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The V-2200 Infant Incubator is a device to keep premature infants or neonatal 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. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities. Optional functions include pulse oximetry and oxygen delivery. This device is not intended for home use. This device is not intended as a transport incubator. This is a prescription device.

This product consists of a hood, a sensor module, a mattress platform, a middle deck section, a conditioning chamber, a humidity chamber, an operation control section, a power source, a relay box, an oxygen supply/filter box, a pulse oximeter, an oxygen controller and a weight monitor. 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. The device is also equipped with a skin temperature control function to maintain the infant's skin temperature at a fixed level in response to the patients temperature as measured by the skin probe. There is a humidity control function to adjust the amount of vapor generated in the humidity chamber. The following additional features can be installed into the incubator: a pulse oximeter function to monitor Sp02 concentration and pulse rate non-invasively; an oxygen control function to draw oxygen and outside air and control the oxygen concentration delivered to the patient compartment to the desired level; and a weight monitor to facilitate taking the infants weight without moving them from the incubator. This device is designed to be used in treatment, procedures and observation of low-birth-weight and sick neonates, providing heat to the neonate when the body temperature is low and also to provide humidity if desired

The provided text describes a 510(k) premarket notification for the V-2200 Infant Incubator, focusing on the addition of an optional pulse oximeter. However, the document does not contain any information regarding acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria for the pulse oximetry function.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is primarily a regulatory filing for substantial equivalence, detailing the device description, intended use, modifications, and classification, but it does not include performance study data.

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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.

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The V-505 Atom Infa Warmer is a radiant warming, open type incubator intended to provide an optimum clinical environment for observation, examination, temperature regulation, and management of neonates. Optional functions include pulse oximetry and oxygen delivery.

This device is not intended for home use.

This is a prescription device.

The Atom Infa Warmer V-505 is designed to maintain an infants body temperature by means of infrared radiant heat emitted from a heater located above the mattress. Temperature control is achieved either by manual adjustment of the heater output or by servo control based on changes in the infants skin temperature. All models of the V-505 may also be purchased with the following optional functions: a pulse oximeter that measures the infant's SpO2 and pulse rate, an oxygen delivery system consisting of either an oxygen blender or an oxygen flowmeter, and a suction unit. Other device features (depending on the model) include a timer, illumination lamps, an RS232 connector for communication with an external computer, a rotating/tilting canopy, a tilting mattress platform, baby quards, and support column rails for attaching an optional tray set or IV pole.

The provided document is a 510(k) summary for the Atom Medical Inc. V-505 Infa Warmer, which is an infant radiant warmer. It describes the device, its intended use, modifications from a previous version, and states its substantial equivalence to predicate devices. This document does not contain information about specific acceptance criteria or a study proving the device meets them in the way typically expected for an AI/ML device (e.g., performance metrics like sensitivity, specificity, or AUC against a ground truth).

The information provided pertains to the regulatory clearance of a medical device (infant radiant warmer) and focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving a specific performance level of an AI algorithm.

Therefore, I cannot populate the table or answer the questions as they relate to AI/ML device performance studies. The document does not contain any of the following:

• Specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
• A study detailing device performance against such criteria.
• Information about sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or details about training sets, because this is not an AI/ML device clearance.

The "Performance Standards: None applicable" section further confirms that there are no specific performance benchmarks detailed in this submission for this device type.

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