Babyleo TN500 is intended for use with premature babies and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. The device provides a thermally regulated environment for patients with a body weight of up to 5 kg (11 lbs) and a height of up to 55 cm (22 in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator.Neonates are kept warm in the patient with humidifiable air, which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer. Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following parameters are regulated, according to the intended use: - Temperature - Humidity - Oxygen (option)

Device Description

The device Babyleo TN500 is a medical device used to maintain environmental conditions suitable for preterm babies and neonates. The important features are temperature and humidity. The operational principle is a combination of a neonatal incubator and an open warmer.

Babyleo TN500 can be operated in closed care therapy as an incubator according to IEC60601-2-19 or in open care therapy as a warmer according to IEC60601-2-21. Additionally, an optional x-ray translucent heated mattress is intended to provide sensible heat to the preterm babies and neonates.

The device consists of the following components: Incubator (=bassinet) with a convection heater and closed humidification system for the patient, trolley, radiant warmer, display, mattress, x-ray and height adjustment. Optional components are scale, heated mattress, drawer, oxygen regulation with cylinder holder and Auto Thermo package and Developmental Care package.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Babyleo TN500, a neonatal incubator and radiant warmer. It aims to demonstrate substantial equivalence to legally marketed predicate devices. The information provided heavily focuses on design verification and validation testing, and therefore, does not contain the details on acceptance criteria and study proving performance in the context of an AI/ML medical device that would typically involve clinical studies, multi-reader multi-case studies, and explicit ground truth establishment with expert consensus.

Given the document talks about a physical medical device (neonatal incubator/radiant warmer) and not an AI/ML diagnostic or prognostic tool, the questions posed about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or AUC, multi-reader multi-case studies, expert consensus for ground truth, effect size for human reader improvement with AI assistance, and training/test set sample sizes and provenance for AI/ML models are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this conventional medical device primarily revolve around safety and performance standards, electrical safety, EMC, software verification, biocompatibility, human factors, and reprocessing validation.

Here's how to address the prompt based on the provided document:

1. A table of acceptance criteria and the reported device performance:

The document lists compliance with various standards and provides specifications that serve as performance criteria.

Acceptance Criteria (Standard Compliance / Performance Spec)	Reported Device Performance (Compliance / Value)
Electrical Safety: IEC 60601-1, IEC 60601-2-19, IEC 60601-2-21, IEC 60601-2-35	Device complies with all listed standards.
Electromagnetic Compatibility (EMC): IEC 60601-1-2	Device complies with the standard.
Software Verification and Validation: FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (2005)	Software verification and validation testing conducted; documentation provided; considered "major" level of concern.
Biocompatibility: ISO 10993, ISO 10993-1, ISO 10993-17, ISO 10993-18	Evaluation conducted in accordance with FDA guidance; battery of testing included: Integral Test for volatile organic compounds, Photogenic bacteria test, Emission of particles, Material characterization, Toxicological Evaluation, Cytotoxicity, Irritation, Sensitization.
Human Factors: FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff, 2016	Usability evaluation conducted in accordance with FDA guidance.
Reprocessing: FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Guidance for Industry and Food and Drug Administration Staff, 2015	Reprocessing validation conducted in accordance with FDA guidance.
Operating Noise Volume in Patient Compartment	Typically 40 dB(A) (Measured without oxygen application) - (Compared to predicate <49 dB(A), Caleo 47 ± 2 dB(A))
Alarm Volume	50 to 70 dB(A) (according to IEC 60601-2-19 and IEC 60601-2-21) - (Compared to predicate "according to IEC 60601-2-19")
Power Failure Alarm	Yes (65 dB(A), 10 min) - (Compared to predicate "Yes")
Maximum Irradiance of Warmer (at 100% power)	32 mW/cm2 - (Compared to Babytherm 30 mW/cm2)
Warm-up Time	15 to 20 min - (Compared to predicate <50 min, Caleo 20 min)
Flow Velocity over Mattress Surface	10 cm/s (3.94 in/s) (at 36°C) - (Compared to predicate <10 cm/s, Caleo <8 cm/s)
Maximum Carbon Dioxide (CO2) concentration in incubator	<0.5 Vol% - (Compared to predicate 0.2 %, Caleo <0.5 Vol%, Babytherm max 0.5 Vol%)
Air Temperature Measurement Range	13 to 45 °C (55.4 to 113 °F) - (Compared to Caleo 13 to 42 °C)
Air Temperature Measurement Uncertainty	± 0.8°C (1.44 °F) - (Compared to Caleo ± 0.8°C)
Skin Temperature Measurement Uncertainty (Entire System)	± 0.3°C (0.54 °F) - (Matches predicate and reference devices)
Oxygen Measurement Range (Normal)	18 to 65 Vol% - (Matches Caleo)
Oxygen Measurement Uncertainty	± 2.5 Vol% (+ 2.5 % of measured value) - (Compared to predicate 5%, Caleo ± 3 Vol%)
Humidity Measurement Range (Normal)	30 to 99 % r. H. - (Matches Caleo)
Humidity Measurement Uncertainty	±10 % - (Matches predicate and Caleo)
Heated Mattress Setting Range	Off, 35°C to 39°C, AUTO - (Compared to Babytherm Off, 30°C to 38.5°C)
Scale Range	200 g to 10 kg - (Compared to predicate 300 g to 8 kg, Caleo 250 g to 10 kg, Babytherm 250 g to 8 kg)
Scale Resolution	5 g (OIML) or 1 g (standard version) - (Compared to predicate 10 g or 5 g, Caleo 1 g or 5 g, Babytherm 1 g or 10 g)

