(165 days)
The Infa Warmer i is a radiant-warming open-type incubator for newborns and premature neonates. It is intended for pre-operative and post-operative intensive care in neonatal surgery, temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, etc. The Infa Warmer i is provided with the temperature control function to control the infant's skin temperature and optional functions include pulse oximetry and oxygen density controlling,
Infa Warmer i (Atom Infant Warmer Model 103) consists of a canopy, a warming heater (heater), a pole, a control panel, a mattress, a mattress platform, baby guards and a stand with casters. This product has 3 types (Type Name: HE, MS, ST) according to the following specification.
HE: (1)With mattress platform, stand can go up and down
MS: (2)With mattress platform, stand cannot go up and down
ST: (3)Without mattress platform
A warming heater is installed in the canopy.
Skin temperature sensors are connected to front panel of the pole.
This product has 2 types of function modes; one is "servo control model" (called as "skin temperature control mode") and another is manual control mode.
In "servo control mode", skin temperature can be set from 34°C to 38°C
In "bel to control mode", heater output of the warming heater can be set from 0 to 100% (in 5% increments).
When the product is functioned in "servo control mode", baby's skin temperature is monitored by temperature sensor attached on baby's body, and baby's skin temperature is controlled according to difference between monitored baby's skin temperature and set skin temperature.
When the product is functioned in "manual control mode", heater output of the warming heater is controlled manually according to measured baby's skin temperature. The mattress platform can be tilted.
The mattress platform can be tilted.
The skin temperature sensors and X-ray cassette tray
The skin temperature sensors and X-ray cassette tray are accessories.
The X-ray cassette tray is optional accessory, and it can be installed under the mattress platform. These accessories are available separately as replacements.
SpO2 module is component of this product, and it is optional whether they are attached initially or not. If it is not attached initially, it can be attached later, and SpO2/pulse monitoring can be available. The component can be supplied individually.
This product has a space inside the pole, and gas powered resuscitator or oxygen/air gas blender whose sizes are within the space, can be installed in the space, so that resuscitation or oxygen therapy can be done immediately for any new born baby who needs such the treatments. When the resuscitator or the blender is installed in this space, it is completely separated from this product, and it does not have any connections with this product regarding function, operation and power source. Therefore, this product operates normally without the resuscitator or the blender. Also, this product operates normally, even if the resuscitator or the blender is out of order.
The provided text is a 510(k) summary for a medical device, the Infa Warmer i (Atom Infant Warmer Model 103). It describes the device, its intended use, comparison to a predicate device, and the testing performed. However, it does not provide a detailed study that proves the device meets specific acceptance criteria in the format requested.
The document states that "tests based on IEC60601-1-2 and IEC60601-2-21 standards were carried out for Infa Warmer i, and it was verified that Infa Warmer i is met to requirements of IEC60601-1, IEC60601-1-2 and IEC60601-2-21." It also mentions "Biocompatibility was evaluated based on ISO10993-1" and "Validation has been conducted on the device software."
This indicates that the device met the requirements of these standards, which serve as the acceptance criteria for regulatory clearance. However, the document does not elaborate on:
- Specific performance metrics within those standards (e.g., what specific temperature accuracy was achieved, what EMC levels were passed, etc.).
- The detailed results of these tests.
- Sample sizes for performance testing (beyond the device itself for electrical and biocompatibility).
- Ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these are typically relevant for AI/imaging device evaluations, which this infant warmer is not.
Therefore, I can only extract a very high-level summary based on the provided text, and many of the requested fields cannot be filled.
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | Met requirements of IEC60601-1, IEC60601-1-2, IEC60601-2-21. |
| Biocompatibility | Evaluated based on ISO10993-1; materials are identical to 510(k)-cleared predicate device. Biological safety assured. |
| Software Validation | Validation has been conducted on the device software. |
Detailed Study Information (Based on available text)
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Sample size used for the test set and the data provenance:
- Test set size: Not specified in terms of patient data or clinical trials. The testing primarily involved the device itself for electrical, mechanical, and safety standards.
- Data provenance: Not applicable in the context of clinical data. The tests were performed on the device itself.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is an infant radiant warmer, and its performance testing focused on engineering standards, not interpretation of clinical data by experts.
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Adjudication method for the test set: Not applicable.
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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 is not an AI/imaging diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" here refers to the defined limits and requirements set by the international standards (IEC60601 series, ISO10993) for infant radiant warmers, electrical safety, and biocompatibility.
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The sample size for the training set: Not applicable. This device does not use machine learning or AI that requires a training set.
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How the ground truth for the training set was established: Not applicable.
§ 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.