(186 days)
Babytherm 8004 / 8010 is an infant warmer system intended as a therapeutic device providing warmth for premature and full-term neonates and infants with a weight up to 16 lbs. It is intended for use in delivery rooms, operating theatres, maternity and obstetric units, neonatal wards, neonatal and paediatric intensive care units. Both Systems can be equipped with the optional phototherapy system for treatment of Hyperbilirubinemia.
Babytherm 8004 / 8010 is a warmer system for infants that provides a combination of a heated mattress (Babytherm 8010, only), a radiant heater and an optional phototherapy system. The radiant heater is in a fixed position over the mattress and is equipped with an examination light. The phototherapy system can be installed by the manufacturer or by the biomedical engineer in the housing of the radiant heater. Babytherm 8004 provides warmth by a radiant heater in "manual mode" or with "skin temperature control". Babytherm 8010 provides warmth by a radiant heater in "manual mode" or with "skin temperature control". The Babytherm 8010 also has a heated gel mattress for conductive warmth.
This document is a 510(k) Pre-market Notification for the Dräger Babytherm 8004 / 8010 infant warmer system. The document claims substantial equivalence to several predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document presents a "Table of Comparison" which implicitly serves as the acceptance criteria by comparing the new device (Dräger Babytherm 8004 / 8010) against predicate devices (Babytherm 8000 WB, Radiant Heater RH 600, PT4000, and Microlite™). The "reported device performance" for the Dräger Babytherm 8004 / 8010 is listed within this table.
| Feature / Acceptance Criteria | Dräger Babytherm 8004 / 8010 Reported Performance | Equivalent Predicate Device | Notes/Differences |
|---|---|---|---|
| Intended Use | Infant warmer system providing warmth for premature and full-term neonates and infants up to 16 lbs. Use in delivery rooms, neonatal wards, NICUs. Optional phototherapy for Hyperbilirubinemia. | Babytherm 8000 WB, Radiant Heater RH 600, PT4000, Microlite™ | Combines functions of multiple predicate devices. |
| Physical Size | |||
| Height (mm) | 1820 to 2385 with height adjustment | Babytherm 8000 WB (1220 to 1515) | New device is taller. |
| Length (mm) | 1315 | Babytherm 8000 WB (1070) | New device is longer. |
| Width (mm) | Like Babytherm 8000 WB (750) | Babytherm 8000 WB (750) | Same. |
| Weight | 135 kg max | Babytherm 8000 WB (85 kg max) | New device is heavier. |
| Mattress Size (mm) | Like Babytherm 8000 WB (750 x 490) | Babytherm 8000 WB (750 x 490) | Same. |
| Bassinet Tilt | Like Babytherm 8000 WB (± 10° from horizontal) | Babytherm 8000 WB (± 10° from horizontal) | Same. |
| Case Material | Like Babytherm 8000 WB (PS-TSG) | Babytherm 8000 WB (PS-TSG) | Same. |
| Case Color | Like Babytherm 8000 WB (blue) | Babytherm 8000 WB (blue) | Same. |
| Power Input | |||
| Voltage | Like Babytherm 8000 WB (120 VAC, 60 Hz) | Babytherm 8000 WB (120 VAC, 60 Hz) | Same. |
| Total Power (W) | 670 W (8004) / 790 W (8010) + 120 W (height adjust) + 440 W (Phototherapy) | Babytherm 8000 WB (135 W + 560 W height adjust), RH 600 (735 W), PT4000 (120 W), Microlite™ (300 W) | Higher total power due to combined functionality. |
| Fuses | 2 x 15 A | Babytherm 8000 WB (2 x 1.6 A / 2 x 6.3 A), RH 600 (2 x 6.3 A), PT4000 (2 x 1.6 A), Microlite™ (2 x 4 A) | Higher fuse rating, likely due to increased power draw. |
| Leakage Current | 3, and heater output is reduced to level 2. | RH 600 (Actuates after 15 minutes in manual mode with level > 5) | Alarm condition modified based on IEC 601-2-21 requirements (trigger at >10 mW/cm²). |
| Visible Alarm | Yes | Babytherm 8000 WB, RH 600 | Same. |
| Audible Alarm | Yes | Babytherm 8000 WB, RH 600 | Same. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices. It does not describe a clinical study with a test set, sample size, or data provenance in the way a clinical trial report would. The "testing" referred to is against international standards, not a specific patient cohort for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. As this is not a study involving human interpretation or diagnostic accuracy, there is no "ground truth" established by experts in this context. The document relies on engineering specifications and adherence to international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no test set or human adjudication described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a medical apparatus (infant warmer), not a diagnostic or AI-powered system that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" in this context is the adherence to established international safety and performance standards (like IEC 601-2-21) and the functional specifications of predicate devices.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device.
Summary of the Study and Device Performance:
The "study" described in the 510(k) summary is not a traditional clinical trial but rather an engineering and regulatory comparison. The Dräger Babytherm 8004 / 8010 device demonstrates its "acceptance criteria" and "performance" by:
- Claiming Substantial Equivalence: The primary method is to show that the new device is substantially equivalent in intended use, technological characteristics, safety, and effectiveness to several legally marketed predicate devices.
- Meeting International Standards: The document explicitly states that the Babytherm 8004 / 8010 "fulfill at least the same international standards as the predicate devices of Dräger and has been tested according to these standards" (e.g., IEC 601-2-21). This adherence to standards is the basis for demonstrating safety and effectiveness.
- Detailed Comparison Table: The provided "Table of Comparison" outlines various technical specifications and features, highlighting similarities and differences with predicate devices. Where differences exist (e.g., increased height, improved irradiance, wider temperature range, enhanced safety features), the document often explains these as "improved performance" or modifications to meet current standards.
In essence, the "study" is a regulatory submission that leverages an engineering comparison and compliance with established medical device standards to argue for the device's safety and effectiveness. It does not involve patient data collection or clinical outcomes in the manner of a clinical trial.
§ 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.