2. Sample sized used for the test set and the data provenance:

Test Set Sample Size: Not applicable. This is a conventional medical device; performance testing is often conducted on a representative number of units or components, but the "sample size" concept as used in AI/ML clinical studies for a test dataset does not directly apply. The testing mentioned (electrical safety, EMC, software verification, biocompatibility, human factors, reprocessing) would be performed on the device itself or its materials.
Data Provenance: Not applicable in the sense of patient data. The provenance for the testing data would be from internal lab testing conducted by the manufacturer (Drägerwerk AG & Co. KGaA, Germany) or their designated testing facilities. It's not retrospective or prospective patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth in the context of an AI/ML clinical study (e.g., diagnosis of disease) is not relevant for this device. The "ground truth" for this device's performance is established by objective measurements against engineering specifications and recognized international standards. Experts involved would be engineers, quality assurance personnel, and regulatory specialists.

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

Not applicable. Adjudication methods are typically for resolving discrepancies in expert labeling or diagnoses in AI/ML studies. For a physical device, performance is measured against established limits derived from standards or engineering requirements.

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:

No, not done. This is a physical medical device, not an AI-assisted diagnostic tool. MRMC studies are not relevant for demonstrating the effectiveness of an incubator/warmer.

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

Not applicable. There is no "algorithm only" performance for a neonatal incubator/radiant warmer as it is not an AI/ML-driven diagnostic or treatment algorithm. Its performance is measured by its ability to maintain specified environmental conditions.

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

Objective Measurement against Standards and Specifications: The "ground truth" for this device is the adherence to internationally recognized safety and performance standards (e.g., IEC 60601 series, ISO 10993) and the manufacturer's own detailed engineering specifications. For example, the "truth" of the noise level is the scientifically measured sound pressure level, not an expert's subjective assessment.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of an AI/ML model for this device. Design and development of the device would involve engineering principles, materials science, and iterative testing, not machine learning model training.

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

Not applicable. As there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for the device's design and manufacturing is derived from scientific and engineering principles, regulatory requirements, and established medical device standards.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 23, 2017

Draegerwerk AG & Co. KGaA % Ms. Beth Zis Director, Regulatory Affairs Draeger Medical Systems, Inc. 6 Tech Drive Andover, Massachusetts 01810

Re: K162821

Trade/Device Name: Babyleo TN500 Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: Class II Product Code: FMZ, FMT Dated: May 24, 2017 Received: May 30, 2017

Dear Ms. Beth Zis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

James P. Bertram -S

for

Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162821

Device Name Babyleo TN500

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K162821

Applicants / Manufacturer Name and Address:

Drägerwerk AG & Co. KGaA Moislinger Allee 53-55, 23558 Luebeck, Germany

Contact Person:

Dr. Bettina Möbius Senior Manager Regulatory Affairs

Tel. No.: 011 49 (451) 882-4100 Fax No.: 011 49 (451) 882-3018

Applicants US Contact Person

Beth Zis Director, Regulatory Affairs Draeger Medical Systems, Inc. 6 Tech Drive, Andover, MA 01810 USA

