	------	1 x 11 W, 1 x 19 W
Manual setting	------	Level 0 to 10, 23mW/cm² max. at70 cm distance	------	------	Level 0 to 10, 30mW/cm² max. at 80 cm3
Setting Temp. Range	------	$35°C - 37°C$	------	------	$35°C - 37.5 °C$ 4
Measurement Range	------	$33°C - 38°C$	------	------	$15°C to 42 °C$ 5
Accuracy	------	$± 0.3 °C$	------	------	like RH 600
Applied Part	------	B	------	------	BF6
Power Fail	Actuates if thereis a loss ofsupply voltage	Actuates if thereis a loss ofsupply voltage	------	------	Actuates if thereis a loss ofsupply voltage

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" see explanation of differences

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" see explanation of differences

11:40 PM IST 1

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	DrägerBabytherm 8000 WB	Dräger RadiantHeater RH 600	DrägerPT4000	AirShieldsMicrolite™	DrägerBabytherm 8004 / 8010
Phototherapy Option
Type	-----	-----	Phototherapysystem mountedon a mobilestand for use incombination withradiant warmersor incubators	Phototherapysystem mountedon a mobilestand for use incombination withradiant warmersor incubators	Phototherapy system integrated in radiantwarmer housing for use in combination withradiant warmer, mounted on two columns at thehead end of the bed, with a fixed distance to thepatient
Light source	-----	-----	flourescent bulbs	3 halogen bulbs	6 halogen bulbs7
Power input	-----	-----	120 W	300 W	440 W8
Distance to mattress	-----	-----	variable, 30 cmminimum	variable	80 cm
On/Off switch	-----	-----	yes	yes	yes
effective Irradiancewithin Wave lengthrange	-----	-----	13 μW/cm²/nm at40 cm distance400..500 nm	17 μW/cm²/nm at43 cm distance400..500 nm	12 μW/cm²/nm at80 cm distance425..475 nm
Bulb life	-----	-----	1000 hours	1000 hours	1000 hours
Hour meter	-----	-----	dual timingsystem forpatient exposuretime and bulb life	dual timingsystem forpatient exposuretime and bulb life	dual timingsystem forpatient exposuretime and bulb life.
Control System			-----	-----
Type	Microprocessor based,digital	Microprocessorbased, digital	-----	-----	Microprocessor based,digital
Self-Calibrating	Yes	Yes	-----	-----	Yes
Setpoint-Readout	Digital, 3 digit	Digital, 3 digit	-----	-----	Digital, 3 digit
Power On	Red LED	Red LED	-----	-----	Green LED9
Power Fail	Actuates if thereis a loss ofsupply voltage	Actuates if thereis a loss ofsupply voltage	-----	-----	Actuates if thereis a loss ofsupply voltage

" see explanation of differences

: :

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	DrägerBabytherm 8000 WB	Dräger RadiantHeater RH 600	DrägerPT4000	AirShieldsMicrolite™	DrägerBabytherm 8004 / 8010
Safety System
Overtemperature	40.0°C	------	------	------	For mattress: like Babytherm 8000 WB.For skin temp. 39.0°C in skin mode or in manualmode, if sensor is connected.10
Overheat Protection	Yes.	Yes.	------	------	Yes
Probe Fail	Actuates if mattresstemp. sensors (2 pairs)are open, shorted or un-plugged, or if temp.difference betweenmattress sensors is toolarge	Actuates duringskin temp.control if skintemp. probe hasbeendisconnected oris faulty	------	------	For mattress: Like Babytherm 8000 WB.For radiant heater: like RH 600
Set point deviation	Mattress Set temp. ± 1°C	Skin Set temp.± 0.5°C	------	------	For mattress, same as Babytherm 8000 WB.For skin temp., like RH 60011
Shut off temperature	42.0°C	------	------	------	like Babytherm 8000 WB.
15 Minute Alarm	------	Actuates after 15minutes inmanual modewith level > 5	------	------	Actuates after 15 minutes in manual mode withlevel > 3, and heater output is reduced tolevel 212
Visuable Alarm	Yes	Yes	------	------	Yes.
Audible Alarm	Yes	Yes	------	------	Yes.

6 of 10

September 19.

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Explanation of Differences related to the Table of Comparison:

The ThermoMonitoring function uses two sensors for temperature measurement: One for the core 1 sensor.
2 For the Babytherm 8004 / 8010 other types of ceramic heaters are used. The geometry of the reflectors was improved. The performance still meets the requirements of IEC 601-2-21.
3 The maximum irradiance was improved because of better reflector geometry. The device still meets the requirements of IEC 601-2-21.
4 This is an improved performance. The device still meets the requirements of IEC 601-2-21.
Two temperature channels for core and peripheral temperature with a range from 15°C to 42°C.
This is an improved safety requirement of IEC 601-2-21.
ഗ്രന്ഥം പത്രശ്വ By this modification an even distribution of the irradiance over an area of 20 x 40 cm is achieved.
see explanation number 7.
Change in LED Colour to fullfill exactely this requirement of IEC 601.
10 This is an improved safety feature for the radiant heater.
The allowable deviation may be changed by the user in a range from 0.3℃ to 1.0℃ 11
For the Babytherm 8004/8010 at level 3 the heater output is approximately 9 mWcm², level 2 corresponds to heater output of 12 6 mW/cm². According to 601-2-21 the 15 Minutes-Alarm has to be activated at a heater output of more than 10 mW/cm².

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DESCRIPTION OF THE DEVICE:

Babytherm 8004 provides warmth by a radiant heater in "manual mode" or with "skin temperature control".

Babytherm 8010 provides warmth by a radiant heater in "manual mode" or with "skin temperature control". The Babytherm 8010 also has a heated gel mattress for conductive warmth.

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

The Babytherm 8004 / 8010 are substantially equivalent to the predicate devices Babytherm 8000 WB, Radiant Heater RH 600, Phototherapy PT 4000 and Phototherapy Microlite™

The function of the Babytherm 8004 / 8010 including the optional Phototherapy is also covered by the predicate devices and the equivalent intended use is covered by these devices, too.

The Babytherm 8004 / 8010 fulfil at least the same international standards as the predicate devices of Dräger and has been tested according to these standards. Therefore the Babytherm 8004 / 8010 are as safe and effective as the predicate devices.

Quulle/

Frank Clanzett Regulatory Affairs Specialist (Dragerwerk AG, Germany)

Jan. 08.1997

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Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT - 3 1997

Mr. Harald Kneuer Requlatory Affairs Manager Drager Incorporated 4101 Pleasant Valley Road, Suite 100 Chantilly, VA 20151

Re : K971198 Babytherm 8004 Babytherm 8010 Trade Name: Requlatory Class: II Product Code: FMT Dated: July 7, 1997 Received: July 9, 1997

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Kneuer

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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) 594-4618. 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 requlation 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.gov/cdrh/dsmamain.html".

Sincerely yours,

Celaterud

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

· Enclosure

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INTENDED USE OF THE DEVICE:

Gllullly

Frank Clanzett Regulatory Affairs Specialist (Dragerwerk AG, Germany)

Jan. 08.1997

Patrizia Cucuzza

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

510(k) Number _

Prescription Use
(Per 21 CFR 801.109)

00019

Regulation Number and Section

§ 880.5130 Infant radiant warmer.

(a)
Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.(b)
Classification. Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.