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) and pulse oximetry (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), pulse oximetry (optional), and resuscitation (optional) of neonates and infants.

Device Description

The purpose of this premarket notification is to activate, for the US market, existing optional functionality which enables the display of SpO2 information by the subject Babyroo TN300 via its graphical user interface (GUI). The SpO2 display functionality is facilitated through connection with existing, cleared pulse oximetry accessories which generate the SpO2 information that is displayed on the subject Babyroo TN300 GUI.

As originally cleared under K230278:
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 thermorequlation modes:

Manual mode
Skin temperature mode
Kangaroo mode

The Babyroo TN300 is available with an optional Resuscitation module. The optional Resuscitation module is pneumatically 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a modification to the Babyroo TN300 infant warmer device. The modification involves activating existing optional software functionality to display SpO2 information generated by existing, cleared pulse oximetry accessories. The core device functions for warming, resuscitation, and weighing remain unchanged from the predicate device (K230278).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: The submission focuses on demonstrating substantial equivalence for the new functionality (SpO2 display and associated alarms) by relying on existing clearances of the core device and the OEM pulse oximetry accessories, in conjunction with specific non-clinical verification testing of the integrated system. No new clinical studies were performed.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a modification (enabling SpO2 display), the acceptance criteria primarily revolve around demonstrating that the new functionality performs as expected and does not introduce new safety or effectiveness concerns, especially concerning the integration with existing, cleared pulse oximetry technology. The performance is assessed by confirming conformity to relevant standards and effective data transfer.

Acceptance Criterion (for SpO2 display functionality)	Reported Device Performance (as per document)
Conformity to ISO 80601-2-61:2017 (Medical electrical equipment -Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment)	"Verification testing with respect to conformity to ISO 80601-2-61:2017 is included." and "Verification testing is included to demonstrate conformity of the subject device - in combination with the cleared OEM pulse oximetry accessories - to the FDA-recognized consensus standard relating to pulse oximetry."
Effective Transfer of Pulse Oximetry Data (from OEM accessories to device display)	"Verification testing that confirms the effective transfer of the data generated by the OEM pulse oximetry devices is included in this premarket notification in support of substantial equivalence." and "OEM integration testing demonstrating the integrity of the SpO2 information generated by the cleared accessories and displayed by the subject Babyroo TN300 device is included."
SpO2 Alarms Functionality (Upper/Lower SpO2, Desaturation, Pulse Rate)	The device "Facilitates the setting of SpO2 alarms for: - Upper limit for SpO2 - Lower limit for SpO2 - Lower alarm limit for desaturation - Upper alarm limit for pulse rate - Lower alarm limit for pulse rate." (Performance is implicitly accepted through the successful completion of ISO 80601-2-61:2017 conformity and data transfer testing, as these alarm functions are integral to pulse oximetry equipment.)
Cybersecurity of External Interfaces (including SpO2 interface)	"Cybersecurity assessment of external interfaces, including the SpO2 interface, is included in support of substantial equivalence." and "Software Documentation: With reference to September, 2023, Guidance for Industry and Food and Drug Administration Staff: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions."
Overall Safety and Performance of the Modified Device	"The subject Babyroo TN300 was tested in accordance with applicable standards, guidance, and internal design requirements, including performance testing and functional/operation testing. Testing included the cleared OEM accessories that are relevant to the modification that is the subject of this premarket notification. The results of the non-clinical performance testing support substantial equivalence." This broadly covers the device's continued safe operation with the new feature integrated.

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

The document explicitly states: "No human clinical data are included in support of substantial equivalence." This means there isn't a "test set" in the traditional sense of patient data.

The testing relied on non-clinical performance testing:

Sample Size: Not numerical. The testing involved the Babyroo TN300 device itself, presumably one or more units, integrated with the specific OEM Masimo SET® pulse oximetry accessories. The "sample" here refers to the actual device and integrated components under test in a laboratory/engineering setting.
Data Provenance: The data comes from laboratory/engineering testing performed by the manufacturer (Draeger Medical Systems, Inc.). It is implicitly prospective in the sense that the testing was conducted specifically for this 510(k) submission to demonstrate the safety and effectiveness of the new functionality. No geographic origin for the test data is specified, but it would typically be conducted at the manufacturer's R&D facilities.