Tel: +1 (978) 379-8265 Fax: +1 (978) 379-8335

Date submission was prepared:

06/05/2017

Device Name:

Device Trade Name: Common / Usual Name: Classification Name Regulatory Class: Product Code:

Babyleo TN500 Incubator and Warmer Incubator, neonatal 21 CFR 880.5400 = FMZ, FMT

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Legally Marketed Devices to which Substantial Equivalence is claimed:

Legally Marketed Predicate Device: K010222, Ohmeda Medical Giraffe Incubator Reference Devices: K003067, CALEO K971198, Babytherm 8004/8010

Device Description:

Indications for Use:

Babyleo TN500 is intended for use with premature babies and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. The device provides a thermally regulated environment for patients with a body weight of up to 5 kg (11 lbs) and a height of up to 55 cm (22 in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator. Neonates are kept warm in the patient compartment with humidifiable air, which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer. Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following parameters are regulated, according to the intended use: Temperature; Humidity; Oxygen (option)

Substantial Equivalence Comparison:

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	BabyleoTN500	Omnibed(Giraffe)	Caleo	Babytherm8004/8010	Comments
Status	new device	predicate device	reference device	reference device
Manufacturer	Drägerwerk AG & Co.KGaA	Ohmeda Medical,a Division ofDatex-Ohmeda,Inc. A GECompany	Drägerwerk AG &Co. KGaA	Drägerwerk AG &Co. KGaA
Classification Name /Product code	Incubator, neonatal /FMZ	Incubator, neonatal/ FMZ	Incubator, neonatal/ FMZ	Infant RadiantWarmer / FMT	Same
510(k)	K162821	K010222;	K003067	K971198
Regulation Number:	21 CFR 880.5400	21 CFR 880.5400	21 CFR 880.5400	21 CFR 880.5130	Same
Class:	II	II	II	II	Same
Standards	60601-1: 60601-1-2:60601-2-19: 60601-2-21	60601-1: 60601-1-2: 60601-2-19:60601-2-21	60601-1: 60601-1-2: 60601-2-19:	60601-1; 60601-1-2;60601-2-21	Same
Indications for use	The Babyleo TN500 isintended for use withpremature babies andneonates and can beused as both anincubator and a radiantwarmer. When theproduct is switchedbetween incubator andradiant warmeroperation, patientscontinue to be kept warmduring the transition. Thedevice provides athermally regulatedenvironment for patientswith a body weight of up	The OmniBed is acombination of aninfant incubator(
BabyleoTN500	Omnibed(Giraffe)	Caleo	Babytherm8004/8010	Comments
to 5 kg (11 lbs) and aheight of up to 55 cm (22in). The device can beoperated as either aclosed care unit or anopen care unit. As aclosed care unit, BabyleoTN500 is an incubator.Neonates are kept warmin the patientcompartment withhumidifiable air, whichcan be enriched withoxygen (option). As anopen care unit, BabyleoTN500 is a radiantwarmer. Babyleo TN500provides controlledambient conditions forpremature babies andneonates. The followingparameters areregulated, according tothe intended use:Temperature; Humidity;Oxygen (option)	temperaturecontrolledenvironment andwarmers provideinfrared heat in anopen environment.They may also beused for shortperiods of time tofacilitate theneonate'stransition from theuterus to theexternalenvironment.	treating twins islimited to 5 kg (11lbs). Caleo isintended for use inclinicalenvironmentswhere prematurebabies or infantsare treated whorequire a controlledclimaticenvironment.	neonatal andpediatric intensivecare units.
Operating noise
Operating noise volume inpatient compartment	Typically 40 dB(A)(Measured withoutoxygen application)	<49 dB(A)	47 $\pm$ 2 dB(A)	no closed patientcompartment	Similar
	BabyleoTN500	Omnibed(Giraffe)	Caleo	Babytherm8004/8010	Comments
Alarm Volume	50 to 70 dB(A)(according to IEC 60601-2-19 and IEC 60601-2-21)	according to IEC60601-2-19	according to IEC60601-2-19	Not provided	Similar
