(114 days)
Giraffe Omnibed Carestation CS1 (K152814)
Not Found
No
The description focuses on basic temperature and oxygen control mechanisms, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes.
The device provides heat and controlled oxygen to neonates for thermoregulation, which are therapeutic interventions.
No
The device is described as providing heat in a controlled manner to neonates and maintaining temperature, indicating a therapeutic or supportive function, not a diagnostic one.
No
The device description clearly indicates it is a physical medical device (incubator/warmer) with hardware components for heating, air circulation, and potentially oxygen delivery and weighing. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Giraffe Incubator Carestation and Giraffe OmniBed Carestation are devices that provide a controlled environment (temperature, oxygen) for neonates. They are external support systems for the infant's physiology.
- Lack of Sample Analysis: The descriptions do not mention the device analyzing any biological samples from the infant. Its function is to maintain the infant's external environment.
Therefore, the device's intended use and operation do not align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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%).
Product codes (comma separated list FDA assigned to the subject device)
FMZ, FMT
Device Description
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.
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
neonates who are unable to thermo-regulate based on their own physiology.
Intended User / Care Setting
Labor and Delivery, NICU, Radiology, and Operating Room.
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)
Non-Clinical Testing: Evaluations of safety and effectiveness of the modified wall and porthole latches used controlled performance and reliability testing to substantiate the performance of the new latches in worst-case conditions. The specific tests and verification methods are summarized in the table below. (Table 5.1 – Functional Bench Tests Performed on Modified Latches lists tests such as Rough Handling Testing, Check for Rough surfaces, Humidifier Operating Time, Air Velocity, Opening and Closing of E/W Doors and South Wall, Opening of Doors and Portholes, E/W Doors latch mechanism and N/S Walls as Barriers, Porthole latch mechanism as Barriers, Removing of E/W Doors and infant compartment design, E/W Doors remains secure even if the North Wall and South Wall receptacle is not latched, Maximum sidewall upright angle, Porthole Latch: Over Torque Test, Wall Latch and Porthole Latch: Vibration / Reliability Threshold Test, Porthole Latch: Push Load, Porthole Latch: Pull Load for Cleaning, Porthole Latch: Open Close Cycles of Knob Latch, Porthole Latch: Cleaning Pull Cycles of Knob Latch, Wall Latch: Handling Load Test, Wall Latch: Pull and Push Loads with chemical exposure, Wall Latch: Handling Load on Snap, Wall Latch: Pinch Action Open Close Cycles, Wall Latch: Push Close Cycles (Push to Close from Secondary Latch Position to Primary Latch Position)).
Animal Study: The Giraffe OmniBed Carestation CS1 did not require animal tests to support substantial equivalence.
Clinical Studies: The Giraffe OmniBed Carestation CS1 did not require clinical tests to support substantial equivalence.
Human Factors Analysis: The Giraffe OmniBed Carestation CS1 successfully completed a summative usability study of the modified wall and porthole latches and their instructions for use. There were no findings from the summative usability testing that led to changes in wall latches, porthole latches, or on-product labeling. The latch modifications did not introduce any new risks or use-related issues.
The modifications associated with Giraffe Omnibed Carestation CS1 do not change the Indications for Use or intended use from the predicate, and represent equivalent technological characteristics, with no impact on energy type, operating principles, or primary control mechanisms.
Design verification, along with bench testing demonstrate the proposed Omnibed system is substantially equivalent and as safe and as effective as the legally marketed predicate device. Clinical data was not required to demonstrate substantial equivalence. GE Healthcare's quality system's design, verification, validation, and risk management processes did not identify any new hazards, unexpected results, or adverse effects stemming from the changes to the predicate. The modified system continues to meet all applicable IEC 60601-1 series of standards.
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.
Giraffe Omnibed Carestation CS1 (K152814)
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
§ 880.5400 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 2, 2022
Datex Ohmeda Inc. Shiwani Zalpuri Regulatory Affairs Leader 9900 Innovation Drive Wauwatosa, Wisconsin 53226
Re: K213553
Trade/Device Name: Giraffe Incubator Carestation CS1 Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: Class II Product Code: FMZ Dated: January 28, 2022 Received: January 31, 2022
Dear Shiwani Zalpuri:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gang Peng for Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Giraffe Incubator Carestation CS1
Indications for Use (Describe)
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%).
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | 02-March-2022 |
| Submitter: | Datex-Ohmeda, Inc. |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Primary Contact | |
| Person: | Shiwani Zalpuri |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| Phone: +91 9871090801 | |
| Email: shiwani.zalpuri@ge.com | |
| Secondary Contact | |
| Person: | Lee Bush |
| Regulatory Affairs Director | |
| GE Healthcare | |
| Phone: 262-309-9429 | |
| Email: Lee.Bush@ge.com | |
| Device Trade Name: | Giraffe Omnibed Carestation CS1 |
| Common/Usual Name: | Incubator/Warmer |
| Classification Names: | Neonatal Incubator |
| Regulation | 21 CFR 880.5400 Neonatal Incubator |
| Classification | II |
| Product Code: | FMZ, FMT |
| Predicate Device: | Giraffe Omnibed Carestation CS1 (K152814) |
| Indications for Use: | 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 | |
| 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%). |
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5.1 Device Description:
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.
5.2 Comparison of Technological Characteristics with the Predicate Device
The Porthole Latch design has been modified to change the latch action from "press to open" to "turn to open". The design of the latch mounting part was modified to accommodate the redesigned latch. There were no impacts to form, fit or function of the Porthole Door of Omnibed aside from the latch.
The design of the Wall Latches and latch receptacles on the North side of the device have been modified. A secondary "catch" was added to address the situation where users leave the door vertical/up with the primary latches not engaged. The receptacles and back plates used to secure the latches on the NE and NW side of the wall have also been modified to accommodate the changes to the wall latches. There were no impacts to form, fit or function of the wall of the Omnibed aside from the latches. See detailed comparison of the proposed device relative to the predicate device in the table below.
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Product Comparison with Predicate Device (K152814)
| Specification | Predicate
Giraffe OmniBed
Carestation CS1
(K152814) | Proposed (Redesigned
Latches)
Giraffe OmniBed
Carestation CS1 | Discussion of Differences |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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 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 | Identical |
| Sterility | the operator (21-65%).
non-sterile device | the operator (21-65%).
non-sterile device | Identical |
| Specification | Predicate | Proposed (Redesigned | Discussion of Differences |
| | Giraffe OmniBed | Latches) | |
| | Carestation CS1 | Giraffe OmniBed | |
| | (K152814) | Carestation CS1 | |
| 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 (enhanced
presentation on the touch screen,
colors) and sounds (tones, volumes,
and frequencies) 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: 66 cm
Depth: 114 cm | Different. The proposed change had increased the product
dimension in Width. All other dimensions and weight
remain the same.
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
With this change, the device performance remains the same
and does not raise different 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 |
| Specification | Predicate
Giraffe OmniBed
Carestation CS1
(K152814) | Proposed (Redesigned
Latches)
Giraffe OmniBed
Carestation CS1 | Discussion of Differences |
| 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 |
| 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
(Control Temp vs. Avg. Incubator
Temp)
-Variability: ± 0.5°C (Incubator Temp
vs. Avg. Incubator Temp)
-Warm-up time: