The Babyroo TN300 is an open care radiant warmer that provides a controlled source of heat and regulation of skin temperature for neonates and infants. The optional integrated resuscitation module provides emergency respiratory support administered by clinicians and includes the functionality of suction. Additionally, the device provides weighing (optional) of neonates and infants. The device is designed for use with a body weight up to 10 kg (22 lb).

The device is indicated for thermoregulation, skin temperature regulation, weighing (optional), and resuscitation (optional) of neonates and infants.

Device Description

The Babyroo TN300 is an open care infant radiant warmer that provides controlled source heat and skin temperature display for use with neonates and infants. The device can be configured for either labor and delivery or the newborn intensive care unit (NICU) and can be used for intra hospital transfer. Warming therapy is interrupted during intra hospital transfer and patient is not supplied with heat.

The Babyroo TN300 device is offered with a fixed height or adjustable height trolley configuration and provides two heat sources for infant warming: a radiant warmer and an optional heating plate with conductive gel mattress. The device's bed can be tilted up to 15° in Trendelenburg and reverse Trendelenburg directions and the design of the device is intended to facilitate uniform heat distribution over the entire mattress surface across the range of bed tilt angulation. An optional removable canopy is available for intra-hospital transfer.

Infant warming is facilitated via three (3) available thermoregulation modes:

Manual mode
Skin temperature mode
Kangaroo mode

The Babyroo TN300 is available with an optional Resuscitation module. The optional Resuscitation module is pneumatic powered, can be connected to central gas supplies or gas cylinders and provides emergency resuscitation and suction to the patient. The optional Resuscitation module includes adjustment for gas flow, peak inspiratory pressure, O2 concentration, and suction functionality and is available in three (3) variants:

Resuscitation module with gas mixer and AutoBreath®.
Resuscitation module with gas mixer.
Resuscitation with O2 only.

The optional AutoBreath® function facilitates pneumatically-driven, automatic respiratory rate and positive end-expiratory pressure control.

The Babyroo TN300 can be configured to include an optional integrated electronic scale, as well as, optional heated gel mattress, optional integrated single or dual storage drawers, optional gas cylinder holders, and optional x-ray tray.

The Babyroo TN300 device has an expected service life of 10 years.

AI/ML Overview

The provided text is a 510(k) summary for the Dräger Babyroo TN300 infant radiant warmer. It details the device's indications for use, its comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding reported device performance values in a single, clear format as typically expected for specific performance metrics (e.g., a specific temperature range, with a specific accuracy requirement, and the measured accuracy).

Instead, the "7. Substantial Equivalence Comparison and Discussion" section (pages 6-7) serves as the de-facto presentation of performance characteristics and how they compare to the predicate device. For the characteristics where the proposed device differs, the "Comment" column often implies the acceptance criteria (i.e., that the performance meets safety and effectiveness requirements, even if different from the predicate).

Here's a partial reconstruction of a table based on the provided comparison, focusing on performance-related aspects and inferring acceptance criteria where possible:

