(114 days)
The Giraffe Incubator Carestation is an Infant Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment to the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
The Giraffe OmniBed Carestation is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo- regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
The Giraffe OmniBed Carestation is a device that can function as an incubator (in the closed mode) or as an infant radiant warmer (in the open mode) based on the user's selection.
Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.
In the closed bed mode of operation, the bed functions as an incubator, maintaining the infant's temperature by circulating heated air within the enclosed bed compartment. Warm air is circulated through the closed patient compartment. The operator may select either the air or skin temperature control method. Depending on the control method selected, heat is regulated based on either the air temperature or the infant's skin temperature compared to the operated selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors.
In the open bed mode, this bed operates like a conventional open, radiantly heated infant bed. Radiant heat from an infrared heat source is focused onto the bed to warm the patient. The Giraffe OmniBed Carestation incorporates an optional weighing scale, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.
This document is a 510(k) premarket notification for the "Giraffe Incubator Carestation CS1" (K213553). The submission seeks to demonstrate substantial equivalence to a legally marketed predicate device, the "Giraffe Omnibed Carestation CS1" (K152814), specifically concerning modifications to porthole and wall latches.
Device Description:
The device, Giraffe OmniBed Carestation CS1, is a combination of an infant incubator and an infant radiant warmer. It provides a temperature-controlled environment for neonates. The modified device primarily features changes to the porthole latch design (from "press to open" to "turn to open") and the wall latches (addition of a secondary "catch" mechanism on the north side). The overall dimensions have also slightly increased in width from 66 cm to 68 cm.
Acceptance Criteria and Reported Device Performance:
The provided document defines acceptance criteria through compliance with voluntary standards and system performance metrics, and the reported device performance is that it meets these criteria.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Discussion of Differences |
|---|---|---|---|
| Indications for Use | The Giraffe OmniBed Carestation is a combination of an infant incubator and warmer, providing controlled heat. May incorporate Servo Controlled Oxygen Delivery System (21-65%). | The Giraffe OmniBed Carestation CS1 is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%). | Identical |
| Sterility | non-sterile device | non-sterile device | Identical |
| Display Manual Control | 10.4" Color LCD, 10.4" Touch Screen | 10.4" Color LCD, 10.4" Touch Screen | Identical |
| Alarm Silence | Two Options: - Touch Screen Silence - Hands free Alarm silence (HFAS) | Two Options: - Touch Screen Silence - Hands free Alarm silence (HFAS) | Identical |
| Device Indicators | White Device Indicator light. Updates to alarm display and sounds in compliance with IEC 60601-1-8. Power Fail Indicator LED. | White Device Indicator light. Updates to alarm display (enhanced presentation on the touch screen, colors) and sounds (tones, volumes, and frequencies) in compliance with IEC 60601-1-8. Power Fail Indicator LED. | Identical |
| Environment of use | Labor and Delivery, NICU, Radiology, and Operating Room. | Labor and Delivery, NICU, Radiology, and Operating Room. | Identical |
| Dimensions | Weight: $149 \pm 1$ kg. Mattress Size: 48.8cm x 64.8cm. Height: 152 cm (canopy closed, bed lowered). Width: 66 cm. Depth: 114 cm. | Weight: $149 \pm 1$ kg. Mattress Size: 48.8cm x 64.8cm. Height: 152 cm (canopy closed, bed lowered). Width: 68 cm. Depth: 114 cm. | Different. The proposed change increased the product width to 68 cm. All other dimensions and weight remain the same. The change does not raise new questions of safety and effectiveness. |
| Bed Tilt | Mattress tilt angle: 12° | Mattress tilt angle: 12° | Identical |
| Electrical Power Ratings Requirements | 11.5 @ 100V ~ 50/60 Hz; 9.5A @ 115V ~ 50/60 Hz; 5.5A @ 220/230/240V ~ 50/60 Hz. | 11.5 @ 100V ~ 50/60 Hz; 9.5A @ 115V ~ 50/60 Hz; 5.5A @ 220/230/240V ~ 50/60 Hz. | Identical |
| Primary Electrical Safety Standards | IEC 60601-1, IEC 60601-2-19, IEC 60601-2-21, IEC 60601-1-2. | IEC 60601-1, IEC 60601-2-19, IEC 60601-2-21, IEC 60601-1-3. | Identical (The provided document lists IEC 60601-1-3 for "Proposed" but the discussion is "Identical". This seems to be a typo in the FDA submission, as 1-3 refers to radiographic equipment). Assuming that it is identical as per the discussion. |
| Humidity | Servo control accuracy: ± 10 %; Ramp-up time: ≤50 minutes; Operating time without refill: >12 hours. | Servo control accuracy: ± 10 %; Ramp-up time: ≤50 minutes; Operating time without refill: >12 hours. | Identical |
| System Performance | -Temp Control accuracy: ± 1.0ºC -Variability: ± 0.5°C -Warm-up time: |
§ 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).