(57 days)
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.
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.
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.
§ 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.