Performance Characteristic	Acceptance Criteria (Inferred/Stated)	Reported Device Performance (Babyroo TN300)	Study that Proves Acceptance (Implied from text)
Body Weight Indication	Up to 10 kg (22 lb)	Up to 10 kg (22 lb)	Stated as identical to predicate, and established in contraindications.
Irradiance (30% power)	10 mW/cm²	10 mW/cm²	Implied successful non-clinical performance testing against this specified value.
Irradiance (60% power)	Not specified for predicate, accepted for proposed device.	18 mW/cm²	Implied successful non-clinical performance testing.
Irradiance (100% power)	Not specified for predicate, accepted for proposed device.	32 mW/cm²	Implied successful non-clinical performance testing.
Pre-warm Procedure	Same power sequence (100%, 60%, 30%) as predicate, with specified durations and alarms.	100% for 3 min ("Pre"), 60% for 11.5 min ("Pre"), 30% ("30") until clinician sets value. Alarms at 14 min and shut off at 15 min if above 30%.	Implied successful non-clinical performance testing.
Skin Temperature Mode	Set value control in 0.1 °C (0.1 °F) steps, range 34°C to 37°C, extended 37.1°C to 38°C.	Same as predicate.	Implied successful non-clinical performance testing.
Kangaroo Warming Mode	Adequate warming by parent's body heat, device maintains 30% radiant warmer power, continuous patient temperature monitoring.	Patient warmed by parent's body heat; device switches to manual mode with 30% radiant warmer power; continuous patient temperature monitoring.	Verification of requirements relating to Kangaroo mode included in support of substantial equivalence (i.e., non-clinical performance testing).
Skin Temperature Measurement Range	Inclusive of predicate (18°C to 43°C).	13°C to 43°C (55.4°F to 109.4°F)	Implied successful non-clinical performance testing.
Skin Temperature Measurement Accuracy	Comparable safety and effectiveness to predicate's ± 0.2°C display accuracy.	Overall Accuracy: ± 0.3°C (0.54°F)	Verification testing included in support of substantial equivalence (i.e., non-clinical performance testing).
Skin Temperature Display Resolution	0.1°	0.1°	Implied successful non-clinical performance testing.
Primary Patient Outlet Adjustable Airway Pressure Limit	Does not exceed predicate (50 cmH2O), typical < 30 cm H2O, allows for 30-40 cm H2O for spontaneous ventilation.	0 cmH2O to 40 cmH2O	Implied successful non-clinical performance testing against safety and effectiveness.
Primary Patient Outlet Fixed Airway Pressure Limit	50 cmH2O ± 10%	50 cmH2O ± 10%	Implied successful non-clinical performance testing.
Primary Patient Outlet Flow Control Range	0 L/min to 15 L/min	0 L/min to 15 L/min	Implied successful non-clinical performance testing.
Auxiliary Supply Pressure Limit	Does not exceed predicate (160 cmH2O).	75 cmH2O ± 10%	Implied successful non-clinical performance testing against safety and effectiveness.
Blender Module Adjustable O2 Concentration	21% to 100%	21% to 100%	Implied successful non-clinical performance testing.
I:E Ratio (AutoBreath®)	Non-adjustable, fixed internally at 1:2 nominal (1:1.6 to 1:2.4)	Non-adjustable, fixed internally at 1:2 nominal (1:1.6 to 1:2.4)	Implied successful non-clinical performance testing.
Adjustable PEEP (AutoBreath®)	< 2 cmH2O (at 5 L/min), ≤ 4 cmH2O (at 10 L/min), > 14 cmH2O (at 15 L/min)	Same as predicate.	Implied successful non-clinical performance testing.
Suction Circuit Adjustable Suction Pressure	0 kPa to 20 kPa (0 mmHg to 150 mmHg)	0 kPa to 20 kPa (0 mmHg to 150 mmHg)	Implied successful non-clinical performance testing.
Suction Circuit Maximum Flow Rate	< 20 L/min	< 20 L/min	Implied successful non-clinical performance testing.
AutoThermo SW Package	Safety and effectiveness not affected, requirements verified.	Allows "Tolerate cooling" and "warm-up" functions.	Verification of requirements relating to AutoThermo function included in support of substantial equivalence (non-clinical performance testing).
Bed-tilt	Safety and effectiveness maintained up to 15° for continuous tilt.	Continuous ± 15° from horizontal. Tactile detents at 0° and ± 10°.	Testing included to verify requirements of the bed-tilt specifications of the proposed device (non-clinical performance testing).

Study that Proves Acceptance Criteria:

The primary study proving the device meets the acceptance criteria is non-clinical performance testing conducted according to recognized international consensus standards. The document explicitly states:

"The subject Babyroo TN300 was tested in accordance with applicable standards, guidance, and internal design requirements, including performance testing, functional/operation testing, biocompatibility, human factors, risk analysis and verification of risk control measures. Testing included accessories and optional components. The results of the non-clinical performance testing support substantial equivalence." (Page 12)
"The performance test data were provided to support substantial equivalence included:" followed by a list of IEC and ISO standards (pages 12-13).

