(93 days)
Not Found
No
The description details standard sensor-based feedback loops for temperature control (air and skin temperature servo control) and does not mention any AI/ML algorithms for prediction, analysis, or decision-making beyond basic setpoint maintenance. The "Servo Control Mode" refers to a standard control system, not necessarily AI/ML.
Yes
The device is intended for temperature control in neonatal hypothermia, prevention of body temperature drop, and pre-operative and post-operative intensive care, all of which are direct therapeutic interventions to maintain the health and well-being of newborns and premature neonates.
No
The device is an infant incubator designed for temperature control and observation of newborns and premature neonates. Its functions described are therapeutic and monitoring (temperature, humidity), not diagnostic.
No
The device description clearly outlines physical components such as a hood, main body, control panel, sensors, heater, and fan, indicating it is a hardware device with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Neo-Servo i Atom Infant Incubator Model 102 is a medical device designed to provide a controlled environment (temperature and potentially humidity) for newborns and premature neonates. It directly interacts with the patient's external environment and monitors their skin temperature.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples taken from the infant. The sensors mentioned (humidity and temperature) are monitoring the environment within the incubator and the infant's external skin temperature.
Therefore, the device's function and intended use clearly fall outside the scope of In Vitro Diagnostics. It is a therapeutic and monitoring device used in a clinical setting.
N/A
Intended Use / Indications for Use
The Neo-Servo i Atom Infant Incubator Model 102 is a closed-type 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. The incubator is provided with a function to control the infant's skin temperature.
Environment of Use: Hospitals, delivery suites, NICU
Product codes
FMZ
Device Description
The Neo-Servo i Atom Infant Incubator Model 102 consists of a hood, a main body, a control panel and is offered with or without a stand with casters. The Model 102 incorporates two (2) modes of control: air (manual control) and baby (servo control).
The Model 102 incorporates the sensors (humidity and temperature) inside the hood monitor the air conditions inside the hood. These are connected to the Sensor module. It is equipped with an incubator air temperature control function to circulate air containing the heat generated by the heater attached to the conditioning chamber inside the hood by means of a fan in order to maintain the incubator air temperature at a fixed level. It is equipped with a skim temperature control function to maintain the infant's skin temperature at a fixed level in response to the patient's temperature as measured by the skin probe. There are optional humidity chamber and x-ray cassette tray.
There are 2 functional modes:
- Skin temperature control mode referred to as "Servo Control Mode" 1.
- Air temperature control mode referred to as "Manual Control Mode" 2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
newborns and premature neonates, Infant and neonates ≤ 10 kg
Intended User / Care Setting
Hospitals, delivery suites, NICU
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing has been performed according to recognized standards and the proposed device met and passed all testing criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Atom Model V-2200 – K061856
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Premarket Notification 510(k) Section 5 - 510(k) Summary
Neo-Servo i
DEC 2 2 2010
510(k) Summary Page 1 of 4 17-Sept-10
Atom Medical Corporation 3-18-15, Hongo, Bunkyo-ku Tel - 011-81-3-3815-3632
Tokyo, Japan 113-0033
| Tokyo, Japan 113-0033 | Fax – 011-81-3-3812-3199 |
|---|---|
| Official Contact: | Tsuyoshi Sugino – Regulatory Affairs Manager |
| Proprietary or Trade Name: | Neo-Servo i Atom Infant Incubator Model 102 |
| Common/Usual Name: | Neonatal Incubator |
| Classification Name/Code: | FMZ – neonatal incubator |
| CFR 880.5400 | |
| Device: | Neo-Servo i Atom Infant Incubator Model 102 |
| Predicate Devices: | Atom Model V-2200 – K061856 |
Device Description:
The Neo-Servo i Atom Infant incubator Model 102 consists of a hood, a main body, a control panel and is offered with or without a stand with casters. The Model 102 incorporates two (2) modes of control: air (manual control) and baby (servo control).
The Model 102 incorporates the sensors (humidity and temperature) inside the hood monitor the air conditions inside the hood. These are connected to the Sensor module. It is equipped with an incubator air temperature control function to circulate air containing the heat generated b the heater attached to the conditioning chamber inside the hood by means of a fan in order to maintain the incubator air temperature at a fixed level. It is equipped with a skim temperature control function o maintain the infant's skin temperature at a fixed level in response to the patient's temperature as measured by the skin probe. There are optional humidity chamber and x-ray cassette tray.
There are 2 functional modes:
- Skin temperature control mode referred to as "Servo Control Mode" 1.
- Air temperature control mode referred to as "Manual Control Mode" 2.
Indications for Use:
The Neo-Servo i Atom Infant Incubator Model 102 is a closed-type 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. The incubator is provided with a function to control the infant's skin temperature.
