Giraffe Incubator Carestation CS1

K152809 · Ohmeda Medical, A Division of Datex-Ohmeda, Inc. · FMZ · Dec 31, 2015 · General Hospital

Device Facts

• Record ID: K152809
• Device Name: Giraffe Incubator Carestation CS1
• Applicant: Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
• Product Code: FMZ · General Hospital
• Decision Date: Dec 31, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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%).

Device Story

The Giraffe Incubator Carestation is an enclosed infant bed providing thermal support to neonates; it circulates heated air within a closed compartment. The operator selects air or skin temperature control; the system regulates heat based on the selected control method. Access to the patient is via side portholes or doors. The device includes an optional weighing scale, UPS, and storage accessories. The Carestation updates the predicate Giraffe Incubator by replacing the monochrome display with a digital touchscreen UI, upgrading the power supply from 75W to 120W, and adding a visual indicator light and Hands Free Alarm Silencing (HFAS). It is used in clinical settings by healthcare providers to maintain infant temperature, potentially benefiting neonates by providing a stable, controlled environment.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including risk analysis (ISO 14971), design reviews (ISO 13485), module/system integration testing, software verification/validation (IEC 62304), performance testing (IEC 60601-2-19), safety/EMC testing (ES 60601-1, IEC 60601-1-2), and usability validation (IEC 62366).

Technological Characteristics

Enclosed infant incubator; servo-controlled heating and oxygen delivery (21-65%). Materials identical to predicate. Power supply upgraded to 120W. Features color LCD touchscreen UI via Single Board Computer (SBC). Connectivity includes mounting rails/accessories. Safety/EMC compliance per ES 60601-1 and IEC 60601-1-2. Software classified as moderate level of concern.

Indications for Use

Indicated for neonates unable to thermo-regulate based on their own physiology, requiring an enclosed temperature-controlled environment for thermal support. May include servo-controlled oxygen delivery (21-65%).

Regulatory Classification

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.

Predicate Devices

• Giraffe Incubator (K101778)
• Giraffe Incubator (K072512)
• Giraffe Incubator (K020547)
• Giraffe Incubator (K010222)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 31, 2015

Ohmeda Medical, A Division Of Datex-ohmeda, Inc. Mr. Kenny Bello Regulatory Affairs Leader, Product 8880 Gorman Road Laurel, Maryland 20723

Re: K152809

Trade/Device Name: Giraffe Incubator Carestation CS1 Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ Dated: November 25, 2015 Received: November 27, 2015

Dear Mr. Bello:

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. 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.

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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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Tina Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K152809

Device Name Giraffe Incubator Carestation CSI

#### Indications for Use (Describe)

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%).

| 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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# 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

