(148 days)
The Dual Incu i is a combination of an infant incubator and an infant warmer. The device can transition from one mode to the other on user's demand.
The Dual Incu i is an incubator for newborns and premature neonates. It is mainly intended for temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, and pre-operative and post-operative intensive care in neonatal surgery. This incubator is provided with a function to control the infant's skin temperature. Optional functions include pulse oximetry and oxygen density controlling.
Dual Incu i (Atom Infant Incubator Model 100) is a combination of an infant incubator and an infant warmer. This device consists of hood, a main body, a control panel and a warming heater (radiant warmer) and a stand with casters. A hood consists of a canopy and access doors (snapopen access port). An Oxygen sensor, a humidity sensor and a temperature sensor which monitor the air conditions inside the hood, are connected to the sensor module. A main body consists of a mattress, a mattress platform, a conditioning chamber, a humidity chamber. A control panel and skin temperature sensors are connected to the main body.
This device has a function that elevates the canopy. The device operates as an incubator when the canopy is closed, and the device operates as a radiant warmer when the canopy is opened. This product has 2 types of function modes; one is "servo control mode" (called as "skin temperature control mode" also) and another is "manual control mode".
When the device is operated as an incubator, skin temperature can be set from 34° to 38° (including override) in "servo control mode", and air temperature inside the hood can be set from 23 ° to 39 ° (including override) in "manual control mode".
When the device is operated as an infant warmer, skin temperature can be set from 34° to 38° (including override) also in "servo control mode", and heater output of the warming heater can be set from 0 to 100%(in 5% increments) in "manual control mode".
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.
In "manual control mode", air temperature inside the hood is monitored by temperature sensor of sensor module, and air temperature inside the hood is controlled according to difference between monitored air temperature inside the hood and set air temperature, when the device is operated as an incubator.
The mattress platform can be tilted. X-ray cassette tray is installed under the mattress platform. The device has 6 kinds of accessories: "Skin temperature sensor", "Oxygen sensor", "Piping hose for oxygen", "Electrostatics air filter", "Access port cover" and "Oxygen calibration tool", and these 6 accessories are available separately as replacements.
"SpO2 Module", "Oxygen Controller", "Weight Monitor" and "Humidifier Chamber" are components of this device, and it is optional whether they are initial attached initially or not.
If they are not attached initially, they can be attached later, and then SpO2/pulse monitoring, oxygen density controlling, weight monitoring and humidifying function can be available. The 4 kinds of components can be supplied individually. The stand can go up and down.
The provided document, K102226, is a 510(k) summary for the Atom Medical Corporation's Dual Incu i (Atom Infant Incubator Model 100). This document describes the device, its intended use, a comparison to predicate devices, and the testing conducted to support its substantial equivalence.
Based on the provided text, here’s a breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC60601-1 | Met requirements of IEC60601-1 |
| Electromagnetic Compatibility (EMC) | Compliance with IEC60601-1-2 | Met requirements of IEC60601-1-2 |
| Infant Incubators | Compliance with IEC60601-2-19 | Met requirements of IEC60601-2-19 |
| Infant Radiant Warmers | Compliance with IEC60601-2-21 | Met requirements of IEC60601-2-21 |
| Biocompatibility | Compliance with ISO10993-1 | Evaluated based on ISO10993-1; materials are identical to predicate device, ensuring biological safety. |
| Software Validation | Not explicitly stated, but "Validation has been conducted on the device software." | Validation has been conducted on the device software. |
| Intended Use Equivalence | Equivalent to predicate devices (Atom V-2200 and Giraffe OmniBed) | The device's intended use is equivalent to the predicate devices. |
| Feature Equivalence | Equivalent to predicate devices | The device's features are equivalent to the predicate devices. |
| Appearance Equivalence | Equivalent to predicate devices | The device's appearance is equivalent to the predicate devices. |
| Temperature Modes Equivalence | Equivalent to predicate devices | The device's temperature modes are equivalent to the predicate devices. |
| Components & Function Equivalence | Equivalent to predicate devices | The device's components and their functions are equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of data for performance evaluation in the way one might for an AI algorithm. Instead, it refers to compliance testing with established medical device standards.
- Sample Size: Not applicable in the context of a dataset; the testing was performed on the Dual Incu i device itself.
- Data Provenance: Not applicable in the context of a dataset. The testing was conducted based on international standards (IEC, ISO) for medical devices. The country of origin of the device manufacturer is Japan. The studies described are prospective tests conducted on the physical device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not relevant or provided in the context of this 510(k) summary, as it describes a physical medical device (infant incubator/warmer) and its compliance with engineering and safety standards, not an AI algorithm requiring expert ground truth for a diagnostic task.
4. Adjudication Method for the Test Set:
Not applicable, as the evaluation is based on compliance with specific technical standards rather than expert review of a dataset.
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 physical infant incubator/warmer, not an AI system designed to assist human readers in image interpretation or other diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical device.
7. The Type of Ground Truth Used:
For the performance assessment of this device, the "ground truth" refers to the established requirements and standards for medical device safety, performance, and biocompatibility.
- Type of Ground Truth:
- Engineering Standards: IEC60601-1 (Electrical Safety), IEC60601-1-2 (EMC), IEC60601-2-19 (Infant Incubators), IEC60601-2-21 (Infant Radiant Warmers).
- Biocompatibility Standards: ISO10993-1.
- Software Validation Principles: While not explicitly detailed, the statement "Validation has been conducted on the device software" implies adherence to established software validation guidelines for medical devices.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not an AI algorithm that undergoes training on a dataset.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no "training set" for this type of device.
§ 880.5400 Neonatal incubator.
(a)
Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.(b)
Classification. Class II (performance standards).