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

The document details non-clinical performance testing. For non-clinical (laboratory/bench) testing of medical devices, the "sample size" typically refers to the number of devices or components tested. The document does not specify the sample size (number of devices/components) used for the non-clinical performance tests.

Data Provenance: This is non-clinical performance testing, so there is no patient data provenance information like country of origin or retrospective/prospective status. The testing was conducted internally or by testing facilities on physical devices/components.

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

This information is not applicable as the studies were non-clinical performance tests. Ground truth in this context would be defined by the technical specifications and standards (e.g., a thermometer should read within X tolerance, a ventilator should deliver Y pressure). The "experts" would be the engineers and technicians conducting and verifying the tests against these established standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable as the studies were non-clinical performance tests. Adjudication methods like 2+1 are typically used in clinical studies for endpoint assessment or expert review of clinical images/data.

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

This information is not applicable. The Babyroo TN300 is an infant radiant warmer with optional resuscitation and weighing modules. It is a hardware device with software, but it does not involve "human readers" or AI assistance in interpreting diagnostic data, which is the context for MRMC studies.

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

This information is not applicable. The Babyroo TN300 is a physical medical device, not an image analysis algorithm or AI software for diagnosis that would have standalone performance. Its software controls the device functions.

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

For the non-clinical performance testing, the "ground truth" or acceptance criteria are defined by:

International Consensus Standards: A long list of IEC and ISO standards is provided (pages 5, 12-13), which set specific performance, safety, and essential performance requirements.
Internal Design Requirements: The document states testing was against "internal design requirements," meaning the manufacturer's own specifications for the device.
Predicate Device Performance: For characteristics where the proposed device is equivalent to the predicate, the predicate's established performance serves as a benchmark for equivalence.

8. The sample size for the training set

This information is not applicable. This is a hardware medical device with controlling software, not a machine learning model that requires a distinct "training set" of data. The software development process follows IEC 62304.

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

This information is not applicable as there is no "training set" in the context of this device. Ground truth for the device's functional performance refers to compliance with established engineering specifications and international standards, rather than labels on a dataset for machine learning.

Summary

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May 30, 2023

Draeger Medical Systems, Inc. Karl Nittinger Manager, Regulatory Affairs 3135 Quarry Road Telford, Pennsylvania 18969

Re: K230278

Trade/Device Name: Babyroo TN300 Regulation Number: 21 CFR 880.5130 Regulation Name: Infant Radiant Warmer Regulatory Class: Class II Product Code: FMT Dated: April 28, 2023 Received: April 28, 2023

Dear Karl Nittinger:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting

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combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Walloschek

David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230278

Device Name Babyroo TN300

Indications for Use (Describe)

The device is indicated for thermoregulation, skin temperature regulation, weighing (optional), and resuscitation (optional) of neonates and infants.

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

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

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Image /page/3/Picture/0 description: The image shows the word "Dräger" in a bold, blue font. The "ä" in Dräger 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 products.

510(k) Summary K230278

1. Submitter:	Draeger Medical Systems, Inc.3135 Quarry RoadTelford, PA 18951
	Contact Person:	Karl NittingerManager, Regulatory AffairsE-Mail: karl.nittinger@draeger.comTelephone: (267) 272-1913
	Date prepared:	30 May 2023
2.	Device:	Trade Name:Common Name:Classification Name:Regulation Number:Product Code:Class:	Babyroo TN300Infant Radiant WarmerInfant Radiant Warmer21 CFR §880.5130FMTII

3. Predicate Devices

The predicate device that has been identified relating to the substantial equivalence of the Babyroo TN300 device are:

Predicate Devices:

Predicate Device	510(k)	Manufacturer
Resuscitaire® withAutoBreath®	K120642	Draeger Medical Systems,Inc.

The following reference device is utilized in support of substantial equivalence.

