The OmniBed 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%).

Device Description

Giraffe OmniBed is an infant bed, which provides thermal support to infants who are unable to thermo-regulate based on their own physiology. The bed has two modes of operation, enclosed bed operation and open bed operation. In an open mode, the device functions as an incubator and in an enclosed mode it functions as a conventional, infant radiant warmer.

The Giraffe Uninterruptible Power Supply (UPS) is intended to provide a short term source of electrical power Giraffe OmniBed, thus aiding its intra hospital mobility. The Giraffe UPS does not change the indications for use, control mechanisms, operating principles, performance specifications, or other features of the Giraffe Omnibed.

The UPS serves as an extension to the Giraffe OmniBed by providing uninterrupted electric power to the device. The UPS comprises a medical grade battery and a shelf.

AI/ML Overview

Here's an analysis of the provided text regarding the K071175 510(k) submission, focusing on acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Battery life	15 minutes at 37°C and 70% RH at steady state
Battery recharge time	6 hours
Alarm decibel level reduction when UPS is added	Less than 1 dB reduction
Minimum lower level of alarm decibel (as per IEC 601-2-21 Amend 1 clause 102.1 and IEC-601-2-19 Amend 1 clause 102.3)	Within (or above) the minimum lower level of 50dB
Performance of OmniBed with UPS against product specifications and consensus standards	Established by bench testing (implicitly met, as no failures are reported)

2. Sample Size Used for the Test Set and Data Provenance

This submission does not involve a "test set" in the context of AI/ML or clinical efficacy studies with patient data. The performance claims are related to the functional characteristics of a new accessory (UPS) for an existing medical device (Giraffe OmniBed).

Sample Size: Not applicable in the traditional sense of patient or image data. The testing was conducted on the Giraffe OmniBed device with the addition of the UPS.
Data Provenance: The 'data' are results from bench testing performed on the physical device in a controlled environment. There is no information regarding the country of origin, but generally, such testing would be conducted at the manufacturer's facilities. The testing is prospective in the sense that it's designed to evaluate a new component.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth for clinical outcomes or image interpretation is not relevant for this type of device modification. The performance criteria are objective engineering specifications (e.g., battery life, decibel levels).

4. Adjudication Method for the Test Set

Not applicable. There are no subjective assessments or disagreements to adjudicate.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI assistance

Not applicable. This device is an infant incubator/warmer with an uninterruptible power supply, not an AI-powered diagnostic tool. Hence, no MRMC study was conducted or is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm, but a hardware accessory.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on objective engineering and performance specifications derived from:

Product specifications of the Giraffe OmniBed and the new UPS.
Recognized consensus standards (specifically mentioning IEC 601-2-21 Amend 1 clause 102.1 and IEC-601-2-19 Amend 1 clause 102.3 related to alarm decibel levels).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set mentioned or implied in this 510(k) submission.

Summary

{0}------------------------------------------------

K071175

JUL 1-7 2007

510(k) Summary

Submitter Information and Date Prepared

Agata Smieja GE Healthcare 8880 Gorman Road Laurel, MD 20723 USA

Phone: 410 888 5218 Mobile: 410 456 0329

Prepared July 16, 2007

Device Identification

Proprietary Name:
Common Name:

Ohmeda Medical Giraffe OmniBed Giraffe OmniBed

Predicate Device Information

Predicate Device	510(k) Number
Ohmeda Medical Giraffe OmniBed	K993407
Ohmeda Medical Giraffe OmniBed (with optionalServo Controlled Oxygen Delivery System)	K020543

Intended Use Statement

{1}------------------------------------------------

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%).

Functional Description and Technological Characteristics

Functional description of the new features added to the device

The UPS serves as an extension to the Giraffe OmniBed by providing uninterrupted electric power to the device. The UPS comprises a medical grade battery and a shelf.

Performance Data

The battery has a life of 15 minutes at 37° C and 70% RH at steady state. The recharge time is 6 hours.

The addition of the UPS to the Giraffe OmniBed reduces the decibel level of the alarm at 3 meters in front of the equipment by less than 1 dB, within the minimum lower level of 50dB as specified by IEC 601-2-21 Amend 1 clause 102.1 and IEC-601-2-19 Amend 1 clause 102.3.

{2}------------------------------------------------

3 8+3

Performance of the OmniBed with the addition of UPS has been established by bench testing against product specifications and recognized consensus standards.

Prepared by:
Date

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2007

Ms. Agata Smieja Global Compliance Leader Ohmeda Medical, a Division of Datex Ohmeda, a GE Healthcare Company 8880 Gorman Road Laurel, Maryland 20723

Re: K071175

Trade/Device Name: Giraffe OmniBed Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ Dated: June 28, 2007 Received: June 29, 2007

Dear Ms. Smieja:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{4}------------------------------------------------

Page 2 - Ms. Smieja

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K071175

Device Name:

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

S = 006

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: (

Regulation Number and Section

§ 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).