(57 days)
Not Found
No
The document describes standard medical device functionality (thermoregulation, resuscitation, weighing, pulse oximetry) and mentions standard regulatory testing and documentation. There is no mention of AI, ML, or related concepts like algorithms for prediction, classification, or image analysis. The "AutoBreath®" function is described as pneumatically driven, not AI/ML controlled.
Yes
The device acts as a therapeutic device as it provides thermoregulation via radiant heat and optional heating plate, and an optional resuscitation module for emergency respiratory support.
No
The device is primarily a radiant warmer for thermoregulation. While it has optional features like weighing and pulse oximetry, these are for monitoring physiological parameters, not for diagnosing a disease or condition. The "resuscitation module" provides emergency respiratory support, which is a treatment, not a diagnostic function.
No
The device is a radiant warmer with optional hardware components like a resuscitation module, weighing scale, and pulse oximetry. The 510(k) is for activating existing software functionality to display SpO2 data, but the core device is a hardware medical device.
Based on the provided text, the Babyroo TN300 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use/Indications for Use: The intended use and indications for use clearly describe the device's function as providing thermoregulation, skin temperature regulation, weighing, pulse oximetry, and resuscitation for neonates and infants. These are all functions performed on the patient's body or using measurements taken directly from the patient, not on samples of bodily fluids or tissues in vitro (outside the body).
- Device Description: The device description details features like radiant warming, heating plates, bed tilt, resuscitation modules, scales, and pulse oximetry display. None of these involve the analysis of biological samples.
- Lack of IVD Characteristics: The text does not mention any components or functions related to collecting, preparing, or analyzing biological samples (like blood, urine, tissue, etc.) for diagnostic purposes.
Therefore, the Babyroo TN300 is a medical device used for patient care and monitoring, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FMT
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.
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
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.
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
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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonates and infants
Intended User / Care Setting
Intended User: clinicians
Care Setting:
- Labor and delivery units
- Pediatric intensive care units
- Neonatal intensive care units
- Operating rooms
- During intrahospital patient transfer
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical performance testing
Sample Size: Not specified
Key Results: The 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.
Non-clinical performance testing and documentation included:
- 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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"
1
(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).
2
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
3
Indications for Use
510(k) Number (if known) K243606
Device Name Babyroo TN300
Indications for Use (Describe)
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.
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 Road
Telford, PA 18969 | |
|-----------------|-----------------------------------------------------------------------------------------------------------------------|------------------------|
| Contact Person: | Karl Nittinger
Senior Manager, Regulatory Affairs
E-Mail: karl.nittinger@draeger.com
Telephone: 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 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.
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.
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
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 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. 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 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 patients 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.
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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 predicate |
| device (K230278) are Class II devices regulated | |||
| under 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 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 patients | |||
| 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. | 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 | |||
| patients 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. | Different - The subject, device and the | ||
| predicate device (K230278) are both primarily | |||
| intended for use for the thermoregulation of | |||
| infant and neonate patients with the inclusion of | |||
| optional resuscitation and weighing. The weight | |||
| limitation (10 kg) for the subject, device is | |||
| identical to the predicate device (K230278) and | |||
| is established in the contraindications of both | |||
| devices. | |||
| The only difference in the indications for use of | |||
| the subject, device and the predicate device | |||
| (K230278) is the addition of optional pulse | |||
| oximetry in the proposed indications for use of | |||
| the subject device. | |||
| Contraindications | The device is contraindicated for patients with a body | ||
| weight above 10 kg (22 lb).The device is not | |||
| intended for use outside of the specified | |||
| environments of use. | The device is contraindicated for patients with a | ||
| body weight above 10 kg (22 lb).The device is not | |||
| intended for use outside of the specified | |||
| environments of use. | Same - The subject device and the predicate | ||
| device are both contraindicated for patients with | |||
| a body weight above 10 kg (22 lb) and for use | |||
| outside 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 following | ||
| environments: |
- Labor and delivery units
- Pediatric intensive care units
- Neonatal intensive care units
- Operating rooms
- During intrahospital patient transfer | Intended for use in the following
environments: - 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 the
subject device and the predicate device
(K230278) are identical. |
| Fundamental principle of
operation | Controller-based, open care radiant warmer that
facilitates thermoregulation and emergency
resuscitation of infants. | Controller-based, open care radiant warmer that
facilitates thermoregulation and emergency
resuscitation of infants. | Same – The fundamental principle of operation of
the subject device is the identical to that of the
predicate device (K230278). |
| Radiant Warmer | | | |
| Irradiance | 30% power – 10 mW/cm²
60% power – 18 mW/cm²
100% power – 32 mW/cm² | 30% power – 10 mW/cm²
60% power – 18 mW/cm²
100% power – 32 mW/cm² | Same – The subject Babyroo TN300 device
features the same irradiance performance and
specifications as the predicate Babyroo TN300
device (K230278). |
| Pre-warm Procedure | Power Duration Display
- 100% 3 min. "Pre"
- 60% 11.5 min. "Pre"
- 30% * "30"
*Until clinician sets a value. | Power Duration Display - 100% 3 min. "Pre"
- 60% 11.5 min. "Pre"
- 30% * "30"
*Until clinician sets a value. | Same – The subject Babyroo TN300 device
incorporates the same power sequence during
pre-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 by
the subject Babyroo TN300 device are in the
same as the warming therapy modes offered by
the predicate Babyroo TN300 device (K230278). |
| Skin Temperature Mode | Temperature control by set value for the skin
temperature.
