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 ther 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, temperatures 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 uternal environment. 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 Description

The Ohmeda Medical Giraffe OmniBed is an infant bed which provides thermal support for infants who are unable to provide for their own heat requirements. This bed has two modes of operation, enclosed bed operation and open bed operation.

In the enclosed bed mode of operation, the bed functions as an incubator, maintaining the infant's temperature by circulating heated air within the enclosed 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. In the enclosed bed mode, humidity and oxygen may also be increased.

In the open bed mode, this bed operates like a convention open, radiantly heated infant bed. Radiant heat from an infrared heat source is focused on to the bed to warm the patient. The operator may select either the heater power or skin temperature control method. Depending on the control method selected, the heater is either regulated at the operator selected power level or the heater output is modulated to maintain the patient's temperature at the value selected by the operator.

The optional Giraffe Servo Controlled Oxygen System is a fully integrated option available on the Giraffe OmniBed. The Servo Controlled Oxygen System is capable of oxygenating the entire infant compartment at oxygen concentrations of 21-65% by volume. The device uses fuel cell type sensors that generate specific voltages depending on the oxygen concentrations they contact. The microprocessor stores the sensor output and compares it with the value corresponding to the concentration set by the operator. The valves that supply oxygen to the infant compartment are opened and closed as necessary to maintain the oxygen concentration at the set value. Fluctuations in fuel cell performance due to temperature and humidity are compensated for by the microprocessor.

AI/ML Overview

The provided document is a 510(k) summary for the Ohmeda Medical Giraffe® OmniBed™. It describes the device's function, indications for use, and a comparison to predicate devices. However, it explicitly states that no clinical or animal testing was deemed necessary to demonstrate safety and effectiveness for this device. Instead, the submission relies on "extensive bench testing" and software validation.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance (especially those related to clinical studies, human readers, ground truth establishment, and sample sizes for clinical test/training sets) cannot be extracted from this document, as such a study was not conducted or submitted.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance for Ohmeda Medical Giraffe® OmniBed™

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, specific quantitative acceptance criteria or a direct comparison table for performance from a clinical study are not available. The document states: "Since care of newborns in incubators and infant radiant warmers, with or without supplemental oxygen is a well established clinical practice. Ohmeda submits that clinical or animal testing to demonstrate safety and effectiveness is not necessary."

The performance is implicitly understood to meet the functional requirements for an incubator and warmer, including:

Providing thermal support for infants.
Operating in enclosed (incubator) and open (warmer) modes.
Maintaining infant temperature via air or skin temperature control.
Adjusting humidity and oxygen in enclosed mode.
Providing stable oxygen concentration (21-65%) with the optional Servo Controlled Oxygen System.

No quantitative performance metrics (e.g., accuracy of temperature control to within X degrees, stability of oxygen concentration to within Y%) are reported in this 510(k) summary.

2. Sample size used for the test set and the data provenance

Not applicable. No clinical or animal test set was used for a study demonstrating safety and effectiveness. The document refers to "extensive bench testing," which implies laboratory-based tests, but no sample sizes for these tests are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set requiring expert-established ground truth was reported.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication was reported.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical apparatus (incubator/warmer), not an AI-assisted diagnostic or interpretive tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not directly applicable in the sense of an "algorithm" for diagnosis or interpretation. The device itself is the "standalone" entity that performs its functions (heating, oxygen control). Its performance was assessed through "extensive bench testing" and "software validation," rather than a clinical trial.

7. The type of ground truth used

For the "extensive bench testing" and "software validation," the ground truth would have been established by engineering specifications, calibration standards, and validated measurement equipment. For example, for temperature control, the "ground truth" would be the actual temperature measured by precise instruments, compared against the device's set and reported temperatures. For oxygen concentration, it would involve calibrated gas analyzers.

8. The sample size for the training set

Not applicable. This device is hardware with software control, not a machine learning model that requires a training set in the conventional sense. Software validation would involve testing against various inputs and scenarios to ensure correct operation according to specifications.

9. How the ground truth for the training set was established

Not applicable. As above, no training set for a machine learning model was used. The "ground truth" for software validation would be the expected output and behavior based on the software design specifications and functional requirements.

Summary

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MAY 0 9 2002

K020543

Ohmeda Medical Giraffe® OmniBed™ 510(k) Summary

Submitter Information

Alberto F. Profumo, RAC 8880 Gorman Road Laurel, MD 21046-1801 Tel. (410) 888-5104 Summary prepared on 2/12/2002

Device Name(s)

Classification Name:

Neonatal Incubator .
Common Name:
Incubator .
Proprietary Name:
Ohmeda Medical Giraffe" OmniBed with Optional Servo Control Oxygen System .

Predicate Device Information

The Giraffe OmniBed is substantially equivalent to the following Class II devices:

Device	Last 510(k)Number
Ohmeda Medical Giraffe OmniBed (original)	K993407
Drager Incubator 8000 IC	K954204
Isolette Infant Incubator Model C2HS	K001242

Product Description

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Indications for Use

Assessment of Technological Characteristics

The technological characteristics of the Giraffe Incubator are similar to those of predicate devices and do not raise new safety or effectiveness issues.

Performance Data

Since care of newborns in incubators and infant radiant warmers, with or without supplemental oxygen is a well established clinical practice. Ohmeda submits that clinical or animal testing to demonstrate safety and effectiveness is not necessary. The product was subject to extensive bench testing, the software was validated, and, to the best of Ohmeda Medical's knowledge, the requirements of 21 CFR 820, Subpart C -Design Controls - were satisfied.

Sterilization Information

The Giraffe" Incubator is not intended to be sterilized. Cleaning and disinfection instructions can be found in the Operations and Maintenance Manual.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem with three stylized wavy lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 9 2002

Mr. Alberto F. Profumo Director, Product Assurance Ohmeda Medical 8880 Gorman Road Laural . Maryland 20723

Re: K020543

Trade/Device Name: Ohmeda Medical Giraffe OmniBed Regulation Number: 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ and FMT Dated: February 11, 2002 Received: February 19, 2002

Dear Mr. Profumo:

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.

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.

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Page 2 - Mr. Alberto F. Profumo

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runne

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): 11020543

Device Name: Ohmeda Medical OmniBed

Indications for Use:

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, temperatures 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 a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

Patrice Cucenbe

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CDR 801.109)

Over-The Counter Use (Optional Format 1-2-96)

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).