Reference Device	510(k)	Manufacturer
Babyleo TN500	K182859	Drägerwerk AG & Co. KGaA

4. Device Description

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Infant warming is facilitated via three (3) available thermoregulation modes:

Manual mode
· Skin temperature mode
Kangaroo mode

In manual mode, the warmer power is set manually by the clinician. Supply of heat from the radiant warmer at power settings above 30% are limited by the device to predefined time intervals.

In skin temperature mode, the temperature is regulated by means of a temperature setting determined by the clinician and skin temperature sensors applied to the infant patient.

In kangaroo mode, warming is provided by the infant's body heat. The infant's temperature must be monitored continuously during kangaroo mode.

· Resuscitation module with gas mixer and AutoBreath®.
· Resuscitation module with gas mixer.
Resuscitation with O2 only.

The optional AutoBreath® function facilitates pneumatically-driven, automatic respiratory rate and positive end-expiratory pressure control.

The Babyroo TN300 device has an expected service life of 10 years. The expected service life is an attribute related to the conformity requirements of international standard: IEC 60601-1 and is defined as the time period during which the device is expected to remain suitable for its intended use and in which all risk control measures need to remain effective. Maintenance, inspection, and service intervals required to ensure the proper functioning of the device within its expected service life are defined in the instructions for use.

5. Indications for Use

The device is indicated for thermoregulation, skin temperature regulation, weighing (optional), and resuscitation (optional) of neonates and infants.

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List of Consensus Standards 6.

Standard Number and Version	Title
IEC 60601-1:2005/A1:2012/COR1:2014	Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and EssentialPerformance
IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: General requirements for basic safety and essentialperformance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-6: 2010/A1:2013	Medical electrical equipment - Part 1-6: General requirements for basic safety and essentialperformance - Collateral standard: Usability
IEC 62366-1:2015 COR 1 2016	Medical devices - Part 1: Application of usability engineering to medical devices
IEC 60601-1-8:2006/A1:2012	Medical Electrical Equipment, Part 1-8: General Requirements for Basic Safety and Essential Performance –Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
IEC 62304:2006/A1:2015	Medical device software - Software life cycle processes
IEC 60601-2-21:2009/A1:2016	Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essentialperformance of infant radiant warmers
IEC 80601-2-35:2009/A1:2016	Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essentialperformance of heating devices using blankets, pads and mattresses and intended for heating inmedical use
ISO 10079-3:2014	Medical suction equipment — Part 3: Suction equipment powered from a vacuum or pressure gas source
IEC 10651-5:2006	Lung ventilators for medical use - Particular requirements for basic safety and essentialperformance - Part 5: Gas-powered emergency resuscitators
ISO 18562-1:2017-03	Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation andtesting within a risk management Process
ISO 10993-1:2018	Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 17664:2017	Sterilization of medical devices – Information to be provided by the manufacturer for the processing ofresterilizable medical devices

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7. Substantial Equivalence Comparison and Discussion