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 skin
temperature.
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 subject
Babyroo TN300 device is identical to that of the
predicate 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 sets
the radiant warmer power above 30 %, a timer starts
and the following alarms are displayed after predefined
time intervals: - After 14 minutes the "Check patient's condition"
alarm is displayed. | Radiant warmer power is set manually. If the user sets
the radiant warmer power above 30 %, a timer starts
and the following alarms are displayed after predefined
time intervals: - After 14 minutes the "Check patient's condition"
alarm is displayed. | Same - The manual warming mode in the
subject Babyroo TN300 device is identical to that
of the predicate Babyroo TN300 device
(K230278). |
| | - After 15 minutes, the radiant warmer is switched off
and the "Warmer off, check patient's condition
alarm" is displayed. | - After 15 minutes, the radiant warmer is switched off
and the "Warmer off, check patient's condition
alarm" is displayed. | |
| Kangaroo warming mode | The patient is warmed by the parent's body heat
instead of the device. Once kangaroo mode has been
activated, the device is maintained in manual mode
with 30 % of the radiant warmer power. | The patient is warmed by the parent's body heat
instead of the device. Once kangaroo mode has been
activated, the device is maintained in manual mode
with 30 % of the radiant warmer power. | Same - The subject Babyroo TN300 device
incorporates the identical kangaroo warming
mode as the predicate Babyroo TN300 device. |
| | During kangarooing, the patient's temperature is
monitored continuously. | During kangarooing, the patient's temperature is
monitored continuously. | |
| Skin temperature
measuring 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 measurement
range of the subject Babyroo TN300 device is
identical to that of the predicate Babyroo TN300
device (K230278). |
| Skin Temperature
Measurement Accuracy | Overall Accuracy: ± 0.3° C (0.54° F) | Overall Accuracy: ± 0.3° C (0.54° F) | Same - The skin temperature measurement
accuracy of the subject Babyroo TN300 device
is identical to that of the predicate Babyroo
TN300 device (K230278). |
| Skin Temperature
Display | 0.1° | 0.1° | Same - The skin temperature display resolution
of the subject Babyroo TN300 device is the
identical to that of the predicate Babyroo TN300
device (K230278). |
| | Subject Device | Predicate Device | Comment |
| | Babyroo TN300
(K243606) | Babyroo TN300
(K230278) | |
| System Specifications | | | |
| Resuscitation Module (option) | | | |
| Primary patient outlet
adjustable airway pressure
limit | 0 cmH2O to 40 cmH2O | 0 cmH2O to 40 cmH2O | Same - The subject Babyroo TN300 device
incorporates the same optional resuscitation
module as the predicate Babyroo TN300 device
(K230278). |
| Primary patient outlet fixed
airway pressure limit | 50 cmH2O ± 10% | 50 cmH2O ± 10% | |
| Primary Patient Outlet Flow
Control Range | 0 L/min. to 15 L/min. | 0 L/min. to 15 L/min. | |
| Auxiliary Supply Pressure
Limit | 75 cmH2O ± 10% | 75 cmH2O ± 10% | |
| Blender Module Adjustable
O2 Concentration | 21 % to 100 % | 21 % to 100 % | |
| Resuscitation Module AutoBreath® function (option) | | | |
| 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 subject Babyroo TN300 device
incorporates the same optional resuscitation
module with AutoBreath® functionality as the
predicate Babyroo TN300 device (K230278). |
| I:E Ratio | 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). | |
| | Subject Device | Predicate Device | Comment |
| | Babyroo TN300
(K243606) | Babyroo TN300
(K230278) | |
| System Specifications | | | |
| | Resuscitation module AutoBreath® function (continued) | | |
| Adjustable PEEP | 14 cmH2O (at 15 L/min) | 14 cmH2O (at 15 L/min) | Same – The subject Babyroo TN300 device
incorporates the same optional resuscitation
module with AutoBreath® functionality as the
predicate Babyroo TN300 device (K230278). |
| Suction (with optional Resuscitation Module) | | | |
| 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) | Same – The subject Babyroo TN300 device
incorporates the same optional resuscitation
module with AutoBreath® functionality
(including suction) as the predicate Babyroo
TN300 device (K230278). |
| Suction Circuit Maximum
Flow Rate |