(37 days)
Not Found
No
The device uses a "predictive algorithm" based on the rate of temperature change, which is a deterministic calculation, not AI/ML. The description explicitly mentions it embodies the algorithm of a predicate device from 1994 (K943695), further suggesting it's not a modern AI/ML approach.
No
The device is a thermometer used for measuring temperature, not for treating any medical condition.
Yes
This device is a diagnostic device as it is used to make an accurate prediction of a patient's oral or axillary temperatures, which are metrics used in diagnosing febrile or afebrile conditions.
No
The device description clearly details hardware components such as a thermistor, probe, and resistive warming element, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The IT2CA1 is a thermometer that measures body temperature directly from the patient's oral cavity or axilla. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for measuring oral and axillary temperatures in patients. This is a direct measurement of a physiological parameter, not an in vitro test.
Therefore, the IT2CA1 falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IT2CA1 is used in a home use environment to make an accurate prediction of a febrile, or afebrile compliant patients oral temperatures after a measurement time (in the sublingual pocket) of only 4 seconds, and axillary temperatures in approximately 10 seconds in the Rapid mode. In Normal mode, the IT2CA1 provides accurate determination of actual, oral and axillary temperatures of compliant patients. The IT2CA1 is intended for lay or home use only; in a home use environment. It is not intended for use by the clinical professional, such as those utilized in the hospital, clinical, or mobile environment use.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The MicroLife IT2CA1 Digital 4-Sec Predictive Thermometer is the first predictive "Consumer Version" of the clinical thermistor thermometer for use in adults and children. Consumer thermometers currently available do not utilize the predictive technique, and acquire oral and axillary temperature in the standard mode, in which the measurement period is approximately one minute. The IT2CA1 consumer version 4-Sec predictive thermometer, embodies the predictive algorithm of the SureTemp® from Welch Allyn, San Diego, which provides a safe, simple, rapid and accurate method for determining clinical temperature using the traditional body sites and proven technology.
The IT2CA1 can be used in either "Rapid" (predictive) mode or "Normal" mode. In Normal mode, the IT2CA1 indicates the actual temperature sensed by the thermistor in the probe. In Normal mode, the measurement ends when temperature rise is
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
0
- II. 510(k) Summary [As described in CFR §807.92]
| Submitted by: | Micro Idea Instrument Co., LTD.
7F, NO.361, TA-NAN Road
Shih-lin District
Taipei, 11154 China (Taiwan) |
|----------------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gerhard Frick
Regulatory Manager ML Group |
| Date Prepared: | 12/16/98 |
| Proprietary Name: | Microlife IT2CA1 |
| Common Name: | Thermometer, Electronic Thermometer, Predictive
Thermometer |
| Classification Name: | Class II §880.2910 Clinical Electronic Thermometer
(To be manufactured and marketed for Consumer home
use) |
| Predicate Device: | SureTemp®
Welch Allyn, Inc.
510(k) Document Control Number K943695 |
Description of the Device:
The MicroLife IT2CA1 Digital 4-Sec Predictive Thermometer is the first predictive "Consumer Version" of the clinical thermistor thermometer for use in adults and children. Consumer thermometers currently available do not utilize the predictive technique, and acquire oral and axillary temperature in the standard mode, in which the measurement period is approximately one minute. The IT2CA1 consumer version 4-Sec predictive thermometer, embodies the predictive algorithm of the SureTemp® from Welch Allyn, San Diego, which provides a safe, simple, rapid and accurate method for determining clinical temperature using the traditional body sites and proven technology.
The IT2CA1 can be used in either "Rapid" (predictive) mode or "Normal" mode. In Normal mode, the IT2CA1 indicates the actual temperature sensed by the thermistor in the probe. In Normal mode, the measurement ends when temperature rise is 4-Sec. Predictive Instant Thermometer. ' Rapid Mode:
Normal Mode: Maximum Thermometer (measurement ends when temperature rise is 2 Normal Mode: 4-Sec. Predictive Instant Thermometer.
Monitor Mode: Continuous actual temperature readings sensed by the thermistor in the probe.
3
Microlife IT2CA1 Premarket Notification
4
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 1999
Microlide Systems AG C/O Mr. Gerhard Frick Regulatory Manager ML Group Micro Idea Instrument Co. Ltd. 7F, NO.361, TA-NAN Road Shih-lin District Taipei, 11154 China (TAIWAN)
K990168 Re : Microlife IT2CA1 Trade Name: Regulatory Class: II Product Code: FLL December 16, 1998 Dated: January 19, 1999 Received:
Dear Mr. Frick
We have reviewed your Section 510(k) notification of intent to we have reviewed your becomed above and we have determined the market the device refly equivalent (for the indications for device is substancially equices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Commerce prior comments, or to devices that have been reclassified in accordance with the provisions of the Federal You may, therefore, Food, Drug, and Cosmetic Act (Act). market the device, subject to the general controls provisions The general controls provisions of the Act 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 be subject to back adding your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ rederal negalation determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General che Good Handraosang Barant 820) and that, through periodic (MP inspections, the Food and Drug Administration (FDA) will orn InBpederens) Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. 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.
5
Page 2 - Mr. Frick
This letter will allow you to begin marketing your device as Inis lecter will arrow for market notification. The FDA described in your 510(x) promatence of your device to a legally marketed predicate device results in a classification for your marketed predicate device bur device to proceed to the market.
If you desire specific advice for your device on our labeling If you desire specific advice for fishionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compilance at (50) advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulacion encreted, "Mibidian" = " Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obtained from the Division. 01 638-2041 or (301) 443-6597 or at its internet address "http://www.fday.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
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VII. Indications for Use Statement
| 510(k) Number: | Unknown |
|---|---|
| Device Name: | Microlife IT2CA1 Electronic Intermittent Thermometer |
| Indications for use: | The IT2CA1 is used in a home use environment to make an accurate prediction of a febrile, or afebrile compliant patients oral temperatures after a measurement time (in the sublingual pocket) of only 4 seconds, and axillary temperatures in approximately 10 seconds in the Rapid mode. In Normal mode, the IT2CA1 provides accurate determination of actual, oral and axillary temperatures of compliant patients. The IT2CA1 is intended for lay or home use only; in a home use environment. It is not intended for use by the clinical professional, such as those utilized in the hospital, clinical, or mobile environment use. |
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-The-Counter Use Or
(Per 21 CFR §801.109)
Patricia Vincent
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number