Power failure alarm	Yes (65 dB(A), 10 min)	Yes	Yes	Yes	Same
General	Radiant Warmer andNeonatal Incubator	Radiant Warmerand NeonatalIncubator	Neonatal Incubator	Radiant Warmer	Same
Warmer	Radiant Warmer	Radiant Warmer	NA (Incubator only)	Radiant Warmer	Same
Maximum Irradiance ofWarmer	32 mW/cm2 (at 100%power); 18 mW/cm2 (at60% power) 10 mW/cm2(at 30% Power)	Not provided	NA (Incubator only)	30 mW/cm2 (heatlevel 10); 10mW/cm2(heat level 3)	Same
Heater	Convective heater	Convective heater	Convective heater	NA (Radiant Warmeronly)	Same
Warm up time	15 to 20 min	< 50 min	20 min	NA (warmer only)	Similar
Humidification principle	Boiling of Aquadest(destilled water)	DrawoverEvaporator	Boiling of Aquadest	NA (warmer only)	Similar
Flow velocity over matresssurface	10 cm/s (3.94 in/s) (at36°C)	<10 cm/s	< 8 cm/s	NA (warmer only)	Same
Maximum Carbon Dioxide(CO2) concentration in theincubator measured inaccordance with IEC60601-2-19	<0.5 Vol%	0.2 %	<0.5 Vol%	max 0.5 Vol% (withbed canopy)	Same
	BabyleoTN500	Omnibed(Giraffe)	Caleo	Babytherm8004/8010	Comments
Electrical Description
Power supply	100 V to 240 V, 50/60 Hz	100V, 115V, 220V,230V, 240V, 50/60 Hz	100V, 110V, 120 V,127V, 220V to240V; 50 Hz / 60 Hz	100V, 110 - 127 V;220 - 240 V	Same
Maximum current / powerconsumption	10A / 1000W	not provided	8.7A / 732W	15A / 1750 W	Similar
Electrical safety	according to IEC 60601-1	according to IEC 60601-1	according to IEC 60601-1	according to IEC 60601-1	Same
Gas supply (option)
O2 operating pressure	270 to 600 kPa	not provided	300 and 600 kPa(43.5 and 87 psi).	NA (warmer only)	Similar
Measured value display
Radiant Warmer
Setting range	Off, 10 % to 100 %	0 to100 % in 5%INC	NA (Incubator only)	not provided	Same
Prewarm Mode	Yes	Yes	NA (Incubator only)	Yes	Same
Air temperatureregulation
Measurement regulation	13 to 45 °C (55.4 to 113 °F)	Not provided	13 to 42 °C (55.4 °F to 107.6 °F)	NA (warmer only)	Similar
Measurement uncertainty	$\pm$ 0.8°C (1.44 °F)	Not provided	$\pm$ 0.8°C (1.44 °F)	NA (warmer only)	Same
Air Mode temperaturesetting range	20 to 39 °C (68 to 102.2 °F) in 0.1 ° inc.	20 to 39 °C in 0.1 ° inc.	20 to 39 °C (68 to 102.2 °F)	NA (warmer only)	Same
Air Mode override	<28 °C (82.4 °F), afterconfirmation>37 °C (98.6 °F), afterconfirmation	Not provided	<28 °C (82.4 °F),after confirmation>37 °C (98.6 °F),after confirmation	NA (warmer only)	Same
	BabyleoTN500	Omnibed(Giraffe)	Caleo	Babytherm8004/8010	Comments
Skin Temperatureregulation
Measurement range	13 to 43 °C (55.4 to109.4 °F)	Not provided	NA (Incubator only)	15 °C to 42 °C	Similar
Temperature Sensor forSkin	Thermo Trace (Dräger)	Not provided	Thermo Trace(Dräger)	Thermo Trace(Dräger)	Same
Measurement uncertaintysensors	± 0.1ºC (0.18 °F)	Not provided	± 0.1ºC (0.18 °F)	± 0.1ºC (0.18 °F)	Same
Measurement uncertaintyentire system	± 0.3°C (0.54 °F)	± 0.3°C (0.54 °F)	± 0.3°C (0.54 °F)	± 0.3°C (0.54 °F)	Same
Skin temperature Modesetting range	34 to 38 °C (93.2 to100.4 °F) in 0.1 °C	35 to 37.5 °C in 0.1°C	34 to 38 °C (93.2to 100.4 °F)	not provided	Same
Skin temperature Modeoverride	>37 °C (98.6 °F), afterconfirmation	Not provided	>37 °C (98.6 °F),after confirmation	not provided	Same
Heated mattress (Option)
Setting range	Off, 35°C to 39°C, AUTO	Not provided	NA	Off, 30°C to 38.5°C	Similar
Oxygen regulation(Option)
measurement range	Normal range: 18 to 65Vol %Extended range: 66 to99 Vol%	Not provided	Normal range: 18to 65 Vol %Extended range:66 to 99 Vol%	NA (warmer only)	Same
Measurement uncertainty	± 2.5 Vol% (+ 2.5 % ofmeasured value)	5%	± 3 Vol%	NA (warmer only)	Same
Setting range	21 to 65 Vol%(>40 Vol%, afterconfirmation)	21 to 65%	21 to 75 Vol%	NA (warmer only)	Same