| Date: | 23 DEC 2015 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Ohmeda Medical, a Division of Datex-Ohmeda, Inc., A General Electric<br>Company |
| | 8800 Gorman Road |
| | Laurel, MD 20723 |
| | Tel: [phone] |
| | Fax: [phone] |
| Primary Contact Person: | Kenny M Bello |
| | Regulatory Affairs Leader |
| | Ohmeda Medical, a Division of Datex-Ohmeda, Inc., A General Electric<br>Company |
| | Tel: [phone] |
| | Fax: [phone] |
| | |
| Secondary Contact Person: | Monica Morrison |
| | Regulatory Affairs Director |
| | Ohmeda Medical, a Division of Datex-Ohmeda, Inc., A General Electric<br>Company |
| Device Trade Name: | Giraffe Incubator Carestation CS1 |
| Common/Usual Name: | Incubator |
| Classification Names: | Incubator, Neonatal: (880.5400) |
| Regulatory Class | II |
| Product Code: | FMZ |
| Predicate Device(s): | Giraffe Incubator; K101778, K072512, K020547, K010222 |
| Device Description: | The Giraffe Incubator Carestation is an updated version of the cleared<br>predicate Giraffe Incubator. The Giraffe Incubator Carestation is an<br>enclosed infant bed, which provides thermal support for infants who are<br>unable to provide for their own heat requirements. The device maintains<br>the infant's temperature by circulating heated air within the closed bed<br>compartment. The operator may select either the air or skin temperature<br>control method. Depending on the control method selected, heat is<br>regulated based on either the air temperature or the infant's skin |
| | temperature compared to the operator selected control temperature.<br>Physical access to the patient is obtained through the side portholes or<br>by opening one of the side doors. The Giraffe Incubator Carestation<br>incorporates an optional weighing scale, Uninterruptible Power Supply<br>(UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage<br>drawers. |
| Description of Device<br>Modification | The proposed modification of the Giraffe Incubator is referred to as the<br>Giraffe Incubator Carestation. |
| | The Giraffe Incubator Carestation updates the graphical monochrome<br>display user interface (UI) on the predicate to a digital touchscreen UI,<br>with the required software changes to support the new format and<br>layout. The main system control software was not changed; however the<br>software for the UI was updated because of the UI format change. The<br>modified Giraffe Incubator Carestation maintains the predicate Giraffe<br>Incubator functionality, performance, and clinical workflows. The<br>changes also include a modified device visual indicator light and the<br>capability for Hands Free Alarm Silencing (HFAS). |
| | Other modifications being made for the Giraffe Incubator Carestation<br>include upgrading the power supply from 75W to 120W to support the<br>increased power requirements of the touchscreen and associated<br>electronics. |
| | There is no change in the indications for use or intended use of the<br>system. There are no changes to the patient contacting materials of the<br>device, and they remain identical to the predicate. The changes made do<br>not affect the function, performance, safety, or clinical use of the device. |
| Indication for Use: | The Giraffe Incubator Carestation is an Infant Incubator. Incubators<br>provide heat in a controlled manner to neonates who are unable to<br>thermo-regulate based on their own physiology. They achieve this by<br>providing an enclosed temperature controlled environment to the infant.<br>This device may incorporate a Servo Controlled Oxygen Delivery<br>System. This is indicated to provide a stable oxygen concentration<br>within the infant compartment at the value set by the operator (21-65%). |
| Device Modification<br>Technology: | The Giraffe Incubator Carestation employs the same fundamental<br>scientific technology as its predicate devices. |
| | The Giraffe Incubator Carestation replaces the Graphic Display of the<br>current Giraffe Incubator (GINC) with a new design based on a Single<br>Board Computer (SBC), color LCD, and touch screen. The Graphical<br>User Interface (GUI) incorporates graphical elements that are<br>compatible with current Giraffe functionality and workflow. The<br>information displayed to the user and the device functionality/features<br>are equivalent, with a different layout and touch screen functionality. |
| | The existing 75W power supply was replaced with a 120W part because<br>the new interface have a higher power budget than the predicate unit's |

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graphical monochrome display interface.

The Giraffe Incubator Carestation also introduces an updated device Indicator light and Hands Free Alarm Silence (HFAS) capability.

Determination of Substantial Equivalence and performance Data:

## Summary of Non-Clinical Tests:

The Giraffe Incubator Carestation is an updated version of the cleared predicate Giraffe Incubator; K101778, K072512, K020547, K010222. It complies with voluntary standards and the following quality assurance measures were applied to the development of the system:

- Risk Analysis (ISO 14971)
- Design Reviews (OSR, ISO 13485)
- Testing on unit level (Module verification)
- · Integration testing (System verification)
- Software testing (Verification and Validation IEC 62304, "moderate" level of concern)
- Performance testing (Verification of performance specifications, including IEC 60601-2-19)
- " Safety and EMC testing (Verification ES 60601-1, IEC60601-1-2)
- Usability testing (Validation IEC 62366)

The testing performed to support these modifications was based on the risk assessment and design controls, and summary level data was provided in the 510(k) for the testing described above.

### Summary of Clinical Tests:

The subject of this premarket submission, Giraffe Incubator Carestation, did not require clinical studies to support substantial equivalence.

- Conclusion: GE Healthcare considers the Giraffe Incubator Carestation to be as safe, as effective, and the performance to be substantially equivalent to the predicate device.