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

Since no human clinical data or expert evaluations of images/readings were used for the test set (as this is a device modification for display of existing, cleared parameters), there were:

Number of Experts: N/A.
Qualifications of Experts: N/A.

The acceptance criteria were demonstrated through objective non-clinical performance testing against recognized standards (e.g., ISO 80601-2-61) and internal verification activities. The "ground truth" for the SpO2 display functionality would be the accurate and reliable transmission and display of the SpO2 and pulse rate data generated by the cleared OEM pulse oximetry accessories themselves, as validated in the OEM integration testing.

4. Adjudication Method for the Test Set

Adjudication Method: N/A. As no human interpretation of data (e.g., images, vital signs patterns) was involved in a "test set" requiring ground truth establishment through expert consensus or adjudication, this is not applicable. The performance was verified through direct measurements and compliance with technical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No. The document explicitly states: "No human clinical data are included in support of substantial equivalence." This type of study is typically performed to evaluate diagnostic accuracy or human performance with AI assistance, neither of which is the primary focus of this specific device modification (which is display of a physiological parameter).
Effect Size of Human Readers Improvement with AI vs Without AI Assistance: N/A, as no MRMC study was conducted.

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

Standalone Study: Yes, in a practical sense, the "OEM Integration Validation" is a form of standalone testing. This is described as validating "the effective transfer of pulse oximetry signals generated by a clinical simulator through the cleared OEM Masimo SET® pulse oximetry technology board to the subject Babyroo TN300 device's display." This tests the algorithm's ability (within the Babyroo TN300's software) to receive, process, and display the SpO2 data accurately from the source. The "algorithm" here isn't a complex diagnostic AI but rather the software logic for data handling and display.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for validating the SpO2 display functionality was the known, simulated pulse oximetry signals generated by a "clinical simulator" and then interpreted by the already cleared OEM Masimo SET® pulse oximetry technology board. The test ensured that the Babyroo TN300 accurately displayed what the cleared OEM technology was reporting. Essentially, the ground truth was the output of the "cleared OEM Masimo SET® pulse oximetry technology," and the new device's display was compared directly to that expected output.

8. The Sample Size for the Training Set

Training Set Sample Size: N/A. This device modification does not involve a machine learning or AI algorithm that requires a "training set" in the traditional sense. The software functionality being activated is to display existing, cleared data.

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

Ground Truth for Training Set: N/A, as no training set was used.

Summary

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January 17, 2025

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

Re: K243606

Trade/Device Name: Babyroo TN300 Regulation Number: 21 CFR 880.5130 Regulation Name: Infant Radiant Warmer Regulatory Class: Class II Product Code: FMT Dated: November 21, 2024 Received: November 21, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Porsche Bennett

Porsche Bennett For 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) K243606

Device Name Babyroo TN300

Indications for Use (Describe)

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

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 K243606

1. Submitter:	Draeger Medical Systems, Inc.3135 Quarry RoadTelford, PA 18969
Contact Person:	Karl NittingerSenior Manager, Regulatory AffairsE-Mail: karl.nittinger@draeger.comTelephone: 267-272-1913
Date prepared:	17 January 2025
2. Device:
	Trade Name:	Babyroo TN300
	Classification Name:	Warmer, Infant Radiant
	Regulation Number:	21 CFR §880.5130
	Product Code:	FMT
	Class:	II

3. Predicate Devices

The purpose of this premarket notification is the modification of the subject Babyroo TN300 infant warmer device, which was originally cleared under K230278. The modification consists of the activation, for the US market, of existing optional software functionality to facilitate the subject Babyroo TN300 device's display of SpO2 information that is generated by existing, cleared, pulse oximetry accessories.

The predicate device that is utilized in this premarket notification to support substantial equivalence is:

Primary Predicate Device	510(k)	Manufacturer
Babyroo TN300	K230278	Draeger Medical Systems,Inc.