02 rise time from 21 to 65Vol%	<10 min	10 minutes from21% to 5% belowset point	Not provided	NA (warmer only)	Same
Oxygen Cylinder Holder	Yes	Yes	Yes	NA (warmer only)	Same
	BabyleoTN500	Omnibed(Giraffe)	Caleo	Babytherm8004/8010	Comments
Humidity SystemDescription
Measurement range	Normal range: 30 to 99% r. H.Extended range: 10 to29 % r. H.	up to 85%	set point range: 30to 99 % r. H.measure range: 10to 99 % r. H.	NA (warmer only)	Same
Measurement uncertainty	±10 %	±10 %	±10 %	NA (warmer only)	Same
Setting Range	Off, 30 to 99 % r. H. insteps of 1 %, AUTO	30 to 95% in 5%increments	Off, 30 to 99 % r.H. in steps of 1 %,AUTO	NA (warmer only)	Same
Noise and lightmeasurement(Developmental carepackage Option)	Yes	No	No	No	Different
Noise Measurement range	40 to 90 dB(A)	not available	not available	not available	Different
Light Measurement range	3 to 999 Lux (1 to 93 fc)	not available	not available	not available	Different
AutoThermo package(Option)	Yes	No	No	No	Different
Data exchange andinterfaces	Serial Port (COM,RS232), USB (USB 1.1or USB 2.0); Service port(RJ45 / LAN)	ThermaLink Serialdata interface(RS232);	Serial Port (COM,RS232), Serviceport (RJ45 / LAN)	Serial Port (COM,RS232), Service port(RJ45 / LAN)	Same
Physical Description
Weight (without optionsand accessories)	<140 kg	138 kg	130 kg (max. 230kg)	133 kg	Similar
Width & Depth	690 mm x 1154 mm(27.17 in x 45.43 in)	690 mm x 1120mm	687 mm x 1167mm	750 mm x 1315 mm	Similar
Height (with hood closed)	1850 mm to 2250 mm(72.83 in to 88.58 in)(height adjustmentrange: 400 mm)	1470 mm to 1770mm (heightadjustment range:300 mm)	1220 mm to 1520mm	1896 mm to 2210mm	Similar
	BabyleoTN500	Omnibed(Giraffe)	Caleo	Babytherm8004/8010	Comments
Height of the mattresssurface	700 to 1100 mm (27.56in to 43.31 in)	Not provided	800 mm to 1100mm	885 mm to 1180 mm	Similar
Mattress	450 mm x 690 mm(17.72 in x 27.17 in)	Not provided	500 mm x 645 mm	490 mm x 750 mm	Similar
Material (no implants)
Material used for indirectpatient contact	Metal (e.g. Aluminium)Synthetic material (e.g.TPE)	Unknown	Metal (e.g. Aluminium)Synthetic material(e.g. TPE)	Metal (e.g. Aluminium)Synthetic material(e.g. TPE)	Similar
Material used for directpatient contact	Textile (VowalonMedilind)	Unknown	Textile(Polyurethane)	Textile(Polyurethane)	Similar
Biocompatibility	according to ISO 10993	according to ISO10993	according to ISO10993	according to ISO10993	Same
Sterilization	N/A; non sterile	N/A; non sterile	N/A; non sterile	N/A; non sterile	Same
Scale Description
Range	200 g to 10 kg	300 g to 8 kg	250 g to 10 kg	250 g to 8 kg	Similar
Resolution	5 g (OIML)) or 1 g(standard version)	10 g or 5 g	1 g or 5 g (OIML)	1 g or 10 g (OIML)	Similar
Integrated X-ray cassette/ tray	Yes	Yes	Yes	Yes	Same
Drawer (Option)	Yes	Yes	Yes	Yes	Same
Bed-tilt mechanism(Trendelenburg)	Continuous up to 13°	12° mechanical tilt	Up to 13° (± tiltangle)	15 to 20°	Similar
EnviromentalDescription duringoperation
Ambient operatingtemperature	20 to 35 °C (68 to 95°F)	20 to 30 °C	20 to 25 °C	15 to 35 °C	Similar
Operating barometricrange	620 to 1100 hPa (9.0 to16.0 psi)	Not provided	600 to 1060 hPa	900 hPa to 1060 hPa	Similar
BabyleoTN500	Omnibed(Giraffe)	Caleo	Babytherm8004/8010	Comments
Humidity operating range	20 to 95 %, non-condensing	10 to 95% noncondensating	10 to 95%, non.-condensating	0 to 75 %, nocondensation	Similar
EnviromentalDescription duringstorage	Temperature - 20 to 60°C (to 4 to 140 °F)Ambient pressure 500 to1100 hPa (7.3 to 16.0psi)Relative humidity 10 to95 %, non-condensing	Temperature - 25to 60°CHumidity 0 to 95%Non-condensingrelative humidityPressure 50 to 106kPa	Temperature - 20to 60 °C (- 4 to 140°F)Ambient pressure210 - 1060 hPaRelative humidity10 - 95 %, non-condensing	Temperature - 20 to60 °C (- 4 to 140 °F)Ambient pressure700 - 1060 hPaRelative humidity 0 -90 %, non-condensing	Similar

