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510(k) Data Aggregation
(118 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) of neonates and infants. The device is designed for use with a body weight up to 10 kg (22 lb).
The device is indicated for thermoregulation, skin temperature regulation, weighing (optional), and resuscitation (optional) of neonates and infants.
The Babyroo TN300 is an open care infant radiant warmer that provides controlled source heat and skin temperature display for use with neonates and infants. The device can be configured for either labor and delivery or the newborn intensive care unit (NICU) and can be used for intra hospital transfer. Warming therapy is interrupted during intra hospital transfer and patient is not supplied with heat.
The Babyroo TN300 device is offered with a fixed height or adjustable height trolley configuration and provides two heat sources for infant warming: a radiant warmer and an optional heating plate with conductive gel mattress. The device's bed can be tilted up to 15° in Trendelenburg and reverse Trendelenburg directions and the design of the device is intended to facilitate uniform heat distribution over the entire mattress surface across the range of bed tilt angulation. An optional removable canopy is available for intra-hospital transfer.
Infant warming is facilitated via three (3) available thermoregulation modes:
- Manual mode
- Skin temperature mode
- Kangaroo mode
The Babyroo TN300 is available with an optional Resuscitation module. The optional Resuscitation module is pneumatic powered, can be connected to central gas supplies or gas cylinders and provides emergency resuscitation and suction to the patient. The optional Resuscitation module includes adjustment for gas flow, peak inspiratory pressure, O2 concentration, and suction functionality and is available in three (3) variants:
- Resuscitation module with gas mixer and AutoBreath®.
- Resuscitation module with gas mixer.
- Resuscitation with O2 only.
The optional AutoBreath® function facilitates pneumatically-driven, automatic respiratory rate and positive end-expiratory pressure control.
The Babyroo TN300 can be configured to include an optional integrated electronic scale, as well as, optional heated gel mattress, optional integrated single or dual storage drawers, optional gas cylinder holders, and optional x-ray tray.
The Babyroo TN300 device has an expected service life of 10 years.
The provided text is a 510(k) summary for the Dräger Babyroo TN300 infant radiant warmer. It details the device's indications for use, its comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate substantial equivalence.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with corresponding reported device performance values in a single, clear format as typically expected for specific performance metrics (e.g., a specific temperature range, with a specific accuracy requirement, and the measured accuracy).
Instead, the "7. Substantial Equivalence Comparison and Discussion" section (pages 6-7) serves as the de-facto presentation of performance characteristics and how they compare to the predicate device. For the characteristics where the proposed device differs, the "Comment" column often implies the acceptance criteria (i.e., that the performance meets safety and effectiveness requirements, even if different from the predicate).
Here's a partial reconstruction of a table based on the provided comparison, focusing on performance-related aspects and inferring acceptance criteria where possible:
| Performance Characteristic | Acceptance Criteria (Inferred/Stated) | Reported Device Performance (Babyroo TN300) | Study that Proves Acceptance (Implied from text) |
|---|---|---|---|
| Body Weight Indication | Up to 10 kg (22 lb) | Up to 10 kg (22 lb) | Stated as identical to predicate, and established in contraindications. |
| Irradiance (30% power) | 10 mW/cm² | 10 mW/cm² | Implied successful non-clinical performance testing against this specified value. |
| Irradiance (60% power) | Not specified for predicate, accepted for proposed device. | 18 mW/cm² | Implied successful non-clinical performance testing. |
| Irradiance (100% power) | Not specified for predicate, accepted for proposed device. | 32 mW/cm² | Implied successful non-clinical performance testing. |
| Pre-warm Procedure | Same power sequence (100%, 60%, 30%) as predicate, with specified durations and alarms. | 100% for 3 min ("Pre"), 60% for 11.5 min ("Pre"), 30% ("30") until clinician sets value. Alarms at 14 min and shut off at 15 min if above 30%. | Implied successful non-clinical performance testing. |
| Skin Temperature Mode | Set value control in 0.1 °C (0.1 °F) steps, range 34°C to 37°C, extended 37.1°C to 38°C. | Same as predicate. | Implied successful non-clinical performance testing. |
| Kangaroo Warming Mode | Adequate warming by parent's body heat, device maintains 30% radiant warmer power, continuous patient temperature monitoring. | Patient warmed by parent's body heat; device switches to manual mode with 30% radiant warmer power; continuous patient temperature monitoring. | Verification of requirements relating to Kangaroo mode included in support of substantial equivalence (i.e., non-clinical performance testing). |
| Skin Temperature Measurement Range | Inclusive of predicate (18°C to 43°C). | 13°C to 43°C (55.4°F to 109.4°F) | Implied successful non-clinical performance testing. |
| Skin Temperature Measurement Accuracy | Comparable safety and effectiveness to predicate's ± 0.2°C display accuracy. | Overall Accuracy: ± 0.3°C (0.54°F) | Verification testing included in support of substantial equivalence (i.e., non-clinical performance testing). |
| Skin Temperature Display Resolution | 0.1° | 0.1° | Implied successful non-clinical performance testing. |
| Primary Patient Outlet Adjustable Airway Pressure Limit | Does not exceed predicate (50 cmH2O), typical 14 cmH2O (at 15 L/min) | Same as predicate. | Implied successful non-clinical performance testing. |
| Suction Circuit Adjustable Suction Pressure | 0 kPa to 20 kPa (0 mmHg to 150 mmHg) | 0 kPa to 20 kPa (0 mmHg to 150 mmHg) | Implied successful non-clinical performance testing. |
| Suction Circuit Maximum Flow Rate |
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