4. Device Description

The existing, cleared pulse oximetry technology accessories identified for use with the subject Babyroo TN300 device to facilitate its display of SpQ2 information are:

Draeger Infinity MCable® Masimo SET®: Provides connection interface between . the subject Babyroo TN300 and OEM Masimo SpO2 sensors. Contains the cleared OEM Masimo SET® pulse oximetry technology.
Masimo RD SET OEM neonatal SpO₂ sensors ●
Masimo LNCS Y-I OEM neonatal SpO₂sensors ●
Masimo LNCS OEM neonatal SpO2 sensors ●

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As subject to the modification in this premarket notification, in addition to the display of SpO2 information by the Babyroo TN300, the clinician user can also set SpO2 alarm limits via the subject device's GUI.

There are no other modifications under the scope of this premarket notification to the subject Babyroo TN300 device compared to its original clearance under K230278.

As originally cleared under K230278:

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.

Infant warming is facilitated via three (3) available thermorequlation 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 requlated 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.

The Babyroo TN300 is available with an optional Resuscitation module. The optional Resuscitation module is pneumatically 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, Q2 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 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.

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5. Indications for Use

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

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6. Substantial Equivalence Comparison and Discussion

	Subject Device	Predicate Device	Comment
	Babyroo TN300(K243606)	Babyroo TN300(K230278)
Regulation	880.5130	880.5130	Same - The subject, device and the predicatedevice (K230278) are Class II devices regulatedunder 880.5130 (product code: FMT).
Product Code	FMT	FMT
Classification	Class II	Class II
Indications for Use	The Babyroo TN300 is an open care radiant warmerthat provides a controlled source of heat and regulationof skin temperature for neonates and infants. Theoptional integrated resuscitation module providesemergency respiratory support administered byclinicians and includes the functionality of suction.Additionally, the device provides weighing (optional)and pulse oximetry (optional) of neonates andinfants. The device is designed for use with patientswith a body weight up to 10 kg (22 lb).The device is indicated for thermoregulation, skintemperature regulation, weighing (optional), pulseoximetry (optional), and resuscitation (optional) ofneonates and infants.	The Babyroo TN300 is an open care radiantwarmer that provides a controlled source of heatand regulation of skin temperature for neonatesand infants. The optional integrated resuscitationmodule provides emergency respiratory supportadministered by clinicians and includes thefunctionality of suction. Additionally, the deviceprovides weighing ( optional) of neonates andinfants. The device is designed for use withpatients with a body weight up to 10 kg (22 lb).The device is indicated for thermoregulation, skintemperature regulation, weighing (optional), andresuscitation (optional) of neonates and infants.	Different - The subject, device and thepredicate device (K230278) are both primarilyintended for use for the thermoregulation ofinfant and neonate patients with the inclusion ofoptional resuscitation and weighing. The weightlimitation (10 kg) for the subject, device isidentical to the predicate device (K230278) andis established in the contraindications of bothdevices.The only difference in the indications for use ofthe subject, device and the predicate device(K230278) is the addition of optional pulseoximetry in the proposed indications for use ofthe subject device.
Contraindications	The device is contraindicated for patients with a bodyweight above 10 kg (22 lb).The device is notintended for use outside of the specifiedenvironments of use.	The device is contraindicated for patients with abody weight above 10 kg (22 lb).The device is notintended for use outside of the specifiedenvironments of use.	Same - The subject device and the predicatedevice are both contraindicated for patients witha body weight above 10 kg (22 lb) and for useoutside of the specified environments of use.
	Subject Device	Predicate Device	Comment
	Babyroo TN300(K243606)	Babyroo TN300(K230278)
System Specifications
Environment of Use	Intended for use in the followingenvironments:- Labor and delivery units- Pediatric intensive care units- Neonatal intensive care units- Operating rooms- During intrahospital patient transfer	Intended for use in the followingenvironments:- Labor and delivery units- Pediatric intensive care units- Neonatal intensive care units- Operating rooms- During intrahospital patient transfer	Same – The intended environments of use for thesubject device and the predicate device(K230278) are identical.
Fundamental principle ofoperation	Controller-based, open care radiant warmer thatfacilitates thermoregulation and emergencyresuscitation of infants.	Controller-based, open care radiant warmer thatfacilitates thermoregulation and emergencyresuscitation of infants.	Same – The fundamental principle of operation ofthe subject device is the identical to that of thepredicate device (K230278).
Radiant Warmer
Irradiance	30% power – 10 mW/cm²60% power – 18 mW/cm²100% power – 32 mW/cm²	30% power – 10 mW/cm²60% power – 18 mW/cm²100% power – 32 mW/cm²	Same – The subject Babyroo TN300 devicefeatures the same irradiance performance andspecifications as the predicate Babyroo TN300device (K230278).
Pre-warm Procedure	Power Duration Display1. 100% 3 min. "Pre"2. 60% 11.5 min. "Pre"3. 30% * "30"*Until clinician sets a value.	Power Duration Display1. 100% 3 min. "Pre"2. 60% 11.5 min. "Pre"3. 30% * "30"*Until clinician sets a value.	Same – The subject Babyroo TN300 deviceincorporates the same power sequence duringpre-warm as the predicate Babyroo TN300 device(K230278).
Warming Therapy Modes	- Skin temperature mode- Manual mode- Kangaroo mode	- Skin temperature mode- Manual mode- Kangaroo mode	Same – The warming therapy modes offered bythe subject Babyroo TN300 device are in thesame as the warming therapy modes offered bythe predicate Babyroo TN300 device (K230278).
Skin Temperature Mode	Temperature control by set value for the skintemperature.The temperature can be set in steps of 0.1 °C (0.1°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)	Temperature control by set value for the skintemperature.The temperature can be set in steps of 0.1 °C (0.1 °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)	Same – The skin temperature mode in the subjectBabyroo TN300 device is identical to that of thepredicate Babyroo TN300 device (K230278).
	Subject Device	Predicate Device	Comment
	Babyroo TN300(K243606)	Babyroo TN300(K230278)
System Specifications
Radiant Warmer (continued)
Manual warming mode	Radiant warmer power is set manually. If the user setsthe radiant warmer power above 30 %, a timer startsand the following alarms are displayed after predefinedtime intervals:- After 14 minutes the "Check patient's condition"alarm is displayed.	Radiant warmer power is set manually. If the user setsthe radiant warmer power above 30 %, a timer startsand the following alarms are displayed after predefinedtime intervals:- After 14 minutes the "Check patient's condition"alarm is displayed.	Same - The manual warming mode in thesubject Babyroo TN300 device is identical to thatof the predicate Babyroo TN300 device(K230278).
	- After 15 minutes, the radiant warmer is switched offand the "Warmer off, check patient's conditionalarm" is displayed.	- After 15 minutes, the radiant warmer is switched offand the "Warmer off, check patient's conditionalarm" is displayed.
Kangaroo warming mode	The patient is warmed by the parent's body heatinstead of the device. Once kangaroo mode has beenactivated, the device is maintained in manual modewith 30 % of the radiant warmer power.	The patient is warmed by the parent's body heatinstead of the device. Once kangaroo mode has beenactivated, the device is maintained in manual modewith 30 % of the radiant warmer power.	Same - The subject Babyroo TN300 deviceincorporates the identical kangaroo warmingmode as the predicate Babyroo TN300 device.
