(154 days)
Not Found
No
The device description focuses on basic temperature control, power management, and alarm functions, with no mention of AI or ML capabilities.
No.
The primary function of the device is to transport neonates while maintaining a stable temperature, which is a supportive and protective function rather than a direct therapeutic intervention for a specific disease or condition. Its purpose is to create a controlled environment, not to treat.
No
Explanation: The device is a transport incubator designed to control temperature and transport neonatal and premature infants. While it monitors temperature (air and skin), its primary function is not to diagnose a disease, condition, or state of health.
No
The device description clearly outlines multiple hardware components including a hood, main body, control panel, external power pack with batteries, and a heat source. It also describes physical measurements (temperature) and physical outputs (heat, alarms).
Based on the provided information, the Atom Transcapsule V-707 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to transport neonatal and premature infants and control their temperature. This is a life support and transport function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on temperature control, power sources, alarms, and physical configuration. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: IVD devices typically involve reagents, assays, or instruments designed to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. None of these characteristics are present in the description of the Atom Transcapsule V-707.
The Atom Transcapsule V-707 is a medical device, specifically a transport incubator, but it falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates.
Environment of use -- Hospitals, delivery suites, NICU, and transport
Product codes (comma separated list FDA assigned to the subject device)
FPL
Device Description
The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates. It is intended to be used in hospitals, delivery suites, NICU, and transport.
The Transcapsule V-707 controls temperature based on air temperature within the incubator. The front panel shows set temperature and the actual temperature. The heat source is electrically powered and can be set between 23.0 to 38.0℃ in 0.1℃ increments. The measured temperature within the incubator has a range of 20.0-42.0℃ in 0.1℃ increments with an accuracy of +/-1.0°C. It can also show skin temperature of the infant between 30.0 and 42.0°C in 0.1°C increments with an accuracy of +/-0.3℃.
The Transcapsule V-707 can be mounted in a variety of mechanical configurations, the HL Stand for transport and Cabinet Stand for internal hospital use are typical examples, see Section 11 for further details. The HL Stand for transport and the Cabinet Stand for internal hospital use (and oxygen gas cylinder) are not included in this submission.
The Transcapsule V-707 consists of a hood, a main body, a control panel and an external power pack which provides DC power to the incubator. The external power pack also contains batteries to allow for operation when external power is lost. The battery is automatically kept charged when there is an external source of power provided to the device. Battery status (charging and capacity) is indicated on the power pack.
The device provides audible and visual alarms for: High temperature, set point, power failure, fan, system failure, silence, skin temperature probe, low voltage (when the voltage from the battery or the external DC power source falls to approx. 10.5V).
The device complies with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-20.
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
neonatal, premature infants, low birth weight infants, neonates
Intended User / Care Setting
Hospitals, delivery suites, NICU, and transport
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 per the following standards: IEC 60601-1 (1988) - Medical Electrical Equipment - Part 1: General Requirements for Safety+Al+A2Amendment 2; IEC 60601-1-2 : 2007- Medical Electrical Equipment - Part 1-2: General requirements for Safety-Collateral standard: Electromagnetic compatibility Requirements and tests (Edition 3); IEC 60061-2-20 (1996) - Amendment 1 - Medical Electrical Equipment - Part 2: Particular Requirements for the Basic Safety and Essential Performance of Infant Transport Incubators. The proposed device met and passed all testing criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5410 Neonatal transport incubator.
(a)
Identification. A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.(b)
Classification. Class II (performance standards).
0
123937
MAY 2 3 2013
510(k) Summary Page 1 of 4 つつ、あるの ...
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3-May-
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Atom Medical Corporation | |
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3-18-15, Hongo, Bunkyo-ku | Tel - 011-81-3-3815-3632 |
Tokyo, Japan 113-0033 | Fax - 011-81-3-3812-3199 |
Official Contact: | Tsuyoshi Sugino - Regulatory Affairs Manager |
Proprietary or Trade Name: | Atom Transcapsule V-707 |
Common/Usual Name: | Neonatal Transport Incubator |
Classification Name/Code: | FPL - neonatal transport incubator |
CFR 880.5410 | |
Device: | Atom Transcapsule V-707 |
Predicate Devices: | Air-Shields (Draeger) TI500 Isolette - K941106 |
Device Description:
The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates. It is intended to be used in hospitals, delivery suites, NICU, and transport.
