(154 days)
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.
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.
Here's an analysis of the provided text regarding the Atom Transcapsule V-707, focusing on acceptance criteria and the study proving it meets these criteria:
Device: Atom Transcapsule V-707 (Neonatal Transport Incubator)
The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria for a novel device. Therefore, much of the requested information (like sample sizes for test sets, expert qualifications, MRMC studies, standalone performance with specific thresholds, and ground truth for training data) is not present. The "acceptance criteria" discussed are primarily related to meeting recognized performance standards and comparing features to a predicate.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the 510(k) Summary, the "acceptance criteria" are implied by the standards the device complies with and its performance characteristics as compared to the predicate. The "reported device performance" is a statement of compliance or the specified operating range/accuracy.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Performance Standards Compliance: | |
| IEC 60601-1 (1988) - Medical Electrical Equipment - Part 1: General Requirements for Safety+A1+A2Amendment 2 | Complied and passed all testing criteria. |
| IEC 60601-1-2 : 2007 - Medical Electrical Equipment - Part 1-2: General requirements for Safety - Collateral standard: Electromagnetic compatibility Requirements and tests (Edition 3) | Complied and passed all testing criteria. |
| 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 | Complied and passed all testing criteria. |
| Temperature Control: | |
| Incubator air temperature setting range: Adequate for neonates | 23.0 to 38.0℃ in 0.1℃ increments |
| Measured air temperature display range | 20.0-42.0℃ in 0.1℃ increments |
| Accuracy of measured air temperature | +/-1.0°C |
| Skin temperature measurement display range | 30.0-42.0°C in 0.1°C increments |
| Accuracy of skin temperature measurement | +/-0.3℃ |
| Warm-up time: Efficient operation | Approximately 40 min @ 25℃ |
| Alarms: Sufficient for safety monitoring | High temperature, Set point, Power failure, Fan, System failure, Silence, Skin temperature probe, Low voltage |
| Environmental Control: | |
| CO2 concentration in the hood: Safe levels |
§ 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).