	During kangarooing, the patient's temperature ismonitored continuously.	During kangarooing, the patient's temperature ismonitored continuously.
Skin temperaturemeasuring range	13°C to 43°C (55.4° F to 109.4° F)	13°C to 43°C (55.4° F to 109.4° F)	Same - The skin temperature measurementrange of the subject Babyroo TN300 device isidentical to that of the predicate Babyroo TN300device (K230278).
Skin TemperatureMeasurement Accuracy	Overall Accuracy: ± 0.3° C (0.54° F)	Overall Accuracy: ± 0.3° C (0.54° F)	Same - The skin temperature measurementaccuracy of the subject Babyroo TN300 deviceis identical to that of the predicate BabyrooTN300 device (K230278).
Skin TemperatureDisplay	0.1°	0.1°	Same - The skin temperature display resolutionof the subject Babyroo TN300 device is theidentical to that of the predicate Babyroo TN300device (K230278).
	Subject Device	Predicate Device	Comment
	Babyroo TN300(K243606)	Babyroo TN300(K230278)
System Specifications
Resuscitation Module (option)
Primary patient outletadjustable airway pressurelimit	0 cmH2O to 40 cmH2O	0 cmH2O to 40 cmH2O	Same - The subject Babyroo TN300 deviceincorporates the same optional resuscitationmodule as the predicate Babyroo TN300 device(K230278).
Primary patient outlet fixedairway pressure limit	50 cmH2O ± 10%	50 cmH2O ± 10%
Primary Patient Outlet FlowControl Range	0 L/min. to 15 L/min.	0 L/min. to 15 L/min.
Auxiliary Supply PressureLimit	75 cmH2O ± 10%	75 cmH2O ± 10%
Blender Module AdjustableO2 Concentration	21 % to 100 %	21 % to 100 %
Resuscitation Module AutoBreath® function (option)
Operating principle	Gas powered, continuous flow, time cycled breathsper minute, pneumatically driven logic circuit.	Gas powered, continuous flow, time cycled breathsper minute, pneumatically driven logic circuit.	Same - The subject Babyroo TN300 deviceincorporates the same optional resuscitationmodule with AutoBreath® functionality as thepredicate Babyroo TN300 device (K230278).
I:E Ratio	Non-adjustable. Fixed internally at 1:2 nominal (1:1.6to 1:2.4).	Non-adjustable. Fixed internally at 1:2 nominal (1:1.6to 1:2.4).
	Subject Device	Predicate Device	Comment
	Babyroo TN300(K243606)	Babyroo TN300(K230278)
System Specifications
	Resuscitation module AutoBreath® function (continued)
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 subject Babyroo TN300 deviceincorporates the same optional resuscitationmodule with AutoBreath® functionality as thepredicate Babyroo TN300 device (K230278).
Suction (with optional Resuscitation Module)
Suction Circuit AdjustableSuction Pressure	0 kPa to 20 kPa (0 mmHg to 150 mmHg)	0 kPa to 20 kPa (0 mmHg to 150 mmHg)	Same – The subject Babyroo TN300 deviceincorporates the same optional resuscitationmodule with AutoBreath® functionality(including suction) as the predicate BabyrooTN300 device (K230278).
Suction Circuit MaximumFlow Rate	< 20 L/min.	< 20 L/min.
AutoThermo Package (option)
AutoThermo SW Packageoption.	Allows the use of “Tolerate cooling” and “warm-up”functions.	Allows the use of “Tolerate cooling” and “warm-up”functions.
Tolerate cooling function	The device switches to manual mode with switchedoff radiant warmer.Although all heat sources are switched off, the skintemperature is still monitored continuously.	The device switches to manual mode with switchedoff radiant warmer.Although all heat sources are switched off, the skintemperature is still monitored continuously.	Same - The AutoThermo SW package option inthe subject Babyroo TN300 device is the sameoptional feature as that of the predicate BabyrooTN300 device (K230278).
Warm-up function	The patient can be warmed in small steps. Whenwarm-up is activated, the device switches to skintemperature mode.The device is operated with the skin temperaturesettings from the previously set mode.	The patient can be warmed in small steps. Whenwarm-up is activated, the device switches to skintemperature mode.The device is operated with the skin temperaturesettings from the previously set mode.

