(134 days)
The V-808 Atom Transcapsule is a neonatal transport incubator. The incubator is a device with a transparent hood intended to contain a premature infant or a neonatal infant within the compartment covered by said hood and intended to safely convey the infant accommodated in that compartment, providing the infant with isolated environment from ambient air where temperature - controlled air is supplied. The V-808 also provides oxygen monitoring and supply as well as an integrated pulse oximetry capability. This device is not intended for home use. This is a prescription device.
This product consists of a hood section, a mattress platform section, a middle deck section, a conditioning chamber section, an operation section and a pedestal section. It is equipped with an incubator air temperature control function to circulate the air containing the heat energy 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, an oxygen supply function to deliver oxygen into the inner hood from outside, and a function to determine and display the oxygen concentration of the endosed compartment covered by the hood. It is further equipped with a function to measure and display the skin temperature of the neonate, as well as a pulse oximeter function to determine oxygen saturation and pulse rate non-invasively. It is a transport incubator, wherein said functions are intended to be used in treatment, procedures and observation of low-birth-weight and sick neonates, allowing provision of heat to the neonate when the body temperature is low.
This document is a 510(k) summary for the V-808 Atom Transcapsule, a neonatal transport incubator. However, the provided text does not contain the specific acceptance criteria or a study proving the device meets acceptance criteria for performance metrics like temperature control accuracy, oxygen concentration accuracy, or pulse oximetry accuracy.
Instead, the document focuses on:
- Device Description: What the device is and its components (hood, mattress platform, etc.), its functions (temperature control, oxygen supply, oxygen concentration monitoring, skin temperature measurement, pulse oximetry).
- Intended Use: For treatment, procedures, and observation of low-birth-weight and sick neonates, providing heat, isolated environment, temperature-controlled air, oxygen monitoring and supply, and integrated pulse oximetry.
- Modifications: The key difference from the predicate device (T1500 Transport Incubator) is the addition of the SpO2 feature, which is provided by a currently marketed Masimo Pulse Oximeter.
- FDA Clearance Letter: A letter from the FDA confirming the device's substantial equivalence to predicate devices and allowing it to be marketed.
- Indications for Use Statement: A formal statement of the device's intended use.
Therefore, based only on the provided text, I cannot complete the requested table or answer the specific questions about acceptance criteria and study details. The document confirms the device's existence and FDA clearance, but not the technical performance details of a study against specific acceptance criteria.
If such a study or acceptance criteria were present, they would typically be found in a separate section detailing performance testing, clinical studies, or engineering verification and validation reports.
§ 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).