	Predicate Device	Proposed Device	Comment
	Resuscitaire® with AutoBreath(K120642)	Babyroo TN300
Regulation	880.5130	880.5130	Same - The proposed device and
Product Code	FMT	FMT	the predicate device (K120642) areClass II devices regulated under
Classification	II	II	880.5130 (product code: FMT).
Indications for Use	The Resuscitaire® Radiant Warmeris intended for thermoregulation,skin temperature monitoring,APGAR timing and resuscitation ofnewly born infants up to 10 kg. It isnot for long term resuscitation orhome use.	The Babyroo TN300 is an opencare radiant warmer that provides acontrolled source of heat andregulation of skin temperature forneonates and infants. The optionalintegrated resuscitation moduleprovides emergency respiratorysupport administered by cliniciansand includes the functionality ofsuction. Additionally, the deviceprovides weighing (optional) ofneonates and infants. The device isdesigned for use with patients witha body weight up to 10 kg (22 lb).The device is indicated forthermoregulation, skin temperatureregulation, weighing (optional), andresuscitation (optional) of neonatesand infants.	Same - The proposed device andthe predicate device are bothprimarily intended for use for thethermoregulation of infant patientswith the inclusion of resuscitation(optional in both cases). The weighlimitation (10 kg) for the proposeddevice, is identical to the primarypredicate device (K120642) and isestablished in the proposed devicecontraindications. While not statedin the cleared indications, weighingfunctionality in the predicate device(K120642) and APGAR timing in thproposed device are present.
Contraindications	The Resuscitaire Radiant Warmeris not intended for home use orlong-term resuscitation.	The device is contraindicated forpatients with a body weight above 10kg (22 lb). The device is not intendedfor use outside of the specifiedenvironments ofuse.
	Predicate Device	Proposed Device	Comment
	Resuscitaire® with AutoBreath(K120642)	Babyroo TN300
Environment of Use	For use in any location within a healthcare facility where labor and deliverymay occur.	For use in labor and delivery units,neonatal intensive care units,operating rooms, and during intra-hospital transfer where some of thefunctions described in the intendeduse description are not available.	Same - The intended environmentsof use for the predicate device(K120642) is inclusive of those forthe proposed device.
Fundamental principle ofoperation	Controller-based, open care radiantwarmer that facilitatesthermoregulation and emergencyresuscitation of infants.	Controller-based, open care radiantwarmer that facilitatesthermoregulation and emergencyresuscitation of infants.	Same - The fundamental principle ofoperation of the proposed device isthe same as that of the primarypredicate device (K120642).
Irradiance	30% power - 10 mW/cm²	30% power - 10 mW/cm²60% power - 18 mW/cm²100% power - 32 mW/cm²	Same – The proposed devicefeatures the same irradiance at 30%power as the predicate device(K120642).
Pre-warm Procedure	PowerDuration1. 100%3 min.2. 60%12 min.3. 30%*Until clinician sets a value.	PowerDurationDisplay1. 100%3 min."Pre"2. 60%11.5 min."Pre"3. 30%"30"Until clinician sets a value.	Same - The proposed deviceincorporates the same powersequence during pre-warm as thepredicate device (K120642).
Warming Therapy Modes	- Skin temperature mode- Manual mode	- Skin temperature mode- Manual mode- Kangaroo mode	Different - The warming therapymodes offered in the predicate device(K120642) include skin temperaturemode and manual mode. Kangaroomode is not present in the predicatedevice (K120642). However, theunderlying questions of safety andeffectiveness are not affected as bothdevice have warming features and theverification of requirements relating toKangaroo mode in the proposedBabyroo TN300 device is included insupport of substantial equivalence.
Skin Temperature Mode	Temperature control by set valuefor the skin temperature.	Temperature control by set value forthe skin temperature.	Same - The skin temperaturemode in the proposed device is
	The temperature can be set insteps of 0.1 °C (0.1 °F).	The temperature can be set in stepsof 0.1 °C (0.1 °F).	identical to that of the predicatedevice (K120642).
	Temperature Range Settings:34°C to 37°C (93.2°F to 98.6°F)	Temperature Range Settings:34°C to 37°C (93.2°F to 98.6°F)
	Extended range: 37.1°C to 38°C(98.7°F to 100.4°F)	Extended range: 37.1°C to 38°C(98.7°F to 100.4°F)
	Predicate Device	Proposed Device	Comment
	Resuscitaire® with AutoBreath(K120642)	Babyroo TN300
Manual warming mode	Radiant warmer power is setmanually.After the user sets the radiantwarmer power, a timer starts:– After 10 minutes the "Checkpatient" alarm is displayed.– After 15 minutes, the radiantwarmer is switched off.	Radiant warmer power is set manually.If the user sets the radiant warmerpower above 30 %, a timer starts andthe following alarms are displayed afterpredefined time intervals:– After 14 minutes the "Check patient'scondition" alarm is displayed.– After 15 minutes, the radiant warmeris switched off and the "Warmer off,check patient's condition alarm" isdisplayed.	Same - The manual warming modespecification in the predicate device (K120642)is inclusive of that of the proposed device.
Kangaroo warming mode	N/A	The patient is warmed by the parent'sbody heat instead of the device. Oncekangaroo mode has been activated, thedevice is maintained in manual modewith 30 % of the radiant warmer power.During kangarooing, the patient'stemperature is monitored continuously.	Different - The proposed device incorporateskangaroo warming mode, which is not presentin the predicate device (K120642). While thepredicate device (K120642) does notincorporate Kangaroo mode, the underlyingquestions of safety and effectiveness are notaffected as both devices have warmingfeatures and the verification of requirementsrelating to Kangaroo mode in the proposedBabyroo TN300 device is included in supportof substantial equivalence.
Skin temperaturemeasuring range	18°C to 43°C (64.4° F to 109.4° F)	13°C to 43°C (55.4° F to 109.4° F)	Different - The skin temperaturemeasurement range of the proposed deviceis inclusive of that of the predicate device(K120642).
Skin TemperatureMeasurement Accuracy	Display Accuracy: ± 0.2°C	Overall Accuracy: ± 0.3° C (0.54° F)	Different - The skin temperaturemeasurement display accuracy of theproposed device is slightly different than thepredicate device (K120642) Verificationtesting included in support of substantialequivalence demonstrates that underlyingquestions of safety and effectiveness arenot affected .
Skin TemperatureDisplay	0.1°	0.1°	Same - The skin temperature displayresolution of the proposed device is thesame as that of the predicate device(K120642).
	Predicate Device	Proposed Device	Comment
	Resuscitaire® with AutoBreath(K120642)	Babyroo TN300
Primary patient outletadjustable airway pressurelimit	0 cmH2O to 50 cmH2O	0 cmH2O to 40 cmH2O	Different -The maximum airway pressure ofthe proposed device does not exceed that ofthe predicate device (K120642). Typical airwaypressures are administered at < 30 cm H2O. Insome cases, >30 to 40 cm H2O may berequired for patients without spontaneousventilation. As recommended by the AmericanAcademy of Pediatrics (AAP)1
Primary patient outlet fixedairway pressure limit	50 cmH2O ± 10%	50 cmH2O ± 10%	Same - The proposed device's primary patientoutlet fixed airway pressure limit is identical tothat of the predicate device (K120642).
Primary Patient Outlet FlowControl Range	0 L/min. to 15 L/min.	0 L/min. to 15 L/min.	Same - The proposed device's primary patientoutlet Flow Control Range is identical to that ofthe predicate device (K120642).
Auxiliary Supply PressureLimit	160 cmH2O ± 10%	75 cmH2O ± 10%	Different -The maximum auxiliary supplypressure limit of the proposed device doesnot exceed the predicate device (K120642).Typical airway pressures are administered at< 30 cm H₂O. In some cases. ≥30 to 40 cmH2O may be required for patients withoutspontaneous ventilation. As recommended bythe American Academy of Pediatrics (AAP)1