APGAR Timer
APGAR Timer Function	– Tone is emitted after one minute, after 5 minutes,and 10 minutes.– Timer counts up to 99:59 minutes.	– Tone is emitted after one minute, after 5 minutes,and 10 minutes.– Timer counts up to 99:59 minutes.	Same – The subject Babyroo TN300 device andthe predicate Babyroo TN300 device (K230278)incorporate the same APGAR timer functionality.

	Subject Device	Predicate Device	Comment
	Babyroo TN300(K243606)	Babyroo TN300(K230278)
System Specifications
SpO2 Display (option)
Display of PulseOximetry Data	Facilitates the display of pulse oximetryinformation via connection to the existing,cleared Draeger Infinity Mcable SET®connection interface (which contains existing,cleared OEM Masimo SET® pulse oximetrytechnology board) and existing, cleared OEMMasimo SpO2 sensors.	N/A	Different – The subject of this premarketnotification is the modification of the BabyrooTN300 device, originally cleared in K230278, toenable functionality in the US market for thedisplay of pulse oximetry information through theconnection of the subject device with existing,cleared OEM pulse oximetry accessories.
SpO2 Alarms	Facilitates the setting of SpO2 alarms for:- Upper limit for SpO2- Lower limit for SpO2- Lower alarm limit for desaturation- Upper alarm limit for pulse rate- Lower alarm limit for pulse rate	N/A	In support of substantial equivalence, verificationtesting with respect to conformity to ISO 80601-2-61:2017 is included.In addition, verification testing that confirms theeffective transfer of the data generated by theOEM pulse oximetry devices is included in thispremarket notification in support of substantialequivalence.
Physical Attributes
Bed-tilt	Continuous ± 15° from horizontal.Tactile detents at 0° and ± 10°.	Continuous ± 15° from horizontal.Tactile detents at 0° and ± 10°.	Same – The subject Babyroo TN300 device andthe predicate Babyroo TN300 device (K230278)incorporate the same patient bassinet assemblyand the same bed-tilt functionality.
Height adjustment	Available in fixed and variable height versions.	Available in fixed and variable height versions.	Same – The subject Babyroo TN300 device andthe predicate Babyroo TN300 device (K230278)incorporate the same patient fixed and variableheight features.

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System SpecificationsExternal Interfaces	Subject DeviceBabyroo TN300(K243606)	Predicate DeviceBabyroo TN300(K230278)	Comment
External Interfaces	OEM SpO2 connection interface.	N/A	Different -The subject device features theSpO2 connection interface to facilitateconnection with the existing, cleared OEM pulseoximetry accessory.As described in the "SpO2 Display" section ofthis comparison table, verification testing withrespect to conformity to ISO 80601-2-61:2017 aswell as verification testing that confirms theeffective transfer of the data generated by theOEM pulse oximetry devices is included in thispremarket notification in support of substantialequivalence.In addition, cybersecurity assessment ofexternal interfaces, including the SpO2 interface,is included in support of substantial equivalence.
	USB interface: Connection for mass storage mediafor importing / exporting of device configurations.	USB interface: Connection for mass storage media forimporting / exporting of device configurations.	Same - The subject Babyroo TN300 device andthe predicate Babyroo TN300 device (K230278)feature the same USB storage interface, RJ45service port interface, and nurse call interface.
	Service port: RJ45 interface for specialized servicefunctions.	Service port: RJ45 interface for specialized servicefunctions.
	Nurse call interface	Nurse call interface

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Image /page/14/Picture/0 description: The image shows the word "Dräger" in blue. The font is bold and sans-serif. The two dots above the "a" are also blue. The word is likely a logo for the Dräger company, which is a German company that makes medical and safety technology.

7. Substantial Equivalence Discussion

The subject Babyroo TN300 device has the same intended use as the predicate Babyroo TN300 (K230278) device. Under requlation 21 CFR 880.5130, both the subject Babyroo TN300 and the predicate Babyroo TN300 (K230278) device are infant radiant warmers intended for the thermoregulation and skin temperature monitoring of infant patients. Both the subject device and the predicate device (K230278) are open care radiant warming devices.

In addition to the thermoregulation of infants, the subject Babyroo TN300 and the predicate Babyroo TN300 device (K230278) include indications for optional resuscitation. Both devices include the same optional resuscitation module to provide emergency respiratory support administered by the clinician to newborns.

