ACCUTEMP-PROBE

K970686 · Kentec Medical, Inc. · FMT · Aug 25, 1997 · General Hospital

Device Facts

• Record ID: K970686
• Device Name: ACCUTEMP-PROBE
• Applicant: Kentec Medical, Inc.
• Product Code: FMT · General Hospital
• Decision Date: Aug 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5130
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Accutemp-Probe is a reusable skin temperature sensor for newborn and sick infants in clinical settings (incubators/warmers). Device consists of a thermistor tip taped to infant skin connected via wires to an incubator/warmer controller. Principle of operation: thermistor resistance changes with temperature; controller measures return current to compute temperature. In 'manual mode', nurse monitors temperature and adjusts heater manually. In 'skin temperature control mode', controller uses probe input to automatically adjust heater output to maintain pre-selected temperature. Benefits include automated thermal regulation for infants. Operated by clinical staff.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable thermistor-based temperature probe. Utilizes Steinhart-Hart equation for thermistor curve description. Features disc-type tip and heavy-duty wiring for durability. Connects to incubator/warmer controllers to provide analog resistance-based temperature feedback.

Indications for Use

Indicated for newborn and sick infants to monitor skin temperature or maintain thermal regulation in incubators and infant warmers.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Air Shields/Ohmeda (no 510(k) number provided)
• Kentec Medical disposable skin temperature sensors (K960080)

Submission Summary (Full Text)

{0}

X970686
Page 13

AUG 25 1997

SAFETY AND EFFECTIVENESS SUMMARY

Date: _________________________
By: _________________________
Page 1 of 2

*This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Company Name: Kentec Medical, Inc. Contact Person: Matt Wilken
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.

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.

2. 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.

3. 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}

Page 14

# SAFETY AND EFFECTIVENESS SUMMARY

4. Intended Use of the device

A. The diseases or conditions the device will diagnose, treat, prevent, cure, or 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.

5. Does the indication statement (4) differ from those of the predicate device?
check one: ☐ Differs (complete section 6)
☑ Does not differ (skip to section 7)

6. Explanation of why the differences are not critical to the intended use of the device and why the differences do not affect the safety or effectiveness of the device.

7. 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"

{2}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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

Re: K970686
Trade Name: Accutemp-Probe
Regulatory 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 of the Act. The general controls provisions 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 Regulations, 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 regulations.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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): K970686

Device Name: ACCUTEMP - PROBE

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) Director, Inc.

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K970686

Prescription Use ☑

(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)