(114 days)
Not Found
No
The document describes a standard infant incubator/warmer with thermal control based on air or skin temperature. There is no mention of AI, ML, or any advanced data processing beyond basic control loops. The modifications described relate to physical latches.
Yes
The device is described as an infant incubator and warmer that provides heat in a controlled manner to neonates who are unable to thermoregulate, indicating a direct therapeutic function. It also incorporates a Servo Controlled Oxygen Delivery System to provide stable oxygen concentration, which is a therapeutic intervention.
No
Explanation: The device provides thermal support and controlled environments for neonates. It does not perform diagnostic functions such as detecting, diagnosing, or monitoring diseases or conditions.
No
The device description clearly outlines a physical medical device (infant incubator/warmer) with hardware components like a bed compartment, heating elements, doors, portholes, and optional accessories like a weighing scale and UPS. While it has a software user interface, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide thermal support (heat) to neonates who cannot regulate their own body temperature. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description focuses on the physical structure, heating mechanisms, and user interface for controlling the environment around the infant. It does not mention any components or processes for analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens.
- Detection or measurement of analytes.
- Providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies described focus on the safety and effectiveness of physical components (latches) and compliance with electrical and medical device standards. They do not involve any studies related to diagnostic accuracy or performance with biological samples.
In summary, the Giraffe OmniBed Carestation is a medical device designed to provide a controlled thermal environment for neonates. Its function is entirely external to the patient's body and does not involve in vitro analysis for diagnostic purposes.
N/A
Intended Use / 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 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%).
Product codes (comma separated list FDA assigned to the subject device)
FMT, FMZ
Device Description
The Giraffe Incubator Carestation is an enclosed infant bed, which provides thermal support for infants who are unable to provide for their own heat requirements. The device maintains the infant's temperature by circulating heated air within the closed bed 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 operator selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors. The Giraffe Incubator Carestation has a color touchscreen user interface (UI) and includes a Hands-Free Alarm Silence (HFAS) feature. The incubator includes a mattress for patient comfort. The Giraffe Incubator 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/Infant
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. Specific tests included: Rough Handling Testing as per IEC60601-1 Cl 15.3.5a, b, c and IEC60601-2-19; Check for Rough surfaces, sharp corners and edges (IEC 60601-1 Clause 9.3); 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 (IEC 60601-2-19 Clause 201.9.8.3.101); Porthole latch mechanism as Barriers (IEC 60601-2-19 Clause 201.9.8.3.101); Removing of E/W Doors and infant compartment design; Maximum sidewall upright angle. Reliability tests conducted were: 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).
Clinical Studies: The Giraffe Incubator Carestation CS1 did not require clinical tests to support substantial equivalence.
Human Factors Analysis: The Giraffe Incubator 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.
Key Results: The modifications associated with Giraffe Incubator 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 incubator system is substantially equivalent and as safe and as effective as the legally marketed predicate device.
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.
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
§ 880.5130 Infant radiant warmer.
(a)
Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.(b)
Classification. Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
March 2, 2022
Datex Ohmeda Inc. Shiwani Zalpuri Regulatory Affairs Leader 9900 Innovation Drive Wauwatosa, Wisconsin 53226
Re: K213551
Trade/Device Name: Giraffe Omnibed Carestation CS1 Regulation Number: 21 CFR 880.5130 Regulation Name: Infant Radiant Warmer Regulatory Class: Class II Product Code: FMT, 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 Omnibed Carestation CS1
Indications for Use (Describe)
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 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%).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| 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 Incubator Carestation CS1 |
| Common/Usual Name: | Neonatal Incubator |
| Classification Names: | Neonatal Incubator |
| Regulation | 21 CFR 880.5400 Neonatal Incubator |
| Classification | II |
| Product Code: | FMZ |
| Predicate Device: | Giraffe Incubator (K152809) |
| Indications for Use: | The Giraffe Incubator Carestation is an Infant Incubator. |
| 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%). |
4
5.1 Device Description:
The Giraffe Incubator Carestation is an enclosed infant bed, which provides thermal support for infants who are unable to provide for their own heat requirements. The device maintains the infant's temperature by circulating heated air within the closed bed 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 operator selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors. The Giraffe Incubator Carestation has a color touchscreen user interface (UI) and includes a Hands-Free Alarm Silence (HFAS) feature. The incubator includes a mattress for patient comfort. The Giraffe Incubator 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 incubator 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 incubator aside from the latches. See detailed comparison of the proposed device relative to the predicate device in the table below.
5
| Specification | Predicate Device (K152809) | Proposed Device | Discussion of Differences |
|---|---|---|---|
| Giraffe Incubator Carestation | Giraffe Incubator Carestation | ||
| CS1 | CS1 | ||
| Indications for Use | The Giraffe Incubator Carestation is an Infant | ||
| Incubator. 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 Incubator Carestation is an Infant | ||
| Incubator. 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%). | 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 (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: 138 ± 1 kg | ||
| Mattress Size: 48.8cm x 64.8cm Height: 152 | |||
| cm | |||
| Width: 66 cm | |||
| Depth: 114 cm | Weight: 138 ± 1 kg | ||
| Mattress Size: 48.8cm x 64.8cm Height: 152 | |||
| cm | |||
| Width: 66 cm | |||
| Depth: 114 cm | Identical | ||
| Bed Tilt | Mattress tilt angle: 12° | Mattress tilt angle: 12° | Identical |
| Specification | Predicate Device (K152809) | ||
| Giraffe Incubator Carestation | |||
| CS1 | Proposed Device | ||
| Giraffe Incubator Carestation | |||
| CS1 | Discussion of Differences | ||
| 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 60601-1-2 | IEC 60601-1 | ||
| IEC 60601-2-19 | |||
| IEC 60601-1-2 | Identical | ||
| Humidity | Servo control accuracy: ± 10 % Ramp-up | ||
| time: 12 hours | Servo control accuracy: ± 10 % Ramp-up | ||
| time: 12 hours | Identical | ||
| System Performance | Temp Control accuracy: ± 1.0℃ (Control | ||
| Temp vs. Avg. Incubator Temp) | |||
| Variability: ± 0.5℃ (Incubator Temp vs. | |||
| Avg. Incubator Temp) Warm-up time: |