Blender Module AdjustableO2 Concentration	21 % to 100 %	21 % to 100 %	Same - The proposed device's adjustableO2 concentration range identical to that ofthe predicate device (K120642).
Operating principle	Gas powered, continuous flow,time cycled breaths per minute,pneumatically driven logic circuit.	Gas powered, continuous flow,time cycled breaths per minute,pneumatically driven logic circuit	Same - The proposed device's optionalAutoBreath® functionality is identical to thatof the predicate device (K120642).
I:E Ratio	Non-adjustable. Fixed internallyat 1:2 nominal (1:1.6 to 1:2.4)	Non-adjustable. Fixed internally at1:2 nominal (1:1.6 to 1:2.4)	Same - The proposed device's I:E ratio forits AutoBreath® functionality is identical tothat of the predicate device (K120642).
	Predicate Device	Proposed Device	Comment
	Resuscitaire® with AutoBreath(K120642)	Babyroo TN300
Adjustable PEEP	< 2 cmH2O (at 5 L/min)≤ 4 cmH2O (at 10 L/min)> 14 cmH2O (at 15 L/min)	< 2 cmH2O (at 5 L/min)≤ 4 cmH2O (at 10 L/min)> 14 cmH2O (at 15 L/min)	Same - The proposed device's adjustable PEEPcharacteristics for its AutoBreath® functionality isidentical to that of the predicate device(K120642).
Suction Circuit AdjustableSuction Pressure	0 kPa to 20 kPa (0 mmHg to 150mmHg)	0 kPa to 20 kPa (0 mmHg to 150mmHg)	Same - The proposed device provides the samesuction pressure range as the predicate device(K120642).
Suction Circuit MaximumFlow Rate	< 20 L/min.	< 20 L/min.	Same - The proposed device provides the samesuction maximum flow rate as the predicatedevice (K120642).
AutoThermo SW Packageoption.	N/A	Allows the use of "Tolerate cooling" and"warm-up" functions.	Different - The proposed device incorporatesoptional AutoThermo functions, which are notpresent in the predicate device (K120642).While the predicate device (K120642) doesnot incorporate these features, the underlyingquestions of safety and effectiveness are notaffected as both device have warming featuresand the verification of requirements relating tothe AutoThermo function in the proposedBabyroo TN300 device is included in supportof substantial equivalence.
Tolerate cooling function	N/A	The device switches to manual modewith switched off radiant warmer.Although all heat sources are switchedoff, the skin temperature is stillmonitored continuously.
Warm-up function	N/A	The patient can be warmed in smallsteps. When warm-up is activated, thedevice switches to skin temperaturemode.The device is operated with the skintemperature settings from thepreviously set mode.
APGAR Timer Function	Tone is emitted after one minute,after 5 minutes, and 10 minutes.- Timer counts up to 59:59minutes.	Tone is emitted after one minute.after 5 minutes, and 10 minutes.Timer counts up to 99:59 minutes.	Same - The proposed device, as well as thepredicate device (K120642) features an APGARtimer function.
	Predicate Device	Proposed Device	Comment
Bed-tilt	Resuscitaire® with AutoBreath(K120642)	Babyroo TN300
	$\pm$ 10° from horizontal	Continuous $\pm$ 15° from horizontal.Tactile detents at 0° and $\pm$ 10°.	Different – The proposed device, as well as thepredicate device (K120642) include bed-tiltcapability. Testing is included to verify therequirements of the bed-tilt specifications of theproposed device and the results supportsubstantial equivalence.
Height adjustment	Available in fixed and variableheight versions.	Available in fixed and variable heightversions.	Same – The proposed, as well as the predicatedevice (K120642) feature versions withadjustable height or include integral heightadjustment.
External Interfaces	COM port: serial interface forspecialized service functions.	Nurse call interfaceUSB interface: Connection of massstorage media for importing / exporting ofdevice configurations.Service port: RJ45 interface forspecialized service functions.	Different – The proposed device and predicatedevice (K120642) incorporate external interfaces.Differences in the specific interfaces areaddresses with the inclusion of relevantverification testing and analysis in support ofsubstantial equivalence.