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Image /page/9/Picture/1 description: The image shows the word "Dräger" in a bold, blue font. The "ä" in the word has two dots above it. The word is the logo for the Dräger company, which is a German company that makes medical and safety technology.

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Image /page/11/Picture/1 description: The image shows the word "Dräger" in a bold, blue font. The two dots above the "a" are also blue. The word is slightly slanted to the right.

Image /page/11/Picture/2 description: The image shows the word "Dräger" in a bold, blue font. The "ä" in Dräger has two dots above it. The logo is simple and clean, with a focus on the company name.

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The Omnibed (Giraffe) is the predicate device for Babyleo TN500. Both devices are operated as an infant radiant warmer.

The Caleo is a reference device for Babyleo TN500. Both devices are operated as a neonatal incubator.

The Babytherm 8004/8010 is a reference device for Babyleo TN500. Both devices are operated as an infant radiant warmer.

Differences:

The noise and light measurement and audio stimulation are new optional features to enable further developmental care activities in the nicu.

The Auto Thermo Package is a new optional feature cooling, warm up and weaning to ease processes in the NICU. The indications for use of the Babyleo TN500 and the predicate device are equivalent.

The differences do not raise questions about the safety or effectiveness for the subject device.

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Summary of Testing

The following performance data were provided:

Electrical safety and electromagnetic compatibility (EMC), incl. performance testing

Electrical safety and EMC testing were conducted on the Babyleo TN500. The device complies with the IEC 60601-1, IEC 60601-2-19, IEC 60601-2-21 and IEC 60601-2-35 standards for safety and performance and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."2005. The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

Biocompatibility testing

The biocompatibility evaluation for the Babyleo TN500 was conducted in accordance with the FDA guidance on Biocompatibility on the International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,', and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

Integral Test for volatile organic compounds Photogenic bacteria test Emission of particles Material characterization according to ISO 10993-18 Toxicological Evaluation according to ISO 10993-17 Cytotoxicity Irritation Sensitization

Human Factor

The usability evaluation for the Babyleo TN500 device was conducted in accordance with the FDA guidance: Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff, 2016.

Reprocessing

The reprocessing validation for the Babyleo TN500 device was conducted in accordance with the FDA guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Guidance for Industry and Food and Drug Administration Staff, 2015

Animal Study

No animal study have been conducted.

Clinical Studies

No Clinical testing has been done.

Conclusion:

Based on device comparison information and non-clinical bench testing data, the proposed device is substantially equivalent to legally marketed predicate device K010222.

Regulation Number and Section

§ 880.5400 Neonatal incubator.

(a)
Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.(b)
Classification. Class II (performance standards).