(181 days)
No
The description details a standard feedback control loop based on a thermistor and the Steinhart-Hart equation, which is a deterministic, non-AI/ML method for temperature sensing and control. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML.
No
The device described is a skin temperature probe used with incubators and infant warmers. While it plays a role in temperature control, it does not directly provide therapy; rather, it monitors a parameter in conjunction with a therapeutic device (the warmer/incubator).
No
This device is a temperature control system for infant incubators and warmers. While it monitors skin temperature, its primary function is to regulate the heater output to maintain a pre-selected temperature for warming, not to diagnose a medical condition.
No
The device description explicitly details hardware components like a thermistor tip, wires, and a plug, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: This device is a skin temperature probe used to measure the surface temperature of an infant's skin. It does not analyze any bodily fluids or tissues.
- Intended Use: The intended use is to monitor or control the temperature of an infant using an incubator or warmer. This is a direct physiological measurement, not an in vitro analysis.
The device is a sensor that interacts directly with the patient's skin to measure a physical parameter (temperature). This falls under the category of a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
There are two modes of operation for temperature control in incubators and infant warmers where these products are used, air or manual mode and baby or skin temperature control mode.
When operating in the air or manual mode, a skin temperature probe may be used just to monitor the patient's skin temperature. Here, a nurse would control the heater output manually.
When operating in the "Baby" or "Skin Temperature Control Mode" the warming units controller utilizes the skin temperature probe, connected between the controller and the infant, to automatically adjust the heater output of the unit to maintain a pre-selected skin temperature.
Product codes
FMT
Device Description
-
- Brief explanation of how the device functions.
There are two modes of operation for temperature control in incubators and infant warmers where these products are used, air or manual mode and baby or skin temperature control mode.
- Brief explanation of how the device functions.
When operating in the air or manual mode, the skin temperature probe may be used just to monitor the patient's skin temperature. Here, a nurse would control the heater output manually.
When operating in the "Baby" or "Skin Temperature Control Mode" the warming units controller utilizes the skin temperature to automatically adjust the heater output of the unit to maintain a pre-selected skin temperature.
-
- Basic scientific concepts that form the basis for the device.
The thermistor tip which gets taped to the infant is made of a material whose resistance to electrical flow changes when the tip materials temperature changes. Two small wires run from the plug end at the incubator or warmer to the thermistor tip. One wire to each side.
- Basic scientific concepts that form the basis for the device.
A very small current goes to the tip and depending on how warm the tip is has to do with how much current returns via the other wire to the plug. That current is computed into temperatures.
- Significant physical and performance characteristics of the device. (Ex. device design and physical properties.)
These products fit the Steinhart-Hart equation which is the standard for describing thermistor curves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Newborn and sick infants.
Intended User / Care Setting
Nurse, hospital setting (implied by incubator/warmer use)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Air Shields/Ohmeda, K960080
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5130 Infant radiant warmer.
(a)
Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.(b)
Classification. Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.
0
K970i86
Page 13
AUG 25 1997
| SAFETY AND EFFECTIVENESS SUMMARY | ||
|---|---|---|
| -- | ---------------------------------- | -- |
Date: Bv: l of 2 Page
*This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Contact Person: Matt Wilken Company Name:_______________________________________________________________________________________________________________________________________________________________ Kentec Medical, Inc.
Common or usual name of device Reusable Temperature Sensor (probe)
Trade or proprietary name Accutemp-Probe
Classification name (if known) Class II as required by 21 CFR.94
Predicate device(s) to which substantial equivalence is being claimed Air Shields/Ohmeda
Device Description
-
- Brief explanation of how the device functions.
There are two modes of operation for temperature control in incubators and infant warmers where these products are used, air or manual mode and baby or skin temperature control mode.
- Brief explanation of how the device functions.
When operating in the air or manual mode, the skin temperature probe may be used just to monitor the patient's skin temperature. Here, a nurse would control the heater output manually.
When operating in the "Baby" or "Skin Temperature Control Mode" the warming units controller utilizes the skin temperature to automatically adjust the heater output of the unit to maintain a pre-selected skin temperature.
-
- Basic scientific concepts that form the basis for the device.
The thermistor tip which gets taped to the infant is made of a material whose resistance to electrical flow changes when the tip materials temperature changes. Two small wires run from the plug end at the incubator or warmer to the thermistor tip. One wire to each side.
- Basic scientific concepts that form the basis for the device.
A very small current goes to the tip and depending on how warm the tip is has to do with how much current returns via the other wire to the plug. That current is computed into temperatures.
- Significant physical and performance characteristics of the device. (Ex. device design and physical properties.)
These products fit the Steinhart-Hart equation which is the standard for describing thermistor curves.
1
SAFETY AND EFFECTIVENESS SUMMARY
Page 2 of 2
-
- Intended Use of the device
- The diseases or conditions the device will diagnose, treat, prevent, cure, or A. mitigate. This product is used in the maintaining of normal thermal temperatures in newborn and sick infants.
- B. The patient population for which the device is intended. Newborn and sick infants.
-
- Does the indication statement (4) differ from those of the predicate device? Differs (complete section 6) check one: X_ Does not differ (skip to section 7)
-
Explanation of why the differences are not critical to the intended use of the device and 6. why the differences do not affect the safety or effectiveness of the device.
-
- The technological characteristics of the device compared to the predicate product.
None- other than, possibly, the color.
- The technological characteristics of the device compared to the predicate product.
S.S.I. manufacturers predicate product.
[Comparison Chart]
Pictures and Thermistor Values are in Attachment "B"
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Matt Wilken Official Correspondent Kentec Medical, Incorporated 17871 Fitch Irvine, California 92714
AUG 25 1997
K970686 Re: Accutemp-Probe Trade Name: Requlatory Class: II Product Code: FMT Dated: May 28, 1997 Received: May 30, 1997
Dear Mr. Wilken:
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 reguirements 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 requlations 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 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 Drug 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:
3
Page 2 - Mr. Wilken
this response to your premarket notification submission does not affect any obligation you might have under sections 531 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.gov/cdrh/dsmamain.html".
Sincerely yours,
Susan Juarez
Timothy A. Ulatowski 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: _________________________________________________________________________________________________________________________________________________________________
REUSABLE SKIN TEMPERATURE SENSORS
Indications For Use:
There are two modes of operation for temperature control in incubators and infant warmers where these products are used, air or manual mode and baby or skin temperature control mode.
When operating in the air or manual mode, a skin temperature probe may be used just to monitor the patient's skin temperature. Here, a nurse would control the heater output manually.
When operating in the "Baby" or "Skin Temperature Control Mode" the warming units controller utilizes the skin temperature probe, connected between the controller and the infant, to automatically adjust the heater output of the unit to maintain a pre-selected skin temperature.
This product looks like and has identical indications for use as the disposable products we now sell under 510(k) # 960080, issued May 1, 1996.
This product differs only in its durability. It uses heavier wire and a disc type tip (which primarily identifies it as a reusable unit.)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)их Сite
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use >> (Per 21 CFR 801.109) OR
Over-The-Counter Use ------