The OmniBed is a combination of an infant incubator ("incubator") and an infant radiant warmer ("warmer"). Incubators and warmers provide heat in a controlled manner to neonates who arc 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.

Device Description

The Ohmeda Medical 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 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.

This bed can be changed from either mode to the other by the activation of a foot or hand operated switch. The hood canopy will automatically open or close creating either an open or enclosed bed respectively. It should be noted that the device can be operated as conventional incubator or as a conventional infant radiant warmer, but both modes of operation cannot be active at the same time.

AI/ML Overview

The provided text describes the Ohmeda Medical OmniBed, a combination infant incubator and radiant warmer, and its 510(k) submission to the FDA. However, the document does not contain specific acceptance criteria, performance data in a quantitative format, or details of a study designed to prove the device meets such criteria.

The submission focuses on establishing substantial equivalence to predicate devices and describes the device's technological characteristics and indications for use. It explicitly states:

"Since care of newborns in incubators and warmers 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."

Therefore, I cannot populate the table or answer most of your specific questions as the information is not present in the provided text.

Here's what I can extract and state based on the document:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in quantitative terms.
- Reported Device Performance: Not provided in quantitative terms. The document only generally states that "The product was subject to extensive bench testing, the software was validated."
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The document states "clinical or animal testing to demonstrate safety and effectiveness is not necessary," implying no formal clinical test set was used for this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no external "test set" with ground truth was used for a clinical study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no external "test set" with ground truth was used for a clinical study.
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. The device is a medical apparatus (incubator/warmer), not an AI-assisted diagnostic tool for "human readers."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a medical apparatus (incubator/warmer), not an AI algorithm. Its performance is inherent in its electromechanical function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a clinical performance study. The "ground truth" for this device's function would be its ability to maintain a set temperature within specified tolerances, alarms functioning correctly, etc., which would be verified during bench testing.
The sample size for the training set: Not applicable. The device is a physical medical apparatus, not a machine learning model that requires a training set of data.
How the ground truth for the training set was established: Not applicable.

Summary of available information regarding performance:

Type of Testing: "extensive bench testing" and software validation.
Rationale for absence of clinical/animal testing: "care of newborns in incubators and warmers is a well established clinical practice, Ohmeda submits that clinical or animal testing to demonstrate safety and effectiveness is not necessary."
Compliance: "requirements of 21 CFR 820, Subpart C -- Design Controls -- were satisfied."

Essentially, the basis for clearance here is substantial equivalence to existing, legally marketed devices (Ohmeda Ohio Care Plus Incubator, Ohmeda Ohio Infant Warmer System, Ohmeda Ohio Intensive Care Incubator) combined with internal bench testing and software validation, rather than a prospective clinical study with defined acceptance criteria and performance metrics.

Summary

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

Ohmeda Medical OmniBed

510(k) Summary

Submitter Information

Alberto F. Profumo, RAC 9065 Guilford Road Columbia, MD 21046-1801 Tel. (410) 381- 4004 Summary prepared on September 30, 1999

Device Name(s)

Classification Names:

Neonatal Incubator .
. Infant Radiant Warmer

Common Names:

Incubator .
- Infant Radiant Warmer .

Proprietary Name:

Ohmeda Medical OmniBed .

Predicate Device Information

The OmniBed is substantially equivalent to the following, legally marketed products:

Ohmeda Ohio Care Plus Incubator (all models) .
Ohmeda Ohio Infant Warmer System (all models) ●
Ohmeda Ohio Intensive Care Incubator .

Indications for Use

The OmniBed is a combination of an infant incubator ("incubator") and an infant radiant warmer")

Incubators and warmers provide heat n a controlled manner to neonates who are unable to thermoregulate 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. Most incubators and warmers can be used in two operating modes:

Air Control: The clinician sets the appropriate air temperature (in an incubator) or the appropriate heat 1. output (in a warmer) for maintaining the desired patient temperature. These parameters are initially selected based on the clinician's training and experience, and then are adjusted based on the patients' needs and clinical status.
510(k) Summary Page 1 of 3

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

1. Patient Control: The clinician sets the desired patient temperature probe senses the patient temperature and feeds this information to the controller of the incubator. The controller then adjusts the heater output to maintain the patient temperature at the set value. These adjustments to the heater output are made in such a way to gradually change the patient's temperature while minimizing overshooting and patient stress.
  Incubators and warmers have alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient's temperature from the set value.

Incubators and warmers may incorporate other features such as tilting of the bed, oxygen supply, and data output to remote monitors or nurse call systems. Incubators may provide humidification of the enclosed infant environment.

The device can be operated as conventional incubator or as a conventional infant radiant warmer, but both modes of operation cannot be active at the same time.

Product Description

Assessment of Technological Characteristics

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

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

Performance Data

Since care of newborns in incubators and warmers 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 OmniBed is not intended to be sterilized. Cleaning and disinfection instructions can be found in the Operations and Maintenance Manual.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 5 2000

Mr. Alberto F. Profumo, R.A.C. Director, Product Assurance Ohmeda Medical 9065 Guilford Road Columbia, MD 21046-1801

K993407 Re : Ohmeda Medical OmniBed Trade Name: Class : II Product Code: FMZ September 30, 1999 Dated: Received: October 8, 1999

Dear Mr. Profumo:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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

Page 2 - Mr. Profumo

the Federal Register. Please note: this response to your premarket notification submission does not affect any premailor you might have under sections 531 through 542 of obligation you mages under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asborizon in formalence of your device to a legally marketed predicate device results in a classification for your marice 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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

510(k) Number (if known):

Device Name: OmniBed

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

U Prescription Use _ (Per 21 CFR 801.109)

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

Valeria Cucchi

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

510(k) Number

** TOTAL PAGE.02 **

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).