Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. 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 can be used in two operating modes:

Air Control: The clinician sets the appropriate air temperature for maintaining the desired patient temperature. The air temperature is initially selected based on the clinician's training and experience and then is adjusted based on the patients needs and clinical status.
Patient Control: The clinician sets the desired patient temperature. A skin 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 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 may incorporate other features, such as humidification of the infant environment, tilting of the bed, oxygen supply, and data output to remote monitors or nurse call systems.

Device Description

The modified Care Plus Incubator is substantially equivalent to the currently marketed Care Plus Incubator.
The modifications which are the subject of this submission are summarized below:
a) Created two new models -- Care Plus 1000/2000 modified as follows:
i) The front control switch panel has been simplified to contain nonlanguage specific symbols with a legend located above the front panel which explain the meaning of these symbols.
ii) Twenty-three labels affixed to the current Care Plus have been consolidated into five labels.
iii) The tilt mechanism has been simplified to provide two (0° and 10°) rather than three (0°, 3°, and 6°) tilt positions. Continuous tilt is not an available option for these models
iv) The hood assembly (including the portholes, front access door, and inner walls) have been partially modified to improve access to the infant and reduce cost.
v) The refresher instructions located on the unit have been eliminated (a complete set of instructions continues to be provided in the Operation and Maintenance Manual), the refresher instructions continue to be provided with the Care Plus 3000 and 4000.
vi) The passive humidifier, standard in the Care Plus 3000, has been made an optional feature in these models. The servo-controlled humidifier, standard in the Care Plus 4000 is not an available option for these models
vii) The material of the optional humidifier tray has been changed from Polysulfone to polypropylene.
viii)The Care Plus 1000 can be operated in one mode (air control) only rather than in the two modes (air control and patient control) available in the other models.
b) Modified the printed circuit boards included in all models (1000, 2000, 3000, and 4000) to incorporate surface mount technology rather than the current through hole technology.
c) An optional, larger hood is available for Care Plus 3000 and 4000.

AI/ML Overview

The provided text describes modifications to an infant incubator (Ohmeda - Ohio® Care Plus® Incubator) for a 510(k) submission. It explicitly states that clinical or animal testing to demonstrate safety and effectiveness was not necessary because the modifications did not change how treatment was administered and the care of newborns in incubators is a well-established clinical practice.

Therefore, the following information, typically associated with a medical device algorithm's performance study, is not available from the provided text:

A table of acceptance criteria and reported device performance (for an algorithm)
Sample sizes for test sets or training sets
Data provenance (country of origin, retrospective/prospective)
Number and qualifications of experts for ground truth
Adjudication methods
MRMC comparative effectiveness studies or effect sizes
Standalone algorithm performance
Types of ground truth
How ground truth for training data was established

Instead, the text indicates that the device's acceptance was based on:

Bench testing: Used to verify the design changes.
User validation: Used to verify the labeling changes.
Substantial equivalence: The primary mechanism for clearance, arguing that the modified device is substantially equivalent to a previously marketed device, as the technological changes (Surface Mount Technology PCBs) are mature and do not raise new safety or effectiveness concerns.

Summary of Acceptance and Performance Evidence Based on Provided Text:

Acceptance Criteria (Implicit for 510(k))	Reported Device Performance/Verification Method
Safety and Effectiveness of Modified Design (simplified control panel, tilt, hood, etc.)	Verified by Bench Testing: The design changes were assessed on the bench to ensure they met specifications and did not introduce new hazards or compromise existing functionality. The submission posits that these modifications "do not change the way in which treatment is being administered."
Clarity and Accuracy of Labeling (non-language specific symbols, consolidated labels)	User Validated: The changes to the device's labeling were reviewed and validated by users to ensure clarity and correct interpretation of the new symbols and consolidated information.
Safety and Effectiveness of Technological Change (SMT PCBs)	Substantial Equivalence Argument: The use of Surface Mount Technology (SMT) was argued to be a "very mature technology, widely used in most computer and other electronic equipment manufactured today" and thus "does not raise new issues of safety or effectiveness." This was accepted by the FDA for clearance.

Study Details (Not Applicable/Information Not Provided in Text):

Sample size for test set and data provenance: Not applicable as no clinical or animal testing was performed. Design changes verified by bench testing, labeling by user validation.
Number of experts and qualifications: Not applicable.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. No human readers or AI involved in the performance assessment for this device submission.
Standalone algorithm performance: Not applicable. This is a physical medical device (incubator), not an AI algorithm.
Type of ground truth: Not applicable. Bench testing and user validation do not rely on "ground truth" in the same way an AI algorithm test does (e.g., expert consensus, pathology).
Sample size for training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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

Ohmeda - Ohio® Care Plus® Incubator (modified) 510(k) Summary

Predicate Device Information 1.