The subject Babyroo TN300 incorporates the identical radiant heating element as that of the Babyroo TN300 predicate device (K230278). The radiant power (irradiance) specifications and warming modes remain in the subject device as compared to predicate device (K230278).

With the exception of the enabling of existing functionality to display SpO2 information generated by existing, cleared OEM pulse oximetry accessories, all other features and functionality in the subject Babyroo TN300 device are identical to the predicate Babyroo TN300 device (K230278).

The sole modification and only difference between the subject Babyroo TN300 device and the predicate Babyroo TN300 device (K230278) that is introduced in the scope of this premarket notification is the enabling of the SpO2 display functionality.

Verification testing conducted on the subject Babyroo TN300 device has been included in support of substantial equivalence.

8. Non-clinical Performance Testing

The subject Babyroo TN300 was tested in accordance with applicable standards, guidance, and internal design requirements, including performance testing and functional/operation testing. Testing included the cleared OEM accessories that are relevant to the modification that is the subject of this premarket notification. The results of the non-clinical performance testing support substantial equivalence.

The non-clinical performance testing and documentation included in support substantial equivalence consisted of:

Electromagnetic Compatibility: Conformity assessment according to ● IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
. Electrical, Thermal, and Mechanical Safety: Conformity assessment according to IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
Documentation: Developed according to processes Software conforming to IEC 62304: Medical device software - Software life cycle processes.
. Software Documentation: With reference to June, 2023, Guidance for Industry and Food and Drug Administration Staff: Content of Premarket Submissions for Device Software Functions.
. Software Documentation: With reference to August, 2023, Guidance for Industry and Food and Drug Administration Staff: Off-The-Shelf

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Software Use in Medical Devices

. Software Documentation: With reference to September, 2023. Guidance for Industry and Food and Drug Administration Staff: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
. ISO 80601-2-61:2017, COR1:2018: Medical electrical equipment -Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
OEM Integration Validation: Validation of the effective transfer of pulse oximetry . signals generated by a clinical simulator through the cleared OEM Masimo SET® pulse oximetry technology board to the subject Babyroo TN300 device's display.

9. Clinical Performance Testing

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

10. Conclusion Regarding Substantial Equivalence

The subject Babyroo TN300 infant radiant warmer device has been compared for the purpose of substantial equivalence to the predicate Babyroo TN300 device which was cleared under premarket notification K230278.

As open care, infant radiant warmers, the subject Babyroo TN300 device and the predicate Babyroo TN300 device (K230278) have the same intended use under requlation 21 CFR 880.5130 (Infant radiant warmer). Both the subject Babyroo TN300 and the predicate Babyroo TN300 device (K230278) are open-care infant radiant warmers intended for the thermoregulation and skin temperature monitoring of infant patients under product code: FMT (Warmer, Infant Radiant).

All warming therapy component designs and warming therapy modes are unmodified as subject to this premarket notification and remain identical to those of the predicate Babyroo TN300 device (K230278). Additionally, the optional integrated scale, heated plate with conductive gel mattress, and emergency resuscitation module features are unmodified in this premarket notification and are identical to the predicate device (K230278).

The indications for use for the subject Babyroo TN300 device are identical to the cleared indications for use of the predicate Babyroo TN300 device (K230278), with the exception of the addition optional pulse oximetry. The addition of the optional pulse oximetry indication is the result of the activation of an existing software feature which was disabled for the US market under the scope of the K230278 clearance.

In support of substantial equivalence, verification testing is included to demonstrate conformity of the subject device - in combination with the cleared OEM pulse oximetry accessories - to the FDA-recognized consensus standard relating to pulse oximetry. Additionally, OEM integration testing demonstrating the integrity of the SpO2 information generated by the cleared accessories and displayed by the subject Babyroo TN300 device is included. Software verification and cybersecurity documentation is also provided.

The results of the testing, with the comparison of the intended use, proposed indications for use, technology and features of the subject Babyroo TN300 device to the predicate Babyroo TN300 device (K230278), 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.