The Transcapsule V-707 controls temperature based on air temperature within the incubator. The front panel shows set temperature and the actual temperature. The heat source is electrically powered and can be set between 23.0 to 38.0℃ in 0.1℃ increments. The measured temperature within the incubator has a range of 20.0-42.0℃ in 0.1℃ increments with an accuracy of +/-1.0°C. It can also show skin temperature of the infant between 30.0 and 42.0°C in 0.1°C increments with an accuracy of +/-0.3℃.
The Transcapsule V-707 can be mounted in a variety of mechanical configurations, the HL Stand for transport and Cabinet Stand for internal hospital use are typical examples, see Section 11 for further details. The HL Stand for transport and the Cabinet Stand for internal hospital use (and oxygen gas cylinder) are not included in this submission.
The Transcapsule V-707 consists of a hood, a main body, a control panel and an external power pack which provides DC power to the incubator. The external power pack also contains batteries to allow for operation when external power is lost. The battery is automatically kept charged when there is an external source of power provided to the device. Battery status (charging and capacity) is indicated on the power pack.
The device provides audible and visual alarms for: High temperature, set point, power failure, fan, system failure, silence, skin temperature probe, low voltage (when the voltage from the battery or the external DC power source falls to approx. 10.5V).
The device complies with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-20.
1
510(k) Summary Page 2 of 4 23-May-13
Indications for Use:
The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates.
Environment of Use: Hospitals, delivery suites, NICU, and transport
Comparison to Predicate
| | Proposed
Transcapsule V-707 | Predicate
K941106
Air-Shields (Draeger) T1500 Isolette
Infant Incubator |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Indications for Use | The Atom Transcapsule V-707 is a
closed-type transport incubator for
neonatal and premature infants intended
to transport low birth weight infants and
neonates. | Specific indications as submitted to the
FDA are unknown. Intended use is
equivalent |
| Environment of use | Hospitals, delivery suites, NICU, and
transport | Hospital, NICU |
| Patient Population | Infant and neonates | Premature infants |
| Technology | Electrically heated and controlled on air
temperature | Electrically heated and controlled on air
temperature |
| Features and Performance Characteristics | | |
| Overall dimensions | Main Body:
95(W) X 44(D) X 42(H) cm
Power Pack:
29(W) X 17.5(D) X 25(H) cm
Alternate Power Pack:
35(W) X 20(D) X 33(H) cm
Mattress - 55(W) x 28(D) x 2.5(H) cm | 52.7(W) X 95.9(L) X 50.8(H)
Mattress - 74(W) x 36(D) x 2(T) cm |
| Weight | Main Body and Power Pack
approximately 32kg | 49kg |
| Major components | Hood
Main body
Power Pack | Hood
Main body |
| Power | 100-240 VAC
47-63 Hz or 47-440Hz
220 or 280VA max
11.0- 14V DC 10A | 110/120 V, 50/60/400 Hz - 220/240 V,
50/60/400 Hz
11-13/26-30 VDC 200W |
| Operating conditions | Temperature: 10-30 °C
RH - 30-75% | Temperature: Not specified
RH - 0-95% |
2
510(k) Summary
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| | Proposed
Transcapsule V-707 | Predicate
K941106
Air-Shields (Draeger) T1500 Isolette
Infant Incubator |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Maximum load capacity | IV Pole ~ 3 kg | Not specified |
| Features and Performance Characteristics (continued) | | |
| Accessories / optional
components | Skin Temperature Probe
Access port covers
Infant Fixing Band
IV Pole | Skin Temperature Probe
Accessory Shelf
IV Pole
Infant restraint straps
High Hood, Pressure Regulator and
flowmeter
Humidity Pad |
| Control modes | Automatic based on incubator air
temperature | Automatic based on incubator air
temperature |
| Skin Temperature
Measurement Range | 30.0 and 42.0℃ in 0.1℃ increments
with an accuracy of +/-0.3°C | Not specified |
| Incubator air temperature
setting range | 23.0 to 38.0℃ in 0.1℃ increments | 22 - 38°C |
| Display range | Skin - 30.0 - 42 °C in 0.1°C increments,
Accuracy - ± 0.3 °C
Air - 20.0 - 42.0 °C
Accuracy - ± 1.0 °C | Skin - Not specified
Air - Not specified |
| Heater output | 0 - 100% in 10 increments | Not specified |
| Warm-up time | Approximately 40 min @ 25℃ | ≤ 60 min @ 25°C |
| Alarms | High temperature
Set point
Skin Temperature Probe Fault | High temperature
Heater temperature
Skin temperature probe fault |
| Humidity | N/A | Passive |
| Oxygen supply | ≥ 60% @ 10 Lpm | 21% to 58% minimum |
| Environment CO₂
concentration in the hood |