1994

K974349
Feb. 12, 1998

The modified Care Plus Incubator is substantially equivalent to the currently marketed Care Plus Incubator.

1. Intended Use Statement
  Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. 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 can be used in two operating modes:
1. Air Control: The clinician sets the appropriate air temperature for maintaining the desired patient temperature. The air temperature is initially selected based on the clinician's training and experience and then is adjusted based on the patients needs and clinical status.
Patient Control: The clinician sets the desired patient temperature. A skin 2. 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 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 may incorporate other features, such as humidification of the infant environment, tilting of the bed, oxygen supply, and data output to remote monitors or nurse call systems.

3. Description of the Modifications

The modifications which are the subject of this submission are summarized below:

a) Created two new models -- Care Plus 1000/2000 modified as follows:
- i) The front control switch panel has been simplified to contain nonlanguage specific symbols with a legend located above the front panel which explain the meaning of these symbols.
- ii) Twenty-three labels affixed to the current Care Plus have been consolidated into five labels.
- iii) The tilt mechanism has been simplified to provide two (0° and 10°) rather than three (0°, 3°, and 6°) tilt positions. Continuous tilt is not an available option for these models

6h8

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

iv) The hood assembly (including the portholes, front access door, and inner walls) have been partially modified to improve access to the infant and reduce cost.
v) The refresher instructions located on the unit have been eliminated (a complete set of instructions continues to be provided in the Operation and Maintenance Manual), the refresher instructions continue to be provided with the Care Plus 3000 and 4000.
vi) The passive humidifier, standard in the Care Plus 3000, has been made an optional feature in these models. The servo-controlled humidifier, standard in the Care Plus 4000 is not an available option for these models
vii) The material of the optional humidifier tray has been changed from Polysulfone to polypropylene.
viii)The Care Plus 1000 can be operated in one mode (air control) only rather than in the two modes (air control and patient control) available in the other models.
b) Modified the printed circuit boards included in all models (1000, 2000, 3000, and 4000) to incorporate surface mount technology rather than the current through hole technology.
c) An optional, larger hood is available for Care Plus 3000 and 4000.

Assessment of Technological Characteristics 4.

The only change in the technological characteristics of the device is the use of Surface Mount Technology (SMT) printed circuit boards instead of through hole printed circuit boards. Ohmeda submits that this change does not raise new issues of safety or effectiveness because SMT is a very mature technology, widely used in most computer and other electronic equipment manufactured today. In fact, the currently used technology (through hole printed circuit boards) is rapidly becoming obsolete and the availability of components for this technology is decreasing as time goes by.

1. Performance Data
  Since (1) care of newborns in incubators is a well established clinical practice and (2) the modifications which are the subject of this submission do not change the way in which treatment is being administered, Ohmeda submits that clinical or animal testing to demonstrate safety and effectiveness is not necessary. The design changes were verified by bench testing and the labeling change was user validated.

bhg

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

Image /page/2/Picture/2 description: The image shows a logo with the words "DEPT OF HEALTH" vertically aligned on the left side. To the right of the text is a circular emblem. Above the emblem are three curved lines that resemble a stylized graphic element.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

FEB 12 1998

Re: K974349 Ohmeda-Ohio Care Plus Incubator Trade Name: Requlatory Class: II Product Code: FMZ Dated: November 10, 1997 Received: November 19, 1997

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, qood 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. ਉ substantially equivalent determination assumes compliance with- ..... the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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

Page 2 - Mr. Profumo

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (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.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ultehrich

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

Enclosure

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

510(k) Number (if known):

Device Name: Ohio® Care Plus® Incubator

Indications For Use:

Air Control: The clinician sets the appropriate air temperature for maintaining the desired patient 】. temperature. The air temperature is initially selected based on the clinician's training and experience and then is adjusted based on the patients needs and clinical status.
Patient Control: The clinician sets the desired patient temperature. A skin temperature probe 2. 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 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 may incorporate other features, such as humidification of the infant environment, tilting of the bed, oxygen supply, and data output to remote monitors or nurse call systems.

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

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

510(k) Number _

Prescription Use (Per 21 CFR 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).