ACCUTEMP-PROBE by KENTEC MEDICAL, INC.

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.

Device Description

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, 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.

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.

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.

These products fit the Steinhart-Hart equation which is the standard for describing thermistor curves.

AI/ML Overview

The provided text outlines the safety and effectiveness summary for a Reusable Temperature SENSOR (probe) called "Accutemp-Probe". However, it is a 510(k) submission for substantial equivalence to a predicate device, not a study demonstrating performance against specific acceptance criteria.

The document claims substantial equivalence based on the device's technological characteristics and intended use being the same as the predicate device (Air Shields/Ohmeda). It does not present specific performance criteria or the results of a study designed to meet such criteria in the format requested.

Therefore, many of the requested sections regarding a study cannot be directly extracted from this document.

Here's a breakdown of what can be inferred or stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as a table of performance metrics with specific thresholds. The acceptance criteria for this submission appear to be demonstrating substantial equivalence to a predicate device, primarily based on the device functioning and intended use being identical, and fitting the Steinhart-Hart equation for thermistor curves.
Reported Device Performance:
- Functionality: "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. 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."
- Scientific Basis: "These products fit the Steinhart-Hart equation which is the standard for describing thermistor curves."
- Comparison to Predicate: "None [technological characteristics difference] – other than, possibly, the color." and "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.)"

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable. The document does not describe a performance study with a test set. This is a 510(k) premarket notification claiming substantial equivalence, not a clinical or performance validation study with a test set of data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set:

Not Applicable. No test set or adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is not described. The device is a temperature sensor, not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study:

Not Applicable. The device is a physical temperature sensor, not an algorithm. Its performance is based on its physical properties and adherence to established thermistor curve standards.

7. Type of Ground Truth Used:

Not Applicable. For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily the technological characteristics and intended use of the predicate device (Air Shields/Ohmeda) and adherence to a recognized scientific standard (Steinhart-Hart equation). No "expert consensus," "pathology," or "outcomes data" ground truth is mentioned in the context of a performance study.

8. Sample Size for the Training Set:

Not Applicable. The document does not describe a training set as this is not an AI/machine learning device. The design principles are based on established physics of thermistors.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. There is no training set mentioned.

Summary

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K970i86

Page 13

AUG 25 1997

	SAFETY AND EFFECTIVENESS SUMMARY
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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

1. 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.

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.

1. 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.

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.

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SAFETY AND EFFECTIVENESS SUMMARY

Page 2 of 2

1. 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.
1. 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.
1. The technological characteristics of the device compared to the predicate product.
  None- other than, possibly, the color.

S.S.I. manufacturers predicate product.

[Comparison Chart]

Pictures and Thermistor Values are in Attachment "B"

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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:

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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

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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.

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 ------

Regulation Number and Section

§ 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.