Environment of Use: Hospitals, delivery suites, NICU
1
510(k) Summary Page 2 of 4
17-Sept-10
·
Summary of substantial equivalence
| Proposed | Predicate | |
|---|---|---|
| Neo-Servo i | K061856 | |
| Atom Infant Incubator Model 102 | Atom V-2200 Infant Incubator | |
| Indications for Use | The Neo-Servo i Incubator Model 102 | |
| is a closed-type 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. The incubator is | ||
| provided with a function to control the | ||
| infant's skin temperature. | The V-2200 infant incubator is intended | |
| to keep premature neonates or infants in | ||
| a warm environment which is covered | ||
| by a hood and isolated from ambient air | ||
| and of which internal air temperature | ||
| and humidity, are controlled. | ||
| Environment of use | Hospital, delivery suites, NICU | |
| Not for transport | Hospital, delivery suites, NICU | |
| Not for transport | ||
| Patient Population | Infant and neonates ≤ 10 kg | Infant and neonates ≤ 10 kg |
| Features and Performance Characteristics | ||
| Overall dimensions | With HL stand | |
| 100(D) x 60(W) x 138-158(H) cm | ||
| Mattress - 65(W) x 36.5(D) x 2(T) cm | ||
| Adjustable height of 86 - 106 cm from | ||
| the floor to the mattress top | With HL stand | |
| 109 (D) x 61(W) x 133-153(H) cm | ||
| Mattress - 74(W) x 36(D) x 2(T) cm | ||
| Weight | 90 kg | 107.5 kg |
| Major components | Hood | |
| Main body | ||
| Control unit | Hood | |
| Main body | ||
| Control unit | ||
| Power | AC 120V | AC 120 V |
| Operating conditions | Ambient - 20-30 °C | |
| RH - 30-75% | Ambient - 20-30 °C | |
| RH - 30-75% | ||
| Storing conditions | Ambient - 0-50 °C | |
| RH - 30-75% | Ambient - 0-50 °C | |
| RH - 30-75% | ||
| Maximum load capacity | IV Pole ~ 10 kg | |
| Drawer ~ 3kg | IV Pole ~ 5kg | |
| Drawer ~ 5kg | ||
| MF Rail ~ 10kg | ||
| Proposed | Predicate | |
| Neo-Servo i | K061856 | |
| Atom Infant Incubator Model 102 | Atom V-2200 Infant Incubator | |
| Features and Performance Characteristics (continued) | ||
| Accessories / optional | ||
| components | Skin Temperature Probe | |
| Electrostatic Air filter | ||
| Access port covers | ||
| X-ray cassette tray (optional) | ||
| Humidifier chamber (optional) | Skin Temperature Probe | |
| Electrostatic Air filter | ||
| Access port covers | ||
| X-ray cassette tray (optional) | ||
| Humidifier chamber (optional) | ||
| Optional only on V-2200 | ||
| Pulse oximeter | ||
| Oxygen sensor | ||
| Control modes | Manual and Servo | Manual and Servo |
| Skin Temperature Setting | ||
| Range | Servo | |
| 34 - 37.5 °C | ||
| (override mode 37.6 - 38.0 °C) | Servo | |
| 34 - 37.5 °C | ||
| (override mode 37.6 - 38.0 °C) | ||
| Incubator air temperature | 23 - 39 °C (including override) | 23 - 39 °C (including override) |
| Display range | Skin - 30.0 - 42 °C | |
| Accuracy - ± 0.3 °C | ||
| Air - 20.0 - 42.0°C | ||
| Accuracy - ± 0.3 °C | Skin - 30.0 - 42 °C | |
| Accuracy - ± 0.3 °C | ||
| Air - 20.0 - 42.0°C | ||
| Accuracy - ± 0.3 °C | ||
| Heater output | 0 - 100% in 10 increments | 0 - 100% in 10 increments |
| Warm-up time | ≤ 60 min @ 25°C | ≤ 60 min @ 25°C |
| Alarms | High temperature | |
| Set temperature | ||
| Skin temperature | High temperature | |
| Set temperature | ||
| Skin temperature | ||
| Humidity | In Servo mode | In Servo mode |
| Humidity setting range | 40 - 95% RH | 40 - 95% RH |
| Humidity display | 15 - 99% RH | 15 - 99% RH |
| Continuous humidity | ~ 8 hours | ~ 8 hrs |
| Alarms | Humidity sensor | |
| Low water level | ||
| No water | ||
| Humidity chamber off | ||
| Set humidity | Humidity sensor | |
| No water | ||
| Humidity chamber off | ||
| Set humidity | ||
| Oxygen supply | Maximum concentration ≥ 65% @ 10 | |
| Lpm | Maximum concentration ≥ 65% @ 10 | |
| Lpm | ||
| Environment CO2 | ||
| concentration in the hood |