(85 days)
No
The document describes a standard incubator with basic control modes (air and patient control) and alarms. The modifications are related to physical design, user interface simplification, and manufacturing technology (surface mount technology). There is no mention of AI or ML in the intended use, device description, or performance studies. The control logic described is based on simple feedback loops (patient control mode) and manual clinician input (air control mode), which are not indicative of AI/ML.
Yes
The device is used to provide a controlled thermal environment for neonates who are unable to regulate their own body temperature, which is a therapeutic function.
No
Explanation: The device, an incubator, is designed to provide a controlled thermal environment for neonates and adjust temperature based on set values or patient feedback. It is a therapeutic device that manages the patient's environment, not a diagnostic one that identifies or measures a condition to make a diagnosis.
No
The device description clearly details modifications to physical components of an incubator, such as the control switch panel, labels, tilt mechanism, hood assembly, and printed circuit boards. These are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides a controlled thermal environment for neonates and facilitates their transition to the external environment. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description details the physical components and operational modes related to temperature control and environmental support for the infant. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a medical device used for patient care and support, specifically thermoregulation for neonates.
N/A
Intended Use / Indications for Use
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.
Product codes
FMZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonates
Intended User / Care Setting
Clinician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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.
-
- 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:
- Intended Use Statement
-
- 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.
-
- 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.
- Performance Data
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:
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 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)
OR
(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)