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Dräger

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Dräger

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Dräger

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¹PEDIATRICS Volume 126 Number 5, November 2010

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Image /page/12/Picture/0 description: The image shows the logo for Dräger, a German company that manufactures medical and safety technology products. The logo is in blue and features the company's name in a bold, sans-serif font. The two dots above the 'a' in Dräger are a distinctive feature of the logo. The logo is simple and recognizable, and it is often used on the company's products and marketing materials.

8. Substantial Equivalence Discussion

The subject Babyroo TN300 device has the same intended use as the primary predicate Resuscitaire® with AutoBreath® (K120642). Under regulation 21 CFR 880.5130, both the subject Babyroo TN300 and the predicate device (K120642) are infant warmers intended for the thermoregulation and skin temperature monitoring of infant patients. Both the subject device and the predicate device (K120642) are open care radiant warming devices.

In addition to the thermoregulation of infants, the subject Babyroo TN300 and the predicate devices (K120642) include indications for resuscitation. Both devices include optional resuscitation modules to provide emergency respiratory support administered by the clinician to newborns. Both the subject and predicate (K120642) devices offer the Draeger AutoBreath® functionality in their resuscitation modules. The AutoBreath® functionality automates the resuscitation process by allowing the clinician to set the respiratory rate which is time-cycled by the pneumatically driven logic circuit.

With reference to the July. 2014 Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], the Babyleo TN500 device (K182859) is included as a reference device in support of the substantial equivalence of the subject Babyroo TN300. Specifically, the reference device (K182859) is utilized to support the previously demonstrated substantial equivalence of technological features in the subject device that are not present in the primary predicate device (K120642). The reference device is utilized to leverage the test methods for these new features.

As summarized in the "Non-clinical Performance Testing" section of this 510(k) Summary, testing according to the requirements of FDA-recognized consensus standards was conducted on the subject device and included in this premarket notification. The tests were conducted to confirm that the specific design of the subject device relating to its essential performance meets the requirements of the consensus FDA-recognized standards. The results of the testing demonstrated that the subject device conforms to the requirements of the standards and support substantial equivalence.

9. Non-clinical Performance Testing

The subject Babyroo TN300 was tested in accordance with applicable standards, quidance, and internal design requirements, including performance testing, functional/operation testing, biocompatibility, human factors, risk analysis and verification of risk control measures. Testing included accessories and optional components. The results of the non-clinical performance testing support substantial equivalence.

The performance test data were provided to support substantial equivalence included:

IEC 60601-1:2005/A1:2012/ COR1:2014: Medical Electrical Equipment, Part ● 1: General Requirements for Basic Safety and Essential Performance
. IEC 60601-1-2:2014: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromaqnetic disturbances - Requirements and tests
. IEC 60601-1-6: 2010/A1:2013: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
. IEC 62366-1:2015 COR 1 2016: Medical devices - Part 1: Application of usability engineering to medical devices
. Human Factors Testing: With reference to February, 2016, Guidance for Industry and Food and Drug Administration Staff: Applving Human Factors and Usability Engineering to Medical Devices

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IEC 62304:2006/A1:2015: Medical device software Software life cycle ● processes
Software Documentation: With reference to November, 2021, Draft Guidance for Industry and Food and Drug Administration Staff: Content of Premarket Submissions for Device Software Functions
. Software Documentation: According to September, 2019, Guidance for Industry and Food and Drug Administration Staff: Off-The-Shelf Software Use in Medical Devices
. Software Documentation: With reference to April, 2022, Draft Guidance for Industry and Food and Drug Administration Staff: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
. IEC 60601-2-21:2009/A1:2016: Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
IEC 80601-2-35:2009/A1:2016: Medical electrical equipment Part 2-35: ● Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
. IEC 10651-5:2006: Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
. ISO 10079-3:2014: Medical suction equipment -- Part 3: Suction equipment powered from a vacuum or pressure gas source
ISO 10993-1:2018: Biological evaluation of medical devices -- Part 1: ● Evaluation and testing within a risk management process
ISO 18562-1:2017-03: Biocompatibility evaluation of breathing gas . pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
ISO 17664:2017: Sterilization of medical devices Information to be . provided by the manufacturer for the processing of resterilizable medical devices

10. Clinical Performance Testing

No human clinical data are included in support of substantial equivalence.

11. Conclusion Regarding Substantial Equivalence

The information included in this premarket notification supports the substantial equivalence of the subject Babyroo TN300. As requlated under 21 CFR 880.5130, the subject device has the identical intended use as the legally marketed primary predicate device cleared under premarket notification K120642. While the proposed indications for use for the subject device are not identical to the primary predicate device (K120642), conformity assessment test data are included to support the conformity of the differences.

Performance and software data are included in this premarket notification to demonstrate that the subject Babyroo TN300 device meets its design, functional, and safety

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requirements. The results of the testing included in this premarket notification, in conjunction with the comparison to the fundamental intended use and fundamental technology of the subject device to that of the primary predicate device (K120642) support a determination of substantial equivalence.

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.